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Results The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P=0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, −0.53%; 95% confidence interval [CI], −0.71 to −0.35; P. Figure 1 Glycated Hemoglobin Levels during 26-Week Study Period, According to Age. Shown are glycated hemoglobin levels for patients 25 years of age or older (Panel A), 15 to 24 years (Panel B), and 8 to 14 years (Panel C) who were receiving either continuous glucose monitoring or usual monitoring (control group). Points below the diagonal line represent an improvement in the glycated hemoglobin level from baseline. The horizontal dotted line represents the American Diabetes Association target of 7.0%.
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Despite the increased use of insulin pumps and multiple-injection regimens and the introduction of insulin analogues, intensive treatment of type 1 diabetes mellitus often does not achieve the target glycated hemoglobin levels recommended by the Diabetes Control and Complications Trial (DCCT) more than 15 years ago. Although self-monitoring of blood glucose plays an important role in achieving target glycated hemoglobin levels, few patients with type 1 diabetes measure glucose levels after meals or overnight. Consequently, postprandial hyperglycemia and asymptomatic nocturnal hypoglycemia are commonly seen, even in patients with well-controlled type 1 diabetes who measure blood glucose several times daily with a home glucose meter. In many patients, fear of hypoglycemia or development of hypoglycemia-associated autonomic failure hinders the successful implementation of intensive insulin therapy. The availability of devices for continuous glucose monitoring permits the measurement of interstitial glucose in an ongoing fashion.
However, the first-generation continuous monitors either provided data only for short-term retrospective analysis or were too difficult and uncomfortable for clinical use. Although not yet as accurate as blood glucose meters, newer real-time devices for continuous glucose monitoring provide improved accuracy and functionality, such as sounding alarms when the glucose trend projects future hypoglycemia, and are better tolerated by users.
Although short-term or uncontrolled studies have suggested benefit, whether these systems help to produce a sustained lowering of glycated hemoglobin levels and reduce hypoglycemia in patients with type 1 diabetes has not been established. Therefore, in this randomized, multicenter clinical trial, we evaluated the efficacy and safety of continuous glucose monitoring in adults and children with type 1 diabetes.
Patients All eligible patients were 8 years of age or older, had received a diagnosis of type 1 diabetes at least 1 year before randomization, either used an insulin pump or received at least three daily insulin injections, had a glycated hemoglobin level of 7.0 to 10.0%, and had not used continuous glucose monitoring at home in the 6 months leading up to the trial. Patients completed a run-in phase using a continuous glucose monitor that was modified so that the glucose values were recorded in the receiver but were not visible to the patient; we refer to this as a “blinded” continuous glucose monitor. Eligibility required that patients wear a sensor for at least 6 of 7 days before randomization, with a minimum of 96 hours of glucose values including at least 24 hours overnight, and that home blood glucose monitoring be performed at least three times daily. Study Treatment Patients meeting these criteria were randomly assigned to receive continuous glucose monitoring (continuous-monitoring group) or home monitoring with a blood glucose meter (control group) with the use of a permuted-block design stratified according to clinical center, age group (≥25 years, 15 to 24 years, and 8 to 14 years), and glycated hemoglobin level (≤8.0% and >8.0%). A total of 23 patients (1 in the ≥25-year group, 8 in the 15-to-24–year group, and 14 in the 8-to-14–year group) were screened for the study but were not enrolled, either because the run-in phase was not successfully completed or because the patient elected not to enter the study after using the blinded continuous glucose monitor. Patients in the continuous-monitoring group were provided with one of the following devices: the DexCom Seven (DexCom), the MiniMed Paradigm Real-Time Insulin Pump and Continuous Glucose Monitoring System (Medtronic), or the FreeStyle Navigator (Abbott Diabetes Care).