| Methods |
DURATION OF INTERVENTION:
4 months.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
3 months.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Insulin dependent patients with persistent elevation of fasting blood glucose which could not be corrected.
EXCLUSION CRITERIA:
?
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
1
SETTING:
Out‐patient+inpatient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Human ultralente (BID)+PI
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Porcine lente (BID) + PI
TREATMENT BEFORE STUDY:
Twice day mixture of short and intermediate acting insulins.
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
?
SECONDARY OUTCOMES:
Blood glucose, glycosylated haemoglobin, lactate, pyruvate, alanine, glycerol, NEFA, 3‐hydroxybutyrate, free insulin, GH, cortisol, adrenaline, noradrenaline, hypoglycaemia |
| Notes |
STATED AIM OF STUDY:
Compare human ultralente and porcine lente. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
