Trial Outcomes & Findings for i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management (NCT NCT03652389)

NCT ID: NCT03652389

Last Updated: 2025-02-19

Results Overview

Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 246 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-02-19

Participant Flow

N= 246 participants were enrolled, N=9 of these participants were not randomized to treatment.

Participant milestones

Measure	MJS DIABETES MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care Standard Diabetes Treatment
Overall Study STARTED	117	120
Overall Study COMPLETED	109	114
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Measure	MJS DIABETES MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care Standard Diabetes Treatment
Overall Study Lost to Follow-up	1	5
Overall Study Withdrawal by Subject	5	1
Overall Study New diagnosis	2	0

Baseline Characteristics

i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management

Baseline characteristics by cohort

Measure	MJS DIABETES n=109 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=114 Participants Standard Diabetes Treatment	Total n=223 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 9.54 • n=5 Participants	55.7 years STANDARD_DEVIATION 9.31 • n=7 Participants	56.1 years STANDARD_DEVIATION 9.41 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	66 Participants n=7 Participants	133 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	48 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants	94 Participants n=7 Participants	184 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	38 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants	114 participants n=7 Participants	223 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
HbA1c Level at Baseline	8.37 Percentage of total hemoglobin Interval 8.06 to 8.68	8.29 Percentage of total hemoglobin Interval 7.98 to 8.6

PRIMARY outcome

Timeframe: Month 12

Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
HbA1c Level at Month 12	8.02 Percentage of total hemoglobin Interval 7.69 to 8.35	8.15 Percentage of total hemoglobin Interval 7.82 to 8.48

SECONDARY outcome

Timeframe: Baseline

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score	3.87 score on a scale Standard Deviation 1.68	3.42 score on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: Month 3

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score	4.31 score on a scale Standard Deviation 1.64	4 score on a scale Standard Deviation 1.84

SECONDARY outcome

Timeframe: Month 6

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score	4.21 score on a scale Standard Deviation 1.53	4.13 score on a scale Standard Deviation 1.65

SECONDARY outcome

Timeframe: Month 9

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score	4.47 score on a scale Standard Deviation 1.48	4.18 score on a scale Standard Deviation 1.67

SECONDARY outcome

Timeframe: Month 12

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score	4.48 score on a scale Standard Deviation 1.54	4.29 score on a scale Standard Deviation 1.66

SECONDARY outcome

Timeframe: Baseline

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score	2.93 score on a scale Standard Deviation 2.02	2.59 score on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Month 3

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score	3.56 score on a scale Standard Deviation 2.22	2.98 score on a scale Standard Deviation 2.32

SECONDARY outcome

Timeframe: Month 6

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score	3.68 score on a scale Standard Deviation 2.1	3.1 score on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Month 9

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score	3.54 score on a scale Standard Deviation 2	3.01 score on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: Month 12

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score	3.62 score on a scale Standard Deviation 2.09	3.26 score on a scale Standard Deviation 2.16

SECONDARY outcome

Timeframe: Baseline

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score	3.74 score on a scale Standard Deviation 2.78	3.74 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Month 3

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score	4.4 score on a scale Standard Deviation 2.79	4.07 score on a scale Standard Deviation 2.76

SECONDARY outcome

Timeframe: Month 6

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score	4.32 score on a scale Standard Deviation 2.8	3.95 score on a scale Standard Deviation 2.92

SECONDARY outcome

Timeframe: Month 9

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score	4.24 score on a scale Standard Deviation 2.8	4.04 score on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: Month 12

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score	4.43 score on a scale Standard Deviation 2.71	3.98 score on a scale Standard Deviation 2.89

SECONDARY outcome

Timeframe: Baseline

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score	3.12 score on a scale Standard Deviation 2.69	3.05 score on a scale Standard Deviation 2.63

SECONDARY outcome

Timeframe: Month 3

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score	3.62 score on a scale Standard Deviation 2.42	3.77 score on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: Month 6

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score	4.1 score on a scale Standard Deviation 2.58	3.89 score on a scale Standard Deviation 2.56

SECONDARY outcome

Timeframe: Month 9

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score	4.27 score on a scale Standard Deviation 2.33	3.98 score on a scale Standard Deviation 2.38

SECONDARY outcome

Timeframe: Month 12

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score	4.39 score on a scale Standard Deviation 2.29	4 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline

20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Michigan Diabetes Knowledge Scale Score	0.66 score on a scale Standard Deviation 0.17	0.65 score on a scale Standard Deviation 0.14

SECONDARY outcome

Timeframe: Month 6

20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Michigan Diabetes Knowledge Scale Score	0.68 score on a scale Standard Deviation 0.16	0.64 score on a scale Standard Deviation 0.15

SECONDARY outcome

Timeframe: Month 12

20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Michigan Diabetes Knowledge Scale Score	0.71 score on a scale Standard Deviation 0.15	0.66 score on a scale Standard Deviation 0.16

SECONDARY outcome

Timeframe: Baseline

12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Diabetes Self-Efficacy Scale Score	7.38 score on a scale Standard Deviation 1.86	7.42 score on a scale Standard Deviation 1.91

SECONDARY outcome

Timeframe: Month 3

12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Diabetes Self-Efficacy Scale Score	7.64 score on a scale Standard Deviation 1.85	7.65 score on a scale Standard Deviation 1.86

SECONDARY outcome

Timeframe: Month 6

12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Diabetes Self-Efficacy Scale Score	8.09 score on a scale Standard Deviation 1.62	7.81 score on a scale Standard Deviation 1.84

SECONDARY outcome

Timeframe: Month 9

12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Diabetes Self-Efficacy Scale Score	7.96 score on a scale Standard Deviation 1.58	7.49 score on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Month 12

12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Diabetes Self-Efficacy Scale Score	8.16 score on a scale Standard Deviation 1.48	7.8 score on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: Baseline

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care Score Communication Subscale Score	4.28 score on a scale Standard Deviation 0.71	4.34 score on a scale Standard Deviation 0.61

SECONDARY outcome

Timeframe: Month 3

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care Score Communication Subscale Score	4.36 score on a scale Standard Deviation 0.64	4.47 score on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: Month 6

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care Score Communication Subscale Score	4.31 score on a scale Standard Deviation 0.66	4.4 score on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Month 9

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care Score Communication Subscale Score	4.4 score on a scale Standard Deviation 0.61	4.49 score on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: Month 12

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care Score Communication Subscale Score	4.36 score on a scale Standard Deviation 0.7	4.45 score on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Baseline

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Decision Making Subscale Score	3.74 score on a scale Standard Deviation 1.12	3.71 score on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Month 3

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Decision Making Subscale Score	3.86 score on a scale Standard Deviation 1.01	3.97 score on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: Month 6

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Decision Making Subscale Score	3.93 score on a scale Standard Deviation 1.12	3.98 score on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: Month 9

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Decision Making Subscale Score	3.93 score on a scale Standard Deviation 1.06	4.09 score on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: Month 12

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Decision Making Subscale Score	3.93 score on a scale Standard Deviation 1.06	4.09 score on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: Baseline

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Inter-personal Style Subscale Score	4.48 score on a scale Standard Deviation 0.63	4.6 score on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: Month 3

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Inter-personal Style Subscale Score	4.53 score on a scale Standard Deviation 0.58	4.67 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Month 6

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Inter-personal Style Subscale Score	4.52 score on a scale Standard Deviation 0.56	4.61 score on a scale Standard Deviation 0.62

SECONDARY outcome

Timeframe: Month 9

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Inter-personal Style Subscale Score	4.47 score on a scale Standard Deviation 0.65	4.6 score on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: Month 12

18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).

Outcome measures

Measure	MJS DIABETES n=117 Participants MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs.	Usual Care n=120 Participants Standard Diabetes Treatment
Interpersonal Processes of Care: Inter-personal Style Subscale Score	4.47 score on a scale Standard Deviation 0.65	4.6 score on a scale Standard Deviation 0.63

Adverse Events

MJS DIABETES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Antoinette M. Schoenthaler

NYU Langone Health

Phone: 646-501-3434

Email: Antoinette.Schoenthaler@nyulangone.org

Results disclosure agreements

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