| Methods |
DURATION OF INTERVENTION:
16 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
2 weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Age < 18 years with a history of Type 1 diabetes for at least 1 year, treated with a basal‐bolus insulin regimen for
4 months with basal insulin (once, twice or three times daily) in combination with mealtime IAsp or insulin lispro three to four times daily, able and willing to perform self‐measured plasma glucose (SMPG). Only C‐peptide‐negative persons with glycosylated haemoglobin < 9%, body mass index 35 kg/m2, total daily insulin dose 1.4 IU/kg per day and a basal insulin requirement 30% of the total daily insulin dose were included.
EXCLUSION CRITERIA:
Individuals with significant medical disorders were excluded, as were those with hypoglycaemic unawareness, recurrent major hypoglycaemia, allergy to insulin and pregnant or breast‐feeding women.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
11.
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):
Incidence of total self‐recorded hypoglycaemic episodes with
detemir relative to NPH during the last 10 weeks of each
treatment period.
SECONDARY OUTCOMES:
Glycosylated haemoglobin, day‐to‐day within‐person variation in SMPG, weight. |
| Notes |
STATED AIM OF STUDY:
To establish whether basal‐bolus treatment with detemir in combination with IAsp was associated with lower risks of hypoglycaemia compared with treatment with NPH plus IAsp in individuals with Type 1 diabetes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
