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

Air Liquide

Status

Completed

Conditions

Diabetes type1

Treatments

Device: any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking

Study type

Interventional

Funder types

Industry

Identifiers

NCT04635280

ALMED-19-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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