A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes
Not Applicable
Completed
- Conditions
- Diabetes Mellitus Type 1
- Registration Number
- NCT00772356
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Comparison of glucose infusion rate necessary to keep blood glucose constant Throughout study
- Secondary Outcome Measures
Name Time Method Serum insulin and free fatty acid levels Throughout study