Examining The Role of CGM in T2DM
Condition: DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Continuous glucose monitoring (CGM) technology has advanced the treatment of people with
      diabetes, however to date this technology had been primarily limited to use in patients
      treated with insulin. CGM is a powerful tool that has the potential to enhance the care of
      patients treated with agents other than insulin; however this has not been tested. The
      purpose of this study is to determine whether improved glycemic control can be achieved
      through the use of intensive, periodic CGM monitoring in patients with T2DM treated with oral
      anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be utilized to
      determine if a larger, clinical effectiveness study to assess use of CGM to improve clinical
      outcomes in patients with T2DM treated with OADs is warranted.
    

Detailed description: 
      The study will enroll and follow 90 participants for 187 days at two sites. Participants will
      be randomized (1:1 allocation ratio) to the CGM based intervention (Group 1) or the
      Self-Monitoring Blood Glucose (SMBG) based intervention (Group 2). Group 1 will receive care
      based upon the results of their CGM data while group 2 will receive care based upon
      traditional SMBG values. The clinical management algorithm will be utilized to guide the care
      of all subjects. All study participants will receive the iPro 2 devices (Medtronic Minimed,
      Northridge, CA 91325) to collect glucose measurements during five 1 week periods beginning on
      Day 0, Day 45, Day 90, Day 135 and Day 180. Laboratory measures of glucose control (HbA1c and
      FPG) and quality of life outcomes will be evaluated at Day 0, Day 90 and Day 187.

      The iPro2 device is FDA approved for sale in the US and is a commercial product. The iPro2
      digital recorder is intended to continuously record interstitial glucose levels in persons
      with diabetes mellitus. The iPro 2 is intended to be worn for intermittent periods to uncover
      glycemic variability and patterns. The data obtained can then be used to maximum treatment
      strategies to improve patient outcomes. The advantage to the iPro 2 is that it is blinded and
      will not be influenced by the patient.

      The Enlite sensor, is an investigational device, is a 6 day sensor. The subjects in this
      study will wear the Enlite sensor for a 6 day monitoring period. The Enlite sensor is
      CE-marked and available for sale in over 50 countries and is currently seeking FDA approval.

      CareLink iPro Clinical Therapy Management Software is part of the iPro2 CGM system. The
      Carelink iPro Clinical Software is intended to support clinical trials. This internet based
      software allows data to be viewed and easily evaluated by physicians. A PC links to Carelink
      iPro Clinical via the Internet and allows the user to upload data from Medtronic Diabetes
      iPro2 devices. Because the algorithm proposed in this protocol has been programed into the
      Software, this is an (IDE-exempt) investigational device.

      Adult individuals 18-70 years of age, diagnosed with T2DM who are currently being treated in
      the Principal Investigators or referring physicians practice with a HbA1c between 7.5-9.0%.
    

Intervention name(s): Continuous Glucose Monitoring with treatment algorithm
Intervention type(s): Other
Intervention description(s): those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment