| Methods |
DURATION OF INTERVENTION:
1 year.
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:
Patients with a clinical diagnosis of type 1 diabetes.
EXCLUSION CRITERIA:
Patients with severe retinopathy or neuropathy and patients who had experienced more than two severe hypoglycemic episodes in the past year
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
?
SETTING:
Out‐patient + inpatient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Ultralente (QD) + lispro.
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD) + lispro.
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
?
SECONDARY OUTCOMES:
Eight point blood glucose profile, glycosylated haemoglobin, hypoglycemia, weight, 24‐h free plasma insulin. |
| Notes |
STATED AIM OF STUDY:
To compare human ultralente (UL) insulin with human NPH insulin as basal insulin replacement in patients who use insulin lispro before meals. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
