Trial Outcomes & Findings for Group Visits for High Risk Type 1 Diabetes (T1D) (NCT NCT05431686)

NCT ID: NCT05431686

Last Updated: 2025-12-22

Results Overview

For those who agree to enroll, investigators will classify participant's CGM use status at time of enrollment as either current CGM users, never CGM users, or those with CGM attrition. At the completion of the study, CGM use status will be assessed, with the goal of \>80% current CGM users among study participants as a measure of feasibility.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2025-12-22

Participant Flow

all participants are assigned to a single SMA visit intervention arm

Participant milestones

Measure	SMA Visit Intervention Arm SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver
Overall Study STARTED	14
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	SMA Visit Intervention Arm SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver
Overall Study unable to schedule	10

Baseline Characteristics

Group Visits for High Risk Type 1 Diabetes (T1D)

Baseline characteristics by cohort

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver. Baseline characteristic data was collected for youth, not from caregivers.
Age, Categorical <=18 years	4 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=18 Participants
Age, Categorical >=65 years	0 Participants n=18 Participants
Sex: Female, Male Female	2 Participants n=18 Participants
Sex: Female, Male Male	2 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	3 Participants n=18 Participants
Race (NIH/OMB) White	1 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Inclusion criteria: ages 8-12 years, Non-Hispanic Black (NHB) or Latinx, publicly insured, insulin pump naïve, recent HbA1c \>8%

Investigators will track all patients who screened eligible to participate in the study, as well as those who that were contacted to gauge interest in participating. Investigators will track the percent of people who agreed to participate from those that were approached, with the goal of >60% of those reached/eligible to participate agreeing to enroll as a measure of feasibility.

Outcome measures

Measure	SMA Visit Intervention Arm n=82 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Percentage of Eligible Participants Who Agreed to Participate as Assessed by Tracking Those Who Were Approached to Participate and Those Who Agreed to Participate	14 Participants	—

PRIMARY outcome

Timeframe: 18 months

Population: SMA intervention participants

For those who agree to enroll, investigators will classify participant's CGM use status at time of enrollment as either current CGM users, never CGM users, or those with CGM attrition. At the completion of the study, CGM use status will be assessed, with the goal of >80% current CGM users among study participants as a measure of feasibility.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Percentage of Participants With CGM Use, as Assessed by Tracking CGM Use Status From Enrollment to the End of the Study.	87.5 percentage of 14 day CGM wear Interval 80.1 to 92.7	—

PRIMARY outcome

Timeframe: 12 months

For those who agree to enroll, investigators will document if participants attended or were absent from scheduled study visits. At the completion of the study, attendance will be assessed, with the goal of >80% sessions attended among study participants as a measure of feasibility.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Frequency of SMA Sessions Attended, as Assessed by Tracking Study Visit Attendance.	90 percentage of visits attended Interval 80.0 to 100.0	—

PRIMARY outcome

Timeframe: 12 months

Population: 2 youth-caregiver dyads participated in semi-structured interviews

Thematic analysis of qualitative data will be conducted by two team members who independently review interview transcripts to generate initial codes. Initial codes will be discussed by the group to generate a list of second-cycle codes and each team member will then apply coding framework to all transcripts before identifying dominant themes. ATLAS.ti software will be used to organize and analyze qualitative data.

Outcome measures

Measure	SMA Visit Intervention Arm n=2 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Perceived Satisfaction of SMA Intervention as Assessed by Semi-structured Interviews.	2 Participants	—

PRIMARY outcome

Timeframe: 12 months

Population: user satisfaction ratings were not collected given the small study sample population, instead, semi-structured interviews were performed to collect acceptability data

Youth and caregivers randomized to the SMA intervention will complete user satisfaction ratings at the end of the SMA intervention to evaluate intervention utility. Investigators will report results of the satisfaction ratings, with the goal of >80% reporting perceived utility as a measure of acceptability.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Population: user satisfaction ratings were not collected given the small study sample population, instead, semi-structured interviews were performed to collect acceptability data

Youth and caregivers randomized to the SMA intervention will complete user satisfaction ratings at the end of the SMA intervention to evaluate intervention benefit. Investigators will report results of the satisfaction ratings, with the goal of >80% reporting perceived benefit as a measure of acceptability.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in the percent of time that blood sugar values are in range within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Percentage of Time in Range (70-180 mg/dl) 9 months	29.00 percentage of time Standard Deviation 5.66	—
Percentage of Time in Range (70-180 mg/dl) 12 months	33.33 percentage of time Standard Deviation 8.33	—
Percentage of Time in Range (70-180 mg/dl) 15 months	38.00 percentage of time Standard Deviation 3.61	—
Percentage of Time in Range (70-180 mg/dl) 18 months	27.00 percentage of time Standard Deviation 9.17	—
Percentage of Time in Range (70-180 mg/dl) Baseline	27.25 percentage of time Standard Deviation 1.71	—
Percentage of Time in Range (70-180 mg/dl) 3 months	21.75 percentage of time Standard Deviation 10.56	—
Percentage of Time in Range (70-180 mg/dl) 6 months	23.67 percentage of time Standard Deviation 3.79	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in the percent of time that blood sugar values are below range within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Continuous Glucose Monitor Time Below Range (<70 mg/dL) Baseline	2.45 percentage of time below range Standard Deviation 1.73	—
Continuous Glucose Monitor Time Below Range (<70 mg/dL) 3 months	0.97 percentage of time below range Standard Deviation 1.00	—
Continuous Glucose Monitor Time Below Range (<70 mg/dL) 6 months	4.00 percentage of time below range Standard Deviation 4.58	—
Continuous Glucose Monitor Time Below Range (<70 mg/dL) 9 months	2.00 percentage of time below range Standard Deviation 0.00	—
Continuous Glucose Monitor Time Below Range (<70 mg/dL) 12 months	1.60 percentage of time below range Standard Deviation 1.47	—
Continuous Glucose Monitor Time Below Range (<70 mg/dL) 15 months	2.50 percentage of time below range Standard Deviation 0.71	—
Continuous Glucose Monitor Time Below Range (<70 mg/dL) 18 months	1.67 percentage of time below range Standard Deviation 2.08	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in the percent of time that blood sugar values are above range within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Continuous Glucose Monitor Time Above Range (>180 mg/dL) 12 months	61.33 percentage of time above range Standard Deviation 20.03	—
Continuous Glucose Monitor Time Above Range (>180 mg/dL) 15 months	60.00 percentage of time above range Standard Deviation 4.24	—
Continuous Glucose Monitor Time Above Range (>180 mg/dL) 18 months	71.00 percentage of time above range Standard Deviation 11.53	—
Continuous Glucose Monitor Time Above Range (>180 mg/dL) baseline	78.00 percentage of time above range Standard Deviation 15.62	—
Continuous Glucose Monitor Time Above Range (>180 mg/dL) 3 months	80.77 percentage of time above range Standard Deviation 10.51	—
Continuous Glucose Monitor Time Above Range (>180 mg/dL) 6 months	72.33 percentage of time above range Standard Deviation 8.33	—
Continuous Glucose Monitor Time Above Range (>180 mg/dL) 9 months	69.00 percentage of time above range Standard Deviation 5.66	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in the mean sensor glucose values within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Continuous Glucose Monitor Mean Sensor Glucose baseline	247.75 mg/dl Standard Deviation 17.75	—
Continuous Glucose Monitor Mean Sensor Glucose 3 months	259.25 mg/dl Standard Deviation 35.51	—
Continuous Glucose Monitor Mean Sensor Glucose 6 months	245.33 mg/dl Standard Deviation 13.05	—
Continuous Glucose Monitor Mean Sensor Glucose 9 months	241.50 mg/dl Standard Deviation 3.54	—
Continuous Glucose Monitor Mean Sensor Glucose 12 months	239.00 mg/dl Standard Deviation 30.51	—
Continuous Glucose Monitor Mean Sensor Glucose 15 months	219.67 mg/dl Standard Deviation 15.82	—
Continuous Glucose Monitor Mean Sensor Glucose 18 months	256.67 mg/dl Standard Deviation 47.51	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in the coefficient of variation values within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Continuous Glucose Monitor Coefficient of Variation baseline	41.40 percentage Standard Deviation 7.38	—
Continuous Glucose Monitor Coefficient of Variation 3 months	30.80 percentage Standard Deviation 7.75	—
Continuous Glucose Monitor Coefficient of Variation 6 months	41.47 percentage Standard Deviation 12.52	—
Continuous Glucose Monitor Coefficient of Variation 9 months	42.30 percentage Standard Deviation 4.67	—
Continuous Glucose Monitor Coefficient of Variation 12 months	43.30 percentage Standard Deviation 9.36	—
Continuous Glucose Monitor Coefficient of Variation 15 months	44.85 percentage Standard Deviation 3.61	—
Continuous Glucose Monitor Coefficient of Variation 18 months	39.40 percentage Standard Deviation 5.63	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in percent CGM wear time within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Continuous Glucose Monitor Wear Time baseline	63.40 percentage of CGM wear time Standard Deviation 16.75	—
Continuous Glucose Monitor Wear Time 3 months	67.33 percentage of CGM wear time Standard Deviation 19.79	—
Continuous Glucose Monitor Wear Time 6 months	64.33 percentage of CGM wear time Standard Deviation 44.84	—
Continuous Glucose Monitor Wear Time 9 months	89.50 percentage of CGM wear time Standard Deviation 4.95	—
Continuous Glucose Monitor Wear Time 12 months	74.00 percentage of CGM wear time Standard Deviation 27.07	—
Continuous Glucose Monitor Wear Time 15 months	71.13 percentage of CGM wear time Standard Deviation 18.80	—
Continuous Glucose Monitor Wear Time 18 months	65.90 percentage of CGM wear time Standard Deviation 23.08	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in number of episodes of DKA since the last study visit within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Episodes of Diabetic Ketoacidosis (DKA) 18 months	0 DKA episodes Standard Deviation 0	—
Episodes of Diabetic Ketoacidosis (DKA) 12 months	0 DKA episodes Standard Deviation 0	—
Episodes of Diabetic Ketoacidosis (DKA) 15 months	0 DKA episodes Standard Deviation 0	—
Episodes of Diabetic Ketoacidosis (DKA) baseline	0 DKA episodes Standard Deviation 0	—
Episodes of Diabetic Ketoacidosis (DKA) 3 months	0 DKA episodes Standard Deviation 0	—
Episodes of Diabetic Ketoacidosis (DKA) 6 months	0 DKA episodes Standard Deviation 0	—
Episodes of Diabetic Ketoacidosis (DKA) 9 months	0 DKA episodes Standard Deviation 0	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in number of episodes of severe hypoglycemia since the last study visit within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Episodes of Severe Hypoglycemia baseline	0 severe hypoglycemia episodes Standard Deviation 0	—
Episodes of Severe Hypoglycemia 3 months	0 severe hypoglycemia episodes Standard Deviation 0	—
Episodes of Severe Hypoglycemia 6 months	0 severe hypoglycemia episodes Standard Deviation 0	—
Episodes of Severe Hypoglycemia 9 months	0 severe hypoglycemia episodes Standard Deviation 0	—
Episodes of Severe Hypoglycemia 12 months	0 severe hypoglycemia episodes Standard Deviation 0	—
Episodes of Severe Hypoglycemia 15 months	0 severe hypoglycemia episodes Standard Deviation 0	—
Episodes of Severe Hypoglycemia 18 months	0 severe hypoglycemia episodes Standard Deviation 0	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in number of episodes of emergency room visits since the last study visit within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Number of Emergency Room Visits baseline	0 emergency room visit episodes Standard Deviation 0	—
Number of Emergency Room Visits 3 months	0.5 emergency room visit episodes Standard Deviation 1.0	—
Number of Emergency Room Visits 6 months	0 emergency room visit episodes Standard Deviation 0	—
Number of Emergency Room Visits 9 months	0 emergency room visit episodes Standard Deviation 0	—
Number of Emergency Room Visits 12 months	0 emergency room visit episodes Standard Deviation 0	—
Number of Emergency Room Visits 15 months	0 emergency room visit episodes Standard Deviation 0	—
Number of Emergency Room Visits 18 months	0 emergency room visit episodes Standard Deviation 0	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in number of hospital admissions since the last study visit within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Number of Hospital Admissions baseline	0 hospital admissions Standard Deviation 0	—
Number of Hospital Admissions 3 months	0 hospital admissions Standard Deviation 0	—
Number of Hospital Admissions 6 months	0 hospital admissions Standard Deviation 0	—
Number of Hospital Admissions 9 months	0 hospital admissions Standard Deviation 0	—
Number of Hospital Admissions 12 months	0 hospital admissions Standard Deviation 0	—
Number of Hospital Admissions 15 months	0 hospital admissions Standard Deviation 0	—
Number of Hospital Admissions 18 months	0 hospital admissions Standard Deviation 0	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

We will look at differences in HbA1c at study visits within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Hemoglobin A1c baseline	11.28 percentage of HbA1c Standard Deviation 1.24	—
Hemoglobin A1c 3 months	10.60 percentage of HbA1c Standard Deviation 1.26	—
Hemoglobin A1c 6 months	10.47 percentage of HbA1c Standard Deviation 2.04	—
Hemoglobin A1c 9 months	9.35 percentage of HbA1c Standard Deviation 0.64	—
Hemoglobin A1c 12 months	9.67 percentage of HbA1c Standard Deviation 0.81	—
Hemoglobin A1c 15 months	10.70 percentage of HbA1c Standard Deviation 2.46	—
Hemoglobin A1c 18 months	10.70 percentage of HbA1c Standard Deviation 1.22	—

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

The T1DAL is a validated survey assessing diabetes specific quality of life. Scores range from 0 to 100, with higher scores reflecting greater quality of life. Surveys will be completed at each of the study visits, and scores will be compared within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Type 1 Diabetes and Life (T1DAL) Survey baseline	67.95 score on a scale Standard Deviation 6.91	74.70 score on a scale Standard Deviation 11.39
Type 1 Diabetes and Life (T1DAL) Survey 3 months	66.63 score on a scale Standard Deviation 10.44	72.32 score on a scale Standard Deviation 15.01
Type 1 Diabetes and Life (T1DAL) Survey 6 months	68.45 score on a scale Standard Deviation 9.26	76.49 score on a scale Standard Deviation 16.65
Type 1 Diabetes and Life (T1DAL) Survey 9 months	69.31 score on a scale Standard Deviation 5.04	75.40 score on a scale Standard Deviation 17.83
Type 1 Diabetes and Life (T1DAL) Survey 12 months	63.51 score on a scale Standard Deviation 6.69	74.70 score on a scale Standard Deviation 15.01
Type 1 Diabetes and Life (T1DAL) Survey 15 months	59.23 score on a scale Standard Deviation 9.93	77.78 score on a scale Standard Deviation 9.25
Type 1 Diabetes and Life (T1DAL) Survey 18 months	62.82 score on a scale Standard Deviation 7.46	75.00 score on a scale Standard Deviation 17.47

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

The DSMP is a validated survey assessing T1D adherence. Scores range from 0 to 90, with higher scores reflecting better T1D management. Surveys will be completed at each of the study visits, and scores will be compared within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Diabetes Self-Management Profile (DSMP) Survey baseline	47.97 score on a scale Standard Deviation 9.37	42.44 score on a scale Standard Deviation 10.42
Diabetes Self-Management Profile (DSMP) Survey 3 months	37.65 score on a scale Standard Deviation 7.3	65.41 score on a scale Standard Deviation 38.46
Diabetes Self-Management Profile (DSMP) Survey 6 months	33.58 score on a scale Standard Deviation 6.39	38.95 score on a scale Standard Deviation 27.66
Diabetes Self-Management Profile (DSMP) Survey 9 months	42.21 score on a scale Standard Deviation 11.32	42.64 score on a scale Standard Deviation 10.80
Diabetes Self-Management Profile (DSMP) Survey 12 months	40.03 score on a scale Standard Deviation 13.41	44.19 score on a scale Standard Deviation 10.70
Diabetes Self-Management Profile (DSMP) Survey 15 months	30.51 score on a scale Standard Deviation 7.46	37.98 score on a scale Standard Deviation 13.38
Diabetes Self-Management Profile (DSMP) Survey 18 months	38.23 score on a scale Standard Deviation 11.2	42.15 score on a scale Standard Deviation 9.37

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

The SED is a validated survey assessing diabetes-specific self-efficacy. Scores range from 0-4 for each question, with higher scores indicating increasing levels of child responsibility. The total scores can range from 0-100. Surveys will be completed at each of the study visits, and scores will be compared within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Self-Efficacy for Diabetes Scale (SED) Survey baseline	45.84 score on a scale Standard Deviation 12.64	70.23 score on a scale Standard Deviation 7.17
Self-Efficacy for Diabetes Scale (SED) Survey 3 months	65.29 score on a scale Standard Deviation 4.9	68.41 score on a scale Standard Deviation 9.22
Self-Efficacy for Diabetes Scale (SED) Survey 6 months	53.77 score on a scale Standard Deviation 27.08	65.91 score on a scale Standard Deviation 10.64
Self-Efficacy for Diabetes Scale (SED) Survey 9 months	57.21 score on a scale Standard Deviation 18.87	63.94 score on a scale Standard Deviation 14.09
Self-Efficacy for Diabetes Scale (SED) Survey 12 months	70.6 score on a scale Standard Deviation 7.68	69.32 score on a scale Standard Deviation 9.91
Self-Efficacy for Diabetes Scale (SED) Survey 15 months	73.17 score on a scale Standard Deviation 8.74	72.12 score on a scale Standard Deviation 9.33
Self-Efficacy for Diabetes Scale (SED) Survey 18 months	68.12 score on a scale Standard Deviation 14.19	67.05 score on a scale Standard Deviation 9.01

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

The Problem Areas in Diabetes (PAID) scale is widely used for measuring diabetes-related emotional distress. Scores range from 0-5 for each question, with higher scores indicating greater burden relating to having diabetes. The total scores can range from 0-80. Surveys will be completed at each of the study visits, and scores will be compared within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
Problem Areas in Diabetes (PAID) Scale baseline	50.0 score on a scale Standard Deviation 16.96	59.69 score on a scale Standard Deviation 10.38
Problem Areas in Diabetes (PAID) Scale 3 months	50.66 score on a scale Standard Deviation 21.8	64.06 score on a scale Standard Deviation 10.48
Problem Areas in Diabetes (PAID) Scale 6 months	27.28 score on a scale Standard Deviation 36.0	67.81 score on a scale Standard Deviation 18.72
Problem Areas in Diabetes (PAID) Scale 9 months	44.09 score on a scale Standard Deviation 28.07	60.83 score on a scale Standard Deviation 6.41
Problem Areas in Diabetes (PAID) Scale 12 months	48.18 score on a scale Standard Deviation 25.74	64.06 score on a scale Standard Deviation 16.88
Problem Areas in Diabetes (PAID) Scale 15 months	49.04 score on a scale Standard Deviation 22.64	65.00 score on a scale Standard Deviation 13.75
Problem Areas in Diabetes (PAID) Scale 18 months	47.88 score on a scale Standard Deviation 14.58	61.25 score on a scale Standard Deviation 4.79

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Population: given the small sample size, there is not sufficient power to evaluate changes over time so statistical analysis was not performed for this outcome

The CGM Benefits and Burdens scale is widely used for measuring perceptions of CGM benefit and burdens. Raw scores range from 1-5 for each question, with higher scores reflecting greater burdens/benefits. Total scores are scaled and combined, ranging from 0-200. Surveys will be completed at each of the study visits, and scores will be compared within subject measures across the SMA intervention and during the follow up period.

Outcome measures

Measure	SMA Visit Intervention Arm n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period	SMA Visit Intervention Arm - Caregiver n=4 Participants SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver SMA visits: SMA visit once every 3 months over a 12 month period
CGM Benefits and Burdens Scale baseline	133.12 score on a scale Standard Deviation 48.5	81.25 score on a scale Standard Deviation 31.19
CGM Benefits and Burdens Scale 3 months	96.25 score on a scale Standard Deviation 23.56	68.13 score on a scale Standard Deviation 32.87
CGM Benefits and Burdens Scale 6 months	108.12 score on a scale Standard Deviation 2.65	46.88 score on a scale Standard Deviation 37.99
CGM Benefits and Burdens Scale 9 months	103.44 score on a scale Standard Deviation 18.21	62.50 score on a scale Standard Deviation 26.34
CGM Benefits and Burdens Scale 12 months	100.0 score on a scale Standard Deviation 16.36	54.38 score on a scale Standard Deviation 15.19
CGM Benefits and Burdens Scale 15 months	87.5 score on a scale Standard Deviation 7.5	39.17 score on a scale Standard Deviation 1.44
CGM Benefits and Burdens Scale 18 months	97.5 score on a scale Standard Deviation 15.21	51.88 score on a scale Standard Deviation 22.30

Adverse Events

SMA Visit Intervention Arm - Youth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SMA Visit Intervention Arm - Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jody Grundman

Children's National Hospital

Phone: 2024762121

Email: jgrundman@childrensnational.org

Results disclosure agreements

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