<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04406766</url>
  </required_header>
  <id_info>
    <org_study_id>38RC19.343</org_study_id>
    <nct_id>NCT04406766</nct_id>
  </id_info>
  <brief_title>Evaluation of a Connected Parenteral Pump for Patients Treated by Home Parenteral Nutrition (HPN).</brief_title>
  <acronym>SERENE-eNUTRI</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Investigation Centre for Innovative Technology Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MAATEL</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Orange Labs</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients requiring long-term home parenteral nutrition (HPN) suffer from chronic intestinal&#xD;
      insufficiency. The causes of this syndrome can be either anatomical (extensive resection of&#xD;
      the small bowel) or functional (occlusion, pseudo-occlusion, malabsorption). Consequences&#xD;
      mean that patients are unable to cover their oral energy and / or hydroelectrolytic needs.&#xD;
&#xD;
      As a result, these patients survive only through a nutritional support by the venous route&#xD;
      (parenteral nutrition). However, this lifesaving therapy requires complex technological&#xD;
      nutritional support issues at home, which will influence the personal life of the patients.&#xD;
&#xD;
      At home, HPN therapy is performed by nutrition pumps providing a constant flow and able to&#xD;
      detect anomalies.&#xD;
&#xD;
      In this context, the development of connected systems that allow informations transmission&#xD;
      could help patient's caregiving by the different persons involved in his follow-up&#xD;
      (prescribing physicians, home support nurses, patients and relatives, manufacturers).&#xD;
&#xD;
      The main objective of this study is to evaluate the performance of an end-to-end data&#xD;
      transmission chain which integrates a nutrition pump connected to a medical IoT module&#xD;
      (developped by Maatel) able to send information to an applicative layer (software interface&#xD;
      PatHView2, developped by Orange Labs) via different transmission modes : LoRaWAN (Long Range&#xD;
      Wide-area network), BLE (Bluetooth Low Energy), GSM LTE-M (Global System for Mobile&#xD;
      Communications, Long Term Evolution - Machine Type Communication).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Context of the COVID-19 pandemic, strict eligibility criteria (especially 15 km radius from the&#xD;
    CHUGA) significantly reducing the active file and the recruitment capacities.&#xD;
  </why_stopped>
  <start_date type="Actual">September 28, 2020</start_date>
  <completion_date type="Actual">July 16, 2021</completion_date>
  <primary_completion_date type="Actual">July 16, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ratio of all data and anomaly events correctly transmitted from the connected infusion pump to the software interface.</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>1 month</time_frame>
    <description>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 &lt; 98%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and typology of problems encountered.</measure>
    <time_frame>1 month</time_frame>
    <description>Descriptive analysis of the problems encountered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <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).</measure>
    <time_frame>1 month</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <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).</measure>
    <time_frame>1 month</time_frame>
    <description>Evaluate the usability of the software interface by the medical team (physicians, nurses, ...).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Customised hetero-questionnaire at the end study visit.</measure>
    <time_frame>1 month</time_frame>
    <description>Assess the acceptability of the proposed solution (connected pump) by the patient.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Parenteral Nutrition, Home</condition>
  <arm_group>
    <arm_group_label>Connected nutrition pump system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Connected nutrition pump system</intervention_name>
    <description>For the patient, it consists of the installation of the connected pump at his home for a duration of one month.&#xD;
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.&#xD;
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.</description>
    <arm_group_label>Connected nutrition pump system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Patient receiving a home parenteral nutrition (HPN) and followed by the Artificial&#xD;
             Nutrition Service of the CHUGA&#xD;
&#xD;
          -  Patient carrying out all his infusions at home during the month of use of the&#xD;
             connected pump (constraint due to the LoRaWAn transmission mode)&#xD;
&#xD;
          -  Patient affiliated to the French social security system or an equivalent system&#xD;
&#xD;
          -  Patient who has signed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presenting any other pathology or treatment that the physician may deem incompatible&#xD;
             with this study&#xD;
&#xD;
          -  Patient under exclusion period from another study&#xD;
&#xD;
          -  Protected persons (patient concerned by articles L1121-5, L1121-6, L1121-8 of the&#xD;
             French public health code)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Fontaine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Grenoble Alpes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://maatel.com/savoir-faire/etudes-de-cas-conception-electronique/serene-iot/</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.has-sante.fr/upload/docs/application/pdf/2008-07/rapport_nutrition_parenterale_a_domicile_2008-07-31_14-29-41_874.pdf</url>
    <description>Related Info</description>
  </link>
  <reference>
    <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>
    <PMID>8286774</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>3095514</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Connected feeding pump</keyword>
  <keyword>Reduction of costs due to late management of complications</keyword>
  <keyword>Patients quality of life improvement</keyword>
  <keyword>Clinical management of patients' pathology improvement</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04406766
org study id: 38RC19.343
nct id: NCT04406766
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Ratio of all data and anomaly events correctly transmitted from the connected infusion pump to the software interface.
time frame: 1 month
description: 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.
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.
time frame: 1 month
description: 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.
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.
time frame: 1 month
description: 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%.
measure: Frequency and typology of problems encountered.
time frame: 1 month
description: Descriptive analysis of the problems encountered.
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).
time frame: 1 month
description: 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).
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).
time frame: 1 month
description: Evaluate the usability of the software interface by the medical team (physicians, nurses, ...).
measure: Customised hetero-questionnaire at the end study visit.
time frame: 1 month
description: Assess the acceptability of the proposed solution (connected pump) by the patient.
arm group label: Connected nutrition pump system
arm group type: Experimental
intervention type: Device
intervention name: Connected nutrition pump system
description: 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.
arm group label: Connected nutrition pump system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Fontaine, MD
role: Principal Investigator
affiliation: CHU Grenoble Alpes
facility: 
country: France
url: https://maatel.com/savoir-faire/etudes-de-cas-conception-electronique/serene-iot/
description: Related Info
url: https://www.has-sante.fr/upload/docs/application/pdf/2008-07/rapport_nutrition_parenterale_a_domicile_2008-07-31_14-29-41_874.pdf
description: Related Info
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.
PMID: 8286774
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.
PMID: 3095514
responsible party type: Sponsor
sharing ipd: No