| Methods |
DURATION OF INTERVENTION:
12 months.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
? weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Patients initiated had a history of type 1 diabetes for over 1 year and had used basal‐bolus therapy for at least 2 months prior to enrolment.
EXCLUSION CRITERIA:
Proliferative retinopathy, impaired hepatic or renal function, severe cardiac problems, uncontrolled hypertension, recurrent major hypoglycaemia or allergy to insulin. Pregnant or breast‐feeding women were also excluded
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
42
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Detemir (BID) + Aspart
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (BID) + Aspart
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
?
SECONDARY OUTCOMES:
Glycosylated haemoglobin, FPG and 9‐point BG profiles, weight gain, hypoglycaemia. |
| Notes |
STATED AIM OF STUDY:
To assess the relative safety and efficacy over a 1‐year period of insulin detemir in comparison to NPH insulin, with IAsp as mealtime insulin. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
