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Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Diabetes Foundation Basel
University Hospital, Basel, Switzerland
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00595569
First received: December 28, 2007
Last updated: January 15, 2008
Last verified: December 2007
History of Changes
  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)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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

No publications provided

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

Keywords provided by University of Lausanne Hospitals:
flexible insulin therapy
diabetes education
diabetes
insulin
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013