Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients

Type 1 Diabetes Clinical Trial

— IFOPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512680
• Other study ID #: 8749
• Secondary ID: ID-RCB : 2011-A0
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2011
• Last updated: November 28, 2016
• Start date: November 2011
• Est. completion date: November 2015

Study information

• Verified date: November 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

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

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between HbA1c at Month 12 and Month 0 > 0.5%		at baseline et at Month 12	No
Secondary	Difference between HbA1c at Month 3 and Month 0 > 0.3%		at baseline et at Month 3	No
Secondary	Difference between HbA1c at Month 6 and Month 0 > 0.5%		at baseline and at Month 6	No
Secondary	Difference between HbA1c at Month 9 and Month 0 > 0.5%		at baseline and at Month 9	No
Secondary	Reduction of 50% of hypoglycemia < 60mg/dl		at Month 12	No
Secondary	Reduction of 30% of hypoglycemia between 60 and 80mg/dl		at Month 12	No
Secondary	Reduction of number of patients who have severe hypoglycemia		at MONTH 12	No
Secondary	Better score at surveys of quality of life (SF-6D, DQOL) and auto-management		at baseline, at Month 6 and at Month 12	No