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

Diabetes type1 Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04635280
Study type Interventional
Source Air Liquide Santé International
Contact
Status Completed
Phase N/A
Start date May 10, 2021
Completion date January 12, 2022
View Details
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