Clinical trial NCT04406766: Evaluation of a Connected Parenteral Pump for Patients Treated by Home Parenteral Nutrition (HPN).
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parenteral Nutrition, Home
Keywords: Connected feeding pump
Reduction of costs due to late management of complications
Patients quality of life improvement
Clinical management of patients' pathology improvement
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
name: MAATEL
name: Orange Labs
First posted: 2020-05-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Ratio of all data and anomaly events correctly transmitted from the connected infusion pump to the software interface.
timeFrame: 1 month
Secondary outcomes:
measure: Volume of all data and anomaly events correctly transmitted from the nutrition pump to the software interface, compared to the volume of data to be transmitted.
timeFrame: 1 month
measure: Type and variable (value / field / date / time) for data and events from extracted files : - from the pump before the IoT module; - from the software interface.
timeFrame: 1 month
measure: Frequency and typology of problems encountered.
timeFrame: 1 month
measure: - Quantitative evaluation: number of cases in which the physician would have changed the patient follow-up over the entire study ; - Qualitative evaluation: nature of the follow-up change (no change, delayed change, immediate change).
timeFrame: 1 month
measure: Analysis of the efficacy, the efficiency, the difficulties and usage errors of the software interface by the medical team according to specific scenarios tests performed with an ergonomist (with voice and screen recording).
timeFrame: 1 month
measure: Customised hetero-questionnaire at the end study visit.
timeFrame: 1 month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Eric Fontaine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pironi L, Miglioli M, Ruggeri E, Longo N, Suriani U, Maselli S, Gnudi S, Barbara L. Home parenteral nutrition for the management of chronic intestinal failure: a 34 patient-year experience. Ital J Gastroenterol. 1993 Oct;25(8):411-8.
citation: Detsky AS, McLaughlin JR, Abrams HB, L'Abbe KA, Whitwell J, Bombardier C, Jeejeebhoy KN. Quality of life of patients on long-term total parenteral nutrition at home. J Gen Intern Med. 1986 Jan-Feb;1(1):26-33. doi: 10.1007/BF02596321.