| Methods |
DURATION OF INTERVENTION:
26 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
? weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic children.
INCLUSION CRITERIA:
Children with Type 1 diabetes aged between 6 and 17 years, treated with insulin for at least 12 months (total daily dose 2.0 U/kg), and with HbA1c 12.0%
EXCLUSION CRITERIA:
?
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
44.
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Detemir (QD/BID) + aspart.
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD/BID) + Aspart.
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD: |
| Outcomes |
PRIMARY OUTCOME(S):
Glycosylated haemoglobin.
SECONDARY OUTCOMES:
Eight‐point plasma glucose profiles, self‐measured FPG, hypoglycaemia. |
| Notes |
STATED AIM OF STUDY:
To investigate the efficacy and safety of insulin detemir compared with NPH insulin in children with
Type 1 diabetes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
