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

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

Sponsors

Lead sponsor: Hoffmann-La Roche

Source 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.

Overall Status Completed
Start Date January 2008
Completion Date May 2008
Primary Completion Date May 2008
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Comparison of glucose infusion rate necessary to keep blood glucose constant Throughout study
Secondary Outcome
Measure Time Frame
Serum insulin and free fatty acid levels Throughout study
Enrollment 14
Condition
Intervention

Intervention type: Device

Intervention name: Accu-Chek Spirit Insulin Pump

Arm group label: A

Intervention type: Device

Intervention name: Comparator insulin pump

Arm group label: B

Eligibility

Criteria:

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

Gender: Male

Minimum age: 18 Years

Maximum age: 65 Years

Overall Official
Last Name Role Affiliation
Bettina Dr. Petersen Study Director Roche Diagnostics
Location
facility
Location Countries

Germany

Verification Date

June 2010

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: A

Arm group type: Experimental

Arm group label: B

Arm group type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov