Examining The Role of CGM in T2DM

Overview

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.

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%.