| Methods |
DURATION OF INTERVENTION:
6 months.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
? weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic children.
INCLUSION CRITERIA:
Patients with type 1 diabetes, aged 5‐16 years, who were using at least three daily preprandial injections of normal insulin and who had an HbA1c value of <12%.
EXCLUSION CRITERIA:
?
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
Multy‐center.
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine (QD) + HI
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD/BID) + HI.
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD: |
| Outcomes |
PRIMARY OUTCOME(S):
Mean change from baseline in GHb levels.
SECONDARY OUTCOMES:
Mean change in FBG levels from baseline and incidence of hypoglycemia. |
| Notes |
STATED AIM OF STUDY:
To compare the metabolic effect and safety of insulin glargine with NPH insulin in children and adolescents with type 1 diabetes. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
