<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/NCT03819335</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-SUG-2018-01</org_study_id>
    <nct_id>NCT03819335</nct_id>
  </id_info>
  <brief_title>¿Can mySugr App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus?</brief_title>
  <official_title>¿Puede Una aplicación móvil Mejorar el Conocimiento y la autogestión de Las Personas Con Diabetes Tipo 1? Evaluación clínica de la App mySugr</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This project is based on the contribution that an app can offer for improving knowledge and&#xD;
      self-management of people with type 1 diabetes.&#xD;
&#xD;
      The main objective of this study is to assess mySugr app as a tool for empowering people with&#xD;
      type 1 diabetes.&#xD;
&#xD;
      The study population are type 1 diabetes people, aged more than 18 years old and with more&#xD;
      than one year from diagnosis. They will be randomised to standard care or use of mySugr app&#xD;
      and will be followed-up during 48 weeks.&#xD;
&#xD;
      Control group will attend 5 face-to-face visits (baseline, 3, 6, 9 and 12 months) with the&#xD;
      possibility of telephone contact and hospital assistance if necessary. Intervention group&#xD;
      will attend 3 face-to-face visits (baseline, 6 and 12 months) and 2 telematic visits (at 3&#xD;
      and 9 months) and will also have the possibility of telephone contact and hospital assistance&#xD;
      if necessary.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2019</start_date>
  <completion_date type="Actual">April 13, 2021</completion_date>
  <primary_completion_date type="Actual">February 26, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Empowerment</measure>
    <time_frame>Baseline visit and month 12</time_frame>
    <description>Change from baseline score in the Diabetes Empowerment Scale-Short Form Spanish version (DES-SF-S) (8, worse to 40, better) at 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to glycemic monitoring</measure>
    <time_frame>Baseline visit and month 3, 6, 9 and 12</time_frame>
    <description>Change from baseline frequency of glycemic monitoring (number of capillary blood glucose tests per day) at each follow-up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to recommendations</measure>
    <time_frame>Each follow-up visit (month 3, 6, 9 and 12)</time_frame>
    <description>Percentage of recommendations given by the medical team followed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to visits</measure>
    <time_frame>Each follow-up visit (month 3, 6, 9 and 12)</time_frame>
    <description>Percentage of face-to-face visits and telematic visits attended</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to the app</measure>
    <time_frame>End of the study (month 12) and 3 months after</time_frame>
    <description>Percentage of patients who continue using the app after the end of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily management of diabetes</measure>
    <time_frame>Baseline visit and month 12</time_frame>
    <description>Change from baseline score in the questionnaire that evaluates the number of tasks performed in relation to diabetes (ad hoc) at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life related to diabetes</measure>
    <time_frame>Baseline visit and month 12</time_frame>
    <description>Change from baseline score in the Spanish version of the Diabetes Quality Of Life questionnaire (EsDQOL) (satisfaction: 75, worse, to 15, better; impact: 85, worse, to 17, better; social and vocational concern: 45, worse, to 7, better; concern related to diabetes: 20, worse, to 4, better) at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Baseline visit and month 12</time_frame>
    <description>Change from baseline score in the Diabetes Distress Scale Spanish version (DSS-S) (102, worse, to 17, better) at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>Baseline visit and month 3, 6, 9 and 12</time_frame>
    <description>Change from baseline mean blood glucose (mg/dl), standard deviation, low and high blood glucose index at each follow-up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>Baseline visit and month 6 and 12</time_frame>
    <description>Change from baseline HbA1c DCA (%) at 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the app</measure>
    <time_frame>End of the study (month 12)</time_frame>
    <description>Score in the satisfaction questionnaire in relation to the use of the platform (ad hoc)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual follow-up of diabetes type 1 with face-to-face visits</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mySugr app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telemedical assistance with mySugr app</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mySugr app</intervention_name>
    <description>mySugr is a mobile medical app for diabetes management. It has been developed by Roche Diabetes Care and it has two versions, free and Pro. It allows to carry out the diary of diabetes, including the collection and analysis of data on glycaemia, food, physical activity or insulin dose. In addition, it is compatible with continuous glucose measurement systems. It has the possibility to add functionalities such as estimation of HbA1c levels, more detailed data analysis or integration with Google Fit type motion sensors, as well as a bolus calculator, reminders for measuring blood glucose or photo gallery in the Pro version, which is the one that will be provided to the patients for the study.</description>
    <arm_group_label>mySugr app</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>Face-to-face visits</description>
    <arm_group_label>Standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
          -  People with type 1 diabetes (&gt; 1 year diagnosis)&#xD;
&#xD;
          -  Treatment with insulin in basal-bolus regimen&#xD;
&#xD;
          -  Glucometer that connects automatically with the app&#xD;
&#xD;
          -  HbA1c 7-9%&#xD;
&#xD;
          -  Understanding of carbohydrate counting and concepts of ratio and factor of sensitivity&#xD;
&#xD;
          -  Have a smartphone or tablet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use at the time of randomization of another app for diabetes management&#xD;
&#xD;
          -  Use of continuous monitoring or flash glucose systems&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any other disease or condition that may interfere with the completion of the protocol&#xD;
             or completion of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>September 18, 2021</last_update_submitted>
  <last_update_submitted_qc>September 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes Mellitus, Type 1</keyword>
  <keyword>Mobile Applications</keyword>
  <keyword>Telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <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/NCT03819335
org study id: IIBSP-SUG-2018-01
nct id: NCT03819335
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project is based on the contribution that an app can offer for improving knowledge and
      self-management of people with type 1 diabetes.

      The main objective of this study is to assess mySugr app as a tool for empowering people with
      type 1 diabetes.

      The study population are type 1 diabetes people, aged more than 18 years old and with more
      than one year from diagnosis. They will be randomised to standard care or use of mySugr app
      and will be followed-up during 48 weeks.

      Control group will attend 5 face-to-face visits (baseline, 3, 6, 9 and 12 months) with the
      possibility of telephone contact and hospital assistance if necessary. Intervention group
      will attend 3 face-to-face visits (baseline, 6 and 12 months) and 2 telematic visits (at 3
      and 9 months) and will also have the possibility of telephone contact and hospital assistance
      if necessary.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Empowerment
time frame: Baseline visit and month 12
description: Change from baseline score in the Diabetes Empowerment Scale-Short Form Spanish version (DES-SF-S) (8, worse to 40, better) at 12 months
measure: Adherence to glycemic monitoring
time frame: Baseline visit and month 3, 6, 9 and 12
description: Change from baseline frequency of glycemic monitoring (number of capillary blood glucose tests per day) at each follow-up visit
measure: Adherence to recommendations
time frame: Each follow-up visit (month 3, 6, 9 and 12)
description: Percentage of recommendations given by the medical team followed
measure: Adherence to visits
time frame: Each follow-up visit (month 3, 6, 9 and 12)
description: Percentage of face-to-face visits and telematic visits attended
measure: Adherence to the app
time frame: End of the study (month 12) and 3 months after
description: Percentage of patients who continue using the app after the end of the study
measure: Daily management of diabetes
time frame: Baseline visit and month 12
description: Change from baseline score in the questionnaire that evaluates the number of tasks performed in relation to diabetes (ad hoc) at 12 months
measure: Quality of life related to diabetes
time frame: Baseline visit and month 12
description: Change from baseline score in the Spanish version of the Diabetes Quality Of Life questionnaire (EsDQOL) (satisfaction: 75, worse, to 15, better; impact: 85, worse, to 17, better; social and vocational concern: 45, worse, to 7, better; concern related to diabetes: 20, worse, to 4, better) at 12 months
measure: Self-efficacy
time frame: Baseline visit and month 12
description: Change from baseline score in the Diabetes Distress Scale Spanish version (DSS-S) (102, worse, to 17, better) at 12 months
measure: Glycemic control
time frame: Baseline visit and month 3, 6, 9 and 12
description: Change from baseline mean blood glucose (mg/dl), standard deviation, low and high blood glucose index at each follow-up visit
measure: Glycemic control
time frame: Baseline visit and month 6 and 12
description: Change from baseline HbA1c DCA (%) at 6 and 12 months
measure: Satisfaction with the app
time frame: End of the study (month 12)
description: Score in the satisfaction questionnaire in relation to the use of the platform (ad hoc)
arm group label: Standard care
arm group type: Active Comparator
description: Usual follow-up of diabetes type 1 with face-to-face visits
arm group label: mySugr app
arm group type: Experimental
description: Telemedical assistance with mySugr app
intervention type: Device
intervention name: mySugr app
description: mySugr is a mobile medical app for diabetes management. It has been developed by Roche Diabetes Care and it has two versions, free and Pro. It allows to carry out the diary of diabetes, including the collection and analysis of data on glycaemia, food, physical activity or insulin dose. In addition, it is compatible with continuous glucose measurement systems. It has the possibility to add functionalities such as estimation of HbA1c levels, more detailed data analysis or integration with Google Fit type motion sensors, as well as a bolus calculator, reminders for measuring blood glucose or photo gallery in the Pro version, which is the one that will be provided to the patients for the study.
arm group label: mySugr app
intervention type: Other
intervention name: Standard care
description: Face-to-face visits
arm group label: Standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No