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Previous Volume 359:1464-1476 October 2, 2008 Number 14 Next

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ABSTRACT

Background The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined.

Methods In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks.

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<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, –0.17 to 0.33; P=0.52) or among those who were 8 to 14 years of age (mean difference, –0.13; 95% CI, –0.38 to 0.11; P=0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference.

Conclusions Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133 [ClinicalTrials.gov] .)

Source Information

The members of the writing committee (William V. Tamborlane, M.D., Roy W. Beck, M.D., Ph.D., Bruce W. Bode, M.D., Bruce Buckingham, M.D., H. Peter Chase, M.D., Robert Clemons, M.D., Rosanna Fiallo-Scharer, M.D., Larry A. Fox, M.D., Lisa K. Gilliam, M.D., Ph.D., Irl B. Hirsch, M.D., Elbert S. Huang, M.D., M.P.H., Craig Kollman, Ph.D., Aaron J. Kowalski, Ph.D., Lori Laffel, M.D., M.P.H., Jean M. Lawrence, Sc.D., M.P.H., M.S.S.A., Joyce Lee, M.D., M.P.H., Nelly Mauras, M.D., Michael O'Grady, Ph.D., Katrina J. Ruedy, M.S.P.H., Michael Tansey, M.D., Eva Tsalikian, M.D., Stuart Weinzimer, M.D., Darrell M. Wilson, M.D., Howard Wolpert, M.D., Tim Wysocki, Ph.D., and Dongyuan Xing, M.P.H.) assume responsibility for the overall content and integrity of the article.

This article (10.1056/NEJMoa0805017) was published at www.nejm.org on September 8, 2008.

Address reprint requests to Dr. Beck at the Jaeb Center for Health Research, 15310 Amberly Dr., #350, Tampa, FL 33647, or at rbeck{at}jaeb.org.

Full Text of this Article

Related Letters:

Continuous Glucose Monitoring and Type 1 Diabetes
Montagnana M., Lippi G., Guidi G. C., Finlayson A. E.T., Cronin N. J., Choudhary P., Tamborlane W. V., Beck R. W., Laffel L., the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group
Extract | Full Text | PDF  
N Engl J Med 2009; 360:190-192, Jan 8, 2009. Correspondence

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