| Methods |
DURATION OF INTERVENTION:
1 year.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
1 month.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
T1 DM (Table 1) and fasting plasma C‐peptide 0.15 nmol/L, on intensified treatment with multiple daily combinations of lispro and NPH insulin at each meal, and NPH at bedtime for at least 2 years.
EXCLUSION CRITERIA:
Free of any detectable microangiopathic complication and were negative at the screening for autonomic neuropathy, as judged on the basis of standard battery of cardiovascular tests.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
1
SETTING:
Out‐patient + inpatient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine (QD) + lispro
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QID) + lispro
TREATMENT BEFORE STUDY:
NPH + lispro
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
Glycosylated haemoglobin.
SECONDARY OUTCOMES:
Home blood glucose monitoring, percantage of at target blood glucose measurements, blood glucose variability, hypoglycaemia, weight |
| Notes |
STATED AIM OF STUDY:
First, to compare the long‐term glycaemic control in T1 DM with two regimens of optimized replacement of basal insulin, i.e. NPH combined with lispro insulin at each meal (and a fourth NPH injection at bedtime), and insulin glargine once daily. Second, to test the hypothesis that the less frequent hypoglycaemia expected to occur with insulin glargine as compared with NPH, resulted in better responses of counter‐regulatory hormones, symptoms and onset of cognitive dysfunction to hypoglycaemia. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
