My Diabetes, My Community

Type 2 Diabetes Clinical Trial

Official title:

My Diabetes, My Community

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04970810
• Other study ID #: IRB20-0870
• Secondary ID: 1R01DK127961-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 29, 2021
• Est. completion date: July 28, 2024

Study information

• Verified date: September 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 505
• Est. completion date: July 28, 2024
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c	Change in A1c	Baseline to 12 months
Secondary	Assessment of personalized diabetes care goal	Investigators will compare diabetes care goals documented in the EHR against the study survey. The possible values will be yes or no goals documented in the EHR.	Baseline to 12 months
Secondary	Patients' ability to reach personalized goals	Investigators will measure whether or not patients are reaching the 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
Secondary	Diabetes Self-Efficacy	Evaluate subject self-efficacy through the diabetes empowerment scale.	Baseline to 12 months