Trial Outcomes & Findings for My Diabetes, My Community (NCT NCT04970810)
NCT ID: NCT04970810
Last Updated: 2025-12-17
Results Overview
Mean change in percent of hemoglobin A1C from baseline to month 12.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
512 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2025-12-17
Participant Flow
Participant milestones
| Measure |
Attention Control
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
|
My Diabetes Goal
My Diabetes Goal protocol
My Diabetes Goal: Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
|
My Diabetes Goal + Community Rx
My Diabetes Goal protocol + Community Rx protocol
My Diabetes Goal + CommunityRx: Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
|
|---|---|---|---|
|
Overall Study
STARTED
|
170
|
173
|
169
|
|
Overall Study
Completed 6 Month Follow up Survey
|
156
|
152
|
149
|
|
Overall Study
Completed 12 Month Follow-up Survey
|
156
|
146
|
147
|
|
Overall Study
COMPLETED
|
167
|
173
|
165
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
4
|
Reasons for withdrawal
| Measure |
Attention Control
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
|
My Diabetes Goal
My Diabetes Goal protocol
My Diabetes Goal: Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
|
My Diabetes Goal + Community Rx
My Diabetes Goal protocol + Community Rx protocol
My Diabetes Goal + CommunityRx: Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
|
|---|---|---|---|
|
Overall Study
deemed ineligible after randomization
|
3
|
0
|
4
|
Baseline Characteristics
My Diabetes, My Community
Baseline characteristics by cohort
| Measure |
Attention Control
n=167 Participants
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
|
My Diabetes Goal
n=173 Participants
My Diabetes Goal protocol
My Diabetes Goal: Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
|
My Diabetes Goal + Community Rx
n=165 Participants
My Diabetes Goal protocol + Community Rx protocol
My Diabetes Goal + CommunityRx: Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
|
Total
n=505 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 6.3 • n=6 Participants
|
68.8 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
69.2 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
69.0 years
STANDARD_DEVIATION 6.3 • n=122 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=6 Participants
|
114 Participants
n=5 Participants
|
113 Participants
n=5 Participants
|
332 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=6 Participants
|
59 Participants
n=5 Participants
|
52 Participants
n=5 Participants
|
173 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
123 Participants
n=6 Participants
|
126 Participants
n=5 Participants
|
129 Participants
n=5 Participants
|
378 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=6 Participants
|
33 Participants
n=5 Participants
|
25 Participants
n=5 Participants
|
86 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 Participants
n=6 Participants
|
14 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=122 Participants
|
|
Region of Enrollment
United States
|
167 participants
n=6 Participants
|
173 participants
n=5 Participants
|
165 participants
n=5 Participants
|
505 participants
n=122 Participants
|
|
Most Recent A1C Value
|
9.0 % (percentage of A1C)
STANDARD_DEVIATION 1.5 • n=6 Participants
|
9.1 % (percentage of A1C)
STANDARD_DEVIATION 1.6 • n=5 Participants
|
9.0 % (percentage of A1C)
STANDARD_DEVIATION 1.5 • n=5 Participants
|
9.0 % (percentage of A1C)
STANDARD_DEVIATION 1.5 • n=122 Participants
|
|
Diabetes Empowerment Scale (DES)
|
4.2 units on a scale
STANDARD_DEVIATION 0.6 • n=6 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 0.6 • n=122 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: There are missing 12 month A1C values for all three study arms.
Mean change in percent of hemoglobin A1C from baseline to month 12.
Outcome measures
| Measure |
Attention Control
n=138 Participants
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
|
My Diabetes Goal
n=139 Participants
My Diabetes Goal protocol
My Diabetes Goal: Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
|
My Diabetes Goal + Community Rx
n=129 Participants
My Diabetes Goal protocol + Community Rx protocol
My Diabetes Goal + CommunityRx: Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
|
|---|---|---|---|
|
Mean Change in Percent of Hemoglobin A1C
|
-1.1 percentage of hemoglobin A1C
Standard Deviation 1.79
|
-0.8 percentage of hemoglobin A1C
Standard Deviation 2.1
|
-0.8 percentage of hemoglobin A1C
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: The number of analyzed A1C goal results is dependent on the number of survey respondents.
We reviewed the electronic health records (EHR) to assess how many participants had a documented goal in the EHR at baseline and at 12 months. The possible values will be yes or no goals documented in the EHR.
Outcome measures
| Measure |
Attention Control
n=167 Participants
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
|
My Diabetes Goal
n=173 Participants
My Diabetes Goal protocol
My Diabetes Goal: Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
|
My Diabetes Goal + Community Rx
n=165 Participants
My Diabetes Goal protocol + Community Rx protocol
My Diabetes Goal + CommunityRx: Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
|
|---|---|---|---|
|
Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12
Documented Goals at Baseline
|
52 Participants
|
60 Participants
|
43 Participants
|
|
Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12
Documented Goals After Baseline
|
43 Participants
|
165 Participants
|
156 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 1 CallPopulation: The number of analyzed A1C goal results is dependent on the number of survey respondents in the two intervention arms. The Attention Control arm did not include a goal setting conversation with a nurse.
The A1C goal outcome is based on a survey response and is distinct from the measured A1C from laboratory testing. Goal setting conversation with nurse occurred during Month 1 call.
Outcome measures
| Measure |
Attention Control
n=173 Participants
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
|
My Diabetes Goal
n=165 Participants
My Diabetes Goal protocol
My Diabetes Goal: Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
|
My Diabetes Goal + Community Rx
My Diabetes Goal protocol + Community Rx protocol
My Diabetes Goal + CommunityRx: Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
|
|---|---|---|---|
|
Personalized A1C Goals
Initial Goal
|
6.6 % (percentage A1c)
Standard Deviation 0.9
|
6.7 % (percentage A1c)
Standard Deviation 0.7
|
—
|
|
Personalized A1C Goals
Modified Goal
|
7.1 % (percentage A1c)
Standard Deviation 0.8
|
7.1 % (percentage A1c)
Standard Deviation 0.7
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: The number of analyzed A1C goal results is dependent on the number of survey respondents in the two intervention arms. The Attention Control arm did not include a goal setting exercise.
Investigators will measure whether or not patients are reaching the modified goals they have documented in the survey, among those who have set up their personalized goals. The possible values will be yes or no reaching personalized goals.
Outcome measures
| Measure |
Attention Control
n=170 Participants
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
|
My Diabetes Goal
n=160 Participants
My Diabetes Goal protocol
My Diabetes Goal: Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
|
My Diabetes Goal + Community Rx
My Diabetes Goal protocol + Community Rx protocol
My Diabetes Goal + CommunityRx: Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
|
|---|---|---|---|
|
Number of Participants Who Achieved Personalized A1C Goals
Achieved Goal at Baseline
|
5 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Achieved Personalized A1C Goals
Achieved Goal at 12 Months
|
38 Participants
|
34 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Number analyzed is dependent on survey respondents.
Evaluate subject self-efficacy through the Diabetes Empowerment Scale (DES). DES is a standardized questionnaire including 28 questions with response categories of 'strongly disagree', 'somewhat disagree', 'neutral', 'somewhat agree', and 'strongly agree'. A total score for the DES is calculated by summing all of the item scores and dividing by 28 for a possible score range of 1-5 where a higher score indicates a higher level of empowerment.
Outcome measures
| Measure |
Attention Control
n=156 Participants
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
|
My Diabetes Goal
n=146 Participants
My Diabetes Goal protocol
My Diabetes Goal: Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
|
My Diabetes Goal + Community Rx
n=148 Participants
My Diabetes Goal protocol + Community Rx protocol
My Diabetes Goal + CommunityRx: Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
|
|---|---|---|---|
|
Diabetes Empowerment Scale (DES)
|
-0.1 score on a scale
Standard Deviation 1.0
|
-0.2 score on a scale
Standard Deviation 1.2
|
0.03 score on a scale
Standard Deviation 1.1
|
Adverse Events
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
My Diabetes Goal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
My Diabetes Goal + Community Rx
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place