NCT04406766

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

Evaluation of a Data Transmission Solution for Connected Nutrition Pump for Patients Treated by Home Parenteral Nutrition (HPN). Proof of Concept, Prospective, Monocentric, Non-randomized, and Open-label Study.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Parenteral Nutrition, Home

Interventions

Type	Name	Description
DEVICE	Connected nutrition pump system	For the patient, it consists of the installation of the connected pump at his home for a duration of one month. Infusion data and events will be continuously collected and transmitted by the 4 different modes (LoRaAN, BLE , GSM and multimodality).Transmitted data won't be used to change the follow up of the patient. At the end of the month, patients will be solicited by an ergonomic engineer to complete a specific questionnaire in order to evaluate the future acceptability of the proposed solution.

Timeline

• Start date: 2020-09-28
• Primary completion: 2021-07-16
• Completion: 2021-07-16
• First posted: 2020-05-28
• Last updated: 2023-01-09

Locations

1 site across 1 country: France