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My Diabetes, My Community

NCT ID: NCT04970810

Last Updated: 2025-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-29

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
This will be a single-blind study, and subjects will blinded to the different group assignment.

Study Groups

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Attention Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

My Diabetes Goal

My Diabetes Goal protocol

Group Type ACTIVE_COMPARATOR

My Diabetes Goal

Intervention Type 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 + Community Rx

My Diabetes Goal protocol + Community Rx protocol

Group Type ACTIVE_COMPARATOR

My Diabetes Goal + CommunityRx

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elbert Huang

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Stacy Lindau

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36909590 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01DK127961-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB20-0870

Identifier Type: -

Identifier Source: org_study_id