<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/NCT03784027</url>
  </required_header>
  <id_info>
    <org_study_id>KidsAP02</org_study_id>
    <nct_id>NCT03784027</nct_id>
  </id_info>
  <brief_title>The Artificial Pancreas in Very Young Children With T1D</brief_title>
  <acronym>KidsAP02</acronym>
  <official_title>An Open-label, Multi-centre, Multi-national, Randomised, 2-period Crossover Study to Assess the Efficacy, Safety and Utility of Closed Loop Insulin Delivery in Comparison With Sensor Augmented Pump Therapy Over 4 Months in Children With Type 1 Diabetes Aged 1 to 7 Years in the Home Setting With Extension to Evaluate the Efficacy of Home Use of Closed Loop Insulin Delivery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cambridge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Luxembourg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jaeb Center for Health Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Glooko</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cambridge</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>
      The suggested clinical trial is part of the KidsAP project funded by the European&#xD;
      Commission's Horizon 2020 Framework Programme with additional funding by JDRF. The project&#xD;
      evaluates the use of the Artificial Pancreas (or closed loop system) in very young children&#xD;
      with type 1 diabetes (T1D) aged 1 to 7 years. The suggested trial is an outcome study to&#xD;
      determine whether 24/7 automated closed loop glucose control will improve glucose control as&#xD;
      measured by time in range compared to sensor augmented pump therapy. In the extension phase,&#xD;
      the purpose is to evaluate the effect of long-term home use of 24/7 automated hybrid closed&#xD;
      loop insulin delivery on glucose control (UK sites only).&#xD;
&#xD;
      The study adopts an open-label, multi-centre, multi-national, randomised, two period,&#xD;
      cross-over design study, comparing two 16-week periods during which glucose levels will be&#xD;
      controlled either by a closed loop system (intervention period) or by sensor augmented pump&#xD;
      therapy (control period).&#xD;
&#xD;
      Participants will complete a 2 to 4 week run-in period, followed by two treatment periods&#xD;
      that will last 16 weeks each, with a 1 to 4 week washout period in between. The order of the&#xD;
      two treatments will be random. A total of up to 80 young children aged 1 to 7 years with T1D&#xD;
      on insulin pump therapy (aiming for 72 randomised subjects) will be recruited through&#xD;
      paediatric outpatient diabetes clinics of the investigation centres.&#xD;
&#xD;
      Prior to the use of study devices, participants and parents/guardians will receive&#xD;
      appropriate training by the research team on the safe use of the study pump and continuous&#xD;
      glucose monitoring device, and the hybrid closed loop insulin delivery system. Carers at&#xD;
      nursery or school may also receive training by the study team if required.&#xD;
&#xD;
      During the closed loop study arm, subjects and parents/guardians will use the closed loop&#xD;
      system for 16 weeks under free-living conditions in their home and nursery/school environment&#xD;
      without remote monitoring or supervision by research staff.&#xD;
&#xD;
      During the control study arm, subjects and parents/guardians will use sensor augmented pump&#xD;
      therapy for 16 weeks under free-living conditions in their home and nursery/school&#xD;
      environment. All subjects will have regular contact with the study team during the home study&#xD;
      phase including 24/7 telephone support.&#xD;
&#xD;
      The primary endpoint is time spent in target range, between 3.9 and 10.0 mmol/l as recorded&#xD;
      by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as&#xD;
      recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the&#xD;
      frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA).&#xD;
&#xD;
      During the extension phase, participants will have follow-up contacts every 3 months.&#xD;
&#xD;
      The primary endpoint is time spent in target range, between 3.9 and 10.0 mmol/l as recorded&#xD;
      by CGM, over 18 months from the end of the primary phase, as compared to sensor augmented&#xD;
      pump therapy during the primary phase. Secondary outcomes as well as safety and utility will&#xD;
      be assessed as per primary phase.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose of clinical trial:&#xD;
&#xD;
      To determine whether 24/7 automated hybrid closed loop will improve glucose control as&#xD;
      measured by time within the target range compared with sensor augmented pump therapy in very&#xD;
      young children with T1D.&#xD;
&#xD;
      Study objectives:&#xD;
&#xD;
      The study objective is to evaluate the safety, efficacy and utility of automated hybrid&#xD;
      closed loop glucose control in very young children with type 1 diabetes.&#xD;
&#xD;
        1. EFFICACY: The objective is to assess the ability of a hybrid closed loop system to&#xD;
           maintain CGM glucose levels within the target range of 3.9 to 10 mmol/l (70 to 180&#xD;
           mg/dl) in comparison with sensor augmented pump therapy in very young children with type&#xD;
           1 diabetes.&#xD;
&#xD;
        2. SAFETY: The objective is to evaluate the safety of closed loop glucose control compared&#xD;
           with sensor augmented pump therapy in terms of episodes and severity of hypoglycaemia,&#xD;
           frequency of diabetic ketoacidosis (DKA) and nature and severity of other adverse&#xD;
           events.&#xD;
&#xD;
        3. UTILITY: The objective is to determine the acceptability and duration of use of the&#xD;
           closed loop system in this population.&#xD;
&#xD;
        4. HUMAN FACTORS: The objective is to assess emotional and behavioural characteristics of&#xD;
           participants and parents/guardians and their response to the closed loop system and&#xD;
           clinical trial using validated surveys and semi-structured qualitative interviews.&#xD;
&#xD;
        5. HEALTH ECONOMICS: The objective is to perform a cost utility analysis to inform&#xD;
           reimbursement decision-making.&#xD;
&#xD;
      Participating clinical centres:&#xD;
&#xD;
        1. Addenbrooke's Hospital, Cambridge University Hospital NHS Foundation Trust, Cambridge,&#xD;
           UK&#xD;
&#xD;
        2. Leeds Teaching Hospitals NHS Trust, Leeds, UK&#xD;
&#xD;
        3. DECCP, Centre Hospitalier de Luxembourg, Grand Duché de Luxembourg&#xD;
&#xD;
        4. University of Leipzig, Leipzig, Germany&#xD;
&#xD;
        5. Medical University of Graz, Graz, Austria&#xD;
&#xD;
        6. Medical University of Innsbruck, Innsbruck, Austria&#xD;
&#xD;
        7. Medical University of Vienna, Vienna, Austria&#xD;
&#xD;
      Sample Size:&#xD;
&#xD;
      72 participants randomised (8-12 participants per centre). At the primary phase final visit,&#xD;
      participants (UK sites only) on sensor-augmented pump therapy as their standard clinical care&#xD;
      will be invited to participate in an extension phase of closed loop therapy for a further 18&#xD;
      months.&#xD;
&#xD;
      Maximum duration of study for a subject: 11 months (primary phase). 29 months for&#xD;
      participants (UK sites only) opting to participate in 18-month extension phase.&#xD;
&#xD;
      Recruitment:&#xD;
&#xD;
      The subjects will be recruited through paediatric diabetes outpatient clinics at&#xD;
      participating clinical centres (see above). Enrolment will target up to 80 (aiming for 8-12&#xD;
      participants per centre) to allow for dropouts during run-in.&#xD;
&#xD;
      Participants (UK sites only) completing the primary phase, who are on sensor-augmented pump&#xD;
      therapy as their standard clinical care, will be invited to participate in the extension&#xD;
      phase.&#xD;
&#xD;
      Consent:&#xD;
&#xD;
      Written informed consent will be obtained from all parents/guardians and written assent from&#xD;
      older children before any study related activities.&#xD;
&#xD;
      Additional written consent will be obtained for the extension phase from all&#xD;
      parents/guardians.&#xD;
&#xD;
      Baseline Assessment:&#xD;
&#xD;
      Eligible subjects will undergo a baseline assessment including a blood sample for the&#xD;
      measurement of HbA1c. Questionnaires will be completed by parents/guardians.&#xD;
&#xD;
      Pre-Study Training and Run-in:&#xD;
&#xD;
      Training sessions on the use of the study CGM and insulin pump will be provided by the&#xD;
      research team. During a 2-4 week run-in period, subjects will use study CGM and insulin pump.&#xD;
      For compliance and to assess the ability of the subject to use the study devices safely, at&#xD;
      least 8 days of CGM data need to be recorded and safe use of study insulin pump demonstrated&#xD;
      during the last 14 days of run-in period. The CGM data will also be used to assess baseline&#xD;
      glucose control and may be used for treatment optimization as necessary.&#xD;
&#xD;
      Competency Assessment:&#xD;
&#xD;
      Competency on the use of study insulin pump and study CGM will be evaluated using a&#xD;
      competency assessment tool developed by the research team. Training may be repeated if&#xD;
      required.&#xD;
&#xD;
      Randomisation:&#xD;
&#xD;
      Eligible subjects will be randomised using randomisation software to the initial use of&#xD;
      automated hybrid closed loop glucose system or to sensor augmented pump therapy for 16 weeks&#xD;
      with a 1 to 4 week washout period before crossing over to the other study arm.&#xD;
&#xD;
      Automated day and night closed loop insulin delivery (intervention arm)&#xD;
&#xD;
      Participants in the closed loop arm and their caregivers will receive an additional training&#xD;
      session covering the use of the closed loop system provided by the research team prior to&#xD;
      starting closed loop insulin delivery. During this 1-2 hour session, parents/guardians will&#xD;
      operate the system under the supervision of the clinical research team. Competency on the use&#xD;
      of closed loop system will be evaluated. Thereafter, subjects and their parents/guardians&#xD;
      will use the hybrid closed loop system for 16 weeks at home.&#xD;
&#xD;
      Crossover Assessment:&#xD;
&#xD;
      At the end of the first study arm, a blood sample for the measurement of HbA1c will be taken&#xD;
      and weight and height will be measured. Validated surveys evaluating the impact of the&#xD;
      devices employed on quality of life, psychosocial function, diabetes management and treatment&#xD;
      satisfaction will be completed.&#xD;
&#xD;
      Parents/guardians will be invited to be interviewed to gather feedback on and reactions to&#xD;
      their current treatment, the clinical trial, and quality of life changes.&#xD;
&#xD;
      Sensor augmented pump therapy (control arm):&#xD;
&#xD;
      Participants in the sensor augmented pump therapy arm and their caregivers will receive&#xD;
      refresher training on key aspects of insulin pump therapy and CGM use.&#xD;
&#xD;
      Subjects and their parents/guardians will continue using sensor augmented pump therapy for 16&#xD;
      weeks at home.&#xD;
&#xD;
      Study contacts:&#xD;
&#xD;
      Participants will be contacted 24h after starting each study arm to ensure there are no&#xD;
      concerns regarding the study devices. In between study visits, participants will be contacted&#xD;
      by the study team (email/phone) once monthly and 3-monthly in the extension phase, in order&#xD;
      to record any adverse events, device deficiencies, and changes in insulin settings, other&#xD;
      medical conditions and/or medication.&#xD;
&#xD;
      In case of any problems related to the technical device or diabetes management such as hypo-&#xD;
      or hyperglycaemia, subjects will be able to contact a 24-hour telephone helpline to the local&#xD;
      research team at any time. The local research team will have access to central 24 hour advice&#xD;
      on technical issues.&#xD;
&#xD;
      End of study assessments (primary phase):&#xD;
&#xD;
      A blood sample will be taken for measurement of HbA1c at the end of the study. Height and&#xD;
      weight will be recorded. Study devices will be downloaded and returned. Participants will&#xD;
      resume usual care using their pre-study insulin pump. Validated surveys evaluating the impact&#xD;
      of the devices employed on quality of life, psychosocial function and diabetes management and&#xD;
      treatment satisfaction will be completed.&#xD;
&#xD;
      Parents/guardians will be invited to participate in a sleep sub-study prior to the final&#xD;
      visit (UK &amp; Luxembourg only).&#xD;
&#xD;
      Parents/guardians will be invited to be interviewed to gather feedback on and reactions to&#xD;
      their current treatment, the clinical trial, and quality of life changes.&#xD;
&#xD;
      Extension Phase (UK sites only):&#xD;
&#xD;
      Follow up contacts will be conducted 3-monthly, in line with routine clinic visits, including&#xD;
      recording of adverse events, medical history, insulin requirements and HbA1c.&#xD;
&#xD;
      After 18 months from the end of the primary phase, parents/guardians will complete validated&#xD;
      questionnaires evaluating the impact of the technology on quality of life, diabetes&#xD;
      management, sleep quality and fear of hypoglycaemia. Height and weight will be measured. A&#xD;
      blood sample will be taken for measurement of HbA1c at the end of the extension phase&#xD;
&#xD;
      Procedures for safety monitoring during trial:&#xD;
&#xD;
      Standard operating procedures for monitoring and reporting of all adverse events will be in&#xD;
      place, including serious adverse events (SAE), serious adverse device effects (SADE) and&#xD;
      specific adverse events (AE) such as severe hypoglycaemia.&#xD;
&#xD;
      A data safety and monitoring board (DSMB) will be informed of all serious adverse events and&#xD;
      any unanticipated serious adverse device effects that occur during the study and will review&#xD;
      compiled adverse event data at periodic intervals.&#xD;
&#xD;
      Criteria for withdrawal of subjects on safety grounds:&#xD;
&#xD;
      A subject/guardian may terminate participation in the study at any time without necessarily&#xD;
      giving a reason and without any personal disadvantage. An investigator can stop the&#xD;
      participation of a subject after consideration of the benefit/risk ratio. Possible reasons&#xD;
      are:&#xD;
&#xD;
        -  Serious adverse events&#xD;
&#xD;
        -  Non-compliance&#xD;
&#xD;
        -  Serious protocol violation&#xD;
&#xD;
        -  Decision by the investigator, or the sponsor, that termination is in the subject's best&#xD;
           medical interest&#xD;
&#xD;
        -  Allergic reaction to insulin&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">October 3, 2022</completion_date>
  <primary_completion_date type="Actual">February 22, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>Device: CamAPS FX&#xD;
The automated closed loop system (CamAPS FX) will consist of:&#xD;
Dana RS insulin pump (Diabecare, Sooil, Seoul, South Korea)&#xD;
Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)&#xD;
An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor&#xD;
Cloud upload system to monitor CGM/insulin data.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time in target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl)</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Between group difference in time spent with sensor glucose levels between 3.9 to 10.0 mmol/l (70 to 180 mg/dl) during the 4 months intervention period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time spent above target glucose (10.0 mmol/l) (180 mg/dl)</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Percentage of time spent with sensor glucose readings above target glucose (10.0mmol/l) (180mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>16-week home stay</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average glucose</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Average of sensor glucose levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent below target glucose (3.0 mmol/l) (70 mg/dl)</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Percentage of time spent with sensor glucose readings below target glucose (3.9mmol/l)(70mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard deviation</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Standard deviation of sensor glucose levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coefficient of variation of glucose levels</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Coefficient of variation of sensor glucose levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time with glucose levels &lt;3.0 mmol/l (54 mg/dl)</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Percentage of time spent with glucose levels &lt; 3.5mmol/l (63 mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time with glucose levels in significant hyperglycaemia (glucose levels &gt; 16.7 mmol/l) (300 mg/dl)</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Percentage of time spent with glucose levels in significant hyperglycaemia (glucose levels &gt; 16.7mmol/l) (300mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of glucose below 3.5 mmol/l (63 mg/dl)</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Area under the curve of sensor glucose readings below 3.5mmol/l (63mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI SDS</measure>
    <time_frame>16-week home stay</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total, basal, and bolus insulin dose</measure>
    <time_frame>16-week home stay</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of episodes of severe hypoglycaemia</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Safety evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects experiencing severe hypoglycaemia</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Safety evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of diabetic ketoacidosis</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Safety evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and nature of other adverse events or serious adverse events</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Safety evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time of closed-loop operation</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Utility evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time of CGM availability</measure>
    <time_frame>16-week home stay</time_frame>
    <description>Utility evaluation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Automated closed loop insulin delivery (intervention arm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.&#xD;
Intervention: Device: CamAPS FX</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensor augmented pump therapy (control arm)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sensor augmented pump therapy over 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CamAPS FX</intervention_name>
    <description>CamAPS FX closed loop system comprises:&#xD;
Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)&#xD;
Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)&#xD;
An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor&#xD;
Cloud upload system to monitor CGM/insulin data</description>
    <arm_group_label>Automated closed loop insulin delivery (intervention arm)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sensor augmented therapy</intervention_name>
    <description>Study insulin pump and study CGM.</description>
    <arm_group_label>Sensor augmented pump therapy (control arm)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 1 and 7 years (inclusive) (Luxembourg and Austria)&#xD;
&#xD;
          2. Age between 2 and 7 years (inclusive) (Germany and UK)&#xD;
&#xD;
          3. Type 1 diabetes as defined by WHO for at least 6 months [WHO definition: 'The&#xD;
             aetiological type named type 1 encompasses the majority of cases which are primarily&#xD;
             due to beta-cell destruction, and are prone to ketoacidosis. Type 1 includes those&#xD;
             cases attributable to an autoimmune process, as well as those with beta-cell&#xD;
             destruction for which neither an aetiology nor a pathogenesis is known (idiopathic).&#xD;
             It does not include those forms of beta-cell destruction or failure to which specific&#xD;
             causes can be assigned (e.g. cystic fibrosis, mitochondrial defects, etc.).']&#xD;
&#xD;
          4. Insulin pump user (with or without continuous glucose monitoring or flash glucose&#xD;
             monitoring system) for at least 3 months, with subject/carer good knowledge of insulin&#xD;
             self-adjustment as judged by the investigator&#xD;
&#xD;
          5. On sensor-augmented pump as standard clinical care (extension phase only)&#xD;
&#xD;
          6. Treated with rapid or ultra-rapid acting insulin analogue&#xD;
&#xD;
          7. Subject/carer is willing to perform regular finger-prick blood glucose monitoring,&#xD;
             with at least 2 blood glucose measurements taken every day&#xD;
&#xD;
          8. Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory&#xD;
&#xD;
          9. Willing to wear glucose sensor&#xD;
&#xD;
         10. Willing to wear closed loop system 24/7 during intervention arm&#xD;
&#xD;
         11. The subject/carer is willing to follow study specific instructions&#xD;
&#xD;
         12. The subject/carer is willing to upload pump and CGM data at regular intervals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Physical or psychological disease likely to interfere with the normal conduct of the&#xD;
             study and interpretation of the study results as judged by the investigator&#xD;
&#xD;
          2. Untreated coeliac disease or thyroid disease based on local investigations prior to&#xD;
             study enrolment&#xD;
&#xD;
          3. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic&#xD;
             corticosteroids&#xD;
&#xD;
          4. Use of closed loop insulin delivery within the past 2 months&#xD;
&#xD;
          5. Known or suspected allergy to insulin&#xD;
&#xD;
          6. Carer's lack of reliable telephone facility for contact&#xD;
&#xD;
          7. Subject/carer's severe visual impairment&#xD;
&#xD;
          8. Subject/carer's severe hearing impairment&#xD;
&#xD;
          9. Medically documented allergy towards the adhesive (glue) of plasters or subject is&#xD;
             unable to tolerate tape adhesive in the area of sensor placement&#xD;
&#xD;
         10. Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located in&#xD;
             parts of the body which could potentially be used for localisation of the glucose&#xD;
             sensor)&#xD;
&#xD;
         11. Sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or&#xD;
             erythropoietin within 3 months prior to time of screening&#xD;
&#xD;
         12. Plan to receive red blood cell transfusion or erythropoietin over the course of study&#xD;
             participation&#xD;
&#xD;
         13. Subject/carer not proficient in English (UK, Germany, Austria, Luxembourg) or German&#xD;
             (Germany, Austria, Luxembourg) or French (Luxembourg)&#xD;
&#xD;
             Additional exclusion criteria - Germany only&#xD;
&#xD;
         14. Known microvascular diabetes complications (retinopathy, renal disease, neuropathy)&#xD;
&#xD;
         15. Eating disorders&#xD;
&#xD;
         16. Psychiatric diseases of the parents that would possibly interfere with the ability to&#xD;
             comply to study procedures&#xD;
&#xD;
         17. Major needle phobia that would complicate to wear pump catheter and sensor&#xD;
&#xD;
         18. Congenital malformations that would interfere with diabetes treatment (e.g. congenital&#xD;
             heart malformations, lung diseases, renal malformations)&#xD;
&#xD;
         19. Growth hormone deficiency&#xD;
&#xD;
         20. Combined Hypopituitarism&#xD;
&#xD;
         21. Down Syndrome (high risk for comorbidity with coeliac disease, autoimmune thyroiditis)&#xD;
&#xD;
         22. Cancer under treatment&#xD;
&#xD;
         23. Current participation in other interventional clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roman Hovorka</last_name>
    <role>Study Director</role>
    <affiliation>Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Graz Department of Pediatrics and Adolescent Medicine</name>
      <address>
        <city>Graz</city>
        <zip>A-8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Innsbruck Department of Pediatrics I</name>
      <address>
        <city>Innsbruck</city>
        <zip>A-6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Vienna Department of Pediatrics</name>
      <address>
        <city>Wien</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Leipzig Division for Paediatric Diabetology</name>
      <address>
        <city>Leipzig</city>
        <zip>D-04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pédiatrique de Luxembourg Centre Hospitalier de Luxembourg</name>
      <address>
        <city>Luxembourg</city>
        <zip>L-1210</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Department of Paediatrics</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James's University Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Luxembourg</country>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Elleri D, Allen JM, Tauschmann M, El-Khairi R, Benitez-Aguirre P, Acerini CL, Dunger DB, Hovorka R. Feasibility of overnight closed-loop therapy in young children with type 1 diabetes aged 3-6 years: comparison between diluted and standard insulin strength. BMJ Open Diabetes Res Care. 2014 Dec 11;2(1):e000040. doi: 10.1136/bmjdrc-2014-000040. eCollection 2014.</citation>
    <PMID>25512874</PMID>
  </reference>
  <reference>
    <citation>Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, Acerini CL, Dellweg S, Benesch C, Heinemann L, Mader JK, Holzer M, Kojzar H, Exall J, Yong J, Pichierri J, Barnard KD, Kollman C, Cheng P, Hindmarsh PC, Campbell FM, Arnolds S, Pieber TR, Evans ML, Dunger DB, Hovorka R. Home Use of an Artificial Beta Cell in Type 1 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2129-2140. doi: 10.1056/NEJMoa1509351. Epub 2015 Sep 17.</citation>
    <PMID>26379095</PMID>
  </reference>
  <reference>
    <citation>Tauschmann M, Allen JM, Wilinska ME, Thabit H, Stewart Z, Cheng P, Kollman C, Acerini CL, Dunger DB, Hovorka R. Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial. Diabetes Care. 2016 Jul;39(7):1168-74. doi: 10.2337/dc15-2078. Epub 2016 Jan 6.</citation>
    <PMID>26740634</PMID>
  </reference>
  <reference>
    <citation>Tauschmann M, Allen JM, Wilinska ME, Thabit H, Acerini CL, Dunger DB, Hovorka R. Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial. Diabetes Care. 2016 Nov;39(11):2019-2025. doi: 10.2337/dc16-1094. Epub 2016 Sep 9.</citation>
    <PMID>27612500</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cambridge</investigator_affiliation>
    <investigator_full_name>Dr Roman Hovorka</investigator_full_name>
    <investigator_title>Study Director</investigator_title>
  </responsible_party>
  <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>Yes</sharing_ipd>
    <ipd_description>Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication. To gain access, data requestors will need to sign a data access agreement.&#xD;
Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication.</ipd_access_criteria>
  </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/NCT03784027
org study id: KidsAP02
nct id: NCT03784027
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The suggested clinical trial is part of the KidsAP project funded by the European
      Commission's Horizon 2020 Framework Programme with additional funding by JDRF. The project
      evaluates the use of the Artificial Pancreas (or closed loop system) in very young children
      with type 1 diabetes (T1D) aged 1 to 7 years. The suggested trial is an outcome study to
      determine whether 24/7 automated closed loop glucose control will improve glucose control as
      measured by time in range compared to sensor augmented pump therapy. In the extension phase,
      the purpose is to evaluate the effect of long-term home use of 24/7 automated hybrid closed
      loop insulin delivery on glucose control (UK sites only).

      The study adopts an open-label, multi-centre, multi-national, randomised, two period,
      cross-over design study, comparing two 16-week periods during which glucose levels will be
      controlled either by a closed loop system (intervention period) or by sensor augmented pump
      therapy (control period).

      Participants will complete a 2 to 4 week run-in period, followed by two treatment periods
      that will last 16 weeks each, with a 1 to 4 week washout period in between. The order of the
      two treatments will be random. A total of up to 80 young children aged 1 to 7 years with T1D
      on insulin pump therapy (aiming for 72 randomised subjects) will be recruited through
      paediatric outpatient diabetes clinics of the investigation centres.

      Prior to the use of study devices, participants and parents/guardians will receive
      appropriate training by the research team on the safe use of the study pump and continuous
      glucose monitoring device, and the hybrid closed loop insulin delivery system. Carers at
      nursery or school may also receive training by the study team if required.

      During the closed loop study arm, subjects and parents/guardians will use the closed loop
      system for 16 weeks under free-living conditions in their home and nursery/school environment
      without remote monitoring or supervision by research staff.

      During the control study arm, subjects and parents/guardians will use sensor augmented pump
      therapy for 16 weeks under free-living conditions in their home and nursery/school
      environment. All subjects will have regular contact with the study team during the home study
      phase including 24/7 telephone support.

      The primary endpoint is time spent in target range, between 3.9 and 10.0 mmol/l as recorded
      by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as
      recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the
      frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA).

      During the extension phase, participants will have follow-up contacts every 3 months.

      The primary endpoint is time spent in target range, between 3.9 and 10.0 mmol/l as recorded
      by CGM, over 18 months from the end of the primary phase, as compared to sensor augmented
      pump therapy during the primary phase. Secondary outcomes as well as safety and utility will
      be assessed as per primary phase.
Purpose of clinical trial:

      To determine whether 24/7 automated hybrid closed loop will improve glucose control as
      measured by time within the target range compared with sensor augmented pump therapy in very
      young children with T1D.

      Study objectives:

      The study objective is to evaluate the safety, efficacy and utility of automated hybrid
      closed loop glucose control in very young children with type 1 diabetes.

        1. EFFICACY: The objective is to assess the ability of a hybrid closed loop system to
           maintain CGM glucose levels within the target range of 3.9 to 10 mmol/l (70 to 180
           mg/dl) in comparison with sensor augmented pump therapy in very young children with type
           1 diabetes.

        2. SAFETY: The objective is to evaluate the safety of closed loop glucose control compared
           with sensor augmented pump therapy in terms of episodes and severity of hypoglycaemia,
           frequency of diabetic ketoacidosis (DKA) and nature and severity of other adverse
           events.

        3. UTILITY: The objective is to determine the acceptability and duration of use of the
           closed loop system in this population.

        4. HUMAN FACTORS: The objective is to assess emotional and behavioural characteristics of
           participants and parents/guardians and their response to the closed loop system and
           clinical trial using validated surveys and semi-structured qualitative interviews.

        5. HEALTH ECONOMICS: The objective is to perform a cost utility analysis to inform
           reimbursement decision-making.

      Participating clinical centres:

        1. Addenbrooke's Hospital, Cambridge University Hospital NHS Foundation Trust, Cambridge,
           UK

        2. Leeds Teaching Hospitals NHS Trust, Leeds, UK

        3. DECCP, Centre Hospitalier de Luxembourg, Grand Duché de Luxembourg

        4. University of Leipzig, Leipzig, Germany

        5. Medical University of Graz, Graz, Austria

        6. Medical University of Innsbruck, Innsbruck, Austria

        7. Medical University of Vienna, Vienna, Austria

      Sample Size:

      72 participants randomised (8-12 participants per centre). At the primary phase final visit,
      participants (UK sites only) on sensor-augmented pump therapy as their standard clinical care
      will be invited to participate in an extension phase of closed loop therapy for a further 18
      months.

      Maximum duration of study for a subject: 11 months (primary phase). 29 months for
      participants (UK sites only) opting to participate in 18-month extension phase.

      Recruitment:

      The subjects will be recruited through paediatric diabetes outpatient clinics at
      participating clinical centres (see above). Enrolment will target up to 80 (aiming for 8-12
      participants per centre) to allow for dropouts during run-in.

      Participants (UK sites only) completing the primary phase, who are on sensor-augmented pump
      therapy as their standard clinical care, will be invited to participate in the extension
      phase.

      Consent:

      Written informed consent will be obtained from all parents/guardians and written assent from
      older children before any study related activities.

      Additional written consent will be obtained for the extension phase from all
      parents/guardians.

      Baseline Assessment:

      Eligible subjects will undergo a baseline assessment including a blood sample for the
      measurement of HbA1c. Questionnaires will be completed by parents/guardians.

      Pre-Study Training and Run-in:

      Training sessions on the use of the study CGM and insulin pump will be provided by the
      research team. During a 2-4 week run-in period, subjects will use study CGM and insulin pump.
      For compliance and to assess the ability of the subject to use the study devices safely, at
      least 8 days of CGM data need to be recorded and safe use of study insulin pump demonstrated
      during the last 14 days of run-in period. The CGM data will also be used to assess baseline
      glucose control and may be used for treatment optimization as necessary.

      Competency Assessment:

      Competency on the use of study insulin pump and study CGM will be evaluated using a
      competency assessment tool developed by the research team. Training may be repeated if
      required.

      Randomisation:

      Eligible subjects will be randomised using randomisation software to the initial use of
      automated hybrid closed loop glucose system or to sensor augmented pump therapy for 16 weeks
      with a 1 to 4 week washout period before crossing over to the other study arm.

      Automated day and night closed loop insulin delivery (intervention arm)

      Participants in the closed loop arm and their caregivers will receive an additional training
      session covering the use of the closed loop system provided by the research team prior to
      starting closed loop insulin delivery. During this 1-2 hour session, parents/guardians will
      operate the system under the supervision of the clinical research team. Competency on the use
      of closed loop system will be evaluated. Thereafter, subjects and their parents/guardians
      will use the hybrid closed loop system for 16 weeks at home.

      Crossover Assessment:

      At the end of the first study arm, a blood sample for the measurement of HbA1c will be taken
      and weight and height will be measured. Validated surveys evaluating the impact of the
      devices employed on quality of life, psychosocial function, diabetes management and treatment
      satisfaction will be completed.

      Parents/guardians will be invited to be interviewed to gather feedback on and reactions to
      their current treatment, the clinical trial, and quality of life changes.

      Sensor augmented pump therapy (control arm):

      Participants in the sensor augmented pump therapy arm and their caregivers will receive
      refresher training on key aspects of insulin pump therapy and CGM use.

      Subjects and their parents/guardians will continue using sensor augmented pump therapy for 16
      weeks at home.

      Study contacts:

      Participants will be contacted 24h after starting each study arm to ensure there are no
      concerns regarding the study devices. In between study visits, participants will be contacted
      by the study team (email/phone) once monthly and 3-monthly in the extension phase, in order
      to record any adverse events, device deficiencies, and changes in insulin settings, other
      medical conditions and/or medication.

      In case of any problems related to the technical device or diabetes management such as hypo-
      or hyperglycaemia, subjects will be able to contact a 24-hour telephone helpline to the local
      research team at any time. The local research team will have access to central 24 hour advice
      on technical issues.

      End of study assessments (primary phase):

      A blood sample will be taken for measurement of HbA1c at the end of the study. Height and
      weight will be recorded. Study devices will be downloaded and returned. Participants will
      resume usual care using their pre-study insulin pump. Validated surveys evaluating the impact
      of the devices employed on quality of life, psychosocial function and diabetes management and
      treatment satisfaction will be completed.

      Parents/guardians will be invited to participate in a sleep sub-study prior to the final
      visit (UK & Luxembourg only).

      Parents/guardians will be invited to be interviewed to gather feedback on and reactions to
      their current treatment, the clinical trial, and quality of life changes.

      Extension Phase (UK sites only):

      Follow up contacts will be conducted 3-monthly, in line with routine clinic visits, including
      recording of adverse events, medical history, insulin requirements and HbA1c.

      After 18 months from the end of the primary phase, parents/guardians will complete validated
      questionnaires evaluating the impact of the technology on quality of life, diabetes
      management, sleep quality and fear of hypoglycaemia. Height and weight will be measured. A
      blood sample will be taken for measurement of HbA1c at the end of the extension phase

      Procedures for safety monitoring during trial:

      Standard operating procedures for monitoring and reporting of all adverse events will be in
      place, including serious adverse events (SAE), serious adverse device effects (SADE) and
      specific adverse events (AE) such as severe hypoglycaemia.

      A data safety and monitoring board (DSMB) will be informed of all serious adverse events and
      any unanticipated serious adverse device effects that occur during the study and will review
      compiled adverse event data at periodic intervals.

      Criteria for withdrawal of subjects on safety grounds:

      A subject/guardian may terminate participation in the study at any time without necessarily
      giving a reason and without any personal disadvantage. An investigator can stop the
      participation of a subject after consideration of the benefit/risk ratio. Possible reasons
      are:

        -  Serious adverse events

        -  Non-compliance

        -  Serious protocol violation

        -  Decision by the investigator, or the sponsor, that termination is in the subject's best
           medical interest

        -  Allergic reaction to insulin
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Device: CamAPS FX
The automated closed loop system (CamAPS FX) will consist of:
Dana RS insulin pump (Diabecare, Sooil, Seoul, South Korea)
Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
Cloud upload system to monitor CGM/insulin data.
primary purpose: Treatment
masking: None (Open Label)
measure: Time in target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl)
time frame: 16-week home stay
description: Between group difference in time spent with sensor glucose levels between 3.9 to 10.0 mmol/l (70 to 180 mg/dl) during the 4 months intervention period.
measure: Time spent above target glucose (10.0 mmol/l) (180 mg/dl)
time frame: 16-week home stay
description: Percentage of time spent with sensor glucose readings above target glucose (10.0mmol/l) (180mg/dl)
measure: HbA1c
time frame: 16-week home stay
measure: Average glucose
time frame: 16-week home stay
description: Average of sensor glucose levels
measure: Time spent below target glucose (3.0 mmol/l) (70 mg/dl)
time frame: 16-week home stay
description: Percentage of time spent with sensor glucose readings below target glucose (3.9mmol/l)(70mg/dl)
measure: Standard deviation
time frame: 16-week home stay
description: Standard deviation of sensor glucose levels
measure: Coefficient of variation of glucose levels
time frame: 16-week home stay
description: Coefficient of variation of sensor glucose levels
measure: Time with glucose levels <3.0 mmol/l (54 mg/dl)
time frame: 16-week home stay
description: Percentage of time spent with glucose levels < 3.5mmol/l (63 mg/dl)
measure: Time with glucose levels in significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300 mg/dl)
time frame: 16-week home stay
description: Percentage of time spent with glucose levels in significant hyperglycaemia (glucose levels > 16.7mmol/l) (300mg/dl)
measure: AUC of glucose below 3.5 mmol/l (63 mg/dl)
time frame: 16-week home stay
description: Area under the curve of sensor glucose readings below 3.5mmol/l (63mg/dl)
measure: BMI SDS
time frame: 16-week home stay
measure: Total, basal, and bolus insulin dose
time frame: 16-week home stay
measure: Number of episodes of severe hypoglycaemia
time frame: 16-week home stay
description: Safety evaluation
measure: Number of subjects experiencing severe hypoglycaemia
time frame: 16-week home stay
description: Safety evaluation
measure: Frequency of diabetic ketoacidosis
time frame: 16-week home stay
description: Safety evaluation
measure: Frequency and nature of other adverse events or serious adverse events
time frame: 16-week home stay
description: Safety evaluation
measure: Percentage of time of closed-loop operation
time frame: 16-week home stay
description: Utility evaluation
measure: Percentage of time of CGM availability
time frame: 16-week home stay
description: Utility evaluation
arm group label: Automated closed loop insulin delivery (intervention arm)
arm group type: Experimental
description: Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
arm group label: Sensor augmented pump therapy (control arm)
arm group type: Active Comparator
description: Sensor augmented pump therapy over 16 weeks.
intervention type: Device
intervention name: CamAPS FX
description: CamAPS FX closed loop system comprises:
Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
Cloud upload system to monitor CGM/insulin data
arm group label: Automated closed loop insulin delivery (intervention arm)
intervention type: Other
intervention name: Sensor augmented therapy
description: Study insulin pump and study CGM.
arm group label: Sensor augmented pump therapy (control arm)
criteria: 
gender: All
minimum age: 1 Year
maximum age: 7 Years
healthy volunteers: No
last name: Roman Hovorka
role: Study Director
affiliation: Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
country: Luxembourg
country: United Kingdom
citation: Elleri D, Allen JM, Tauschmann M, El-Khairi R, Benitez-Aguirre P, Acerini CL, Dunger DB, Hovorka R. Feasibility of overnight closed-loop therapy in young children with type 1 diabetes aged 3-6 years: comparison between diluted and standard insulin strength. BMJ Open Diabetes Res Care. 2014 Dec 11;2(1):e000040. doi: 10.1136/bmjdrc-2014-000040. eCollection 2014.
PMID: 25512874
citation: Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, Acerini CL, Dellweg S, Benesch C, Heinemann L, Mader JK, Holzer M, Kojzar H, Exall J, Yong J, Pichierri J, Barnard KD, Kollman C, Cheng P, Hindmarsh PC, Campbell FM, Arnolds S, Pieber TR, Evans ML, Dunger DB, Hovorka R. Home Use of an Artificial Beta Cell in Type 1 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2129-2140. doi: 10.1056/NEJMoa1509351. Epub 2015 Sep 17.
PMID: 26379095
citation: Tauschmann M, Allen JM, Wilinska ME, Thabit H, Stewart Z, Cheng P, Kollman C, Acerini CL, Dunger DB, Hovorka R. Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial. Diabetes Care. 2016 Jul;39(7):1168-74. doi: 10.2337/dc15-2078. Epub 2016 Jan 6.
PMID: 26740634
citation: Tauschmann M, Allen JM, Wilinska ME, Thabit H, Acerini CL, Dunger DB, Hovorka R. Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial. Diabetes Care. 2016 Nov;39(11):2019-2025. doi: 10.2337/dc16-1094. Epub 2016 Sep 9.
PMID: 27612500
responsible party type: Principal Investigator
investigator affiliation: University of Cambridge
investigator full name: Dr Roman Hovorka
investigator title: Study Director
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Yes
ipd description: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication. To gain access, data requestors will need to sign a data access agreement.
Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication.
ipd access criteria: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication.