Starting Basal Rate Profiles Used in Continuous Subcutaneous Insulin Infusion

This study has been completed.

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00569452

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

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Proparacaine Proparacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Parallel Assignment
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

Further study details as provided by Hoffmann-La Roche:

Study Start Date:	January 2006
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Locations

Germany

Ulm, Germany

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Study ID Numbers:	DMS-01-CIRCADIAN-01, RD000278
Study First Received:	December 6, 2007
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00569452
Health Authority:	Germany: Regierungsprasidium Tubingen

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Proxymetacaine
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009