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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

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ClinicalTrials.gov Identifier: NCT00569452
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Diabetes Mellitus Type 1 Device: Accu-Chek Spirit Insulin Pump Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : January 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine


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




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00569452     History of Changes
Other Study ID Numbers: RD000278
DMS-01-CIRCADIAN-01
First Posted: December 7, 2007    Key Record Dates
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