My Diabetes, My Community

NCT04970810 | Completed Results

• 2 other identifiers: IRB20-08701R01DK127961-01
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Change in Percent of Hemoglobin A1C

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

  Baseline to 12 months

Secondary Outcomes (4)

• Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12

  Baseline to 12 months

• Personalized A1C Goals

  Baseline to Month 1 Call

• Number of Participants Who Achieved Personalized A1C Goals

  Baseline to 12 months

• Diabetes Empowerment Scale (DES)

  Baseline to 12 months

Study Arms (3)

Attention Control

NO INTERVENTION

Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)

My Diabetes Goal

ACTIVE COMPARATOR

My Diabetes Goal protocol

Behavioral: My Diabetes Goal

My Diabetes Goal + Community Rx

ACTIVE COMPARATOR

My Diabetes Goal protocol + Community Rx protocol

Behavioral: My Diabetes Goal + CommunityRx

Interventions

My Diabetes Goal BEHAVIORAL

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

My Diabetes Goal + CommunityRx BEHAVIORAL

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.

My Diabetes Goal + Community Rx

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• 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.

  PMID: 36909590 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jacqueline Kanoon
• Organization: University of Chicago

kanoon@bsd.uchicago.edu

773-834-3419

Study Officials

• Elbert Huang

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Stacy Lindau

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This will be a single-blind study, and subjects will blinded to the different group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: July 21, 2021
• Study Start: July 29, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)