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

Milwaukee VA Medical Center

Status: Not yet enrolling

Conditions: Type 2 Diabetes (T2DM); Diabetes; Non Insulin Dependent Diabetes Mellitus; Obesity Type 2 Diabetes Mellitus

Treatments: Device: CGM Group; Device: FSBG group

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07128342

1856488

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CGM group

Active Comparator group

Description:

This group will receive CGM device for glucose monitoring

Treatment:

Device: CGM Group

FSBG group

Active Comparator group

Description:

This group will receive fingerstick device for glucose monitoring

Treatment:

Device: FSBG group