Status:
COMPLETED
Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT ...
Detailed Description
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. In this study we plan to en...
Eligibility Criteria
Inclusion
- Age between 18 and 70
- Type 1 diabetes for more than 1 year
- Treatment by basal/bolus insulin therapy and insulin pump for more than 6 months
- HbA1c between 7.5 and 12%
- Volunteer to be educated to Functional Insulin Therapy
- Patient must be willing to undergo all study procedures
- Patient must be affiliated or beneficiary of a social medical insurance
- Patient has signed informed consent form prior to study entry
Exclusion
- Type 2 diabetes
- Difficulties with mathematics calculation (simple algebra)
- Patient is pregnant, or breast feeding during the period of the study
- Manifest psychological disorders
- Patient with eating behaviour desorder
- Alcohol or drug addiction, as identified by investigator during screening visit
- Persons deprived of freedom, adults protected by law or vulnerable persons
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01512680
Start Date
November 1 2011
End Date
November 1 2015
Last Update
November 29 2016
Active Locations (1)
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1
Montpellier University Hospital
Montpellier, France, 34000