| Methods |
DURATION OF INTERVENTION:
3 months.
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 already in long‐term near‐normoglycemia (HbA1c 6.0‐7.5%) during intensive therapy were studied. Treated with intensive insulin therapy and attending the Diabetes Clinic at least quarterly every year. C‐peptide negative (plasma C‐peptide <0.10 nmol/L after 1 mg i.v. glucagon).
EXCLUSION CRITERIA:
Free of any detectable microangiopathic complication and negative at the screening for autonomic neuropathy, as judged on the basis of a standard battery of cardiovascular tests
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
1.
SETTING:
Out‐patient + inpatient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine dinner/et‐time (QD) + Lispro
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QID) + Lispro
TREATMENT BEFORE STUDY:
NPH QID basal therapy + Lispro
TITRATION PERIOD:
?. |
| Outcomes |
PRIMARY OUTCOME(S):
GLycated haemoglobin
SECONDARY OUTCOMES:
blood glucose profile from home monitoring, percentage of measurements at target, blood glucose variability, hypoglycaemia,plasma insulin and glucose profiles. |
| Notes |
STATED AIM OF STUDY:
To establish glycaemic control between optimised NPH administration and glargine, and to compare dinnertime glargine with bedtime glargine. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
