| Methods |
DURATION OF INTERVENTION:
26 weeks.
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:
Patients with a history of type 1 diabetes for at least 1 year who had received basal (once or multiple times daily) bolus insulin treatment for at least 2 months were included in the trial. Only patients with an HbA1c level <=12%, a BMI <=35 kg/m2, and a total basal insulin dosage of <=100 IU/day were included.
EXCLUSION CRITERIA:
patients with proliferative retinopathy, impaired hepatic or renal function, severe cardiac problems, uncontrolled hypertension, recurrent major hypoglycemia, or allergy to insulin. Pregnant or breast‐feeding women were also excluded. DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
46.
SETTING:
Out‐patient + inpatient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Detemir (BID) + Aspart.
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (BID) + Aspart.
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
1 month. |
| Outcomes |
PRIMARY OUTCOME(S):
Glycosylated haemoglobin.
SECONDARY OUTCOMES:
Within subject SMBG flactuations, nightly glucose profile, weight, hypoglycaemia. |
| Notes |
STATED AIM OF STUDY:
To evaluate the metabolic control, risk of hypoglycemia, and other potential effects of treatment with insulin detemir in patients with type 1 diabetes on such a basal‐bolus regimen. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
