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

This is an open randomized pilot clinical study, comparing the effectiveness of medical decision assisted by this bio-mathematical model ("augmented physician") versus unassisted medical decision, to define the parameters of flexible insulin therapy based on data from a continuous glucose measurement record for 7 days.

Inclusion criteria

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

Exclusion criteria

• Patient with type 2 diabetes or secondary diabetes
• Patient with any serious medical condition that may affect participation in the study,
• Patient benefiting from a legal protection measure,
• 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,
• Breastfeeding,
• Psychological and/or physical condition that may affect the proper monitoring of study procedures,
• Severe hypoglycemia leading to convulsions or loss of consciousness within the last 12 months,
• Decreased hypoglycemic feelings (as judged by the clinician),
• Impaired renal function (creatinine clearance calculated by CKD-EPI < 30mL/min),
• Patient who has had a pancreas transplant or pancreatic islets,
• Persons with severe uncorrected hearing and/or visual acuity problems,
• Insulin resistance defined by daily insulin requirements > 1 U/kg/day in the week prior to inclusion,
• Patient treated with oral corticosteroid therapy.