Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System (SATURN)

This is an interventional health services research trial for Diabetes type1 focused on measuring Artificial pancreas, Patient management, Technical telemonitoring, Home Healthcare Provider Read More

Inclusion Criteria:

• Type 1 diabetic patient diagnosed for at least 2 years
• Patient treated with an external insulin pump for at least 6 months
• Patient with an HbA1c level less than or equal to 10% in the past 4 months
• Patient with U100 short-acting insulin (Novorapid or Humalog) requirements between the lower and upper bounds set by the pump of the closed-loop automatic insulin delivery system (or artificial pancreas)
• Patient who is not isolated, who does not live alone or who has a "resource" person living nearby with her/his own telephone and a key to the patient's home
• Patient living in an area covered by a GSM (Global System for Mobile Communications) network and not planning to travel outside France or outside an area covered by a GSM network within 30 days of the closed-loop automatic insulin delivery system (or artificial pancreas) being installed
• Patient at least 18 years old and whose age complies with the eligibility criteria for each medical device of the closed-loop automatic insulin delivery system (or artificial pancreas)
• Patient registered with a Social Security scheme
• Patient who has agreed to comply with the requirements of the study and has signed the free and informed consent form
• Patient who the investigator deems capable of using a closed-loop automatic insulin delivery system (or artificial pancreas) under normal conditions of use.

Exclusion Criteria:

• Patient with any serious pathology that could affect his/her participation in the study
• Patient undergoing treatment that could affect the physiology of diabetes, i.e., that leads to interactions with glucose and/or insulin, in the investigator's judgement
• Patient benefiting from a legal protection measure
• Pregnant or breastfeeding woman
• Absence of contraception deemed effective by the investigator for a woman of child-bearing age
• Psychological and/or physical state which could affect the proper follow-up of the study procedures
• Severe hypoglycaemia which has led to convulsions or a loss of consciousness in the last 12 months
• Decrease in the perceived sensation of hypoglycaemia, in the investigator's judgement
• Altered renal function (creatinine clearance < 30 ml/min measured in the last 6 months)
• Patient who has had a pancreas or pancreatic islet transplant
• Patient with serious uncorrected hearing and/or visual problems
• Patient included in another clinical study or who has taken part in another clinical study in the last 30 days