<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/NCT03838900</url>
  </required_header>
  <id_info>
    <org_study_id>LOOP</org_study_id>
    <nct_id>NCT03838900</nct_id>
  </id_info>
  <brief_title>The Loop Observational Study</brief_title>
  <acronym>LOS</acronym>
  <official_title>An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaeb Center for Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tidepool Project</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RileyLink</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jaeb Center for Health Research</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>
      An observational study to collect data on the efficacy, safety, usability, and quality of&#xD;
      life/psychosocial effects of the Loop DIY automated insulin delivery system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include both adults and youth in the United States, with a recruitment goal of&#xD;
      at least 300-1,250 participants. Data to be collected to address the study objective will&#xD;
      include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from&#xD;
      HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis,&#xD;
      hospitalizations); self-reported device issues; and psychosocial and user&#xD;
      experience/treatment satisfaction surveys.&#xD;
&#xD;
      Online forms will allow participants to report weekly device issues and serious adverse&#xD;
      events including severe hypoglycemia, diabetic ketoacidosis, and hospitalizations. General&#xD;
      data updates will be obtained after three, six, and 12 months (and every six months&#xD;
      thereafter if study participation continues). A fingerstick blood sample will be collected&#xD;
      for HbA1c measurement after three months for cohort A and after six and 12 months for both&#xD;
      cohorts. Quality-of-life/psychosocial and treatment satisfaction questionnaires will be&#xD;
      completed after six and 12 months; new users also will complete questionnaires after 3&#xD;
      months. Virtual focus groups will be completed within the first three months of starting Loop&#xD;
      and at 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">April 25, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events</measure>
    <time_frame>6 Months</time_frame>
    <description>Number of DKA events and event outcomes on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events</measure>
    <time_frame>6 Months</time_frame>
    <description>Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of Loop Safety by Self-Report of Hospitalization Events</measure>
    <time_frame>6 Months</time_frame>
    <description>Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events</measure>
    <time_frame>12 Months</time_frame>
    <description>Number of DKA events and event outcomes on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events</measure>
    <time_frame>12 Months</time_frame>
    <description>Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Loop Safety by Self-Report of Hospitalization Events</measure>
    <time_frame>12 Months</time_frame>
    <description>Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Loop Baseline General Data Collection</measure>
    <time_frame>Enrollment</time_frame>
    <description>Self-report participant's basic information. No scale provided, variable responses.</description>
  </other_outcome>
  <other_outcome>
    <measure>Summary statistics for CGM metrics</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Continuous CGM data from participant's Tidepool account.</description>
  </other_outcome>
  <other_outcome>
    <measure>Loop Additional Form for Current Loop Users</measure>
    <time_frame>Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months</time_frame>
    <description>Self-report of participant's use of Loop and Loop related features. No scale provided, variable responses.</description>
  </other_outcome>
  <other_outcome>
    <measure>LoopHoles Survey</measure>
    <time_frame>Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months</time_frame>
    <description>Self-report of participant's patterns of Loop use. No scale provided, variable responses.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>Enrollment, 3 Months (cohort A), 6 Months, and 12 Months</time_frame>
    <description>Standardized questionnaire and scoring. Usual sleeping habits for past month. Questions 1 - 9. Overall scores range from 0 to 21, with lower values representing better sleep quality.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction of diabetes technology.</measure>
    <time_frame>Enrollment, 3 Months (cohort A), 6 Months, and 12 Months</time_frame>
    <description>Standardized Diabetes Technology Attitudes - 5 with likert scale questions. Each question is scored on a scale of 1 to 5, with a higher score indicating greater satisfaction with diabetes technology.</description>
  </other_outcome>
  <other_outcome>
    <measure>Automated Insulin Delivery Satisfaction</measure>
    <time_frame>Enrollment (Cohort B), Month 3 (Cohort A), Month 6, Month 12</time_frame>
    <description>Change in satisfaction of using Loop. Measured using the standardized INSPIRE (Adult, Parent, and Child) questionnaires. The higher the score the more positive the opinion that automated insulin delivery has had a positive impact on the participant's life.</description>
  </other_outcome>
  <other_outcome>
    <measure>HbA1c</measure>
    <time_frame>Enrollment, Month 3 (Cohort A), Month 6, Month 12</time_frame>
    <description>Blood sample.</description>
  </other_outcome>
  <other_outcome>
    <measure>Device issues related to Loop</measure>
    <time_frame>Weekly from 7 days after enrollment to 12 months</time_frame>
    <description>Weekly self-report of any device issues that interfered with their ability to use Loop on the Adverse Event and Device Issue - Loop survey. No scale provided.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypoglycemia Confidence Scale</measure>
    <time_frame>Enrollment, Month 3 (Cohort A), Month 6, Month 12</time_frame>
    <description>Standardized questionnaire. Confidence of managing hypoglycemia during daily tasks. Overall scores range from 1 to 4, with higher scores indicating greater confidence in managing hypoglycemia.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypoglycemia Fear Survey - Worry Scale</measure>
    <time_frame>Enrollment, Month 3 (Cohort A), Month 6, Month 12</time_frame>
    <description>Standardized survey. Measures level of worry of low blood sugar, for Adult, Parent, and Child. Items are rated on a 5 point Likert scale from 0 to 4. Total scores and sub-scale scores are sum scores of all relative items. For the adult survey, the score ranges from 0-52. For the children's survey, the score ranges from 0-60. For the parent survey, the score ranges from 0-60. A higher score indicates greater fear of hypoglycemia.</description>
  </other_outcome>
  <other_outcome>
    <measure>Risk Taking Questions</measure>
    <time_frame>Enrollment, Month 3 (Cohort A), Month 6, Month 12</time_frame>
    <description>Standardized questionnaire about risk taking behavior. Items are scored on a scale of 1 to 10, with a higher score indicating a greater disposition to take risks.</description>
  </other_outcome>
  <other_outcome>
    <measure>T1-DDS (Management Distress Items)</measure>
    <time_frame>Enrollment, Month 3 (Cohort A), Month 6, Month 12</time_frame>
    <description>Standardized questionnaire. Feelings about diabetes management. Overall scores range from 1 to 6, with higher scores indicating higher distress over diabetes management.</description>
  </other_outcome>
  <other_outcome>
    <measure>Device Discontinuation or Non-start Reasons</measure>
    <time_frame>Up to 12 months, as needed</time_frame>
    <description>No scale questionnaire allowing varied responses about why participant's stopped using Loop or why they never started.</description>
  </other_outcome>
  <other_outcome>
    <measure>Loop Follow-Up General Data Collection</measure>
    <time_frame>Month 3 (Cohort A), Month 6, Month 12</time_frame>
    <description>Self-report of participant's basic information. No scale provided, variable responses.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1212</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <description>Individuals who have not started Loop or who have been on Loop fewer than 7 days at the time of enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <description>Participants who have been using Loop 7 or more days at the time of enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Loop</intervention_name>
    <description>The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals using or planning to use the Loop system&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Currently have, or have ordered, the hardware devices necessary to use Loop&#xD;
&#xD;
          -  Currently use Loop or have plans to start using Loop for insulin delivery&#xD;
&#xD;
          -  Willing and able to provide informed consent (or be a parent or other legally&#xD;
             authorized representative) and to provide the data and complete questionnaires that&#xD;
             are part of the protocol&#xD;
&#xD;
          -  Resident of U.S.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Lum, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaeb Center for Health Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jaeb Center for Health Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>August 12, 2020</last_update_submitted>
  <last_update_submitted_qc>August 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Loop</keyword>
  <keyword>RileyLink</keyword>
  <keyword>Type 1 Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03838900
org study id: LOOP
nct id: NCT03838900
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An observational study to collect data on the efficacy, safety, usability, and quality of
      life/psychosocial effects of the Loop DIY automated insulin delivery system.
The study will include both adults and youth in the United States, with a recruitment goal of
      at least 300-1,250 participants. Data to be collected to address the study objective will
      include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from
      HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis,
      hospitalizations); self-reported device issues; and psychosocial and user
      experience/treatment satisfaction surveys.

      Online forms will allow participants to report weekly device issues and serious adverse
      events including severe hypoglycemia, diabetic ketoacidosis, and hospitalizations. General
      data updates will be obtained after three, six, and 12 months (and every six months
      thereafter if study participation continues). A fingerstick blood sample will be collected
      for HbA1c measurement after three months for cohort A and after six and 12 months for both
      cohorts. Quality-of-life/psychosocial and treatment satisfaction questionnaires will be
      completed after six and 12 months; new users also will complete questionnaires after 3
      months. Virtual focus groups will be completed within the first three months of starting Loop
      and at 12 months.
observational model: Cohort
time perspective: Prospective
measure: Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
time frame: 6 Months
description: Number of DKA events and event outcomes on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider.
measure: Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
time frame: 6 Months
description: Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.
measure: Measure of Loop Safety by Self-Report of Hospitalization Events
time frame: 6 Months
description: Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.
measure: Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
time frame: 12 Months
description: Number of DKA events and event outcomes on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider.
measure: Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
time frame: 12 Months
description: Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.
measure: Measure of Loop Safety by Self-Report of Hospitalization Events
time frame: 12 Months
description: Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.
measure: Loop Baseline General Data Collection
time frame: Enrollment
description: Self-report participant's basic information. No scale provided, variable responses.
measure: Summary statistics for CGM metrics
time frame: 6 months and 12 months
description: Continuous CGM data from participant's Tidepool account.
measure: Loop Additional Form for Current Loop Users
time frame: Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months
description: Self-report of participant's use of Loop and Loop related features. No scale provided, variable responses.
measure: LoopHoles Survey
time frame: Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months
description: Self-report of participant's patterns of Loop use. No scale provided, variable responses.
measure: Pittsburgh Sleep Quality Index
time frame: Enrollment, 3 Months (cohort A), 6 Months, and 12 Months
description: Standardized questionnaire and scoring. Usual sleeping habits for past month. Questions 1 - 9. Overall scores range from 0 to 21, with lower values representing better sleep quality.
measure: Satisfaction of diabetes technology.
time frame: Enrollment, 3 Months (cohort A), 6 Months, and 12 Months
description: Standardized Diabetes Technology Attitudes - 5 with likert scale questions. Each question is scored on a scale of 1 to 5, with a higher score indicating greater satisfaction with diabetes technology.
measure: Automated Insulin Delivery Satisfaction
time frame: Enrollment (Cohort B), Month 3 (Cohort A), Month 6, Month 12
description: Change in satisfaction of using Loop. Measured using the standardized INSPIRE (Adult, Parent, and Child) questionnaires. The higher the score the more positive the opinion that automated insulin delivery has had a positive impact on the participant's life.
measure: HbA1c
time frame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
description: Blood sample.
measure: Device issues related to Loop
time frame: Weekly from 7 days after enrollment to 12 months
description: Weekly self-report of any device issues that interfered with their ability to use Loop on the Adverse Event and Device Issue - Loop survey. No scale provided.
measure: Hypoglycemia Confidence Scale
time frame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
description: Standardized questionnaire. Confidence of managing hypoglycemia during daily tasks. Overall scores range from 1 to 4, with higher scores indicating greater confidence in managing hypoglycemia.
measure: Hypoglycemia Fear Survey - Worry Scale
time frame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
description: Standardized survey. Measures level of worry of low blood sugar, for Adult, Parent, and Child. Items are rated on a 5 point Likert scale from 0 to 4. Total scores and sub-scale scores are sum scores of all relative items. For the adult survey, the score ranges from 0-52. For the children's survey, the score ranges from 0-60. For the parent survey, the score ranges from 0-60. A higher score indicates greater fear of hypoglycemia.
measure: Risk Taking Questions
time frame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
description: Standardized questionnaire about risk taking behavior. Items are scored on a scale of 1 to 10, with a higher score indicating a greater disposition to take risks.
measure: T1-DDS (Management Distress Items)
time frame: Enrollment, Month 3 (Cohort A), Month 6, Month 12
description: Standardized questionnaire. Feelings about diabetes management. Overall scores range from 1 to 6, with higher scores indicating higher distress over diabetes management.
measure: Device Discontinuation or Non-start Reasons
time frame: Up to 12 months, as needed
description: No scale questionnaire allowing varied responses about why participant's stopped using Loop or why they never started.
measure: Loop Follow-Up General Data Collection
time frame: Month 3 (Cohort A), Month 6, Month 12
description: Self-report of participant's basic information. No scale provided, variable responses.
arm group label: Cohort A
description: Individuals who have not started Loop or who have been on Loop fewer than 7 days at the time of enrollment.
arm group label: Cohort B
description: Participants who have been using Loop 7 or more days at the time of enrollment.
intervention type: Device
intervention name: Loop
description: The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.
arm group label: Cohort A
arm group label: Cohort B
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: John Lum, MS
role: Principal Investigator
affiliation: Jaeb Center for Health Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Undecided