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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00569452
First received: December 6, 2007
Last updated: August 26, 2014
Last verified: June 2010
  Purpose

This is a pilot trial to establish study procedures that allow comparison of var ious starting basal rate profiles used in Continuous Subcutaneous Insulin Infusi on (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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC, MAGE, HbA1c, body weight change [ Time Frame: Study duration ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569452

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00569452     History of Changes
Other Study ID Numbers: RD000278, DMS-01-CIRCADIAN-01
Study First Received: December 6, 2007
Last Updated: August 26, 2014
Health Authority: Germany: Regierungspräsidium Tübingen

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

ClinicalTrials.gov processed this record on November 20, 2014