| Methods |
DURATION OF INTERVENTION:
3 months.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
1 year (in another study).
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Insulin dependent with C‐peptide < 0.18, age > 18.
EXCLUSION CRITERIA:
Proliferatice retinopathy, nephropathy, autonomic neuropathy, on medication likely to interfere with metabolic control, or pregnant.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
4.
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Ultralente (BID) + HI (premixed)
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Lente (BID) + HI (premixed).
TREATMENT BEFORE STUDY:
Lente and NPH
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
?
SECONDARY OUTCOMES:
Mean blood glucose, FBG, 0300 BG, HGA1C, fructosamine/albumin, triglycerides, weight, hypoglycaemia. |
| Notes |
STATED AIM OF STUDY:
Assess the efficacy of human ultralente given twice daily, with special interest on hypoglycaemic rate |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
