Type 1 Diabetes
Conditions
Keywords
Functional Insulin Thearpy, Carbs counting, Type 1 diabetes mellitus, Insulin pump, Treatment by external insulin pump
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.
Interventions
BEHAVIORALEducation 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
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between HbA1c at Month 12 and Month 0 > 0.5% | at baseline et at Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Difference between HbA1c at Month 3 and Month 0 > 0.3% | at baseline et at Month 3 |
| 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 |
| Reduction of 30% of hypoglycemia between 60 and 80mg/dl | at Month 12 |
Countries
France
Outcome results
None listed