Trial information
A study of Basal Rate Changes in Patients with Type-1 Diabetes Mellitus
Status: Completed
Protocol number: RD000559
Sponsor: Hoffmann-La Roche
Company division: Diagnostic
Official Scientific Title: A monocenter, open-label glucose clamp study examining the metabolic effect of insulin infusion intervals for basal insulin infusion in patients with type-1 diabetes
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.
Study type: Interventional; Randomized; Open Label; Crossover study
Condition: Diabetes Mellitus, Type 1
Intervention type: Device
Intervention name: Accu-Chek Spirit Pump
Primary outcome: Comparison of glucose infusion rate necessary to keep blood glucose constant
Key secondary outcomes: Serum insulin and free fatty acid levels
Inclusion criteria: - male patients 18-65 years of age;
- type-1 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
Gender: Males
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: January, 2008
Trial registration date: 10/09/2008
Date last updated: 12/19/2008
Link to trial result
This trial was conducted at the following locations:
Germany
