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OpenTrials
Completed

NCT Number: NCT00595569

Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Basel Hospital

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Flexible insulin therapy (FIT)

Behavioral

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

Primary outcomes

  1. Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge

    Time frame: Over 18 months

Secondary outcomes

  1. Changes in insulin doses, changes in weight

    Time frame: Over 18 months

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Collaborators

  • Diabetes Association Basel
  • University Hospital, Basel, Switzerland

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Jan 16, 2008
Registry last updated
Jan 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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