NCT04970810

My Diabetes, My Community

Completed NA Results posted Last updated 17 December 2025

What this trial tests

NA trial testing My Diabetes Goal in Type 2 Diabetes in 512 participants. Completed in 31 October 2024.

Timeline

29 July 2021

Primary endpoint
31 October 2024

31 October 2024

Quick facts

Lead sponsor	University of Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	512
Start date	29 July 2021
Primary completion	31 October 2024
Estimated completion	31 October 2024
Sites	1 location across United States

Drugs / interventions tested

• My Diabetes Goal
• My Diabetes Goal + CommunityRx

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

University of Chicago

Who can join

60 and older, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Percent of Hemoglobin A1C Primary · Baseline to 12 months

Mean change in percent of hemoglobin A1C from baseline to month 12.

Group	Value	95% CI
Attention Control	-1.1	± 1.79
My Diabetes Goal	-0.8	± 2.1
My Diabetes Goal + Community Rx	-0.8	± 1.5

Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12 Secondary · Baseline to 12 months

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.

Documented Goals at Baseline

Group	Value	95% CI
Attention Control	52
My Diabetes Goal	60
My Diabetes Goal + Community Rx	43

Documented Goals After Baseline

Group	Value	95% CI
Attention Control	43
My Diabetes Goal	165
My Diabetes Goal + Community Rx	156

Personalized A1C Goals Secondary · Baseline to Month 1 Call

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.

Initial Goal

Group	Value	95% CI
My Diabetes Goal	6.6	± 0.9
My Diabetes Goal + Community Rx	6.7	± 0.7

Modified Goal

Group	Value	95% CI
My Diabetes Goal	7.1	± 0.8
My Diabetes Goal + Community Rx	7.1	± 0.7

Number of Participants Who Achieved Personalized A1C Goals Secondary · Baseline to 12 months

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.

Achieved Goal at Baseline

Group	Value	95% CI
My Diabetes Goal	5
My Diabetes Goal + Community Rx	1

Achieved Goal at 12 Months

Group	Value	95% CI
My Diabetes Goal	38
My Diabetes Goal + Community Rx	34

Diabetes Empowerment Scale (DES) Secondary · Baseline to 12 months

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.

Group	Value	95% CI
Attention Control	-0.1	± 1.0
My Diabetes Goal	-0.2	± 1.2
My Diabetes Goal + Community Rx	0.03	± 1.1

Sponsor's own description

Older adults with diabetes are a highly vulnerable population that suffers the highest rates of cardiovascular and microvascular complications as well as adverse drug events such as hypoglycemia. Investigators will conduct a 12-month pragmatic clinical trial evaluating the impact of scalable interventions that are designed to support personalized goal setting and self-care through remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage. This highly personalized approach to diabetes care has to potential to improve quality of life of this high-risk population while avoiding adverse drug events.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care
   Abramsohn EM, De Ornelas M, Borson S, Frazier CR, et al · · 2023 · DOI 10.21203/rs.3.rs-2464681/v1