Evaluation of a Connected Parenteral Pump for Patients Treated by Home Parenteral Nutrition (HPN). (SERENE-eNUTRI)

Grenoble Alpes University Hospital Center (CHU)

Status

Terminated

Conditions

Parenteral Nutrition, Home

Treatments

Device: Connected nutrition pump system

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT04406766

38RC19.343

Details and patient eligibility

About

Patients requiring long-term home parenteral nutrition (HPN) suffer from chronic intestinal insufficiency. The causes of this syndrome can be either anatomical (extensive resection of the small bowel) or functional (occlusion, pseudo-occlusion, malabsorption). Consequences mean that patients are unable to cover their oral energy and / or hydroelectrolytic needs.

As a result, these patients survive only through a nutritional support by the venous route (parenteral nutrition). However, this lifesaving therapy requires complex technological nutritional support issues at home, which will influence the personal life of the patients.

At home, HPN therapy is performed by nutrition pumps providing a constant flow and able to detect anomalies.

In this context, the development of connected systems that allow informations transmission could help patient's caregiving by the different persons involved in his follow-up (prescribing physicians, home support nurses, patients and relatives, manufacturers).

The main objective of this study is to evaluate the performance of an end-to-end data transmission chain which integrates a nutrition pump connected to a medical IoT module (developped by Maatel) able to send information to an applicative layer (software interface PatHView2, developped by Orange Labs) via different transmission modes : LoRaWAN (Long Range Wide-area network), BLE (Bluetooth Low Energy), GSM LTE-M (Global System for Mobile Communications, Long Term Evolution - Machine Type Communication).

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age < 18 years
Patient receiving a home parenteral nutrition (HPN) and followed by the Artificial Nutrition Service of the CHUGA
Patient carrying out all his infusions at home during the month of use of the connected pump (constraint due to the LoRaWAn transmission mode)
Patient affiliated to the French social security system or an equivalent system
Patient who has signed consent form

Exclusion criteria

Presenting any other pathology or treatment that the physician may deem incompatible with this study
Patient under exclusion period from another study
Protected persons (patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code)