The Landmark JDRF Continuous Glucose Monitoring Randomized Trials: a Look Back at the Accumulated Evidence

ArticleinJournal of Cardiovascular Translational Research 5(4):380-7 · April 2012with24 Reads
DOI: 10.1007/s12265-012-9364-9 · Source: PubMed
Abstract
Despite improvements for management of type 1 diabetes (T1D), patients have difficulty achieving glycated hemoglobin (A1c) levels recommended by the Diabetes Control and Complications Trial (DCCT). Two multicenter randomized trials were conducted to evaluate benefit of using a continuous glucose monitor (CGM) with standard glucose monitoring for T1D management. The primary study evaluated benefits of CGM in 322 patients with A1c >7.0%. The secondary study evaluated 129 patients with A1c <7.0%. In the primary study, CGM resulted in improvements in A1c at 6 m in subjects >25 years, but not those <25. However, all subjects using CGM regularly showed benefit. Improved A1c did not come with increased severe hypoglycemia as seen in the DCCT, and benefit was sustained over 1 year. In the secondary study, CGM use helped subjects maintain target A1c levels with reduced exposure to biochemical hypoglycemia. The data collected allowed for other analyses of important factors in T1D management.
    • "For the development of the metric, we first intended to identify the factors determining the quality of a CGM profile. We performed the first published factor analysis [29,30] of CGM-variables45679,10]. By definition, a factor represents a cluster of highly correlated variables [29,30]. "
    [Show abstract] [Hide abstract] ABSTRACT: Continuous glucose monitoring (CGM) has revolutionised diabetes management. CGM enables complete visualisation of the glucose profile, and the uncovering of metabolic 'weak points'. A standardised procedure to evaluate the complex data acquired by CGM, and to create patient-tailored recommendations has not yet been developed. We aimed to develop a new patient-tailored approach for the routine clinical evaluation of CGM profiles. We developed a metric allowing screening for profiles that require therapeutic action and a method to identify the individual CGM parameters with improvement potential. Fifteen parameters frequently used to assess CGM profiles were calculated for 1,562 historic CGM profiles from subjects with type 1 or type 2 diabetes. Factor analysis and varimax rotation was performed to identify factors that accounted for the quality of the profiles. We identified five primary factors that determined CGM profiles (central tendency, hyperglycaemia, hypoglycaemia, intra- and inter-daily variations). One parameter from each factor was selected for constructing the formula for the screening metric, (the 'Q-Score'). To derive Q-Score classifications, three diabetes specialists independently categorised 766 CGM profiles into groups of 'very good', 'good', 'satisfactory', 'fair', and 'poor' metabolic control. The Q-Score was then calculated for all profiles, and limits were defined based on the categorised groups (<4.0, very good; 4.0-5.9, good; 6.0-8.4, satisfactory; 8.5-11.9, fair; and ≥12.0, poor). Q-Scores increased significantly (P <0.01) with increasing antihyperglycaemic therapy complexity. Accordingly, the percentage of fair and poor profiles was higher in insulin-treated compared with diet-treated subjects (58.4% vs. 9.3%). In total, 90% of profiles categorised as fair or poor had at least three parameters that could potentially be optimised. The improvement potential of those parameters can be categorised as 'low', 'moderate' and 'high'. The Q-Score is a new metric suitable to screen for CGM profiles that require therapeutic action. Moreover, because single components of the Q-Score formula respond to individual weak points in glycaemic control, parameters with improvement potential can be identified and used as targets for optimising patient-tailored therapies.
    Full-text · Article · May 2015
  • [Show abstract] [Hide abstract] ABSTRACT: The use of continuous glucose monitoring (CGM) in the pediatric population is not well characterized. We have evaluated the use of CGM over a 12-month interval in youth with type 1 diabetes (TID) and have provided a description of CGM use. Eighty subjects 8-17 years old with T1D and baseline hemoglobin A1c (HbA1c) >or=7.0% used CGM as part of a 6-month randomized trial and subsequent 6-month extension study. Outcomes included frequency of CGM use, HbA1c levels, rate of severe hypoglycemia, and a CGM satisfaction scale. Seventy-six (95%) of 80 subjects were using CGM after 6 months (median use = 5.5 days/week) compared with 67 (84%) after 12 months (median use = 4.0 days/week). The 17 subjects using CGM >or=6 days/week in month 12 had substantially greater improvement from baseline in HbA1c than did the 63 subjects using CGM <6 days/week in month 12 (mean change - 0.8 +/- 0.6% vs. +0.1 +/- 0.7%, P < 0.001). They also reported greater satisfaction with use of CGM (P = 0.001). The incidence of severe hypoglycemic events was low during the 12 months of the study irrespective of the amount of CGM use. In youth with T1D, frequency of use decreases over time. Individuals who use CGM on a near-daily basis can have substantial improvement in glycemic control.
    Article · Jul 2010
  • Full-text · Article · Jun 2012
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