{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T11:24:10Z","timestamp":1790421850168,"version":"4.1.0"},"reference-count":38,"publisher":"American Diabetes Association","issue":"1","license":[{"start":{"date-parts":[[2019,12,20]],"date-time":"2019-12-20T00:00:00Z","timestamp":1576800000000},"content-version":"vor","delay-in-days":107,"URL":"http:\/\/www.diabetesjournals.org\/content\/license"}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,1,1]]},"abstract":"<jats:sec><jats:title>OBJECTIVE<\/jats:title><jats:p>The HypoCOMPaSS study was designed to test the hypothesis that successful avoidance of biochemical hypoglycemia without compromising overall glycemic control would restore sufficient hypoglycemia awareness to prevent recurrent severe hypoglycemia in the majority of participants with established type 1 diabetes. Before starting the study, we planned to investigate associations between baseline characteristics and recurrent severe hypoglycemia over 2 years\u2019 follow-up.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESEARCH DESIGN AND METHODS<\/jats:title><jats:p>A total of 96 adults with type 1 diabetes and impaired awareness of hypoglycemia participated in a 24-week 2 \u00d7 2 factorial randomized controlled trial comparing insulin delivery and glucose monitoring modalities, with the goal of rigorous biochemical hypoglycemia avoidance. The analysis included 71 participants who had experienced severe hypoglycemia in the 12-month prestudy with confirmed absence (complete responder) or presence (incomplete responder) of severe hypoglycemia over 24 months\u2019 follow-up.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>There were 43 (61%) complete responders and 28 (39%) incomplete responders experiencing mean \u00b1 SD 1.5 \u00b1 1.0 severe hypoglycemia events\/person-year. At 24 months, incomplete responders spent no more time with glucose \u22643 mmol\/L (1.4 \u00b1 2.1% vs. 3.0 \u00b1 4.8% for complete responders; P = 0.26), with lower total daily insulin dose (0.45 vs. 0.58 units\/24 h; P = 0.01) and greater impairment of hypoglycemia awareness (Clarke score: 3.8 \u00b1 2.2 vs. 2.0 \u00b1 1.9; P = 0.01). Baseline severe hypoglycemia rate (16.9 \u00b1 16.3 vs. 6.4 \u00b1 10.8 events\/person-year; P = 0.002) and fear of hypoglycemia were higher in incomplete responders. Peripheral neuropathy was more prevalent in incomplete responders (11 [39%] vs. 2 [4.7%]; P &amp;lt; 0.001) with a trend toward increased autonomic neuropathy.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>Recurrent severe hypoglycemia was associated with higher preintervention severe hypoglycemia rate, fear of hypoglycemia, and concomitant neuropathy.<\/jats:p><\/jats:sec>","DOI":"10.2337\/dc19-0630","type":"journal-article","created":{"date-parts":[[2019,9,4]],"date-time":"2019-09-04T21:15:42Z","timestamp":1567631742000},"page":"44-52","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":28,"title":["Predictors of Recurrent Severe Hypoglycemia in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia During the HypoCOMPaSS Study"],"prefix":"10.2337","volume":"43","clinical-trial-number":[{"clinical-trial-number":"isrctn52164803","registry":"10.18810\/isrctn"}],"author":[{"given":"Anneliese J.S.","family":"Flatt","sequence":"first","affiliation":[{"name":"Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, U.K."},{"name":"Newcastle Diabetes Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart A.","family":"Little","sequence":"additional","affiliation":[{"name":"Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, U.K."},{"name":"Newcastle Diabetes Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1204-6896","authenticated-orcid":false,"given":"Jane","family":"Speight","sequence":"additional","affiliation":[{"name":"School of 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U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Bowes","sequence":"additional","affiliation":[{"name":"Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Lubina-Solomon","sequence":"additional","affiliation":[{"name":"School of Medicine and Biomedical Sciences, The University of Sheffield, Sheffield, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9139-4663","authenticated-orcid":false,"given":"Elizabeth","family":"Holmes-Truscott","sequence":"additional","affiliation":[{"name":"Newcastle Diabetes Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K."},{"name":"School of Psychology, Deakin University, Geelong, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas J.","family":"Chadwick","sequence":"additional","affiliation":[{"name":"Institute of Health & Society, Newcastle University, Newcastle upon Tyne, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth","family":"Wood","sequence":"additional","affiliation":[{"name":"Newcastle Clinical Trials Unit, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3559-6660","authenticated-orcid":false,"given":"Timothy J.","family":"McDonald","sequence":"additional","affiliation":[{"name":"Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Kerr","sequence":"additional","affiliation":[{"name":"Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, U.K."},{"name":"Sansum Diabetes Research 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