Back to resultsComparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
Primary Purpose
Diabetes Mellitus Type 1
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Accu-Chek Spirit Insulin Pump
Accu-Chek Spirit Insulin Pump
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus Type 1
Eligibility Criteria
Inclusion Criteria:
- Adult patients >= 18 years of age
- Type 1 diabetes
- Diabetic for >2 years, and treated with CSII for >= 3 months
- HbA1c <=8.5%
Exclusion Criteria:
- Excessive fibrosis or lipo-hypertrophy at injection or infusion sites
- Unstable chronic disease other than type 1 diabetes
- Severe hypoglycemic event within last week prior to study start
- Severe diabetic ketoacidosis within last month prior to study start
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Pilot trial to establish endpoints such as "time within target range of a composite fasting day"
Secondary Outcome Measures
AUC, MAGE, HbA1c, body weight change
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00569452
Brief Title
Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
Official Title
Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (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 is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Accu-Chek Spirit Insulin Pump
Intervention Description
One basal rate
Intervention Type
Device
Intervention Name(s)
Accu-Chek Spirit Insulin Pump
Intervention Description
Multiple basal rates
Primary Outcome Measure Information:
Title
Pilot trial to establish endpoints such as "time within target range of a composite fasting day"
Time Frame
Study duration
Secondary Outcome Measure Information:
Title
AUC, MAGE, HbA1c, body weight change
Time Frame
Study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Adult patients >= 18 years of age
Type 1 diabetes
Diabetic for >2 years, and treated with CSII for >= 3 months
HbA1c <=8.5%
Exclusion Criteria:
Excessive fibrosis or lipo-hypertrophy at injection or infusion sites
Unstable chronic disease other than type 1 diabetes
Severe hypoglycemic event within last week prior to study start
Severe diabetic ketoacidosis within last month prior to study start
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Buhr
Organizational Affiliation
Disetronic Medical Systems AG
Official's Role
Study Director
Facility Information:
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
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