| Methods |
DURATION OF INTERVENTION:
18 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
?.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Age < 18 years, duration of diabetes > 12 months, BMI < 35 kg/m2, HbA1c < 12%, total daily insulin dose <1.4 U/kg, and current treatment with any basal‐bolus insulin regimen or biphasic insulin treatment for at least 6 months.
EXCLUSION CRITERIA:
Proliferative retinopathy requiring acute treatment, impaired renal or hepatic function, severe cardiac problems, uncontrolled hypertension, recurrent major hypoglycaemia, allergy to insulin, history of drug or alcohol dependence, pregnancy, and breast‐feeding.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
64.
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Detemir (BID) + aspart.
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (BID) + HI
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
6 weeks. |
| Outcomes |
PRIMARY OUTCOME(S):
Glycosylated haemoglobin.
SECONDARY OUTCOMES:
Within‐person day‐today variation in plasma glucose, the 8‐point plasma glucose profiles, hypoglycaemia, body weight. |
| Notes |
STATED AIM OF STUDY:
To bring together these respective components to compare a combination of the two analogues with conventional human insulin in basal‐bolus therapy for patients with Type 1 diabetes mellitus. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
