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Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT00595569
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : January 16, 2008
Diabetes Association Basel
University Hospital, Basel, Switzerland
Information provided by:
University of Lausanne Hospitals

Brief Summary:
To prospectively evaluate the long term metabolic and psychological effects of flexible intensive insulin therapy (FIT) courses in an unselected population of type 1 diabetic patients at the University of Basel Hospital. We hypothesize that both metabolic control and psychological parameters will improve.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Behavioral: Flexible insulin therapy (FIT)

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Flexible, Intensive Insulin Management in Patients With Type 1 Diabetes and Changes in Metabolic Control, Quality of Life, Locus of Control and Diabetes Knowledge
Study Start Date : April 2002
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Group/Cohort Intervention/treatment
Type 1 diabetes Behavioral: Flexible insulin therapy (FIT)
Flexible insulin therapy (FIT) courses consisting in 7 weekly ambulatory sessions lasting 90 minutes each

Primary Outcome Measures :
  1. Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge [ Time Frame: Over 18 months ]

Secondary Outcome Measures :
  1. Changes in insulin doses, changes in weight [ Time Frame: Over 18 months ]

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
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with type 1 diabetes followed at the Division of Endocrinology and Diabetology, University of Basel are strongly encouraged to attend the course 6 to 12 months after having been diagnosed. The population that participates in those FIT courses includes patients from the University of Basel Hospital, but also patients that are referred from out of hospital physicians/diabetologists.

Inclusion Criteria:

  • All patients participating in 5 consecutive FIT courses that began between April 2002 to April 2004

Exclusion Criteria:

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): NCT00595569

University of Basel Hospital
Basel, Switzerland
Sponsors and Collaborators
University of Lausanne Hospitals
Diabetes Association Basel
University Hospital, Basel, Switzerland
Principal Investigator: Jardena J Puder, MD University of Lausanne, University of Basel

Responsible Party: Dr. Jardena Puer, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00595569     History of Changes
Other Study ID Numbers: 120/04
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: December 2007

Keywords provided by University of Lausanne Hospitals:
flexible insulin therapy
diabetes education
Weekly ambulatory sessions

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
Hypoglycemic Agents
Physiological Effects of Drugs