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

Diabetes Mellitus Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569452
• Other study ID #: RD000278
• Secondary ID: DMS-01-CIRCADIAN
• Status: Completed
• Phase: N/A
• First received: December 6, 2007
• Last updated: March 1, 2016
• Start date: January 2006
• Est. completion date: May 2006

Study information

• Verified date: June 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Regierungspräsidium Tübingen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot trial to establish endpoints such as "time within target range of a composite fasting day"		Study duration	No
Secondary	AUC, MAGE, HbA1c, body weight change		Study duration	No