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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569452
First Posted: December 7, 2007
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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 Intervention
Diabetes Mellitus Type 1 Device: Accu-Chek Spirit Insulin Pump

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pilot trial to establish endpoints such as "time within target range of a composite fasting day" [ Time Frame: Study duration ]

Secondary Outcome Measures:
  • AUC, MAGE, HbA1c, body weight change [ Time Frame: Study duration ]

Enrollment: 12
Study Start Date: January 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Accu-Chek Spirit Insulin Pump
One basal rate
Experimental: B Device: Accu-Chek Spirit Insulin Pump
Multiple basal rates

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569452


Locations
Germany
Ulm, Germany, 89081
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Andreas Buhr Disetronic Medical Systems AG
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00569452     History of Changes
Other Study ID Numbers: RD000278
DMS-01-CIRCADIAN-01
First Submitted: December 6, 2007
First Posted: December 7, 2007
Last Update Posted: March 3, 2016
Last Verified: June 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs