Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients

NCT ID: NCT01512680

Last Updated: 2016-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-11-30

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.

Conditions

Type 1 Diabetes

Keywords

Functional Insulin Thearpy; Carbs counting; Type 1 diabetes mellitus; Insulin pump; Treatment by external insulin pump

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Type 1 diabetes patient

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

Group Type: EXPERIMENTAL

Education to Functional Insulin Therapy

Intervention Type: BEHAVIORAL

• 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric ER RENARD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Montpellier University Hospital

Montpellier, , France

Countries

France

Other Identifiers

ID-RCB : 2011-A00645-36

Identifier Type: OTHER

Identifier Source: secondary_id

8749

Identifier Type: -

Identifier Source: org_study_id