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NCT Number: NCT07128342

CGM Use in Non-insulin Patients With DM2

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

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Non Insulin Dependent Diabetes Mellitus Nutritional and Metabolic Diseases Obesity Type 2 Diabetes Mellitus Type 2 Diabetes (T2DM)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CGM Group

Device

This group of patients will receive a CGM device to monitor their blood glucoses

FSBG group

Device

This group of patients will receive a fingerstick blood glucose (FSBG) device for glucose monitoring

Primary outcomes

  1. Glycemic Control

    Time frame: 12 months

    HbA1c

Secondary outcomes

  1. Weight loss

    Time frame: 12 months

    lbs, Kg, and BMI

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos E Mendez, MD

CONTACT

[email protected]

414-384-2000 ext. 41435

Colleen Veenendaal, RN, Research Coordinator

CONTACT

[email protected]

(414) 384-2000 ext. 41484

Sponsors and collaborators

Lead sponsor

Milwaukee VA Medical Center

Fed

Registry information

Official study title

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

Acronym: CGM-DWI

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 18, 2025
Registry last updated
Aug 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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