Jaeb Center for Health Research (JCHR) - Diabetes Research Studies
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    JDRF Continuous Glucose Monitoring Clinical Trial

      A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes
      Study date: Jan 2007 to Jan 2009

      Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (>25, 15-24, 8-14) were randomized to a continuous glucose monitoring (CGM) group or control group. The primary outcome was change in HbA1c after 26 weeks. A parallel randomized trial was conducted for a second cohort with HbA1c <7.0% that followed an identical protocol to that of the first cohort with HbA1c >=7.0%.

      The >=7.0% trial was specifically designed and statistically powered to compare separately the impact of continuous versus standard intensive glucose monitoring in the three age groups. Both trials used standardized treatment algorithms and equivalent frequent contacts with subjects in both the CGM and control group.

      After completion of the 26-week trial, the CGM group continued to use CGM for another 26 weeks to evaluate whether any beneficial effect seen in the first 6 months was sustained with longer-term use and less intensive contact and the control group initiated CGM use with less intensive contact after the first month than was provided at initiation of CGM use in the CGM group in the randomized trial.

      The dataset includes the following:
        • Baseline demographics for subjects
        • Laboratory A1c values at baseline and every 3 months for 1 year
        • Blinded CGM data at baseline for all subjects and at 3 and 6 months for control subjects
        • Unblinded CGM data for 1 year for CGM group subjects and for 6 months for control subjects
        • Reported severe hypoglycemia and hyperglycemia events for all subjects
        • Psychosocial and cost effectiveness questionnaire results for all subjects


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