Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

This study has been completed.

Sponsors and Collaborators:	University of Lausanne Hospitals Diabetes Foundation Basel University Hospital, Basel, Switzerland
Information provided by:	University of Lausanne Hospitals
ClinicalTrials.gov Identifier:	NCT00595569

Purpose

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	Intervention
Diabetes Mellitus, Type 1	Behavioral: Flexible insulin therapy (FIT)

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:

Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge [ Time Frame: Over 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in insulin doses, changes in weight [ Time Frame: Over 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	45
Study Start Date:	April 2002
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Type 1 diabetes	Behavioral: Flexible insulin therapy (FIT) Flexible insulin therapy (FIT) courses consisting in 7 weekly ambulatory sessions lasting 90 minutes each

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595569

Locations

Switzerland
University of Basel Hospital
Basel, Switzerland

Sponsors and Collaborators

University of Lausanne Hospitals

Diabetes Foundation Basel

University Hospital, Basel, Switzerland

Investigators

Principal Investigator:

Jardena J Puder, MD

University of Lausanne, University of Basel

More Information

Responsible Party:	University of Lausanne Hospitals ( Dr. Jardena Puer )
Study ID Numbers:	120/04, 120/04
Study First Received:	December 28, 2007
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00595569
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:

flexible insulin therapy
diabetes education
diabetes
insulin
Weekly ambulatory sessions

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Quality of Life

Endocrine System Diseases
Endocrinopathy
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 16, 2009