Trial Outcomes & Findings for TExT-MED + FANS Full Trial (NCT NCT03178773)

Last Updated: 2021-08-06

Results Overview

Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is baseline value minus follow up value.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

166 participants

Primary outcome timeframe

6 Months

Results posted on

2021-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	TExT-MED Only Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	TExT-MED+FANS Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support
Overall Study STARTED	86	80
Overall Study 3month Phone Follow up	49	51
Overall Study 6month in Person Follow up	54	46
Overall Study 9month Follow up Phone	36	51
Overall Study COMPLETED	47	40
Overall Study NOT COMPLETED	39	40

Reasons for withdrawal

Reasons for withdrawal
Measure	TExT-MED Only Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	TExT-MED+FANS Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support
Overall Study Death	0	1
Overall Study Lost to Follow-up	29	25
Overall Study Withdrawal by Subject	10	14

Baseline Characteristics

2 participants were unable to stand to provide height

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TExT-MED Only n=86 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	TExT-MED+FANS n=80 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=166 Participants Total of all reporting groups
Age, Continuous	50.7 years n=86 Participants	47.7 years n=80 Participants	48.9 years n=166 Participants
Sex: Female, Male Female	49 Participants n=86 Participants	35 Participants n=80 Participants	84 Participants n=166 Participants
Sex: Female, Male Male	37 Participants n=86 Participants	45 Participants n=80 Participants	82 Participants n=166 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	82 Participants n=86 Participants	74 Participants n=80 Participants	156 Participants n=166 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=86 Participants	6 Participants n=80 Participants	9 Participants n=166 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=86 Participants	0 Participants n=80 Participants	1 Participants n=166 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=86 Participants	3 Participants n=80 Participants	5 Participants n=166 Participants
Race (NIH/OMB) Asian	2 Participants n=86 Participants	0 Participants n=80 Participants	2 Participants n=166 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=86 Participants	0 Participants n=80 Participants	0 Participants n=166 Participants
Race (NIH/OMB) Black or African American	3 Participants n=86 Participants	6 Participants n=80 Participants	9 Participants n=166 Participants
Race (NIH/OMB) White	40 Participants n=86 Participants	34 Participants n=80 Participants	74 Participants n=166 Participants
Race (NIH/OMB) More than one race	2 Participants n=86 Participants	1 Participants n=80 Participants	3 Participants n=166 Participants
Race (NIH/OMB) Unknown or Not Reported	37 Participants n=86 Participants	36 Participants n=80 Participants	73 Participants n=166 Participants
Region of Enrollment United States	86 participants n=86 Participants	80 participants n=80 Participants	166 participants n=166 Participants
Language Preferred Spanish	64 Participants n=86 Participants	52 Participants n=80 Participants	116 Participants n=166 Participants
Language Preferred English	22 Participants n=86 Participants	28 Participants n=80 Participants	50 Participants n=166 Participants
Born outside US	75 Participants n=86 Participants	56 Participants n=80 Participants	131 Participants n=166 Participants
HbA1c	10.3 % percentage of hemoglobin glycosylated n=86 Participants	10.6 % percentage of hemoglobin glycosylated n=80 Participants	10.4 % percentage of hemoglobin glycosylated n=166 Participants
BMI	30.78 kg^m2 STANDARD_DEVIATION 7.96 • n=84 Participants • 2 participants were unable to stand to provide height	29.34 kg^m2 STANDARD_DEVIATION 7.18 • n=80 Participants • 2 participants were unable to stand to provide height	30.07 kg^m2 STANDARD_DEVIATION 7.60 • n=164 Participants • 2 participants were unable to stand to provide height
Abdominal circumference (cm)	138.67 cm STANDARD_DEVIATION 174.29 • n=78 Participants • 20 participants were unable to provide abdominal circumference measurement	104.82 cm STANDARD_DEVIATION 16.61 • n=68 Participants • 20 participants were unable to provide abdominal circumference measurement	122.90 cm STANDARD_DEVIATION 128.63 • n=146 Participants • 20 participants were unable to provide abdominal circumference measurement
Systolic Blood Pressure	131.55 mmHg STANDARD_DEVIATION 25.02 • n=86 Participants	131.03 mmHg STANDARD_DEVIATION 28.90 • n=80 Participants	131.30 mmHg STANDARD_DEVIATION 26.88 • n=166 Participants
Diastolic blood pressure	79.98 mmHg STANDARD_DEVIATION 15.81 • n=86 Participants	81.61 mmHg STANDARD_DEVIATION 16.15 • n=80 Participants	80.77 mmHg STANDARD_DEVIATION 15.95 • n=166 Participants
Summary of Diabetes Self-Care Activities Following a generally healthy diet	3.38 units on a scale STANDARD_DEVIATION 2.44 • n=86 Participants	3.07 units on a scale STANDARD_DEVIATION 2.51 • n=80 Participants	3.23 units on a scale STANDARD_DEVIATION 2.47 • n=166 Participants
Summary of Diabetes Self-Care Activities Following a disease specific diet plan	3.98 units on a scale STANDARD_DEVIATION 1.90 • n=86 Participants	3.74 units on a scale STANDARD_DEVIATION 1.89 • n=80 Participants	3.87 units on a scale STANDARD_DEVIATION 1.90 • n=166 Participants
Summary of Diabetes Self-Care Activities Self-monitoring blood glucose as advised by a h	2.55 units on a scale STANDARD_DEVIATION 2.79 • n=86 Participants	2.76 units on a scale STANDARD_DEVIATION 3.06 • n=80 Participants	2.65 units on a scale STANDARD_DEVIATION 2.92 • n=166 Participants
Summary of Diabetes Self-Care Activities Checking feet daily for wounds	4.01 units on a scale STANDARD_DEVIATION 3.00 • n=86 Participants	4.11 units on a scale STANDARD_DEVIATION 2.86 • n=80 Participants	4.06 units on a scale STANDARD_DEVIATION 2.93 • n=166 Participants
Summary of Diabetes Self-Care Activities Spacing carbohydrates throughout the day	2.78 units on a scale STANDARD_DEVIATION 2.65 • n=86 Participants	3.00 units on a scale STANDARD_DEVIATION 2.46 • n=80 Participants	2.89 units on a scale STANDARD_DEVIATION 2.56 • n=166 Participants
Summary of Diabetes Self-Care Activities Getting sufficient physical activity	2.51 units on a scale STANDARD_DEVIATION 2.62 • n=86 Participants	2.43 units on a scale STANDARD_DEVIATION 2.53 • n=80 Participants	2.47 units on a scale STANDARD_DEVIATION 2.57 • n=166 Participants
Wilson 3 Item Scale	67.16 units on a scale STANDARD_DEVIATION 31.13 • n=85 Participants • 1 participant decline to answer questions	65.85 units on a scale STANDARD_DEVIATION 28.23 • n=80 Participants • 1 participant decline to answer questions	66.53 units on a scale STANDARD_DEVIATION 29.67 • n=165 Participants • 1 participant decline to answer questions
Healthcare Utilization ED/UCC Visits	2.45 Number of Healthcare Encounters STANDARD_DEVIATION 2.12 • n=86 Participants	2.38 Number of Healthcare Encounters STANDARD_DEVIATION 3.29 • n=80 Participants	2.42 Number of Healthcare Encounters STANDARD_DEVIATION 2.74 • n=166 Participants
Healthcare Utilization Hospitalization	0.43 Number of Healthcare Encounters STANDARD_DEVIATION 0.80 • n=86 Participants	0.44 Number of Healthcare Encounters STANDARD_DEVIATION 0.78 • n=80 Participants	0.43 Number of Healthcare Encounters STANDARD_DEVIATION 0.79 • n=166 Participants
Healthcare Utilization Clinic Visits Made	3.28 Number of Healthcare Encounters STANDARD_DEVIATION 5.61 • n=86 Participants	2.74 Number of Healthcare Encounters STANDARD_DEVIATION 5.25 • n=80 Participants	3.02 Number of Healthcare Encounters STANDARD_DEVIATION 5.43 • n=166 Participants
Diabetes Empowerment Scale Short Form	30.50 units on a scale STANDARD_DEVIATION 5.56 • n=86 Participants	31.09 units on a scale STANDARD_DEVIATION 4.99 • n=80 Participants	30.78 units on a scale STANDARD_DEVIATION 5.28 • n=166 Participants
Diabetes Distress Scale	2.32 units on a scale STANDARD_DEVIATION 0.86 • n=80 Participants • 11 participants decline to answer questions	2.60 units on a scale STANDARD_DEVIATION 1.11 • n=75 Participants • 11 participants decline to answer questions	2.46 units on a scale STANDARD_DEVIATION 0.10 • n=155 Participants • 11 participants decline to answer questions
Patient Health Questionnaire 9	8.90 units on a scale STANDARD_DEVIATION 6.94 • n=86 Participants	9.45 units on a scale STANDARD_DEVIATION 6.31 • n=80 Participants	9.16 units on a scale STANDARD_DEVIATION 6.63 • n=166 Participants
Fatalism	34.09 units on a scale STANDARD_DEVIATION 9.90 • n=86 Participants	35.86 units on a scale STANDARD_DEVIATION 9.85 • n=80 Participants	34.94 units on a scale STANDARD_DEVIATION 9.89 • n=166 Participants
WHO Quality of life	61.91 units on a scale STANDARD_DEVIATION 26.59 • n=86 Participants	58.00 units on a scale STANDARD_DEVIATION 29.48 • n=80 Participants	60.02 units on a scale STANDARD_DEVIATION 28.00 • n=166 Participants
Diabetes Family Behavior Checklist Supportive	23.65 units on a scale STANDARD_DEVIATION 9.12 • n=86 Participants	24.56 units on a scale STANDARD_DEVIATION 9.32 • n=80 Participants	24.09 units on a scale STANDARD_DEVIATION 9.20 • n=166 Participants
Diabetes Family Behavior Checklist Non-Supportive	18.27 units on a scale STANDARD_DEVIATION 7.23 • n=86 Participants	19.28 units on a scale STANDARD_DEVIATION 7.22 • n=80 Participants	18.75 units on a scale STANDARD_DEVIATION 7.22 • n=166 Participants
Diabetes Care Profile Support Perceived Disease Specific Support Needs	23.22 units on a scale STANDARD_DEVIATION 7.51 • n=86 Participants	24.04 units on a scale STANDARD_DEVIATION 7.55 • n=80 Participants	23.61 units on a scale STANDARD_DEVIATION 7.52 • n=166 Participants
Diabetes Care Profile Support Perceived Disease Specific Support Received	17.91 units on a scale STANDARD_DEVIATION 8.81 • n=86 Participants	19.16 units on a scale STANDARD_DEVIATION 9.06 • n=80 Participants	18.51 units on a scale STANDARD_DEVIATION 8.92 • n=166 Participants
Diabetes Care Profile Support Support Attitudes	6.58 units on a scale STANDARD_DEVIATION 5.50 • n=86 Participants	6.39 units on a scale STANDARD_DEVIATION 4.68 • n=80 Participants	6.49 units on a scale STANDARD_DEVIATION 5.11 • n=166 Participants
Norbeck Social Support Questionnaire Emotional	14.00 units on a scale STANDARD_DEVIATION 3.32 • n=77 Participants • 14 participants decline to answer questions	13.68 units on a scale STANDARD_DEVIATION 3.15 • n=75 Participants • 14 participants decline to answer questions	13.84 units on a scale STANDARD_DEVIATION 3.23 • n=152 Participants • 14 participants decline to answer questions
Norbeck Social Support Questionnaire Tangible	6.83 units on a scale STANDARD_DEVIATION 1.77 • n=77 Participants • 14 participants decline to answer questions	7.15 units on a scale STANDARD_DEVIATION 1.57 • n=75 Participants • 14 participants decline to answer questions	6.99 units on a scale STANDARD_DEVIATION 1.68 • n=152 Participants • 14 participants decline to answer questions
Partner Distress Scale - Total	1.32 units on a scale STANDARD_DEVIATION 0.94 • n=85 Participants • 1 participant decline to answer question	1.52 units on a scale STANDARD_DEVIATION 0.95 • n=80 Participants • 1 participant decline to answer question	1.42 units on a scale STANDARD_DEVIATION 0.95 • n=165 Participants • 1 participant decline to answer question

PRIMARY outcome

Timeframe: 6 Months

Population: 2 of the HbA1c were collected from electronic healthcare records in the active control group. 1 intervention group patient refused blood draw at follow up.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=45 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total Both arms combined	TExT-MED Only n=54 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in HBA1c From Baseline	1.34 %mmHg/dL Interval 0.53 to 2.15	—	1.42 %mmHg/dL Interval 0.83 to 2.02

SECONDARY outcome

Timeframe: 12 months

Population: 2 intervention group patient refused blood draw at follow up.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=38 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total Both arms combined	TExT-MED Only n=47 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in HBA1c From 6 Months to 12 Months	.28 %mmHg/dL Interval -0.3 to 0.86	—	-.36 %mmHg/dL Interval -0.93 to 0.22

SECONDARY outcome

Timeframe: 6 Months

Population: 4 participants were not able to stand on the scale to measure weight

Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=96 Participants Both arms combined	TExT-MED Only n=50 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in BMI From Baseline	-3.84 kg^m2 Standard Deviation 22.94	-5.96 kg^m2 Standard Deviation 29.03	-7.91 kg^m2 Standard Deviation 33.80

SECONDARY outcome

Timeframe: 12 Months

Population: 5 participants unable stand to provide weight

Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=37 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=82 Participants Both arms combined	TExT-MED Only n=45 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in BMI From 6 Months to 12 Months	4.02 kg^m2 Standard Deviation 24.88	-0.04 kg^m2 Standard Deviation 23.75	-3.38 kg^m2 Standard Deviation 22.51

SECONDARY outcome

Timeframe: 6 Months

Population: abdominal circumference unable to be collected from 20 patients

A measure of central adiposity, it correlates with cardiovascular outcomes.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=37 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=80 Participants Both arms combined	TExT-MED Only n=43 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Abdominal Circumference From Baseline	2.73 cm Standard Deviation 22.54	2.11 cm Standard Deviation 18.62	1.58 cm Standard Deviation 14.70

SECONDARY outcome

Timeframe: 12 Months

Population: abdominal circumference not measured in 9 participants

A measure of central adiposity, it correlates with cardiovascular outcomes.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=34 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=78 Participants Both arms combined	TExT-MED Only n=44 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change From Abdominal Circumference From 6 Months to 12 Months	0.85 cm Standard Deviation 18.51	0.93 cm Standard Deviation 12.70	0.99 cm Standard Deviation 5.10

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available. 2 participants refused BP measurement

Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=96 Participants Both arms combined	TExT-MED Only n=50 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Systolic Blood Pressure From Baseline	-13.07 mmHg Standard Deviation 36.34	-11.00 mmHg Standard Deviation 33.28	-9.11 mmHg Standard Deviation 30.45

SECONDARY outcome

Timeframe: 12 Months

Population: 11 patients with SBP unable to be obtained

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=35 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=76 Participants Both arms combined	TExT-MED Only n=41 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Systolic Blood Pressure From 6 Months to 12 Months	2.09 mmHg Standard Deviation 37.46	-1.71 mmHg Standard Deviation 34.47	-4.95 mmHg Standard Deviation 31.81

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available. 2 participants refused BP measurement

Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=96 Participants Both arms combined	TExT-MED Only n=50 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diastolic Blood Pressure From Baseline	-2.56 mmHg Standard Deviation 20.09	-1.36 mmHg Standard Deviation 18.53	-0.27 mmHg Standard Deviation 17.11

SECONDARY outcome

Timeframe: 12 Months

Population: 11 patients with DBP unable to be obtained

Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=35 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=76 Participants Both arms combined	TExT-MED Only n=41 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diastolic Blood Pressure From 6 Months to 12 Months	5.20 mmHg Standard Deviation 20.15	1.95 mmHg Standard Deviation 18.82	-0.82 mmHg Standard Deviation 17.39

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, \& RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert \& Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=98 Participants Both arms combined	TExT-MED Only n=52 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Summary of Diabetes Self-care Activities From Baseline Following a generally healthy diet	-1.17 units on a scale Standard Deviation 2.69	-1.37 units on a scale Standard Deviation 2.80	-1.55 units on a scale Standard Deviation 2.91
Change in Summary of Diabetes Self-care Activities From Baseline Following a disease specific diet plan	-0.78 units on a scale Standard Deviation 1.93	-0.59 units on a scale Standard Deviation 2.03	-0.42 units on a scale Standard Deviation 2.12
Change in Summary of Diabetes Self-care Activities From Baseline Self-monitoring blood glucose as advised by a h	-0.10 units on a scale Standard Deviation 2.84	-0.53 units on a scale Standard Deviation 2.94	-0.91 units on a scale Standard Deviation 3.00
Change in Summary of Diabetes Self-care Activities From Baseline Checking feet daily for wounds	-1.36 units on a scale Standard Deviation 2.69	-1.30 units on a scale Standard Deviation 2.83	-1.25 units on a scale Standard Deviation 2.96
Change in Summary of Diabetes Self-care Activities From Baseline Spacing carbohydrates throughout the day	-0.20 units on a scale Standard Deviation 3.31	-0.47 units on a scale Standard Deviation 3.89	-0.71 units on a scale Standard Deviation 4.34
Change in Summary of Diabetes Self-care Activities From Baseline Getting sufficient physical activity	-0.90 units on a scale Standard Deviation 3.14	-0.63 units on a scale Standard Deviation 3.06	-0.39 units on a scale Standard Deviation 2.99

SECONDARY outcome

Timeframe: 12 Months

Population: one participant did not answer carb spacing as they did not know what that meant.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=40 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=87 Participants Both arms combined	TExT-MED Only n=47 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months Following a generally healthy diet	0.96 units on a scale Standard Deviation 2.74	0.57 units on a scale Standard Deviation 2.62	0.23 units on a scale Standard Deviation 2.50
Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months Following a disease specific diet plan	0.45 units on a scale Standard Deviation 1.85	0.36 units on a scale Standard Deviation 1.84	0.29 units on a scale Standard Deviation 1.85
Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months Self-monitoring blood glucose as advised by a h	-0.18 units on a scale Standard Deviation 2.40	-0.44 units on a scale Standard Deviation 2.84	-0.66 units on a scale Standard Deviation 3.19
Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months Checking feet daily for wounds	0.01 units on a scale Standard Deviation 1.93	-0.43 units on a scale Standard Deviation 2.36	-0.81 units on a scale Standard Deviation 2.64
Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months Carb Spacing carbohydrates throughout the day	0.31 units on a scale Standard Deviation 3.89	0.20 units on a scale Standard Deviation 4.22	0.11 units on a scale Standard Deviation 4.51
Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months Getting sufficient physical activity	0.81 units on a scale Standard Deviation 2.88	0.43 units on a scale Standard Deviation 2.94	0.11 units on a scale Standard Deviation 2.97

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised \& self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=98 Participants Both arms combined	TExT-MED Only n=52 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Wilson 3 Item Scale From Baseline	-12.39 units on a scale Standard Deviation 31.11	-14.16 units on a scale Standard Deviation 30.87	-15.73 units on a scale Standard Deviation 30.87

SECONDARY outcome

Timeframe: 12 Months

Population: 1 Participant decline to answer question

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=40 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=86 Participants Both arms combined	TExT-MED Only n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Wilson 3 Item Scale From 6 Months to 12 Months	3.22 units on a scale Standard Deviation 22.89	2.43 units on a scale Standard Deviation 20.75	1.74 units on a scale Standard Deviation 18.92

SECONDARY outcome

Timeframe: 6 Months

Population: 166 patients who initially enrolled followed in EMR

Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=80 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=166 Participants Both arms combined	TExT-MED Only n=86 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Healthcare Utilization From Baseline ED/UCC Visit	.88 Number of Healthcare Encounters Standard Deviation 2.22	1.18 Number of Healthcare Encounters Standard Deviation 2.06	1.47 Number of Healthcare Encounters Standard Deviation 1.87
Change in Healthcare Utilization From Baseline Hospitalization	.13 Number of Healthcare Encounters Standard Deviation .96	.19 Number of Healthcare Encounters Standard Deviation .84	0.24 Number of Healthcare Encounters Standard Deviation .72
Change in Healthcare Utilization From Baseline Clinic Visits Made	-2 Number of Healthcare Encounters Standard Deviation 6.45	-1.46 Number of Healthcare Encounters Standard Deviation 5.28	-.97 Number of Healthcare Encounters Standard Deviation 3.87

SECONDARY outcome

Timeframe: 12 Months

Population: all patients initially enrolled in trial followed in EMR

Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=80 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=166 Participants Both arms combined	TExT-MED Only n=86 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Healthcare Utilization From 6 Months to 12 Months ED/UCC Visit	.05 Number of Healthcare Encounters Standard Deviation 1.57	.06 Number of Healthcare Encounters Standard Deviation 1.46	0.07 Number of Healthcare Encounters Standard Deviation 1.35
Change in Healthcare Utilization From 6 Months to 12 Months Hospitalization	0 Number of Healthcare Encounters Standard Deviation .83	-.01 Number of Healthcare Encounters Standard Deviation .74	-.02 Number of Healthcare Encounters Standard Deviation .65
Change in Healthcare Utilization From 6 Months to 12 Months Clinic Visits Made	.88 Number of Healthcare Encounters Standard Deviation 6.30	.99 Number of Healthcare Encounters Standard Deviation 5.34	1.10 Number of Healthcare Encounters Standard Deviation 4.30

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, \& Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=98 Participants Both arms combined	TExT-MED Only n=52 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Empowerment Scale Short Form From Baseline	-0.05 units on a scale Standard Deviation 0.69	-0.11 units on a scale Standard Deviation 0.66	-0.17 units on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=40 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=87 Participants Both arms combined	TExT-MED Only n=47 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months	-0.03 units on a scale Standard Deviation 0.54	0.05 units on a scale Standard Deviation 0.52	0.13 units on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=98 Participants Both arms combined	TExT-MED Only n=52 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Distress Scale From Baseline	0.60 units on a scale Standard Deviation 1.15	0.63 units on a scale Standard Deviation 1.06	0.65 units on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=40 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=87 Participants Both arms combined	TExT-MED Only n=47 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Distress Scale From 6 Months to 12 Months	-0.01 units on a scale Standard Deviation 0.71	0.03 units on a scale Standard Deviation 0.83	0.06 units on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available. 1 participant decline to answer question

Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, \& Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=97 Participants Both arms combined	TExT-MED Only n=51 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Patient Health Questionnaire 9 From Baseline	2.33 units on a scale Standard Error 6.20	3.13 units on a scale Standard Error 6.21	3.86 units on a scale Standard Error 6.19

SECONDARY outcome

Timeframe: 12 Months

Population: 2 participants decline to answer questions

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=40 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=85 Participants Both arms combined	TExT-MED Only n=45 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Patient Health Questionnaire 9 From 6 Months to 12 Months	-0.13 units on a scale Standard Deviation 5.17	-0.15 units on a scale Standard Deviation 6.09	-0.18 units on a scale Standard Deviation 6.86

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants decline to answer questions. 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Fatalism is measured by the Diabetes Fatalism Scale (Egede \& Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=96 Participants Both arms combined	TExT-MED Only n=50 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Fatalism From Baseline	0.58 units on a scale Standard Deviation 10.61	-0.47 units on a scale Standard Deviation 10.03	-1.44 units on a scale Standard Deviation 9.47

SECONDARY outcome

Timeframe: 12 Months

Population: 5 participants decline to answer questions

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=38 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=82 Participants Both arms combined	TExT-MED Only n=44 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Fatalism From 6 Months to 12 Months	-1.20 units on a scale Standard Deviation 8.51	-1.26 units on a scale Standard Deviation 8.70	-1.30 units on a scale Standard Deviation 8.97

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, \& Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=98 Participants Both arms combined	TExT-MED Only n=52 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in WHO Quality of Life From Baseline	-4.96 units on a scale Standard Deviation 29.86	-7.47 units on a scale Standard Deviation 30.66	-9.69 units on a scale Standard Deviation 31.47

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=40 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=87 Participants Both arms combined	TExT-MED Only n=47 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in WHO Quality of Life From 6 Months to 12 Months	6.30 units on a scale Standard Deviation 29.90	2.94 units on a scale Standard Deviation 32.16	0.09 units on a scale Standard Deviation 34.02

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=98 Participants Both arms combined	TExT-MED Only n=52 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Family Behavior Checklist - Supportive From Baseline	.12 units on a scale Standard Deviation 9.08	.36 units on a scale Standard Deviation 8.48	.58 units on a scale Standard Deviation 7.99

SECONDARY outcome

Timeframe: 12 Months

Population: patients who achieved follow up at 12 months

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=40 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=87 Participants Both arms combined	TExT-MED Only n=47 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months	-.98 units on a scale Standard Deviation 9.32	-.83 units on a scale Standard Deviation 8.52	-.70 units on a scale Standard Deviation 7.87

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=98 Participants Both arms combined	TExT-MED Only n=52 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline	.56 units on a scale Standard Deviation 6.86	.57 units on a scale Standard Deviation 6.51	.58 units on a scale Standard Deviation 6.25

SECONDARY outcome

Timeframe: 12 Months

Population: patients who achieved follow up at 12 months

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=40 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=87 Participants Both arms combined	TExT-MED Only n=47 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months	-1.13 units on a scale Standard Deviation 6.93	-.98 units on a scale Standard Deviation 6.46	-.85 units on a scale Standard Deviation 6.10

SECONDARY outcome

Timeframe: 6 Months

Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received.

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=98 Participants Both arms combined	TExT-MED Only n=52 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Care Profile Support From Baseline Perceived Disease Specific Support Needs	5.80 units on a scale Standard Error 9.06	5.08 units on a scale Standard Error 9.99	4.44 units on a scale Standard Error 10.79
Change in Diabetes Care Profile Support From Baseline Perceived Disease Specific Support Received	-3.65 units on a scale Standard Error 9.11	-1.76 units on a scale Standard Error 9.54	-0.08 units on a scale Standard Error 9.68
Change in Diabetes Care Profile Support From Baseline Support Attitudes	-0.87 units on a scale Standard Error 5.73	0.10 units on a scale Standard Error 6.20	0.96 units on a scale Standard Error 6.51

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=40 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=87 Participants Both arms combined	TExT-MED Only n=47 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Diabetes Care Profile Support From 6 Months to 12 Months Support Attitudes	0.08 units on a scale Standard Deviation 4.01	-0.38 units on a scale Standard Deviation 4.31	-0.77 units on a scale Standard Deviation 4.56
Change in Diabetes Care Profile Support From 6 Months to 12 Months Perceived Disease Specific Support Needs	0.40 units on a scale Standard Deviation 10.31	-0.02 units on a scale Standard Deviation 9.17	-0.38 units on a scale Standard Deviation 8.17
Change in Diabetes Care Profile Support From 6 Months to 12 Months Perceived Disease Specific Support Received	2.70 units on a scale Standard Deviation 8.17	0.49 units on a scale Standard Deviation 8.06	-1.38 units on a scale Standard Deviation 7.54

SECONDARY outcome

Timeframe: 6 Months

Population: 10 participants decline to answer questions. 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and\&Tangible subscales.(Norbeck, Lindsey, \& Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) \& tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=41 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=88 Participants Both arms combined	TExT-MED Only n=47 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Norbeck Social Support Questionnaire From Baseline Emotional	-0.22 units on a scale Standard Deviation 4.41	0.24 units on a scale Standard Deviation 4.20	0.64 units on a scale Standard Deviation 4.02
Change in Norbeck Social Support Questionnaire From Baseline Tangible	-0.29 units on a scale Standard Deviation 2.02	-0.10 units on a scale Standard Deviation 2.00	0.06 units on a scale Standard Deviation 1.99

SECONDARY outcome

Timeframe: 12 Months

Population: 2 participants decline to answer question

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=39 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=85 Participants Both arms combined	TExT-MED Only n=46 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months Emotional	0.69 units on a scale Standard Deviation 4.01	0.06 units on a scale Standard Deviation 4.04	-0.48 units on a scale Standard Deviation 4.03
Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months Tangible	0.48 units on a scale Standard Deviation 2.08	0.02 units on a scale Standard Deviation 2.16	-0.36 units on a scale Standard Deviation 2.17

SECONDARY outcome

Timeframe: 6 Months

Population: Supporters who were reached for follow up at 6 months

Supporter diabetes-related distress is measured by the Partner Distress Scale (Polonsky, Fisher, Hessler, \&Johnson, 2016). The self-report scale consists of 21 items in 4 domains: "my partner's diabetes management", "how best to help", "diabetes \& me", \& "hypoglycemia". Domains are summed together. Each item is score from 0 to 4, lower scores indicate less distress. The total score is an average of the 21 items. The Cronbach's alpha was 0.76 for total scores. Greater partner distress is correlated with higher A1C among patients, worse self-care \& lower satisfaction with relationship

Outcome measures

Outcome measures
Measure	TExT-MED+FANS n=54 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total n=116 Participants Both arms combined	TExT-MED Only n=62 Participants Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change
Change in Partner Distress Scale From Baseline	.13 units on a scale Standard Deviation .89	.37 units on a scale Standard Deviation .89	.45 units on a scale Standard Deviation 0.83

Adverse Events

TExT-MED Only

Serious events: 21 serious events

Other events: 0 other events

Deaths: 0 deaths

TExT-MED+FANS

Serious events: 19 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	TExT-MED Only n=86 participants at risk Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	TExT-MED+FANS n=80 participants at risk Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support
Endocrine disorders Report of Hypoglycemic events	24.4% 21/86 • Number of events 32 • 1 year	23.8% 19/80 • Number of events 24 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Burner

University of Southern California

Phone: 3234096667

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place