NCT04635280

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

Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Equipped With the "Closed-loop" Automated Insulin Delivery System (or "Artificial Pancreas"), Under Normal Conditions of Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes type1

Interventions

Type	Name	Description
DEVICE	any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking	A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and an algorithm.

Timeline

• Start date: 2021-05-10
• Primary completion: 2022-01-12
• Completion: 2022-01-12
• First posted: 2020-11-19
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

2 sites across 1 country: France