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
• Interventions: Device: Accu-Chek Spirit Insulin Pump; Device: Comparator insulin pump

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Status Verified: 2010-06
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Accu-Chek Spirit Insulin Pump	-
B	Comparator insulin pump	-

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