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StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Del Sindaco and Ciofetta, 199815269 adults with type 1 diabetes
Mean age 30–34 ± 5.2–8.8 years
Italy
Treatment groups. All the studies were for 3 months then swapped over to the other treatment
Study group 2: (n = 18) The conventional soluble insulin at meals (n = 9) of group 1 was compared with a mixture of rapid-acting insulin analogue (insulin lispro) and isophane (n = 9) at each meal. Isophane was given to all patients at bedtime
Study group 4: (n = 24) The effect of a 10–40 min time interval (n = 12) between injection of conventional soluble insulin and meal, as compared with no interval (n = 12) was assessed. Isophane was given to all patients at bedtime
Lispro injected 0–5 min before meals, soluble insulin injected 10–40 min before meals except group 4
HbA1c
Hypoglycaemia (< 3.5 mmol/l)
There were no episodes of severe hypoglycaemia during the studies
Study group 2. Effects of substitution of soluble with lispro insulin and increase in number of daily isophane insulin injections:
The mean daily blood glucose levels and postprandial blood glucose levels were significantly lower with lispro + multiple isophane insulin than soluble insulin (daily blood glucose levels 8.1 ± 0.8 vs. 8.6 ± 0.8 mmol/l, p < 0.05; postprandial blood glucose 8.3 ± 0.7 vs. 9.3 ± 0.8 mmol/l, p < 0.05). There was no significant difference in the pre-meal and nocturnal blood glucose concentrations (8.2 ± 0.7 vs. 8.2 ± 0.7 mmol/l, p < 0.05)
HbA1c was significantly lower after lispro + multiple isophane insulin compared with soluble insulin (lower by 0.35% in the insulin lispro group, p < 0.05)
The frequency of hypoglycaemia was similar between the two groups (3.7 ± 2.9 vs. 3.4 ± 2.9, p > 0.05)
Study group 4. Effect of time interval between injection of soluble insulin and meal:
The mean blood glucose concentration was not significantly lower when conventional soluble insulin was given 10–40 min prior to meals than given at meal ((10–40 min prior vs. 5 min before meal) 8.5 ± 1.1 vs. 8.9 ± 1.2 mmol/l)
The HbA1c was significantly lower when conventional soluble insulin was given 10–40 min prior to meals than given at meal (lower by 0.18 ± 0.15%, p < 0.05)
Hypoglycaemia was more frequent when conventional soluble insulin was given 10–40 min prior to meals than given at meal (4.4 ± 1.4 vs. 6.8 ± 2.4 mmol/l, p < 0.05)
Patients were randomly assigned to the 4 different studies. However, it is not known if randomisation was used to assign the patients to treatments within the study groupsRCT open label crossover studyIa

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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