NCT00772356CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Comparison of glucose infusion rate necessary to keep blood glucose constant
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Experimental
Intervention: Accu-Chek Spirit Insulin Pump (Device)
B
Active Comparator
Intervention: Comparator insulin pump (Device)
Outcomes
Primary Outcomes
Comparison of glucose infusion rate necessary to keep blood glucose constant
Time Frame: Throughout study
Secondary Outcomes
- Serum insulin and free fatty acid levels(Throughout study)
Investigators
Study Sites (1)
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