Virtual Diabetes Group Visits Across Health Systems

NCT06094491 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: IRB23-0325P50MD017349-04
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 2

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).

Conditions

T2DM (Type 2 Diabetes Mellitus); Hypertension; Heart Disease Chronic; Stroke; Hyperlipidemias; Peripheral Vascular Diseases; Obesity

Keywords

virtual group visits

Outcome Measures

Primary Outcomes (1)

• A1c

  This is blood test that measures the percent of glucose and hemoglobin bound together.

  12 months

Secondary Outcomes (3)

• Systolic blood pressure

  12 months

• Body Mass Index

  12 months

• Low density lipoproteins

  12 months

Study Arms (2)

Virtual Group Visit Arm

EXPERIMENTAL

These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.

Behavioral: Virtual Group Visit

Usual Care Arm

NO INTERVENTION

These subjects will receive usual diabetes care at ACCESS or Advocate health centers.

Interventions

Virtual Group Visit BEHAVIORAL

Group visits must have these core components: diabetes education, group social support and goal setting.

Virtual Group Visit Arm

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Wake Forest University Health Sciences: collaborator
• ACCESS Community Health Network: collaborator
• Midwest Clinicians' Network: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Access Community Health Network

Chicago, Illinois, 60661, United States

Location

Advocate Health Care

Orland Park, Illinois, 60462, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Stroke; Hyperlipidemias; Peripheral Vascular Diseases; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arshiya Baig, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Type I hybrid effectiveness-implementation cluster randomized trial among adult patients with T2DM across 9 intervention sites and 9 control sites

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: May 3, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)