Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients (IFOPI)

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01512680
First received: December 16, 2011
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Behavioral: Education to Functional Insulin Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Difference between HbA1c at Month 12 and Month 0 > 0.5% [ Time Frame: at baseline et at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between HbA1c at Month 3 and Month 0 > 0.3% [ Time Frame: at baseline et at Month 3 ] [ Designated as safety issue: No ]
  • Difference between HbA1c at Month 6 and Month 0 > 0.5% [ Time Frame: at baseline and at Month 6 ] [ Designated as safety issue: No ]
  • Difference between HbA1c at Month 9 and Month 0 > 0.5% [ Time Frame: at baseline and at Month 9 ] [ Designated as safety issue: No ]
  • Reduction of 50% of hypoglycemia < 60mg/dl [ Time Frame: at Month 12 ] [ Designated as safety issue: No ]
  • Reduction of 30% of hypoglycemia between 60 and 80mg/dl [ Time Frame: at Month 12 ] [ Designated as safety issue: No ]
  • Reduction of number of patients who have severe hypoglycemia [ Time Frame: at MONTH 12 ] [ Designated as safety issue: No ]
  • Better score at surveys of quality of life (SF-6D, DQOL) and auto-management [ Time Frame: at baseline, at Month 6 and at Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Type 1 diabetes patient
Type 1 diabetes patient are included in this study to have an education to Functional Insulin Therapy (intervention)
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

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 enroll 60 patients who will be educated toFIT and followed during one year. Patient will follow normal path of eductation which is composed of a 3 days inpatient admission, a medical visit one month after the education, and a 4hours reminder session six months after the education. We will compare HbA1c, hypoglycemia, weight, before the education, and after. Patient will also wear a continuous glucose sensor during one week before, at month 6 and month 12 to allow comparison of glucose variablity.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 70
  2. Type 1 diabetes for more than 1 year
  3. Treatment by basal/bolus insulin therapy and insulin pump for more than 6 months
  4. HbA1c between 7.5 and 12%
  5. Volunteer to be educated to Functional Insulin Therapy
  6. Patient must be willing to undergo all study procedures
  7. Patient must be affiliated or beneficiary of a social medical insurance
  8. Patient has signed informed consent form prior to study entry

Exclusion Criteria:

  1. Type 2 diabetes
  2. Difficulties with mathematics calculation (simple algebra)
  3. Patient is pregnant, or breast feeding during the period of the study
  4. Manifest psychological disorders
  5. Patient with eating behaviour desorder
  6. Alcohol or drug addiction, as identified by investigator during screening visit
  7. Persons deprived of freedom, adults protected by law or vulnerable persons
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512680

Contacts
Contact: Eric ER RENARD, MD +33 4 67 33 83 82 e-renard@chu-montpellier.fr
Contact: Anne AF FARRET, MD a-farret@chu-montpellier.fr

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34000
Contact: Eric ER RENARD, MD    +33 4 67 33 83 82    e-renard@chu-montpellier.fr   
Principal Investigator: Eric ER RENARD, MD         
Sub-Investigator: Anne AF FARRET, MD         
Sub-Investigator: Magali MT TRAVERSO-MIRABEL, MD         
Sub-Investigator: Claire CP PARER-RICHARD, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Eric ER RENARD, MD University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01512680     History of Changes
Other Study ID Numbers: UF8749, ID-RCB : 2011-A00645-36
Study First Received: December 16, 2011
Last Updated: November 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Montpellier:
Functional Insulin Thearpy
Carbs counting
Type 1 diabetes mellitus
Insulin pump
Treatment by external insulin pump

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014