Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Flexible insulin therapy (FIT)

• Registration Number: NCT00595569
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Status Verified: 2007-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-15
• Last Update Submitted: 2008-01-15
• Study First Posted: 2008-01-16
• Last Update Posted: 2008-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 diabetes	Flexible insulin therapy (FIT)	-

Primary Outcome Measures

Name	Time	Method
Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge	Over 18 months

Secondary Outcome Measures

Name	Time	Method
Changes in insulin doses, changes in weight	Over 18 months

Trial Locations

Locations (1)

University of Basel Hospital; 🇨🇭 Basel, Switzerland