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

Diabetes Mellitus Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772356
• Other study ID #: RD000559
• Secondary ID: 05/0377-Basal
• Status: Completed
• Phase: N/A
• First received: October 13, 2008
• Last updated: March 1, 2016
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: June 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Device:
• Accu-Chek Spirit Insulin Pump

• Comparator insulin pump

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of glucose infusion rate necessary to keep blood glucose constant		Throughout study	No
Secondary	Serum insulin and free fatty acid levels		Throughout study	No