Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate

Verified by: Hoffmann-La Roche, June 2010
First Received: December 6, 2007 | Last Updated: December 5, 2011 | Phase: N/A | Start Date: January 2006
Overall Status: Completed | Estimated Enrollment: 12
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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
  • Study Primary Completion Date: May 2006

Intervention(s) in this Clinical Trial

  • Device: Accu-Chek Spirit Insulin Pump
    • One basal rate
  • Device: Accu-Chek Spirit Insulin Pump
    • Multiple basal rates

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: A
  • Experimental: B

Outcome Measures for this Clinical Trial

Primary Measures

  • Pilot trial to establish endpoints such as "time within target range of a composite fasting day"
    • Time Frame: Study duration
      Safety Issue?: No

Secondary Measures

  • AUC, MAGE, HbA1c, body weight change
    • Time Frame: Study duration
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Hoffmann-La Roche Industry

Overall Clinical Trial Officials and Contacts

Andreas Buhr Study Director Disetronic Medical Systems AG  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00569452

Study ID Number: RD000278

ClinicalTrials.gov Identifier: NCT00569452

Health Authority: Germany: Regierungspräsidium Tübingen

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