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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00772356 |
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 |
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Diabetes Mellitus, Type 1 |
Device: Accu-Chek Spirit Pump |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Crossover Assignment |
Official Title: | A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Infusion in Patients With Type-1 Diabetes |
Estimated Enrollment: | 14 |
Study Start Date: | January 2008 |
Study Completion Date: | May 2008 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hoffmann-La Roche ( Clinical Trials ) |
Study ID Numbers: | RD000559 |
Study First Received: | October 13, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00772356 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Diabetes |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Proxymetacaine Metabolic disorder Glucose Metabolism Disorders Insulin |
Immune System Diseases |