Trial Outcomes & Findings for Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support (NCT NCT03812614)

NCT ID: NCT03812614

Last Updated: 2025-02-13

Results Overview

Hemoglobin A1c (HbA1c, percent) was measured via finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by patients via home test kit. For analysis, HbA1c first was examined graphically to understand how it changed over time. Main analyses then were conducted using linear mixed-effects models, with 12-month HbA1c values included in the models to increase the power to estimate changes over the initial 6 months. Adjusted outcome and effect estimates at 6 months were derived from linear mixed models using linear contrasts. The model was fitted using all available time points (baseline, 6 months, and 12 months) from all 222 enrollees to make efficient use of the data. Including all time points allows the model to account for individual trajectories over time, thus increasing power to detect treatment effects and reducing bias that could arise from analyzing the 6-month time point in isolation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 444 participants
• Primary outcome timeframe: Baseline vs. 6 months
• Results posted on: 2025-02-13

Participant Flow

Patients were recruited from a Federally Qualified Health Center (FQHC) in the mid-western US that serves a low SES, primarily Spanish-speaking population. Enrollment took place from Sep. 2019 to Dec. 2022, with a several month pause between Mar. 2020 and Feb. 2021 when restrictions were placed on in-person research. Potential participants were identified via FQHC EHR or clinician referral, and recruited by letter and phone. Support Persons were identified by patients and recruited by phone.

No enrolled participants were excluded before being assigned to a study arm.

Participant milestones

Measure	FAM-ACT - Patients FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES - Patients The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.	FAM-ACT - Support Persons FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES - Support Persons The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, bu
Baseline STARTED	112	110	112	110
Baseline COMPLETED	112	110	112	110
Baseline NOT COMPLETED	0	0	0	0
Intervention STARTED	112	110	112	110
Intervention COMPLETED	104	103	94	22
Intervention NOT COMPLETED	8	7	18	88
6-month Follow-up STARTED	105	108	71	71
6-month Follow-up COMPLETED	82	88	59	63
6-month Follow-up NOT COMPLETED	23	20	12	8
12-month Follow-up STARTED	103	108	34	37
12-month Follow-up COMPLETED	85	91	29	35
12-month Follow-up NOT COMPLETED	18	17	5	2

Reasons for withdrawal

Measure	FAM-ACT - Patients FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES - Patients The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.	FAM-ACT - Support Persons FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES - Support Persons The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, bu
Intervention Withdrawal by Subject	7	2	7	2
Intervention Patient declined to participate in the introductory session intervention	1	5	11	86
6-month Follow-up We were prevented from collecting A1c data from many patients due to pandemic-related restrictions	23	20	0	0
6-month Follow-up Lost to Follow-up	0	0	12	8
12-month Follow-up Lost to Follow-up	18	17	5	2

Baseline Characteristics

The main outcome, change in A1c from baseline to 6 months, was assessed for patient participants only. SP participants were not included in the analysis.

Baseline characteristics by cohort

Measure	FAM-ACT-Patients n=112 Participants Patient and Support Person (dyad) will be included together as much as possible. The dyad will: 1. Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. 2. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.	I-DSMES-Patients n=110 Participants This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will: 1. Take part in a one-hour introductory session and review of patient's diabetes management risk assessment. 2. Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. I-DSMES: Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.	FAM-ACT-Support Persons n=112 Participants Patient and Support Person (dyad) will be included together as much as possible. The dyad will: 1. Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. 2. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.	I-DSMES-Support Persons n=110 Participants This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions.	Total n=444 Participants Total of all reporting groups
Age, Continuous	52.4 years STANDARD_DEVIATION 10.0 • n=112 Participants	52.8 years STANDARD_DEVIATION 10.3 • n=110 Participants	44.7 years STANDARD_DEVIATION 12.7 • n=112 Participants	46.0 years STANDARD_DEVIATION 14.2 • n=110 Participants	52.6 years STANDARD_DEVIATION 10.2 • n=444 Participants
Sex: Female, Male Female	72 Participants n=112 Participants	65 Participants n=110 Participants	82 Participants n=112 Participants	87 Participants n=110 Participants	306 Participants n=444 Participants
Sex: Female, Male Male	40 Participants n=112 Participants	45 Participants n=110 Participants	30 Participants n=112 Participants	23 Participants n=110 Participants	138 Participants n=444 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	101 Participants n=112 Participants	87 Participants n=110 Participants	101 Participants n=112 Participants	87 Participants n=110 Participants	376 Participants n=444 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=112 Participants	23 Participants n=110 Participants	11 Participants n=112 Participants	23 Participants n=110 Participants	68 Participants n=444 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=112 Participants	0 Participants n=110 Participants	0 Participants n=112 Participants	0 Participants n=110 Participants	0 Participants n=444 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=112 Participants	1 Participants n=110 Participants	3 Participants n=112 Participants	3 Participants n=110 Participants	10 Participants n=444 Participants
Race/Ethnicity, Customized Asian	0 Participants n=112 Participants	1 Participants n=110 Participants	0 Participants n=112 Participants	3 Participants n=110 Participants	4 Participants n=444 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=112 Participants	0 Participants n=110 Participants	0 Participants n=112 Participants	0 Participants n=110 Participants	0 Participants n=444 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=112 Participants	17 Participants n=110 Participants	9 Participants n=112 Participants	16 Participants n=110 Participants	50 Participants n=444 Participants
Race/Ethnicity, Customized White	8 Participants n=112 Participants	14 Participants n=110 Participants	16 Participants n=112 Participants	15 Participants n=110 Participants	53 Participants n=444 Participants
Race/Ethnicity, Customized More than one race	3 Participants n=112 Participants	0 Participants n=110 Participants	1 Participants n=112 Participants	0 Participants n=110 Participants	4 Participants n=444 Participants
Race/Ethnicity, Customized Other	90 Participants n=112 Participants	77 Participants n=110 Participants	83 Participants n=112 Participants	73 Participants n=110 Participants	323 Participants n=444 Participants
Hemoglobin A1c (A1c)	9.26 % STANDARD_DEVIATION 1.85 • n=112 Participants • The main outcome, change in A1c from baseline to 6 months, was assessed for patient participants only. SP participants were not included in the analysis.	9.14 % STANDARD_DEVIATION 1.66 • n=110 Participants • The main outcome, change in A1c from baseline to 6 months, was assessed for patient participants only. SP participants were not included in the analysis.	—	—	9.2 % STANDARD_DEVIATION 1.8 • n=222 Participants • The main outcome, change in A1c from baseline to 6 months, was assessed for patient participants only. SP participants were not included in the analysis.

PRIMARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete HbA1c data at both baseline and 6-months post-baseline.

Hemoglobin A1c (HbA1c, percent) was measured via finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by patients via home test kit. For analysis, HbA1c first was examined graphically to understand how it changed over time. Main analyses then were conducted using linear mixed-effects models, with 12-month HbA1c values included in the models to increase the power to estimate changes over the initial 6 months. Adjusted outcome and effect estimates at 6 months were derived from linear mixed models using linear contrasts. The model was fitted using all available time points (baseline, 6 months, and 12 months) from all 222 enrollees to make efficient use of the data. Including all time points allows the model to account for individual trajectories over time, thus increasing power to detect treatment effects and reducing bias that could arise from analyzing the 6-month time point in isolation.

Outcome measures

Measure	FAM-ACT n=82 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=88 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change From Baseline in Patient Glycemic Control at 6 Months	-0.43 percentage Interval -0.85 to 0.0	-0.97 percentage Interval -1.38 to -0.55

SECONDARY outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete HbA1c data at both baseline and 12-months post-baseline.

Hemoglobin A1c (HbA1c, percent) was measured through finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.

Outcome measures

Measure	FAM-ACT n=85 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=91 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change From Baseline in Patient Glycemic Control at 12 Months	-0.67 percentage Interval -1.14 to -0.2	-0.65 percentage Interval -1.11 to -0.19

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SBP data at both baseline and 6-months post-baseline.

SBP was measured using an electronic, upper arm blood pressure monitor.

Outcome measures

Measure	FAM-ACT n=82 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=86 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change From Baseline in Patient Systolic Blood Pressure at 6 Months	-0.85 mmHg Interval -4.33 to 2.63	0.66 mmHg Interval -2.78 to 4.1

SECONDARY outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SBP data at both baseline and 12-months post-baseline.

SBP was measured using an electronic, upper arm blood pressure monitor.

Outcome measures

Measure	FAM-ACT n=79 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=87 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change From Baseline in Patient Systolic Blood Pressure at 12 Months	2.69 mmHg Interval -0.98 to 6.35	-3.05 mmHg Interval -6.7 to 0.59

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete PAID-5 data at both baseline and 6-months post-baseline.

Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.

Outcome measures

Measure	FAM-ACT n=93 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=101 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change From Baseline in Patient Diabetes Distress at 6 Months	-2.68 score on a scale Interval -4.01 to -1.35	-2.40 score on a scale Interval -3.71 to -1.09

SECONDARY outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete PAID-5 data at both baseline and 12-months post-baseline.

Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.

Outcome measures

Measure	FAM-ACT n=84 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=96 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change From Baseline in Patient Diabetes Distress at 12 Months	-2.67 score on a scale Interval -3.94 to -1.39	-2.34 score on a scale Interval -3.59 to -1.1

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA diet data at both baseline and 6-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.

Outcome measures

Measure	FAM-ACT n=93 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=101 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy Eating	0.14 score on a scale Interval -0.24 to 0.51	0.37 score on a scale Interval 0.0 to 0.74

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA physical activity data at both baseline and 6-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.

Outcome measures

Measure	FAM-ACT n=93 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=101 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Diabetes Self-care Behaviors in Patient: Physical Activity	0.52 units on a scale Interval -0.14 to 1.17	0.70 units on a scale Interval 0.05 to 1.35

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 patient participants enrolled in the study. Ns represent the number of adult patients with type 2 diabetes who had complete adherence data for diabetes, blood pressure, and cholesterol medications, respectively, at both baseline and 6-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note that the Ns with data for these three measures are smaller than the Ns for diet and physical activity data. Differences are due to some patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications.

Outcome measures

Measure	FAM-ACT n=85 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=93 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Diabetes Self-care Behaviors in Patient: Medication Adherence Diabetes medication	0.12 units on a scale Interval -0.34 to 0.58	0.01 units on a scale Interval -0.43 to 0.45
Change in Diabetes Self-care Behaviors in Patient: Medication Adherence Blood pressure medication	0.05 units on a scale Interval -0.56 to 0.66	0.09 units on a scale Interval -0.64 to 0.81
Change in Diabetes Self-care Behaviors in Patient: Medication Adherence Cholesterol medication	0.01 units on a scale Interval -0.69 to 71.0	0.44 units on a scale Interval -0.32 to 1.2

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete self-efficacy data at both baseline and 6-months post-baseline.

Patient self-efficacy for managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.

Outcome measures

Measure	FAM-ACT n=93 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=101 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Self-efficacy of Patient	0.33 units on a scale Interval -0.05 to 0.71	0.34 units on a scale Interval -0.03 to 0.72

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete patient activation data at both baseline and 6-months post-baseline.

Patient activation was assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set of items. While the metric allows for a potential range of 0-100, the items included in the measure only covered the range from 40 (minimum) to 60 (maximum), not tapping what would be theoretically the lowest or highest ranges of the construct.

Outcome measures

Measure	FAM-ACT n=93 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=101 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Patient Activation in Patient	5.95 units on a scale Interval 1.08 to 10.82	3.02 units on a scale Interval -1.79 to 7.84

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete support satisfaction data at both baseline and 6-months post-baseline.

Patient satisfaction with support person (SP) support for diabetes was assessed with 2* items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses were rated on a 7-point scale ranging from 1, "strongly disagree" to 7 "strongly agree". Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction.

Outcome measures

Measure	FAM-ACT n=93 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=100 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Patient Perceived Overall Satisfaction With SP Support for Diabetes	0.38 units on a scale Interval -0.29 to 1.04	-0.37 units on a scale Interval -1.03 to 0.28

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete IOCQ data at both baseline and 6-months post-baseline.

Patient perception of support persons' (SP) supportive behaviors was assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 0 ("strongly disagree") to 6 ("strongly agree"), with non-supportive behavior items being reversed scored. Item responses were averaged to create a mean score with a possible range of 0 (low support) to 6 (high support).

Outcome measures

Measure	FAM-ACT n=93 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=101 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Patient Perception of SP Support: Supportive and Non-supportive Behaviors	0.22 units on a scale Interval -0.04 to 0.49	0.04 units on a scale Interval -0.22 to 0.3

SECONDARY outcome

Timeframe: Cross-sectional at 6 months

Population: All patient participants with complete impact of COVID on diabetes management data.

Impact of COVID on ability to manage Diabetes was assessed with a single closed-ended item: "In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?" The item is rated on a 5-point scale ranging from "much harder" to "much easier". Due to small numbers, the variable was collapsed to 3 categories for analysis: harder/much harder, no change, easier/much easier.

Outcome measures

Measure	FAM-ACT n=61 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=69 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Impact of COVID on Ability to Manage Diabetes Harder/much harder	6 Participants	4 Participants
Impact of COVID on Ability to Manage Diabetes No change	53 Participants	64 Participants
Impact of COVID on Ability to Manage Diabetes Easier/much easier	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 support persons enrolled in the study. Ns represent the number of support persons who had complete PAID-5 data at both baseline and 6-months post-baseline. See comments on Statistical Analysis 1 for additional detail.

Support person distress about the patient's diabetes was assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.

Outcome measures

Measure	FAM-ACT n=59 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=63 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Diabetes Distress in Support Person	-1.99 units on a scale Interval -3.35 to -0.63	-1.27 units on a scale Interval -2.67 to 0.12

SECONDARY outcome

Timeframe: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 support persons enrolled in the study. Ns represent the number of support persons who had complete self-efficacy data at both baseline and 6-months post-baseline. See comments on Statistical Analysis 1 for additional detail.

Support person self-efficacy for helping the patient with managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.

Outcome measures

Measure	FAM-ACT n=59 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=63 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Self-efficacy of Support Person	-0.27 units on a scale Interval -0.64 to 0.1	-0.02 units on a scale Interval -0.39 to 0.36

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA diet data at both baseline and 12-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.

Outcome measures

Measure	FAM-ACT n=84 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=96 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Diabetes Self-care Behaviors in Patient: Healthy Eating	-0.09 units on a scale Interval -0.45 to 0.27	0.41 units on a scale Interval 0.05 to 0.76

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA physical activity data at both baseline and 12-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.

Outcome measures

Measure	FAM-ACT n=84 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=96 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Diabetes Self-care Behaviors in Patient: Physical Activity	0.22 units on a scale Interval -0.41 to 0.85	0.56 units on a scale Interval -0.06 to 1.17

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete adherence data for diabetes, blood pressure, and cholesterol medication, respectively, at both baseline and 12-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note that the Ns with data for these three measures are smaller than the Ns for diet and physical activity data. Differences are due to patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications.

Outcome measures

Measure	FAM-ACT n=76 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=88 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Diabetes Self-care Behaviors in Patient: Medication Adherence Diabetes medications	0.01 units on a scale Interval -0.42 to 0.44	0.27 units on a scale Interval -0.16 to 0.69
Change in Diabetes Self-care Behaviors in Patient: Medication Adherence Blood pressure medications	0.04 units on a scale Interval -0.57 to 0.65	0.05 units on a scale Interval -0.6 to 0.7
Change in Diabetes Self-care Behaviors in Patient: Medication Adherence Cholesterol medications	-0.02 units on a scale Interval -0.72 to 0.68	0.39 units on a scale Interval -0.34 to 1.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete self-efficacy data at both baseline and 12-months post-baseline.

Patient self-efficacy for managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.

Outcome measures

Measure	FAM-ACT n=84 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=96 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Self-efficacy of Patient	0.09 units on a scale Interval -0.27 to 0.46	0.59 units on a scale Interval 0.23 to 0.94

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete patient activation data at both baseline and 12-months post-baseline.

Patient activation was assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set of items. While the metric allows for a potential range of 0-100, the items included in the measure only covered the range from 40 (minimum) to 60 (maximum), not tapping what would be theoretically the lowest or highest ranges of the construct.

Outcome measures

Measure	FAM-ACT n=84 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=96 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Patient Activation in Patient	3.18 units on a scale Interval -1.72 to 8.08	3.54 units on a scale Interval -1.24 to 8.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete support satisfaction data at both baseline and 12-months post-baseline.

Patient satisfaction with support person (SP) support for diabetes was assessed with 2* items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses were rated on a 7-point scale ranging from 1, "strongly disagree" to 7 "strongly agree". Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction.

Outcome measures

Measure	FAM-ACT n=82 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=95 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Patient Perceived Overall Satisfaction With Support Person Support for Diabetes	0.55 units on a scale Interval -0.09 to 1.19	-0.55 units on a scale Interval -1.17 to 0.07

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete IOCQ data at both baseline and 12-months post-baseline.

Patient perception of support persons' (SP) supportive behaviors was assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 0 ("strongly disagree") to 6 ("strongly agree"), with non-supportive behavior items being reversed scored. Item responses were averaged to create a mean score with a possible range of 0 (low support) to 6 (high support).

Outcome measures

Measure	FAM-ACT n=82 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=96 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Patient Perception of Support Person Support: Supportive and Non-supportive Behaviors	0.30 units on a scale Interval 0.05 to 0.56	-0.04 units on a scale Interval -0.29 to 0.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 support persons enrolled in the study. Ns represent the number of enrolled support persons who had complete PAID-5 data at both baseline and 12-months post-baseline. See comments on Statistical Analysis 1 for additional detail.

Support person distress about the patient's diabetes was assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.

Outcome measures

Measure	FAM-ACT n=29 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=35 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Diabetes Distress in Support Person	0.45 units on a scale Interval -1.99 to 2.9	-0.74 units on a scale Interval -3.07 to 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete self-efficacy data at both baseline and 12-months post-baseline.See comments on Statistical Analysis 1 for additional detail.

Support person self-efficacy for helping the patient with managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.

Outcome measures

Measure	FAM-ACT n=29 Participants FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals.	I-DSMES n=35 Participants The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information.
Change in Self-efficacy of Support Person	0.07 units on a scale Interval -0.57 to 0.7	-0.72 units on a scale Interval -1.32 to -0.11

Adverse Events

FAM-ACT-Patients

Serious events: 18 serious events

Other events: 38 other events

Deaths: 0 deaths

I-DSMES-Patients

Serious events: 20 serious events

Other events: 31 other events

Deaths: 0 deaths

FAM-ACT-Support Persons

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

I-DSMES-Support Persons

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	FAM-ACT-Patients n=112 participants at risk Patient and Support Person (dyad) will be included together as much as possible. The dyad will: 1. Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. 2. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.	I-DSMES-Patients n=110 participants at risk This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will: 1. Take part in a one-hour introductory session and review of patient's diabetes management risk assessment. 2. Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. I-DSMES: Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.	FAM-ACT-Support Persons n=112 participants at risk Patient and Support Person (dyad) will be included together as much as possible. The dyad will: 1. Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. 2. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.	I-DSMES-Support Persons n=110 participants at risk This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will: 1. Take part in a one-hour introductory session and review of patient's diabetes management risk assessment. 2. Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. I-DSMES: Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.
Gastrointestinal disorders Abdominal pain	0.89% 1/112 • Number of events 1 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.91% 1/110 • Number of events 1 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
Vascular disorders Blood clot	0.89% 1/112 • Number of events 1 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
Respiratory, thoracic and mediastinal disorders Pulmonary emphysema	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.91% 1/110 • Number of events 2 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
Renal and urinary disorders Kidney pain	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.91% 1/110 • Number of events 1 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
Infections and infestations COVID-19 complications	1.8% 2/112 • Number of events 2 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
General disorders Hospital admission, unspecified	12.5% 14/112 • Number of events 14 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	15.5% 17/110 • Number of events 17 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.

Other adverse events

Measure	FAM-ACT-Patients n=112 participants at risk Patient and Support Person (dyad) will be included together as much as possible. The dyad will: 1. Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. 2. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.	I-DSMES-Patients n=110 participants at risk This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will: 1. Take part in a one-hour introductory session and review of patient's diabetes management risk assessment. 2. Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. I-DSMES: Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.	FAM-ACT-Support Persons n=112 participants at risk Patient and Support Person (dyad) will be included together as much as possible. The dyad will: 1. Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. 2. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.	I-DSMES-Support Persons n=110 participants at risk This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will: 1. Take part in a one-hour introductory session and review of patient's diabetes management risk assessment. 2. Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each. 3. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. I-DSMES: Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.
Infections and infestations COVID-19	7.1% 8/112 • Number of events 10 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	6.4% 7/110 • Number of events 7 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
Injury, poisoning and procedural complications Injury	2.7% 3/112 • Number of events 3 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.91% 1/110 • Number of events 1 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.89% 1/112 • Number of events 1 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
Musculoskeletal and connective tissue disorders Fibromyalgia pain	0.89% 1/112 • Number of events 1 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.91% 1/110 • Number of events 1 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
General disorders Emergency department, unspecified	22.3% 25/112 • Number of events 52 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	20.9% 23/110 • Number of events 35 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/112 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.	0.00% 0/110 • Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment. Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.

Additional Information

Ann-Marie Rosland, MD, MS

University of Pittsburgh School of Medicine

Phone: 412-648-5660

Email: roslandam@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place