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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00569452
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
3.9
Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Accu-Chek Spirit Insulin Pump
  • Device: Accu-Chek Spirit Insulin Pump
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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 Start Date :
Jan 1, 2006
Actual Primary Completion Date :
May 1, 2006
Actual Study Completion Date :
May 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Device: Accu-Chek Spirit Insulin Pump
One basal rate
Experimental: B

Device: Accu-Chek Spirit Insulin Pump
Multiple basal rates

Outcome Measures

Primary Outcome Measures

  1. Pilot trial to establish endpoints such as "time within target range of a composite fasting day" [Study duration]

Secondary Outcome Measures

  1. AUC, MAGE, HbA1c, body weight change [Study duration]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ulm Germany 89081

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Andreas Buhr, Disetronic Medical Systems AG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00569452
Other Study ID Numbers:
  • RD000278
  • DMS-01-CIRCADIAN-01
First Posted:
Dec 7, 2007
Last Update Posted:
Mar 3, 2016
Last Verified:
Jun 1, 2010
Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Insulin
Insulin, Globin Zinc

Study Results

No Results Posted as of Mar 3, 2016