Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
Not Applicable
Completed
- Conditions
- Diabetes Mellitus Type 1
- Interventions
- Device: Accu-Chek Spirit Insulin Pump
- Registration Number
- NCT00569452
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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%
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Accu-Chek Spirit Insulin Pump - B Accu-Chek Spirit Insulin Pump -
- Primary Outcome Measures
Name Time Method Pilot trial to establish endpoints such as "time within target range of a composite fasting day" Study duration
- Secondary Outcome Measures
Name Time Method AUC, MAGE, HbA1c, body weight change Study duration