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

Hoffmann-La Roche0 sites14 target enrollmentJanuary 2008

ConditionsDiabetes Mellitus Type 1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus Type 1
Sponsor: Hoffmann-La Roche
Enrollment: 14
Primary Endpoint: Comparison of glucose infusion rate necessary to keep blood glucose constant
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

May 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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