Treatment with conventional versus extended insulin regimen

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Wiggam et al, 199750922 adults with diabetic ketoacidosis (pH < 7.25, and/or bicarbonate < 16 mmol/l)
Aged 22.4 ± 2.7 for conventional insulin regimen, 37.1 ± 6.2 years for extended insulin regimen
Belfast
Extended insulin regimen (as conventional treatment until near-normoglycaemia when insulin is continued at 5 units/hour until resolution of hyperketonaemia (3- hydroxybutyrate < 0.5 mmol/l))
versus
conventional insulin regimen (rehydration, electrolyte replacement and insulin at 5 units/hour to near- normoglycaemia (blood glucose ≤ 10 mmol/l) and then at a reduced rate until clinical recovery)
3-hydroxybutyrate and bicarbonate levels during 24 hours after attainment of near- normoglycaemia (correction of hyperglycaemia)Near-normoglycaemia was achieved slightly later with the extended insulin regimen (5.1 ± 1.0 vs. 3.4 ± 0.4 hours, p = 0.3) and 3- hydroxybutyrate was lower at this point
Elevation of blood 3-hydroxybutyrate (> 0.5 mmol/l) persisted for time after correction of hyperglycaemia: 5.9 ± 0.8 vs. 21.8 ± 3.4 hours, RR 0.30, 95% CI 0.16 to 0.54, p = 0.0004 (adjusted for serum 3- hydroxybutyrate level at baseline and age: 0.42 95% CI 0.24 to 0.76, p = 0.006)
Exposure to 3-hydroxybutyrate over the 24 hours following near-normoglycaemia (ratio extended/conventional regimens): non- adjusted: 0.43, 95% CI 0.27 to 0.69, adjusted for serum 3-hydrobutyrate level at baseline and age 0.58, 95% CI 0.25 to 0.94, p = 0.03
Resolution of acidosis after near- normoglycaemia: bicarbonate levels after baseline (mmol/l): 6h: 16.0 ± 1.3 vs. 18.6 ± 0.6, p = 0.09; 12 hours: 16.5 ± 1.2 vs. 19.0 ± 0.7, p = 0.08. Bicarbonate levels tended to be higher with the extended insulin regimen, but this did not reach statistical significance
Electrolyte concentration over the 24 hours after achievement of near-normoglycaemia: plasma glucose was adequately controlled in both groups, and there was no difference in potassium levels between the two treatments. Serum phosphate concentrations at 2 and 6 hours after achieving normoglycaemia (baseline) were significantly lower in patients receiving treatment with extended vs. conventional insulin regimens (p = 0.003, 0.03 and 0.04 respectively)
Unknown how randomisation took place
Patients allocated to the extended insulin regimen were slightly older (p = 0.07) with a longer duration of diabetes and slightly higher plasma glucose and serum urea concentrations, but these differences were not statistically significant
RCTIb

From: Evidence tables

Cover of Type 1 Diabetes
Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People.
NICE Clinical Guidelines, No. 15.2.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2004 Sep.
Copyright © 2004, National Collaborating Centre for Women’s and Children’s Health.

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