Type 1 Diabetes MellitusKidsAP02NCT03784027
The Artificial Pancreas in Very Young Children With T1D
A study testing CamAPS FX and Sensor augmented therapy in people with Type 1 Diabetes Mellitus, run by University of Cambridge at 8 sites in 4 countries.
Trial summary
The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme and JDRF. It evaluates the use of the Artificial Pancreas (closed loop system) in very young children with type 1 diabetes (T1D) aged 1-7 years. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CamAPS FX and Sensor augmented therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 1 May 2019to 3 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 1 and 7 years (inclusive) (Luxembourg and Austria)
- Age between 2 and 7 years (inclusive) (Germany and UK)
- 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.).']
- 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
- On sensor-augmented pump as standard clinical care (extension phase only)
- Treated with rapid or ultra-rapid acting insulin analogue
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- Subject/carer is willing to perform regular finger-prick blood glucose monitoring, with at least 2 blood glucose measurements taken every day
- Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
- Willing to wear glucose sensor
- Willing to wear closed loop system 24/7 during intervention arm
- The subject/carer is willing to follow study specific instructions
- The subject/carer is willing to upload pump and CGM data at regular intervals
Who cannot join
- 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
- Untreated coeliac disease or thyroid disease based on local investigations prior to study enrolment
- Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids
- Use of closed loop insulin delivery within the past 2 months
- Known or suspected allergy to insulin
- Carer's lack of reliable telephone facility for contact
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- Subject/carer's severe visual impairment
- Subject/carer's severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters or subject is unable to tolerate tape adhesive in the area of sensor placement
- 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)
- Sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Plan to receive red blood cell transfusion or erythropoietin over the course of study participation
- Subject/carer not proficient in English (UK, Germany, Austria, Luxembourg) or German (Germany, Austria, Luxembourg) or French (Luxembourg)
- Additional exclusion criteria - Germany only
- Known microvascular diabetes complications (retinopathy, renal disease, neuropathy)
- Eating disorders
- Psychiatric diseases of the parents that would possibly interfere with the ability to comply to study procedures
- Major needle phobia that would complicate to wear pump catheter and sensor
- Congenital malformations that would interfere with diabetes treatment (e.g. congenital heart malformations, lung diseases, renal malformations)
- Growth hormone deficiency
- Combined Hypopituitarism
- Down Syndrome (high risk for comorbidity with coeliac disease, autoimmune thyroiditis)
- Cancer under treatment
- Current participation in other interventional clinical trials
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Austria3 sites
Medical University of Graz Department of Pediatrics and Adolescent Medicine
Graz, A-8036
Medical University of Innsbruck Department of Pediatrics I
Innsbruck, A-6020
Medical University of Vienna Department of Pediatrics
Vienna, A-1090
United Kingdom3 sites
University Department of Paediatrics
Cambridge, Cambridgeshire, CB2 0QQ
Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge
Cambridge, Cambridgeshire, CB2 0QQ
St James's University Hospital
Leeds, LS9 7TF
Germany1 site
University of Leipzig Division for Paediatric Diabetology
Leipzig, D-04103
Luxembourg1 site
Clinique Pédiatrique de Luxembourg Centre Hospitalier de Luxembourg
Luxembourg, L-1210
About this study
Official title: Open-label, Multi-centre, Multi-national, Randomized 2-period Crossover Study Comparing Closed-loop Insulin Delivery With Sensor-augmented Pump Therapy Over 4 Months in Children 1-7 Years With Type 1 Diabetes at Home, With an Extension.
The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme and JDRF. It evaluates the use of the Artificial Pancreas (closed loop system) in very young children with type 1 diabetes (T1D) aged 1-7 years. This outcome study aims to determine whether 24/7 automated closed loop glucose control improves time in range compared to sensor augmented pump therapy. An extension phase will evaluate the effect of long-term home use of the 24/7 automated hybrid closed loop insulin delivery system on glucose control (UK sites only).
The study employs an open-label, multi-centre, multi-national, randomized, two-period, crossover design. Participants undergo a 2-4 week run-in period, followed by two 16-week treatment periods (one for each therapy) separated by a 1-4 week washout. The order of treatments is randomized. Up to 80 young children (with a target of 72 randomized subjects) on insulin pump therapy will be recruited from paediatric outpatient diabetes clinics.
Read more
Before using the study devices, participants and their parents/guardians receive training on the safe use of the study pump, continuous glucose monitoring (CGM) device, and hybrid closed loop system. Nursery or school carers may also be trained if needed. During the closed loop arm, subjects use the system for 16 weeks under free-living conditions at home and in nursery/school without remote monitoring. In the control arm, subjects use sensor augmented pump therapy for 16 weeks under similar conditions, with regular contact and 24/7 telephone support from the study team.
The primary endpoint is the time spent in the target glucose range (3.9-10.0 mmol/l) as recorded by CGM. Secondary outcomes include the time spent with glucose levels above and below target and other CGM metrics. Safety assessments include the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA). In the extension phase, participants have follow-up contacts every 3 months, with the primary endpoint measured over 18 months from the end of the primary phase and compared to sensor augmented pump therapy during that phase. Secondary outcomes, safety, and utility will be assessed similarly.
Read the detailed description
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.
- 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.
- 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.
- UTILITY: The objective is to determine the acceptability and duration of use of the closed loop system in this population.
- 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.
- HEALTH ECONOMICS: The objective is to perform a cost utility analysis to inform reimbursement decision-making.
Participating clinical centres:
- Addenbrooke's Hospital, Cambridge University Hospital NHS Foundation Trust, Cambridge, UK
- Leeds Teaching Hospitals NHS Trust, Leeds, UK
- DECCP, Centre Hospitalier de Luxembourg, Grand Duché de Luxembourg
- University of Leipzig, Leipzig, Germany
- Medical University of Graz, Graz, Austria
- Medical University of Innsbruck, Innsbruck, Austria
- 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
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- CamAPS FX, Sensor augmented therapy
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamAPS FXDevice
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
Sensor augmented therapyOther
Study insulin pump and study CGM.
| Study group | Role | What they receive |
|---|---|---|
| Automated closed loop insulin delivery (intervention arm) | Experimental | Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX Receives: Device: CamAPS FX |
| Sensor augmented pump therapy (control arm) | Active comparator | Sensor augmented pump therapy over 16 weeks. Receives: Other: Sensor augmented therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl)
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.
Measured: 16-week home stay
Secondary outcomes (19)
Key Endpoint: Time Spent Above Target Glucose (10.0 mmol/l) (180 mg/dl)
Percentage of time spent with sensor glucose readings above target glucose (10.0mmol/l) (180mg/dl)
Measured: 16-week home stay
Key Endpoint: HbA1c
HbA1c is measured in % as per NGSP
Measured: 16-week home stay
Key Endpoint: HbA1c
HbA1c, measured using standardized, validated assays, serves as an indicator of long-term glycemic control, reflecting the average blood glucose levels over approximately 3 months.
Measured: 16 weeks
Key Endpoint: Mean Sensor Glucose
Mean sensor glucose is calculated from CGM readings over the study period to reflect overall glycemic control.
Measured: 16-week home stay
Key Endpoint: Time Spent Below Target Glucose (3.9 mmol/l) (70 mg/dl)
Percentage of time spent with sensor glucose readings below target glucose (3.9mmol/l)(70mg/dl)
Measured: 16-week home stay
Standard Deviation
Standard deviation of sensor glucose levels
Measured: 16-week home stay
Coefficient of Variation (Percentage) of Glucose Levels
Coefficient of variation (percentage) of sensor glucose levels
Measured: 16-week home stay
Time With Glucose Levels <3.0 mmol/l (54 mg/dl)
Percentage of time spent with glucose levels < 3.0mmol/l (54 mg/dl)
Measured: 16-week home stay
Time With Glucose Levels in Significant Hyperglycaemia (Glucose Levels > 16.7 mmol/l) (300 mg/dl)
Percentage of time spent with glucose levels in significant hyperglycaemia (glucose levels > 16.7mmol/l) (300mg/dl)
Measured: 16-week home stay
AUC of Glucose Below 3.5 mmol/l (63 mg/dl)
Area under the curve of sensor glucose readings below 3.5mmol/l (63mg/dl). Glucose AUC was calculated by trapezoidal approximation of sensor glucose levels.
Measured: 16-week home stay
BMI SDS
BMI Standard Deviation Score
Measured: 16-week home stay
Total, Basal, and Bolus Insulin Dose
Median daily total, basal and bolus insulin use
Measured: 16-week home stay
Number of Episodes of Severe Hypoglycaemia
This outcome measure records the total number of severe hypoglycaemic episodes-defined as events requiring external assistance-experienced during the study period. Episodes are captured through patient records and clinical confirmation.
Measured: 16-week home stay
Number of Subjects Experiencing Severe Hypoglycaemia
Count of subjects with at least one severe hypoglycaemic event during the study. Severe events are defined as episodes requiring external assistance.
Measured: 16-week home stay
Frequency of Diabetic Ketoacidosis
The incidence of diabetic ketoacidosis (DKA) episodes will be recorded as the number of confirmed events during the study
Measured: 16-week home stay
Frequency and Nature of Other Adverse Events
The frequency and nature of other adverse events will be recorded throughout the study. All events not directly linked to the intervention will be documented, detailing their onset, duration, severity, and potential relation to the treatment.
Measured: 16-week home stay
Percentage of Time of CGM Availability
This outcome assesses the percentage of time the continuous glucose monitoring (CGM) system is active and delivering valid data.
Measured: 16-week home stay
Percentage of Time of Closed-loop Operation
This outcome measure determines the percentage of the total study period during which the closed-loop insulin delivery system operates as intended.
Measured: 16-week home stay
Frequency and Nature of Other Serious Adverse Events
Frequency and nature of other serious adverse events will be documented, including type, severity, and potential treatment association.
Measured: 16-week home stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start1 May 2019
- Primary completion22 Feb 2021
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Dr Roman Hovorka, University of Cambridge
- Investigators
- Roman Hovorka, Study director, Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784027
- Sponsor's protocol ID
- KidsAP02
- Acronym
- KidsAP02
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2018
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25512874Thabit 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; New Collective Author. 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.
PubMed 26379095Tauschmann 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.
PubMed 26740634Tauschmann 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.
PubMed 27612500Vidou A, Pit-Ten Cate IM, Campbell FM, Ware J, Hovorka R, Wilinska ME, Schierloh U, Hofer SE, Frohlich-Reiterer E, Rami-Merhar B, Kapellen TM, de Beaufort C; KidsAP Consortium. Cambridge hybrid closed-loop use in very young children with type 1 diabetes: Parental expectancies during long-term home use. Diabet Med. 2026 Jul 1:e70408. doi: 10.1111/dme.70408. Online ahead of print.
PubMed 42384569Ware J, Allen JM, Boughton CK, Wilinska ME, Hartnell S, Thankamony A, de Beaufort C, Schierloh U, Frohlich-Reiterer E, Mader JK, Kapellen TM, Rami-Merhar B, Tauschmann M, Nagl K, Hofer SE, Campbell FM, Yong J, Hood KK, Lawton J, Roze S, Sibayan J, Bocchino LE, Kollman C, Hovorka R; KidsAP Consortium. Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes. N Engl J Med. 2022 Jan 20;386(3):209-219. doi: 10.1056/NEJMoa2111673.
PubMed 35045227Fuchs J, Allen JM, Boughton CK, Wilinska ME, Thankamony A, de Beaufort C, Campbell F, Yong J, Froehlich-Reiterer E, Mader JK, Hofer SE, Kapellen TM, Rami-Merhar B, Tauschmann M, Hood K, Kimbell B, Lawton J, Roze S, Sibayan J, Cohen N, Hovorka R; KidsAP Consortium. Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol. BMJ Open. 2021 Feb 12;11(2):e042790. doi: 10.1136/bmjopen-2020-042790.
PubMed 33579766
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multi-centre, Multi-national, Randomized 2-period Crossover Study Comparing Closed-loop Insulin Delivery With Sensor-augmented Pump Therapy Over 4 Months in Children 1-7 Years With Type 1 Diabetes at Home, With an Extension.
- ClinicalTrials.gov ID
- NCT03784027
- Acronym / sponsor ID
- KidsAP02 / KidsAP02
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- 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
- Study start
- 1 May 2019 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme and JDRF. It evaluates the use of the Artificial Pancreas (closed loop system) in very young children with type 1 diabetes (T1D) aged 1-7 years. This outcome study aims to determine whether 24/7 automated closed loop glucose control improves time in range compared to sensor augmented pump therapy. An extension phase will evaluate the effect of long-term home use of the 24/7 automated hybrid closed loop insulin delivery system on glucose control (UK sites only).
The study employs an open-label, multi-centre, multi-national, randomized, two-period, crossover design. Participants undergo a 2-4 week run-in period, followed by two 16-week treatment periods (one for each therapy) separated by a 1-4 week washout. The order of treatments is randomized. Up to 80 young children (with a target of 72 randomized subjects) on insulin pump therapy will be recruited from paediatric outpatient diabetes clinics.
Before using the study devices, participants and their parents/guardians receive training on the safe use of the study pump, continuous glucose monitoring (CGM) device, and hybrid closed loop system. Nursery or school carers may also be trained if needed. During the closed loop arm, subjects use the system for 16 weeks under free-living conditions at home and in nursery/school without remote monitoring. In the control arm, subjects use sensor augmented pump therapy for 16 weeks under similar conditions, with regular contact and 24/7 telephone support from the study team.
The primary endpoint is the time spent in the target glucose range (3.9-10.0 mmol/l) as recorded by CGM. Secondary outcomes include the time spent with glucose levels above and below target and other CGM metrics. Safety assessments include the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA). In the extension phase, participants have follow-up contacts every 3 months, with the primary endpoint measured over 18 months from the end of the primary phase and compared to sensor augmented pump therapy during that phase. Secondary outcomes, safety, and utility will be assessed similarly.
Detailed description
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.
- 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.
- 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.
- UTILITY: The objective is to determine the acceptability and duration of use of the closed loop system in this population.
- 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.
- HEALTH ECONOMICS: The objective is to perform a cost utility analysis to inform reimbursement decision-making.
Participating clinical centres:
- Addenbrooke's Hospital, Cambridge University Hospital NHS Foundation Trust, Cambridge, UK
- Leeds Teaching Hospitals NHS Trust, Leeds, UK
- DECCP, Centre Hospitalier de Luxembourg, Grand Duché de Luxembourg
- University of Leipzig, Leipzig, Germany
- Medical University of Graz, Graz, Austria
- Medical University of Innsbruck, Innsbruck, Austria
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Automated closed loop insulin delivery (intervention arm) | Experimental | Device: CamAPS FXUnsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks. Intervention: Device: CamAPS FX |
| Sensor augmented pump therapy (control arm) | Active comparator | Other: Sensor augmented therapySensor augmented pump therapy over 16 weeks. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Age between 1 and 7 years (inclusive) (Luxembourg and Austria)
- Age between 2 and 7 years (inclusive) (Germany and UK)
- 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.).']
- 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
- On sensor-augmented pump as standard clinical care (extension phase only)
Key exclusion criteria (24 listed)
- 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
- Untreated coeliac disease or thyroid disease based on local investigations prior to study enrolment
- Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids
- Use of closed loop insulin delivery within the past 2 months
- Known or suspected allergy to insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamAPS FXCamAPS 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 | Device | Automated closed loop insulin delivery (intervention arm) |
| Sensor augmented therapyStudy insulin pump and study CGM. | Other | Sensor augmented pump therapy (control arm) |
Primary outcome
Time in Target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl)
Time frame: 16-week 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.
19 secondary outcomes
Key Endpoint: Time Spent Above Target Glucose (10.0 mmol/l) (180 mg/dl)
Time frame: 16-week home stay
Key Endpoint: HbA1c
Time frame: 16-week home stay
Key Endpoint: HbA1c
Time frame: 16 weeks
Key Endpoint: Mean Sensor Glucose
Time frame: 16-week home stay
Key Endpoint: Time Spent Below Target Glucose (3.9 mmol/l) (70 mg/dl)
Time frame: 16-week home stay
Standard Deviation
Time frame: 16-week home stay
Coefficient of Variation (Percentage) of Glucose Levels
Time frame: 16-week home stay
Time With Glucose Levels <3.0 mmol/l (54 mg/dl)
Time frame: 16-week home stay
Time With Glucose Levels in Significant Hyperglycaemia (Glucose Levels > 16.7 mmol/l) (300 mg/dl)
Time frame: 16-week home stay
AUC of Glucose Below 3.5 mmol/l (63 mg/dl)
Time frame: 16-week home stay
BMI SDS
Time frame: 16-week home stay
Total, Basal, and Bolus Insulin Dose
Time frame: 16-week home stay
Number of Episodes of Severe Hypoglycaemia
Time frame: 16-week home stay
Number of Subjects Experiencing Severe Hypoglycaemia
Time frame: 16-week home stay
Frequency of Diabetic Ketoacidosis
Time frame: 16-week home stay
Frequency and Nature of Other Adverse Events
Time frame: 16-week home stay
Percentage of Time of CGM Availability
Time frame: 16-week home stay
Percentage of Time of Closed-loop Operation
Time frame: 16-week home stay
Frequency and Nature of Other Serious Adverse Events
Time frame: 16-week home stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25512874Elleri 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.
- Background: PubMed 26379095Thabit 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; New Collective Author. 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.
- Background: PubMed 26740634Tauschmann 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.
- Background: PubMed 27612500Tauschmann 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.
- Derived from this study: PubMed 42384569Vidou A, Pit-Ten Cate IM, Campbell FM, Ware J, Hovorka R, Wilinska ME, Schierloh U, Hofer SE, Frohlich-Reiterer E, Rami-Merhar B, Kapellen TM, de Beaufort C; KidsAP Consortium. Cambridge hybrid closed-loop use in very young children with type 1 diabetes: Parental expectancies during long-term home use. Diabet Med. 2026 Jul 1:e70408. doi: 10.1111/dme.70408. Online ahead of print.
- Derived from this study: PubMed 35045227Ware J, Allen JM, Boughton CK, Wilinska ME, Hartnell S, Thankamony A, de Beaufort C, Schierloh U, Frohlich-Reiterer E, Mader JK, Kapellen TM, Rami-Merhar B, Tauschmann M, Nagl K, Hofer SE, Campbell FM, Yong J, Hood KK, Lawton J, Roze S, Sibayan J, Bocchino LE, Kollman C, Hovorka R; KidsAP Consortium. Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes. N Engl J Med. 2022 Jan 20;386(3):209-219. doi: 10.1056/NEJMoa2111673.
- Derived from this study: PubMed 33579766Fuchs J, Allen JM, Boughton CK, Wilinska ME, Thankamony A, de Beaufort C, Campbell F, Yong J, Froehlich-Reiterer E, Mader JK, Hofer SE, Kapellen TM, Rami-Merhar B, Tauschmann M, Hood K, Kimbell B, Lawton J, Roze S, Sibayan J, Cohen N, Hovorka R; KidsAP Consortium. Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol. BMJ Open. 2021 Feb 12;11(2):e042790. doi: 10.1136/bmjopen-2020-042790.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Hovorka study director
Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CamAPS FX and Sensor augmented therapy in people with Type 1 Diabetes Mellitus, run by University of Cambridge at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria, United Kingdom, Germany, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl) (time frame: 16-week home stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03784027, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.