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
Introduction Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin deli...
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BMJ Publishing Group
2021-02-01
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| Series: | BMJ Open |
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| author | Fiona Campbell Carine de Beaufort Gianluca Musolino Janet M Allen Malgorzata E Wilinska Martin Tauschmann Carlo L Acerini Korey Hood Craig Kollman Judy Sibayan Roman Hovorka Ulrike Schierloh Stephane Roze Barbara Kimbell Sabine E Hofer Carine de Beaufort Julia K Mader James Yong Korey K Hood Julia Fuchs Charlotte K Boughton Ajay Thankamony Elke Froehlich-Reiterer Thomas M Kapellen Birgit Rami-Merhar Nathan Cohen Klemen Dovc Nicole Ashcroft Matthew Haydock Muriel Fichelle Dominique Schaeffer Emily Metcalfe Saima Waheed Joseph Tulip Maria Fritsch Hildegard Jasser-Nitsche Kerstin Faninger Daniela Abt Anita Malik Barbara Lanthaler Matthias Wenzel Heike Bartelt Alena Thiele Gabriele Berger Nicole Blauensteiner Renata Gellai Katrin Nagl Sarah Cvach Sonja Katzenbeisser-Pawlik |
| author_facet | Fiona Campbell Carine de Beaufort Gianluca Musolino Janet M Allen Malgorzata E Wilinska Martin Tauschmann Carlo L Acerini Korey Hood Craig Kollman Judy Sibayan Roman Hovorka Ulrike Schierloh Stephane Roze Barbara Kimbell Sabine E Hofer Carine de Beaufort Julia K Mader James Yong Korey K Hood Julia Fuchs Charlotte K Boughton Ajay Thankamony Elke Froehlich-Reiterer Thomas M Kapellen Birgit Rami-Merhar Nathan Cohen Klemen Dovc Nicole Ashcroft Matthew Haydock Muriel Fichelle Dominique Schaeffer Emily Metcalfe Saima Waheed Joseph Tulip Maria Fritsch Hildegard Jasser-Nitsche Kerstin Faninger Daniela Abt Anita Malik Barbara Lanthaler Matthias Wenzel Heike Bartelt Alena Thiele Gabriele Berger Nicole Blauensteiner Renata Gellai Katrin Nagl Sarah Cvach Sonja Katzenbeisser-Pawlik |
| collection | DOAJ |
| description | Introduction Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group.Methods and analysis The study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1–7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1–4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants’ and caregivers’ experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed.Ethics and dissemination Ethics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d’Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations.Trial registration number NCT03784027. |
| format | Article |
| id | doaj-art-80208ddbf99a466fb56b079ab0c1945a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-80208ddbf99a466fb56b079ab0c1945a2024-11-17T12:55:08ZengBMJ Publishing GroupBMJ Open2044-60552021-02-0111210.1136/bmjopen-2020-042790Assessing 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 0Fiona Campbell1Carine de Beaufort2Gianluca MusolinoJanet M Allen3Malgorzata E Wilinska4Martin Tauschmann5Carlo L AceriniKorey Hood6Craig KollmanJudy Sibayan7Roman Hovorka8Ulrike Schierloh9Stephane Roze10Barbara Kimbell11Sabine E Hofer12Carine de BeaufortJulia K Mader13James Yong14Korey K Hood15Julia Fuchs16Charlotte K Boughton17Ajay Thankamony18Elke Froehlich-Reiterer19Thomas M Kapellen20Birgit Rami-Merhar21Nathan Cohen22Klemen DovcNicole AshcroftMatthew HaydockMuriel FichelleDominique SchaefferEmily MetcalfeSaima WaheedJoseph TulipMaria FritschHildegard Jasser-NitscheKerstin FaningerDaniela AbtAnita MalikBarbara LanthalerMatthias WenzelHeike BarteltAlena ThieleGabriele BergerNicole BlauensteinerRenata GellaiKatrin NaglSarah CvachSonja Katzenbeisser-Pawlik4Association of British NeurologistsstatisticianDiabetes & Endocrine Care, Clinique Pédiatrique, Centre Hospitalier de Luxembourg, Luxembourg, LuxembourgWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UKWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UKDepartment of Pediatrics and Adolescent Medicine, Medical University of Vienna, Wien, AustriaEndocrinology, Stanford University School of Medicine, Stanford, California, USAJaeb Centre for Health Research, Tampa, Florida, USAWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UK7 Clinque Pédiatrique, Centre Hospitalier de Luxembourg, Luxembourg, LuxembourgVyoo Agency Sarl, Lyon, FranceThe University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, Edinburgh, UKDepartment of Pediatrics I, Medical University of Innsbruck, Innsbruck, Tirol, AustriaDepartment of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Steiermark, AustriaLeeds Children’s Hospital, Leeds, West Yorkshire, UKStanford Diabetes Research Center, Stanford, California, USA1Paracelsus Medical University, Institute of Physiology and Pathophysiology, Salzburg, AustriaWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UKDepartment of Paediatrics, University of Cambridge School of Clinical Medicine, Cambridge, UKDepartment of Pediatric and Adolescent Medicine, Medical University of Graz, Graz, Steiermark, AustriaHospital for Children and Adolescents, University of Leipzig Faculty of Medicine, Leipzig, Sachsen, GermanyDepartment of Pediatrics and Adolescent Medicine, Medical University of Vienna, Wien, AustriaJaeb Centre for Health Research, Tampa, Florida, USAIntroduction Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group.Methods and analysis The study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1–7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1–4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants’ and caregivers’ experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed.Ethics and dissemination Ethics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d’Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations.Trial registration number NCT03784027.https://bmjopen.bmj.com/content/11/2/e042790.full |
| spellingShingle | Fiona Campbell Carine de Beaufort Gianluca Musolino Janet M Allen Malgorzata E Wilinska Martin Tauschmann Carlo L Acerini Korey Hood Craig Kollman Judy Sibayan Roman Hovorka Ulrike Schierloh Stephane Roze Barbara Kimbell Sabine E Hofer Carine de Beaufort Julia K Mader James Yong Korey K Hood Julia Fuchs Charlotte K Boughton Ajay Thankamony Elke Froehlich-Reiterer Thomas M Kapellen Birgit Rami-Merhar Nathan Cohen Klemen Dovc Nicole Ashcroft Matthew Haydock Muriel Fichelle Dominique Schaeffer Emily Metcalfe Saima Waheed Joseph Tulip Maria Fritsch Hildegard Jasser-Nitsche Kerstin Faninger Daniela Abt Anita Malik Barbara Lanthaler Matthias Wenzel Heike Bartelt Alena Thiele Gabriele Berger Nicole Blauensteiner Renata Gellai Katrin Nagl Sarah Cvach Sonja Katzenbeisser-Pawlik 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/2/e042790.full |
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assessingtheefficacysafetyandutilityofclosedloopinsulindeliverycomparedwithsensoraugmentedpumptherapyinveryyoungchildrenwithtype1diabeteskidsap02studyanopenlabelmulticentremultinationalrandomisedcrossoverstudyprotocol AT sonjakatzenbeisserpawlik assessingtheefficacysafetyandutilityofclosedloopinsulindeliverycomparedwithsensoraugmentedpumptherapyinveryyoungchildrenwithtype1diabeteskidsap02studyanopenlabelmulticentremultinationalrandomisedcrossoverstudyprotocol |