Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients

Phase 2

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Education to Functional Insulin Therapy

• Registration Number: NCT01512680
• Lead Sponsor: University Hospital, Montpellier

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

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2012-01-14
• Study First Posted: 2012-01-19
• Primary Completion: 2014-12
• Study Completion: 2015-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Type 1 diabetes patient	Education to Functional Insulin Therapy	Type 1 diabetes patient are included in this study to have an education to Functional Insulin Therapy (intervention)

Primary Outcome Measures

Name	Time	Method
Difference between HbA1c at Month 12 and Month 0 > 0.5%	at baseline et at Month 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France