evaluation of satisfaction regarding home healthcare provider (hhp) management of type 1 diabetic patients using a closed-loop automatic insulin delivery system

Conditions: Diabetes type1

Summary: saturn study aims at evaluating home healthcare provider (hhp) management of type 1 diabetic patients using a closed-loop automatic insulin delivery system (or artificial pancreas), and specifically satisfaction and interactions of all people involved (patients, hhps, hospital healthcare teams) after 1 and 3 months of follow-up, under normal conditions of use.

national, multi-centre, longitudinal, non-comparative interventional study with minimal risks and constraints. two french hospitals and their hhp representatives will participate in the study. a recruitment of a total of 35 patients is expected. adult type 1 diabetic patients for whom the investigator prescribes the use of a closed-loop automatic insulin delivery system (or artificial pancreas) consisting in an insulin pump with a continuous glucose monitoring system combined with a dedicated terminal. patients will be monitored for a period of 3 months, starting from the end of the device installation procedure. hhp management comprises three distinct phases: pre-installation, installation and follow-up during which number, nature and duration of contacts (visits/telephone calls) may vary according to patient's needs, investigator's judgement and practice, and judgement of hhp staff. pre-installation and installation phases consist of two patients' visits at hospital, and of two to five visits from hhp staff to patients' home (only one visit at hospital). follow-up phase held after installation consists of four patients' contacts (phone contact and/or home visit) performed by hhp staff.

Eligibility criteria:
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 global system for mobile communications (gsm) 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

Keywords: artificial pancreas patient management technical telemonitoring home healthcare provider