Benefits of Continuous Glucose Monitoring With GEM Lifestyle Modification for Adults With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the use of continuous glucose monitoring with
      the GEM lifestyle modification program (Glycemic load, Exercise and Monitoring glucose) will
      result in better diabetes control than routine care.
    

Detailed description: 
      Type 2 diabetes (t2d) is a major epidemic of the developing world which has huge fiscal
      consequences and many physical complications. It is thought to be brought on in part by
      contemporary easy access to high energy foods and reduced physical activity, resulting in
      increased belly fat that culminates in growing insulin resistance and subsequent
      hyperglycemia. Because of ease and efficacy of medication management, t2d is primarily
      managed with ever-escalating medication use, which significantly contributes to medical cost
      and possibly the progression of the disease itself.

      An effective supplement or alternative to medication management is lifestyle modification.
      Conventional lifestyle modification focuses on reducing body fat and insulin resistance
      through weight reduction from caloric restriction and aerobic exercise. Sustained routine
      application of this approach is limited because some individuals do not need to lose weight,
      some do not want to lose weight, others cannot lose weight, and when successful, lifelong
      weight reduction is difficult to sustain. A useful paradigm shift in lifestyle treatment of
      t2d might be to go from reducing calories to reducing postprandial glucose (PPG), the primary
      contributor to glycosylated hemoglobin (HbA1c).

      PPG spikes can be prevented by replacing high with low glycemic load foods and dampened by
      engaging in postprandial physical activity. This is exemplified by the integrated Glycemic
      load, Exercise and Monitoring glucose (GEM) program. It promotes choices of low glycemic load
      foods and increased physical activity, directed by glucose monitoring feedback. Glucose
      feedback can: 1) educate people as to what food choices minimize PPG and what physical
      activity choices directly lower PPG, 2) activate individuals when glucose is out of their
      desired range by alerting them to make choices to lower high glucose or raise low glucose,
      and 3) motivate individuals to repeat those choices that resulted in desirable glucose
      consequences. The educating, activating and motivating benefits of glucose feedback are
      thought to be qualitatively and quantitatively enhanced through continuous glucose monitoring
      (CGM).

      It is hypothesized that, compared to Routine Care (RC), GEM with CGM (GEM+CGM) administered
      to adults with t2d who are failing with oral medication management will result in better
      diabetes control (lower HbA1c), reduced medication management (less medication), and better
      psychological functioning (e.g. greater sense of empowerment) in the short term (3 month
      follow-up). Further, it is hypothesized that their reduction in HbA1c will be driven by a
      reduction in PPG.
    

Intervention name(s): GEM lifestyle modification & continuous glucose monitoring; Routine Care
Intervention type(s): Behavioral; Other
Intervention description(s): Four treatment sessions of GEM lifestyle modification in 3 months and continuous glucose monitoring during the first 14 days of each of the 3 months.; Subject's current t2d treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment