Back to resultsA Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes
Primary Purpose
Diabetes Mellitus Type 1
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Accu-Chek Spirit Insulin Pump
Comparator insulin pump
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus Type 1
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Comparison of glucose infusion rate necessary to keep blood glucose constant
Secondary Outcome Measures
Serum insulin and free fatty acid levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00772356
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Accu-Chek Spirit Insulin Pump
Intervention Type
Device
Intervention Name(s)
Comparator insulin pump
Primary Outcome Measure Information:
Title
Comparison of glucose infusion rate necessary to keep blood glucose constant
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Serum insulin and free fatty acid levels
Time Frame
Throughout study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Dr. Petersen
Organizational Affiliation
Roche Diagnostics
Official's Role
Study Director
Facility Information:
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
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
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