Clinical trial NCT01512680: Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients
Official title: Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Functional Insulin Thearpy
Carbs counting
Type 1 diabetes mellitus
Insulin pump
Treatment by external insulin pump
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Difference between HbA1c at Month 12 and Month 0 > 0.5%
timeFrame: at baseline et at Month 12
Secondary outcomes:
measure: Difference between HbA1c at Month 3 and Month 0 > 0.3%
timeFrame: at baseline et at Month 3
measure: Difference between HbA1c at Month 6 and Month 0 > 0.5%
timeFrame: at baseline and at Month 6
measure: Difference between HbA1c at Month 9 and Month 0 > 0.5%
timeFrame: at baseline and at Month 9
measure: Reduction of 50% of hypoglycemia < 60mg/dl
timeFrame: at Month 12
measure: Reduction of 30% of hypoglycemia between 60 and 80mg/dl
timeFrame: at Month 12
measure: Reduction of number of patients who have severe hypoglycemia
timeFrame: at MONTH 12
measure: Better score at surveys of quality of life (SF-6D, DQOL) and auto-management
timeFrame: at baseline, at Month 6 and at Month 12
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Eric ER RENARD, MD
role: PRINCIPAL_INVESTIGATOR
References: