CGM Use in Non-insulin Patients With DM2 (CGM-DWI)

Use of Continuous Glucose Monitoring in Veterans With Uncontrolled Diabetes Managed Without Insulin Therapy

The U.S. Food and Drug Administration (FDA) has approved multiple Continuous Glucose Monitoring (CGM) devices from different manufacturers to be used as an aide in patients with type 1 and type 2 diabetes who require medications, and more recently, as over the counter versions for patients with and or without diabetes who want to better understand how diet and exercise may impact blood sugar levels. However robust evidence supporting that CGM is significantly superior to traditional home fingerstick blood glucose monitoring (FSBGM) in this population is lacking. Thus, Medicare and VHA only authorize use of CGM for patients with diabetes who require daily insulin therapy , unless they meet special criteria such as having hypoglycemia or inability to monitor glucose via traditional FSBGM.

Objectives Primary Study Aim: Among veterans with uncontrolled diabetes not requiring insulin therapy who are participating in an intensive multidisciplinary program to improve diabetes control (VDOP), to assess whether use of a CGM compared to use of traditional FSBGM results in greater change in hemoglobin A1c upon VDOP completion and up to 12 months.

Secondary study aims: To assess whether use of CGM in this population leads to greater improvement in diet, physical activity, and weight loss upon VDOP completion and up to 12 months.

Hypothesis

The use of a CGM by Veterans with T2DM who do not use insulin will help them improve their diabetes self - management (diet, physical activity, weight) and glycemic control more so than those using traditional fingerstick glucose monitoring.

Methods

This will be a prospective "open label" randomized controlled trial where participants will be randomly assigned to CGM (intervention group) or FSBGM (control group) during their participation in VDOP.

Relevance to Veterans and VA mission

Most Veterans with T2DM do not use insulin. It is important for both, these Veterans and the VA, to learn whether this more costly and somewhat burdensome technology supports improvement in diabetes self-management

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Type 2 Diabetes (T2DM); Non Insulin Dependent Diabetes Mellitus; Obesity Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: CGM Group; Device: FSBG group

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlos E Mendez, MD; Phone Number: 41435 414-384-2000; Email: carlos.mendez2@va.gov
• Study Contact Backup: Name: Colleen Veenendaal, RN, Research Coordinator; Phone Number: 41484 (414) 384-2000; Email: Colleen.Veenendaal@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Successfully enrolled and ready to begin the VDOP program not on insulin therapy
• Type 2 diabetes by clinical history
• HbA1C between 8.0-12.0% inclusive within 3 months of enrollment
• Assessment by clinician that patient is willing to and able to wear a CGM device
• Stable diabetes medication regimen during the 3 months prior to entry

Exclusion Criteria:

• Patients already or planned on starting insulin therapy, already on CGM, or those who qualify for CGM under VA policy
• Patients with gestational diabetes or pregnant at time of screening or are planning to become pregnant during the study
• Patients with end stage renal disease (ESRD) on dialysis
• Anticipated acute uses of glucocorticoids (oral, injectable, or IV)
• Acute conditions that impact the HbA1c measurement stability such as GI blood loss, recent (within 3 months of study entry), anticipated red blood cell transfusion or erythropoietin administration
• Known or suspected significant allergy to use the Dexcom sensors
• Planning or currently enrolled on different weight program different from MOVE!
• Participating other clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CGM group; This group will receive CGM device for glucose monitoring	Device: CGM Group; This group of patients will receive a CGM device to monitor their blood glucoses
Active Comparator: FSBG group; This group will receive fingerstick device for glucose monitoring	Device: FSBG group; This group of patients will receive a fingerstick blood glucose (FSBG) device for glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control	HbA1c	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	lbs, Kg, and BMI	12 months

Collaborators and Investigators

• Sponsor: Milwaukee VA Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: August 12, 2025
• First Posted (Actual): August 18, 2025

Study Record Updates

• Last Update Posted (Actual): August 18, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 1856488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No