Virtual Diabetes Group Visits Across Health Systems

Phase 2

Recruiting

• Conditions: Obesity; Stroke; T2DM (Type 2 Diabetes Mellitus); Hypertension; Hyperlipidemias; Peripheral Vascular Diseases; Heart Disease Chronic
• Interventions: Behavioral: Virtual Group Visit

• Registration Number: NCT06094491
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of this project is to evaluate the effectiveness of a virtual diabetes group visits on patients with type 2 diabetes mellitus (T2DM).

Detailed Description

Managing diabetes can be complex and burdensome; patients must modify their diet, take medications, check their blood sugar, and visit their healthcare providers regularly. Diabetes group visits (GVs)-virtual group education and diabetes support, including goal setting-create a unique setting where patients can connect with peers and receive medical care and support. GVs can improve glycemic control and decrease healthcare utilization. GVs can provide patients with comprehensive care for their multimorbid chronic condition.

Virtual GVs provide an opportunity to adapt to the current trends of telehealth and the ability to increase reach and scalability across multiple sites. Before the model can be widely adopted, important questions about the effectiveness and implementation of the virtual diabetes GV model need to be addressed. The investigators propose to build on an established program of diabetes GVs. This proposal aims to implement the virtual GV model (VIDA: Virtual Diabetes Group Visits Across Health Systems) in two distinct health systems in the Chicago region. Access Community Health Network (ACCESS) is one of the largest federally qualified health centers (FQHCs) in the United States with 35 sites across the Chicago metropolitan area, providing care for 175,000 medically underserved and low-income patients each year, including over 25,000 patients with diabetes and 30,000 patients who are uninsured; 60% of ACCESS' patients are Hispanic and 30% are African-American. Advocate Health Care (ADVOCATE) is a large, diverse, integrated private not-for-profit health system that includes 26 hospitals and more than 500 ambulatory sites. The system provides care across more than 129 primary care clinics in Illinois serving over 117,000 patients, of which 27% identify as African American/Black and 15% identify as Hispanic/Latino. Both are community-based health systems serving low-income and communities of color in Chicago and are network partners of the Chicago Chronic Condition Equity Network (C3EN).

No studies have systematically implemented virtual diabetes GVs for adults with T2DM in the real-world primary care setting or across distinct health systems. The ability to train, implement, and evaluate virtual GVs across systems with different care models provides the opportunity to learn about adaptation and the barriers and facilitators for implementation. This proposed study will compare virtual diabetes GVs to usual care using a type I hybrid effectiveness-implementation design via a pragmatic cluster randomized trial.

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Study Start: 2024-05-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-06
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• Patient at a participating clinic (at least one visit in year prior to first GV)
• Type 2 diabetes
• ≥ 18 years old
• A1C>8% within 6 months prior to first GV (we will first recruit patients with A1C>9%, then if spaces still available A1C>8.5%, then if spaces still available A1C>8%)
• At least one additional cardiovascular condition (hypertension, heart disease, stroke, hyperlipidemia, peripheral vascular disease, or BMI ≥ 30)
• English or Spanish speaking
• PCP assented to recruiting patient
• Patient provides written consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Group Visit Arm	Virtual Group Visit	These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.

Primary Outcome Measures

Name	Time	Method
A1c	12 months	This is blood test that measures the percent of glucose and hemoglobin bound together.

Secondary Outcome Measures

Name	Time	Method
Low density lipoproteins	12 months	a measure of cholesterol in the blood
Systolic blood pressure	12 months	Systolic blood pressure measures the arterial pressure
Body Mass Index	12 months	Measure of body fat based on height and weight

Trial Locations

Locations (2)

Access Community Health Network; 🇺🇸 Chicago, Illinois, United States

Advocate Health Care; 🇺🇸 Orland Park, Illinois, United States