{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T09:09:55Z","timestamp":1772701795609,"version":"3.50.1"},"reference-count":26,"publisher":"BMJ","issue":"7","funder":[{"DOI":"10.13039\/501100018956","name":"National Institute for Health Research Cambridge Biomedical Research Centre","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100018956","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100008871","name":"JDRF","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008871","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Wellcome Strategic Award"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2017,6,7]]},"published-print":{"date-parts":[[2017,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Despite therapeutic advances, many individuals with type 1 diabetes are unable to achieve tight glycaemic target without increasing the risk of hypoglycaemia. The objective of this study is to determine the effectiveness of a 3-month day-and-night home closed-loop glucose control combined with a pump suspend feature, compared with sensor-augmented insulin pump therapy in youths and adults with suboptimally controlled type 1 diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The study adopts an open-label, multi-centre, multi-national (UK and USA), randomised, single-period, parallel design and aims for 84 randomised patients. Participants are youths (6\u201321 years) or adults (&gt;21 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c) \u22657.5% (58\u2009mmol\/mol) and \u226410% (86\u2009mmol\/mol)). Following a 4-week run-in period, eligible participants will be randomised to a 3-month use of automated closed-loop insulin delivery combined with pump suspend feature or to sensor-augmented insulin pump therapy. Analyses will be conducted on an intention-to-treat basis. The primary outcome is the time spent in the target glucose range from 3.9 to 10.0\u2009mmol\/L based on continuous glucose monitoring levels during the 3-month free-living phase. Secondary outcomes include HbA1c at 3 months, mean glucose, time spent below and above target; time with glucose levels &lt;3.5\u2009and &lt;2.8\u2009mmol\/L; area under the curve when sensor glucose is &lt;3.5\u2009mmol\/L, time with glucose levels &gt;16.7\u2009mmol\/L, glucose variability; total, basal and bolus insulin dose and change in body weight. Participants\u2019 and their families\u2019 perception in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethics\/institutional review board approval has been obtained. Before screening, all participants\/guardians will be provided with oral and written information about the trial. The study will be disseminated by peer-reviewed publications and conference presentations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NCT02523131; Pre-results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-016738","type":"journal-article","created":{"date-parts":[[2017,7,14]],"date-time":"2017-07-14T20:10:17Z","timestamp":1500063017000},"page":"e016738","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["Assessing the effectiveness of a 3-month day-and-night home closed-loop control combined with pump suspend feature compared with sensor-augmented pump therapy in youths and adults with suboptimally controlled type 1 diabetes: a randomised parallel study protocol"],"prefix":"10.1136","volume":"7","author":[{"given":"Lia","family":"Bally","sequence":"first","affiliation":[{"name":"Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK"},{"name":"Department of Diabetes & Endocrinology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hood","family":"Thabit","sequence":"additional","affiliation":[{"name":"Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK"},{"name":"Department of Diabetes & Endocrinology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK"},{"name":"Manchester Diabetes Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Tauschmann","sequence":"additional","affiliation":[{"name":"Wellcome 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