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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 study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772356
First Posted: October 15, 2008
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention
Diabetes Mellitus Type 1 Device: Accu-Chek Spirit Insulin Pump Device: Comparator insulin pump

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Comparison of glucose infusion rate necessary to keep blood glucose constant [ Time Frame: Throughout study ]

Secondary Outcome Measures:
  • Serum insulin and free fatty acid levels [ Time Frame: Throughout study ]

Enrollment: 14
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Accu-Chek Spirit Insulin Pump
Active Comparator: B Device: Comparator insulin pump

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772356


Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Bettina Dr. Petersen Roche Diagnostics
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00772356     History of Changes
Other Study ID Numbers: RD000559
05/0377-Basal
First Submitted: October 13, 2008
First Posted: October 15, 2008
Last Update Posted: March 3, 2016
Last Verified: June 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs