| Methods |
DURATION OF INTERVENTION:
16 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
4 weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic children.
INCLUSION CRITERIA:
Age between 12 and 20 years, currently in puberty (Tanner stage B2/G2 or higher), duration of diabetes longer than 1 year or C‐peptide negative, and already using a basal‐bolus insulin regimen.
EXCLUSION CRITERIA:
Renal or hepatic impairment, evidence of diabetic complications, or unstable metabolic control (defined as HbA1c >12%).
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 (QD) + HI
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
4 weeks. |
| Outcomes |
PRIMARY OUTCOME(S):
Nocturnal
hypoglycaemia.
SECONDARY OUTCOMES:
HbA1c and blood glucose, overnight profile |
| Notes |
STATED AIM OF STUDY:
Comparing the combination of insulin analogs insulin glargine plus lispro with human NPH plus regular human insulin by home blood glucose monitoring and overnight metabolic pro‐files in adolescents with type 1 diabetes who were already on MIR. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
