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. Issue 2 (12th February 2021)

• Record Type: Journal Article
• Authors: Fuchs, Julia; Allen, Janet M; Boughton, Charlotte K; Wilinska, Malgorzata E; Thankamony, Ajay; de Beaufort, Carine; Campbell, Fiona; Yong, James; Froehlich-Reiterer, Elke; Mader, Julia K; Hofer, Sabine E; Kapellen, Thomas M; Rami-Merhar, Birgit; Tauschmann, Martin; Hood, Korey; Kimbell, Barbara; Lawton, Julia; Roze, Stephane; Sibayan, Judy; Cohen, Nathan; Hovorka, Roman
• Other Names: author non-byline.; Hovorka Roman author non-byline.; Acerini Carlo L author non-byline.; Thankamony Ajay author non-byline.; Boughton Charlotte K author non-byline.; Dovc Klemen author non-byline.; Fuchs Julia author non-byline.; Musolino Gianluca author non-byline.; Wilinska Malgorzata E author non-byline.; Allen Janet M author non-byline.; Ashcroft Nicole author non-byline.; Haydock Matthew author non-byline.; Beaufort Carine de author non-byline.; Schierloh Ulrike author non-byline.; Fichelle Muriel author non-byline.; Schaeffer Dominique author non-byline.; Campbell Fiona author non-byline.; Yong James author non-byline.; Metcalfe Emily author non-byline.; Waheed Saima author non-byline.; Tulip Joseph author non-byline.; Froehlich-Reiterer Elke author non-byline.; Fritsch Maria author non-byline.; Jasser-Nitsche Hildegard author non-byline.; Mader Julia K author non-byline.; Faninger Kerstin author non-byline.; Hofer Sabine E author non-byline.; Abt Daniela author non-byline.; Malik Anita author non-byline.; Lanthaler Barbara author non-byline.; Wenzel Matthias author non-byline.; Kapellen Thomas M author non-byline.; Bartelt Heike author non-byline.; Thiele Alena author non-byline.; Rami-Merhar Birgit author non-byline.; Berger Gabriele author non-byline.; Blauensteiner Nicole author non-byline.; Gellai Renata author non-byline.; Nagl Katrin author non-byline.; Tauschmann Martin author non-byline.; Cvach Sarah author non-byline.; Katzenbeisser-Pawlik Sonja author non-byline.; Hood Korey K author non-byline.; Kimbell Barbara author non-byline.; Lawton Julia author non-byline.; Roze Stephane author non-byline.; Cohen Nathan author non-byline.; Kollman Craig author non-byline.; Sibayan Judy author non-byline.;
• Is Part Of: BMJ open. Volume 11:Issue 2(2021)
• Publication Date: 2021-02-12
• Subjects: general diabetes -- paediatric endocrinology -- paediatrics -- diabetes & endocrinology; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-042790
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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 .