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

University Hospital Center (CHU)

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Behavioral: Education to Functional Insulin Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01512680

ID-RCB : 2011-A00645-36 (Other Identifier)

8749

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 1 patient group

Type 1 diabetes patient

Experimental group

Description:

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

Treatment:

Behavioral: Education to Functional Insulin Therapy