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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 13, 2008
Last updated: March 1, 2016
Last verified: June 2010
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: 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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male

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
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Please refer to this study by its identifier: NCT00772356

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

Responsible Party: Hoffmann-La Roche Identifier: NCT00772356     History of Changes
Other Study ID Numbers: RD000559
Study First Received: October 13, 2008
Last Updated: March 1, 2016

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
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017