| Methods |
DURATION OF INTERVENTION:
6 months.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
3 weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Men and women > 18 years with type 1 DM for > 1 year using basal or premixed insulin QD and HI before meals for > 2 months.
EXCLUSION CRITERIA:
Poorly controlled diabetes on QD regimen, pregnant or breastfeading, proliferative retinopathy, hepatic or renal impairment, reccurent major hypoglycaemia, or severe cardiac problems, or concomitent use of medication interfering with glucose metabolism.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
92.
SETTING:
Out‐patient + inpatient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Detemir (QD) + HI
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD) + HI
TREATMENT BEFORE STUDY:
QD basal therapy + HI
TITRATION PERIOD:
1 month. |
| Outcomes |
PRIMARY OUTCOME(S):
?
SECONDARY OUTCOMES:
Glycosylated haemoglobin, FPG, SMBG, 24 hours glucose profiles, hypoglycaemia, weight |
| Notes |
STATED AIM OF STUDY:
To compare the effect of QD basal insulin replacement using insulin detemir versus NPH at bedtime in combination with HI in patients with type 1 DM. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
