Factors predictive of severe hypoglycemia in type 1 diabetes: analysis from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized control trial dataset

TitleFactors predictive of severe hypoglycemia in type 1 diabetes: analysis from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized control trial dataset
Publication TypeJournal Article
Year of Publication2011
AuthorsFiallo-Scharer, R., Cheng J., Beck R. W., Buckingham B. A., Chase H. P., Kollman C., Laffel L., Lawrence J. M., Mauras N., Tamborlane W. V., Wilson D. M., & Wolpert H.
Corporate AuthorsJuvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group
JournalDiabetes Care
Volume34
Issue3
Pagination586-90
Date Published2011 Mar
ISSN1935-5548
KeywordsAdolescent; Adult; Blood Glucose; Blood Glucose Self-Monitoring; Child; Diabetes Mellitus, Type 1; Female; Humans; Hypoglycemia; Male; Young Adult
Abstract

OBJECTIVE: Identify factors predictive of severe hypoglycemia (SH) and assess the clinical utility of continuous glucose monitoring (CGM) to warn of impending SH.
RESEARCH DESIGN AND METHODS: In a multicenter randomized clinical trial, 436 children and adults with type 1 diabetes were randomized to a treatment group that used CGM (N = 224), or a control group that used standard home blood glucose monitoring (N = 212) and completed 12 months of follow-up. After 6 months, the original control group initiated CGM while the treatment group continued use of CGM for 6 months. Baseline risk factors for SH were evaluated over 12 months of follow-up using proportional hazards regression. CGM-derived indices of hypoglycemia were used to predict episodes of SH over a 24-h time horizon.
RESULTS: The SH rate was 17.9 per 100 person-years, and a higher rate was associated with the occurrence of SH in the prior 6 months and female sex. SH frequency increased eightfold when 30% of CGM values were ≤ 70 mg/dL on the prior day (4.5 vs. 0.5%; P < 0.001), but the positive predictive value (PPV) was low (<5%). Results were similar for hypoglycemic area under the curve and the low blood glucose index calculated by CGM.
CONCLUSIONS: SH in the 6 months prior to the study was the strongest predictor of SH during the study. CGM-measured hypoglycemia over a 24-h span is highly associated with SH the following day (P < 0.001), but the PPV is low.




DOI10.2337/dc10-1111
Alternate JournalDiabetes Care
Refereed DesignationRefereed