| Methods |
DURATION OF INTERVENTION:
4 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
? weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Age between 18 and 70 years, BMI of 18‐28 kg/m2, HbA1c of < 10%, and postprandial serum C‐peptide of <0.2 pmol/ml. All study patients had been on a basal‐bolus multiple daily insulin regimen for at least 2 months.
EXCLUSION CRITERIA:
?
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
Multicenter.
SETTING:
Out‐patient + inpatient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine 30 or glargine 80 (QD) + HI
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD/BID) + HI
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
Fasting plasma glucose.
SECONDARY OUTCOMES:
Serial overnight plasma glucose, mean FBG, blood glucose profile, nocturnal blood glucose, stability of fasting glucose, fasting serum insulin, HbA1c, hypoglycaemia. |
| Notes |
STATED AIM OF STUDY:
The primary objective was to compare NPH insulin with the insulin glargine formulations with respect to fasting plasma glucose (FPG) in these patients. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
