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

January 5, 2023 updated by: University Hospital, Grenoble

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.

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Chu Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Connected nutrition pump system
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of all data and anomaly events correctly transmitted from the connected infusion pump to the software interface.
Time Frame: 1 month
Evaluate the ratio of data (volume administered with the perfusion cycles over 24 hours; duration, velocity rate and mode of the perfusions) and events (occlusion of the venous route and presence of bubble in the infusion line) correctly transmitted in different transmission modalities (LoRaWan, BLE+GSM, GSM LTE-M, multimodality) from the connected infusion pump to the software interface.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 month
Evaluate the ratio of all data (volume administered with the perfusion cycles over 24 hours; duration, velocity rate and mode of the perfusions) and events (occlusion of the venous route and presence of bubble in the infusion line) correctly transmitted in terms of volume using different transmission modalities (LoRaWan, BLE+GSM, GSM LTE-M, multimodality), from the connected infusion pump to the software interface.
1 month
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.
Time Frame: 1 month
Evaluate the ratio of each data type (volume administered with the perfusion cycles over 24 hours; duration, velocity rate and mode of the perfusions) and events (technical notifications of system use) correctly transmitted through the four transmission modalities (LoRaWan, BLE+GSM, GSM LTE-M, multimodality), from the connected infusion pump to the software interface. This target will be verified if the proportion of the main target is < 98%.
1 month
Frequency and typology of problems encountered.
Time Frame: 1 month
Descriptive analysis of the problems encountered.
1 month
- 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).
Time Frame: 1 month
Quantitative and qualitative evaluation of the proposed solution (software interface) in terms of medical reasoning help on the potential improvement of patient follow-up (i.e. compliance with a prescription).
1 month
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).
Time Frame: 1 month
Evaluate the usability of the software interface by the medical team (physicians, nurses, ...).
1 month
Customised hetero-questionnaire at the end study visit.
Time Frame: 1 month
Assess the acceptability of the proposed solution (connected pump) by the patient.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Clinical Investigation Centre for Innovative Technology Network
MAATEL
Orange Labs

Investigators

  • Principal Investigator: Eric Fontaine, MD, Chu Grenoble Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2020

Primary Completion (Actual)

July 16, 2021

Study Completion (Actual)

July 16, 2021

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC19.343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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