The Use of Libre to Improve Metabolic Control and Reduce Reliance on Medication
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      GEM (Glycemic Excursion Minimization) is a new lifestyle treatment for type 2 diabetes that
      aims to lower glucose levels after meals and snacks. This is different from the current
      lifestyle treatment, which is to lose weight. This study is trying to find out if people who
      are newly diagnosed with type 2 diabetes can use a continuous glucose monitor together with
      the GEM lifestyle to improve control of their diabetes. Study participants will follow the
      GEM lifestyle for 4 months (1 month of treatment and 3 months of maintenance) instead of
      seeking usual care (medications or weight loss programs) to lower blood glucose.
    

Detailed description: 
      For people who are newly diagnosed with Type 2 Diabetes (T2D), it might be possible to delay
      or prevent the need for diabetic medications by reducing postprandial glucose (PPG). Our
      Glycemic Excursion Minimization (GEM) lifestyle intervention can reduce PPG, but it depends
      on blood glucose feedback to help the user learn what elevates their PPG. This study examines
      if continuous feedback from the Libre 2 continuous glucose monitor (CGM) will be advantageous
      for reaching the goals of GEM. We will recruit 18 adult participants newly diagnosed with
      type 2 diabetes who are interested in using the Libre 2 CGM. Six participants will be
      recruited from each of the primary care clinics at the University of Virginia (Dr. Cox), the
      University of Colorado (Dr. Oser) and the University of West Virginia, East Branch (Dr.
      Cucuzzella). Each site will also search their medical records to select 4 participants who
      match their study participants, meet the study criteria, but are being treated with routine
      care. These data will form the Routine Care control group (n=12). Routine Care participants
      will follow their doctor's treatment recommendations, while GEM participants will complete
      the 1-month, self-directed GEM lifestyle training using the Libre 2 CGM and a FitBit to
      monitor progress. They will then maintain the GEM lifestyle for 3 more months. The Total
      Treatment Effect (a measure of treatment effectiveness that considers both A1c and medication
      changes) will be calculated pre- and post-treatment from medical record data. CGM data from
      GEM participants will be collected and analyzed. CGM sensor use will be tracked to estimate
      participant engagement. We anticipate this multi-center pilot project will demonstrate the
      benefits of using Libre 2 with a structured lifestyle intervention designed to reduce
      postprandial blood glucose excursions for individuals newly diagnosed with T2D.
    

Intervention name(s): GEM + CGM
Intervention type(s): Behavioral
Intervention description(s): Participants follow the GEM guidebook for 4 months (1 month of intervention and 3 months of maintenance) while wearing a FitBit activity monitor and a Freestyle Libre 2 CGM to provide feedback about activity and blood glucose. The GEM guidebook covers Routine choices, Recovering from blood glucose excursions, Reducing blood glucose excursions, and Maintenance.
Intervention model: Single Group Assignment
Intervention model description: All participants will receive the GEM intervention.
Masking: None (Open Label)
Primary purpose: Treatment