Validation of a Biomathematical Model to Help Identify the Parameters of Flexible Insulin Therapy (ModIF)

This is an interventional other trial for Type 1 Diabetes focused on measuring Type 1 diabetes mellitus, biomathematical model, Flexible insulin therapy Read More

Inclusion Criteria:

1. Patient with type 1 diabetes for at least two years with an indication for sensor placement,
2. Patient patient with at least 6 months of external insulin pump therapy and using the Medtronic 640G pump with or without the Enlite® System.
3. Patient having at least 6 months experience of flexible insulin therapy,
4. Patient with HbA1c <10% (less than 4 months' duration of testing in a medical laboratory or equivalent),
5. Patient who has been wearing a Continuous Glucose Monitoring device for at least 3 months,
6. Adult patient,
7. Patient affiliated to a Social Security or equivalent,
8. Patient who has signed Informed Consent Form.

Exclusion Criteria:

1. Patient with type 2 diabetes or secondary diabetes
2. Patient with any serious medical condition that may affect participation in the study,
3. Patient benefiting from a legal protection measure,
4. Woman who is pregnant or likely to become pregnant during the course of the study, i.e., a lack of effective contraception in women of childbearing age,
5. Breastfeeding,
6. Psychological and/or physical condition that may affect the proper monitoring of study procedures,
7. Severe hypoglycemia leading to convulsions or loss of consciousness within the last 12 months,
8. Decreased hypoglycemic feelings (as judged by the clinician),
9. Impaired renal function (creatinine clearance calculated by CKD-EPI < 30mL/min),
10. Patient who has had a pancreas transplant or pancreatic islets,
11. Persons with severe uncorrected hearing and/or visual acuity problems,
12. Insulin resistance defined by daily insulin requirements > 1 U/kg/day in the week prior to inclusion,
13. Patient treated with oral corticosteroid therapy.