CGM Use in Non-insulin Patients With DM2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CGM Group, FSBG group.
- Who it may be relevant to
- Registry conditions: Diabetes, Type 2 Diabetes (T2DM), Obesity Type 2 Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Continuous Glucose Monitoring in Veterans With Uncontrolled Diabetes Managed Without Insulin Therapy
Overview
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
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
Primary outcome measures
- Glycemic Control [Time frame: 12 months]
Secondary outcome measures (1)
- Weight loss [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07128342 · 1856488