My Diabetes, My Community

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: My Diabetes Goal; Behavioral: My Diabetes Goal + CommunityRx

Detailed Description

To address the needs of older patients with diabetes, multiple organizations have called for a personalized approach to setting risk factor goals and self-care plans. The American Geriatrics Society (AGS) and the American Diabetes Association (ADA) have published recommendations urging individualized glycemic goals (hemoglobin A1C (A1C) <7.5%, <8.0%, or <8.5%) for three strata of older patients (healthy, complex, very complex). The guidelines also acknowledge the importance of addressing socioeconomic risks that are barriers to self-care management such as cost-related non-adherence and food insecurity. Despite widespread agreement by experts, the clinical impact of this highly personalized approach to diabetes care for older adults has been rarely studied in controlled trials. Interventions designed to personalize diabetes care must overcome multiple challenges to implementation including the brief clinical encounter, lack of patient engagement between encounters, and lack of systems to leverage community-based self-care resources.

Investigators propose to address these knowledge and care gaps by studying the integration of two evidence-based interventions designed to engage patients and enhance self-care:. Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL) and CommunityRx. The My Diabetes GOAL intervention is designed to engage older patients in personalized goal setting and chronic disease management.

• Study Type: Interventional
• Enrollment (Actual): 512
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. History of type 2 diabetes
2. Seen in clinic within past year
3. A1C>7.5%
4. Community dwelling
5. Access to personal email address OR internet access
6. Speaks and reads English
7. Resides in the target geographic region (zip codes)

Exclusion Criteria:

1. Unable to consent to study for themselves
2. Prior participation in CRxCaregiver, CRxHunger, or My Diabetes GOAL trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Attention Control; Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
Active Comparator: My Diabetes Goal; My Diabetes Goal protocol	Behavioral: 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.
Active Comparator: My Diabetes Goal + Community Rx; My Diabetes Goal protocol + Community Rx protocol	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Percent of Hemoglobin A1C	Mean change in percent of hemoglobin A1C from baseline to month 12.	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12	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.	Baseline to 12 months
Personalized A1C Goals	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.	Baseline to Month 1 Call
Number of Participants Who Achieved Personalized A1C Goals	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.	Baseline to 12 months
Diabetes Empowerment Scale (DES)	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.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Elbert Huang, University of Chicago; Principal Investigator: Stacy Lindau, University of Chicago

Publications and helpful links

General Publications

• Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB20-0870; 1R01DK127961-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No