JDRF randomized clinical trial to assess the efficacy of real-time continuous glucose monitoring in the management of type 1 diabetes: Research design and methods

Background: While real-time (RT) continuous glucose monitoring (CGM) systems may revolutionize treatment of type I diabetes (T1D), there is insufficient evidence currently available to support widespread utilization of these devices. The juvenile Diabetes Research Foundation (JDRF) CGM Study Group developed a randomized clinical trial to determine if RT-CGM can improve glycemic control and quality of life in children and adults with T1D. This paper presents the research design and methods that are being employed in this study. Methods: The JDRF CGM Study Group trial is a randomized, parallel group, efficacy and safety study. Subjects with T1DM who meet eligibility criteria are randomized to either standard self-monitoring of blood glucose (SMBG) alone or use of any of the three current RT-CGM systems as a supplement to SMBG. After the 6-month randomized period, the Control Group is offered use of RT-CGM, and both groups are studied for an additional 6 months. Subjects are divided into two cohorts: the Main Study Cohort includes subjects with baseline glycosylated hemoglobin (HbA1c) 7.0-10.0% inclusive, and the Exploratory Pilot Study Cohort includes subjects with HbA1c < 7.0%. Difference in HbA1c is the primary outcome in the Main Study. Other outcomes include the percentage of sensor glucose values within the 70-180 mg/dL range, scores on questionnaires that assess the impact of RT-CGM on living with T1D, and the cost-effectiveness of RT-CGM. Results: Recruitment for the study was completed on December 15, 2007. Conclusion: Results of this clinical trial should help establish whether or not current RT-CGM devices are beneficial to patients with T1D.