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

Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Education to Functional Insulin Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • Montpellier University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between HbA1c at Month 12 and Month 0 > 0.5%	at baseline et at Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference between HbA1c at Month 3 and Month 0 > 0.3%	at baseline et at Month 3
Difference between HbA1c at Month 6 and Month 0 > 0.5%	at baseline and at Month 6
Difference between HbA1c at Month 9 and Month 0 > 0.5%	at baseline and at Month 9
Reduction of 50% of hypoglycemia < 60mg/dl	at Month 12
Reduction of 30% of hypoglycemia between 60 and 80mg/dl	at Month 12
Reduction of number of patients who have severe hypoglycemia	at MONTH 12
Better score at surveys of quality of life (SF-6D, DQOL) and auto-management	at baseline, at Month 6 and at Month 12

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Eric ER RENARD, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 16, 2011
• First Submitted That Met QC Criteria: January 14, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): November 29, 2016
• Last Update Submitted That Met QC Criteria: November 28, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Insulin pump; Type 1 diabetes mellitus; Functional Insulin Thearpy; Carbs counting; Treatment by external insulin pump
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 8749; ID-RCB : 2011-A00645-36 (Other Identifier: Afssaps)