AzTrials
AzTrials

Parenteral Nutrition, HomeSERENE-eNUTRINCT04406766

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

A study testing Connected nutrition pump system in people with Parenteral Nutrition, Home, run by University Hospital, Grenoble at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parenteral Nutrition, Home
What is being tested?
Connected nutrition pump system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteFrance
Study dates
28 Sep 2020to 16 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Grenoble Alpes

    Grenoble, 38000

Other trials in France

About this study

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.

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.

Read more

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).

Being tested
Connected nutrition pump system
Keywords
Connected feeding pump, Reduction of costs due to late management of complications, Patients quality of life improvement, Clinical management of patients' pathology improvement
Medical subject headings
Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Connected nutrition pump systemDevice

    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.

Study groups in NCT04406766
Study groupRoleWhat they receive
Connected nutrition pump systemExperimentalNot described
Receives: Device: Connected nutrition pump system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ratio of all data and anomaly events correctly transmitted from the connected infusion pump to the software interface.

    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.

    Measured: 1 month

Secondary outcomes (6)

  1. 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.

    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.

    Measured: 1 month

  2. 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.

    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%.

    Measured: 1 month

  3. Frequency and typology of problems encountered.

    Descriptive analysis of the problems encountered.

    Measured: 1 month

  4. - 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).

    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).

    Measured: 1 month

  5. 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).

    Evaluate the usability of the software interface by the medical team (physicians, nurses, ...).

    Measured: 1 month

  6. Customised hetero-questionnaire at the end study visit.

    Assess the acceptability of the proposed solution (connected pump) by the patient.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2020
  2. Study start28 Sep 2020
  3. Primary completion16 Jul 2021
  4. Study completion16 Jul 2021

Why it stopped: Context of the COVID-19 pandemic, strict eligibility criteria (especially 15 km radius from the CHUGA) significantly reducing the active file and the recruitment capacities.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04406766
Sponsor's protocol ID
38RC19.343
Acronym
SERENE-eNUTRI
Status last verified
Jan 2021
First submitted
22 May 2020
Last updated
9 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8286774

  • 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.

    PubMed 3095514

Questions about this trial

What is this clinical trial studying?

A study testing Connected nutrition pump system in people with Parenteral Nutrition, Home, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Context of the COVID-19 pandemic, strict eligibility criteria (especially 15 km radius from the CHUGA) significantly reducing the active file and the recruitment capacities.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio of all data and anomaly events correctly transmitted from the connected infusion pump to the software interface. (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04406766, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in