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document
Factors predictive of severe hypoglycemia in type 1 diabetes : analysis from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized control trial dataset . 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 .
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Intervention_Control
continuous glucose monitoring ( CGM )
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Intervention_Control
CGM
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Intervention_Control
control
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Intervention_Control
standard home blood glucose monitoring
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Intervention_Control
CGM
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Intervention_Control
CGM
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Outcome_Physical
severe hypoglycemia
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Outcome_Physical
severe hypoglycemia ( SH )
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Outcome_Other
clinical utility
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Outcome_Physical
continuous glucose monitoring ( CGM )
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Outcome_Physical
CGM-derived indices of hypoglycemia
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Outcome_Physical
SH rate
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Outcome_Physical
SH
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Outcome_Physical
SH frequency
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Outcome_Physical
CGM values