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NCT00595569 Clinical Trial

Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00595569
Other study ID # 120/04
Secondary ID 120/04
Status Completed
Phase N/A
First received December 28, 2007
Last updated January 15, 2008
Start date April 2002
Est. completion date December 2007

Study information
Verified date December 2007
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• Flexible insulin therapy (FIT)
Flexible insulin therapy (FIT) courses consisting in 7 weekly ambulatory sessions lasting 90 minutes each

Locations
Country Name City State
Switzerland University of Basel Hospital Basel

Sponsors (3)
Lead Sponsor Collaborator
University of Lausanne Hospitals Diabetes Association Basel, University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge Over 18 months No
Secondary Changes in insulin doses, changes in weight Over 18 months No
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