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: Diagnostic, Randomized, Open Label, Parallel Assignment

Intervention(s) in this Clinical Trial

• Device: Accu-Chek Spirit insulin pump

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

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on July 02, 2009

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

Study ID Number: DMS-01-CIRCADIAN-01

ClinicalTrials.gov Identifier: NCT00569452

Health Authority: Germany: Regierungsprasidium Tubingen