Diabetes Mellitus Type 1
Conditions
Brief summary
This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.
Interventions
DEVICEComparator insulin pump
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Inclusion criteria
* Male patients 18-65 years of age * Type I diabetes mellitus * Currently on continuous subcutaneous insulin infusion therapy
Exclusion criteria
* Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months * Use of systemic corticoids in last 3 months * Treatment with medication known to interfere with glucose metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of glucose infusion rate necessary to keep blood glucose constant | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Serum insulin and free fatty acid levels | Throughout study |
Countries
Germany
Outcome results
None listed