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.


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.
Rosanna
R
Fiallo-Scharer
Jing
J
Cheng
Roy W
RW
Beck
Bruce A
BA
Buckingham
H Peter
HP
Chase
Craig
C
Kollman
Lori
L
Laffel
Jean M
JM
Lawrence
Nelly
N
Mauras
William V
WV
Tamborlane
Darrell M
DM
Wilson
Howard
H
Wolpert
D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000503:physiopathology*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000503:physiopathology*; D008297:Male; D055815:Young Adult
D001786:Blood Glucose
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