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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00772356
First received: October 13, 2008
Last updated: August 26, 2014
Last verified: June 2010
  Purpose

This crossover, glucose-clamp study will investigate the impact of different bas al insulin infusion rates on glucose control employing insulin pumps with differ ent 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-contin uous 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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum insulin and free fatty acid levels [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772356

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00772356     History of Changes
Other Study ID Numbers: RD000559, 05/0377-Basal
Study First Received: October 13, 2008
Last Updated: August 26, 2014
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014