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The Artificial Pancreas in Very Young Children With T1D (KidsAP02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03784027
Recruitment Status : Active, not recruiting
First Posted : December 21, 2018
Last Update Posted : November 12, 2020
Sponsor:
Collaborators:
European Commission
Cambridge University Hospitals NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
University of Luxembourg
University of Leipzig
Medical University of Graz
Medical University Innsbruck
Medical University of Vienna
Jaeb Center for Health Research
University of Edinburgh
Stanford University
Glooko
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge

Brief Summary:

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, contrasting a 4 month period during which glucose levels will be controlled either by a closed loop system (intervention group) or by sensor augmented pump therapy (control group).

The two intervention periods will last 4 months each with a 1 to 4 weeks washout period in between. The order of the two interventions 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 4 months 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 4 months 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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: CamAPS FX Other: Sensor augmented therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Automated closed loop insulin delivery (intervention arm)

Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 4 months.

Intervention: Device: CamAPS FX

Device: CamAPS FX

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

Active Comparator: Sensor augmented pump therapy (control arm)
Sensor augmented pump therapy over 4 months
Other: Sensor augmented therapy
Study insulin pump and study CGM.




Primary Outcome Measures :
  1. Time in target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl) [ Time Frame: 4-month home stay ]
    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.


Secondary Outcome Measures :
  1. Time spent above target glucose (10.0 mmol/l) (180 mg/dl) [ Time Frame: 4-month home stay ]
    Percentage of time spent with sensor glucose readings above target glucose (10.0mmol/l) (180mg/dl)

  2. HbA1c [ Time Frame: 4-month home stay ]
  3. Average glucose [ Time Frame: 4-month home stay ]
    Average of sensor glucose levels

  4. Time spent below target glucose (3.0 mmol/l) (70 mg/dl) [ Time Frame: 4-month home stay ]
    Percentage of time spent with sensor glucose readings below target glucose (3.9mmol/l)(70mg/dl)

  5. Standard deviation [ Time Frame: 4-month home stay ]
    Standard deviation of sensor glucose levels

  6. Coefficient of variation of glucose levels [ Time Frame: 4-month home stay ]
    Coefficient of variation of sensor glucose levels

  7. Time with glucose levels <3.0 mmol/l (54 mg/dl) [ Time Frame: 4-month home stay ]
    Percentage of time spent with glucose levels < 3.5mmol/l (63 mg/dl)

  8. Time with glucose levels in significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300 mg/dl) [ Time Frame: 4-month home stay ]
    Percentage of time spent with glucose levels in significant hyperglycaemia (glucose levels > 16.7mmol/l) (300mg/dl)

  9. AUC of glucose below 3.5 mmol/l (63 mg/dl) [ Time Frame: 4-month home stay ]
    Area under the curve of sensor glucose readings below 3.5mmol/l (63mg/dl)

  10. BMI SDS [ Time Frame: 4-month home stay ]
  11. Total, basal, and bolus insulin dose [ Time Frame: 4-month home stay ]
  12. Number of episodes of severe hypoglycaemia [ Time Frame: 4-month home stay ]
    Safety evaluation

  13. Number of subjects experiencing severe hypoglycaemia [ Time Frame: 4-month home stay ]
    Safety evaluation

  14. Frequency of diabetic ketoacidosis [ Time Frame: 4-month home stay ]
    Safety evaluation

  15. Frequency and nature of other adverse events or serious adverse events [ Time Frame: 4-month home stay ]
    Safety evaluation

  16. Percentage of time of closed-loop operation [ Time Frame: 4-month home stay ]
    Utility evaluation

  17. Percentage of time of CGM availability [ Time Frame: 4-month home stay ]
    Utility evaluation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 1 and 7 years (inclusive) (Luxembourg and Austria)
  2. Age between 2 and 7 years (inclusive) (Germany and UK)
  3. Type 1 diabetes as defined by WHO for at least 6 months [WHO definition: 'The aetiological type named type 1 encompasses the majority of cases which are primarily due to beta-cell destruction, and are prone to ketoacidosis. Type 1 includes those cases attributable to an autoimmune process, as well as those with beta-cell destruction for which neither an aetiology nor a pathogenesis is known (idiopathic). It does not include those forms of beta-cell destruction or failure to which specific causes can be assigned (e.g. cystic fibrosis, mitochondrial defects, etc.).']
  4. Insulin pump user (with or without continuous glucose monitoring or flash glucose monitoring system) for at least 3 months, with subject/carer good knowledge of insulin self-adjustment as judged by the investigator
  5. On sensor-augmented pump as standard clinical care (extension phase only)
  6. Treated with rapid or ultra-rapid acting insulin analogue
  7. Subject/carer is willing to perform regular finger-prick blood glucose monitoring, with at least 2 blood glucose measurements taken every day
  8. Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
  9. Willing to wear glucose sensor
  10. Willing to wear closed loop system 24/7 during intervention arm
  11. The subject/carer is willing to follow study specific instructions
  12. The subject/carer is willing to upload pump and CGM data at regular intervals

Exclusion Criteria:

  1. Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
  2. Untreated coeliac disease or thyroid disease based on local investigations prior to study enrolment
  3. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids
  4. Use of closed loop insulin delivery within the past 2 months
  5. Known or suspected allergy to insulin
  6. Carer's lack of reliable telephone facility for contact
  7. Subject/carer's severe visual impairment
  8. Subject/carer's severe hearing impairment
  9. Medically documented allergy towards the adhesive (glue) of plasters or subject is unable to tolerate tape adhesive in the area of sensor placement
  10. Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located in parts of the body which could potentially be used for localisation of the glucose sensor)
  11. Sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  12. Plan to receive red blood cell transfusion or erythropoietin over the course of study participation
  13. Subject/carer not proficient in English (UK, Germany, Austria, Luxembourg) or German (Germany, Austria, Luxembourg) or French (Luxembourg)

    Additional exclusion criteria - Germany only

  14. Known microvascular diabetes complications (retinopathy, renal disease, neuropathy)
  15. Eating disorders
  16. Psychiatric diseases of the parents that would possibly interfere with the ability to comply to study procedures
  17. Major needle phobia that would complicate to wear pump catheter and sensor
  18. Congenital malformations that would interfere with diabetes treatment (e.g. congenital heart malformations, lung diseases, renal malformations)
  19. Growth hormone deficiency
  20. Combined Hypopituitarism
  21. Down Syndrome (high risk for comorbidity with coeliac disease, autoimmune thyroiditis)
  22. Cancer under treatment
  23. Current participation in other interventional clinical trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784027


Locations
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Austria
Medical University of Graz Department of Pediatrics and Adolescent Medicine
Graz, Austria, A-8036
Medical University of Innsbruck Department of Pediatrics I
Innsbruck, Austria, A-6020
Medical University of Vienna Department of Pediatrics
Wien, Austria, A-1090
Germany
University of Leipzig Division for Paediatric Diabetology
Leipzig, Germany, D-04103
Luxembourg
Clinique Pédiatrique de Luxembourg Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, L-1210
United Kingdom
University Department of Paediatrics
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
University of Cambridge
European Commission
Cambridge University Hospitals NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
University of Luxembourg
University of Leipzig
Medical University of Graz
Medical University Innsbruck
Medical University of Vienna
Jaeb Center for Health Research
University of Edinburgh
Stanford University
Glooko
Investigators
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Study Director: Roman Hovorka Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge
Publications:
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Responsible Party: Dr Roman Hovorka, Study Director, University of Cambridge
ClinicalTrials.gov Identifier: NCT03784027    
Other Study ID Numbers: KidsAP02
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases