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Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients

NCT01512680 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-11-29

No results posted yet for this study

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 should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.

Conditions

Interventions

BEHAVIORAL

Education to Functional Insulin Therapy

* Intake of Continuous Glucose Monitor for 5 to 7 days * "Functional Insulinotherapy" training during 3 days, blood sampling, autoevaluation and QOL questionnary. * 1 month after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes * 3 months after the training: Blood sampling, vital signs and data on diabetes * 6 months after the training: 2 sessions of training, blood sampling, autoevaluation and QOL questionnary, vital signs and data on diabetes, Intake of Continuous Glucose Monitor for 5 to 7 days * 9 months after the training: Blood sampling, vital signs and data on diabetes * 1 to 3 weeks before last visit: Intake of Continuous Glucose Monitor for 5 to 7 days * 12 months after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes, autoevaluation and QOL questionnary

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Eric ER RENARD, MD · University Hospital, Montpellier

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-12-31
Completion
2015-11-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01512680 on ClinicalTrials.gov