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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Neuss, 41460, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accu-Chek Spirit Insulin Pump

Device

Comparator insulin pump

Device

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

Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Oct 15, 2008
Registry last updated: Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed