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CGM Use in Non-insulin Patients With DM2

NCT07128342 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-18

No results posted yet for this study

Summary

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

Conditions

  • Diabetes
  • Type 2 Diabetes (T2DM)
  • Obesity Type 2 Diabetes Mellitus
  • Non Insulin Dependent Diabetes Mellitus

Interventions

DEVICE

CGM Group

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

DEVICE

FSBG group

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

Sponsors & Collaborators

  • Milwaukee VA Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-11-30
Completion
2028-11-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128342 on ClinicalTrials.gov