NCT07128342Not yet recruiting
CGM Use in Non-insulin Patients With DM2
Use of Continuous Glucose Monitoring in Veterans With Uncontrolled Diabetes Managed Without Insulin Therapy
Source: ClinicalTrials.gov · Last updated 18 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 12 Aug 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Milwaukee VA Medical Center
- Diseases
- Obesity, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07128342
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Nov 2025 to the primary completion date, 30 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients already or planned on starting insulin therapy, already on CGM, or those who qualify for CGM under VA policy
Other illness
- 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
- Known or suspected significant allergy to use the Dexcom sensors
Lab values
- 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
Other
- Anticipated acute uses of glucocorticoids (oral, injectable, or IV)
- Planning or currently enrolled on different weight program different from MOVE!
- Participating other clinical trials
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.