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
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
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)