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Purpose
The present study describes the epidemiology of severe hypoglycemia and identifies
patient characteristics or behaviors associated with severe hypoglycemia in patients
with insulin-dependent diabetes mellitus (IDDM) participating in the Diabetes Control
and Complications Trial (DCCT).
Patients and Methods
The DCCT is a multicenter randomized clinical trial designed to compare the benefits
and risks of intensive therapy with those of conventional management of IDDM. The
DCCT's feasibility phase demonstrated that intensive therapy, with the aim of achieving
glucose levels as close to the non-diabetic range as possible, was accompanied by
a threefold increase in severe hypoglycemia compared with conventional therapy. This
report is based on the first 817 subjects who entered the DCCT, with a mean follow-up
of 21 months.
Results
Two hundred sixteen subjects reported 714 episodes of severe hypoglycemia; 549 (77%)
occurred in intensively treated subjects. The incidence of severe hypoglycemia in
the intensive treatment group ranged from two to six times that observed with conventional
treatment. Severe hypoglycemia occurred more often during sleep (55%); 43% of all
episodes occurred between midnight and 8 AM. Of episodes that occurred while subjects
were awake, 36% were not accompanied by warning symptoms. In intensively treated subjects,
predictors of severe hypoglycemia included history of severe hypoglycemia, longer
duration of IDDM, higher baseline glycosylated hemoglobin (HbA1c) levels, and a lower recent HbA1c. Multivariate analyses failed to yield predictive models with high sensitivity.
Conclusions
In the DCCT, intensive treatment of IDDM increased the frequency of severe hypoglycemia
relative to conventional therapy. Intensive treatment may cause even more frequent
severe hypoglycemia when applied to less selected and less motivated populations in
the clinical practice setting. These findings underscore the importance of determining
the benefit-risk ratio of intensive and standard therapy of IDDM.
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Article info
Publication history
Accepted:
November 19,
1990
Received:
August 1,
1990
Footnotes
*Prepared by Rodney A. Lorenz, M.D., Julio V. Santiago, M.D., Carolyn Siebert, M.P.M., Patricia A. Cleary, M.S., and Stephen Heyse, M.D.
Identification
Copyright
© 1991 Reed Publishing USA. Published by Elsevier Inc.
