Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

January 15, 2008 updated by: University of Lausanne Hospitals

Flexible, Intensive Insulin Management in Patients With Type 1 Diabetes and Changes in Metabolic Control, Quality of Life, Locus of Control and Diabetes Knowledge

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • University of Basel Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge
Time Frame: Over 18 months
Over 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in insulin doses, changes in weight
Time Frame: Over 18 months
Over 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Collaborators

University Hospital, Basel, Switzerland
Diabetes Association Basel

Investigators

  • Principal Investigator: Jardena J Puder, MD, University of Lausanne, University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

January 16, 2008

Last Update Submitted That Met QC Criteria

January 15, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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