{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T23:38:41Z","timestamp":1788824321368,"version":"build-2803163510"},"reference-count":15,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,12,19]],"date-time":"2019-12-19T00:00:00Z","timestamp":1576713600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabet. Med."],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>To evaluate the effect of final HbA<jats:sub>1c<\/jats:sub> levels on the incidences of hypoglycaemia in participants with type 1 diabetes treated with inhaled Technosphere<jats:sup>\u00ae<\/jats:sup> Insulin or subcutaneous insulin aspart, reported in alignment with the International Hypoglycaemia Study Group recommendations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In the randomized, phase 3, multicentre AFFINITY\u20101 study, adults (<jats:italic>N<\/jats:italic>\u00a0=\u00a0375) who had type 1 diabetes for \u2265\u00a012\u00a0months and an HbA<jats:sub>1c<\/jats:sub> level of 58\u201386\u00a0mmol\/mol (7.5\u201310.0%) were randomized to receive basal insulin plus either inhaled Technosphere Insulin or subcutaneous insulin aspart. This was a post\u2010hoc regression analysis on a subset (<jats:italic>N<\/jats:italic>\u00a0=\u00a0279) of the randomized AFFINITY\u20101 cohort for whom baseline and end\u2010of\u2010treatment HbA<jats:sub>1c<\/jats:sub> values were reported. Primary outcome measures were incidence and event rates for levels 1, 2 and 3 hypoglycaemia, respectively defined as blood glucose levels of \u2264\u00a03.9 mmol\/l, &lt;\u00a03.0 mmol\/l or requiring external assistance for recovery.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Participants treated with Technosphere Insulin experienced statistically significantly fewer level 1 and 2 hypoglycaemic events and a lower incidence of level 3 hypoglycaemia than participants treated with insulin aspart. The lower rate of hypoglycaemia with Technosphere Insulin was observed across the range of end\u2010of\u2010treatment HbA<jats:sub>1c<\/jats:sub> levels. Technosphere Insulin was associated with higher rates of hypoglycaemia 30\u201360\u00a0min after meals, but significantly lower rates 2\u20136\u00a0h after meals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Participants using Technosphere Insulin experienced clinically non\u2010inferior glycaemic control and lower hypoglycaemia rates across a range of HbA<jats:sub>1c<\/jats:sub> levels compared with participants receiving insulin aspart. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>: NCT01445951.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dme.14202","type":"journal-article","created":{"date-parts":[[2019,12,7]],"date-time":"2019-12-07T07:52:35Z","timestamp":1575705155000},"page":"752-759","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Hypoglycaemia is reduced with use of inhaled Technosphere<sup>\u00ae<\/sup> Insulin relative to insulin aspart in type 1 diabetes mellitus"],"prefix":"10.1111","volume":"37","author":[{"given":"E. R.","family":"Seaquist","sequence":"first","affiliation":[{"name":"University of Minnesota Minneapolis MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Blonde","sequence":"additional","affiliation":[{"name":"Ochsner Medical Center New Orleans LA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. B.","family":"McGill","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine St Louis MO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2425-9565","authenticated-orcid":false,"given":"S. R.","family":"Heller","sequence":"additional","affiliation":[{"name":"University of Sheffield Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. M.","family":"Kendall","sequence":"additional","affiliation":[{"name":"MannKind Corporation Westlake Village CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. B.","family":"Bumpass","sequence":"additional","affiliation":[{"name":"MannKind Corporation Westlake Village CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2406-8344","authenticated-orcid":false,"given":"F. M.","family":"Pompilio","sequence":"additional","affiliation":[{"name":"MannKind Corporation Westlake Village CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. L.","family":"Grant","sequence":"additional","affiliation":[{"name":"MannKind Corporation Westlake Village CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,12,19]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199309303291401"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa052187"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/db08-1084"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/1932296816658055"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/193229681200600402"},{"key":"e_1_2_9_7_1","unstructured":"Afrezza [package insert].Danbury CT:MannKind Corporation 2018."},{"key":"e_1_2_9_8_1","unstructured":"FIASP [package insert].Bagsv\u00e6rd Denmark:Novo Nordisk A\/S 2018."},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-0075"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc16-2215"},{"issue":"1","key":"e_1_2_9_11_1","first-page":"S1","article-title":"Standards of medical care in diabetes","volume":"41","author":"American Diabetes Association","year":"2018","journal-title":"Diabetes Care"},{"key":"e_1_2_9_12_1","unstructured":"European Medicines Agency [Internet]. Available athttps:\/\/www.ema.europa.eu\/documents\/scientific-guideline\/draft-guideline-clinical-investigation-medicinal-products-treatment-prevention-diabetes-mellitus_en.pdfLast accessed 3 May 2019."},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-2480"},{"key":"e_1_2_9_14_1","unstructured":"Novolog [package insert].Bagsv\u00e6rd Denmark:Novo Nordisk A\/S 2018."},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.7.2027"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2018.0200"}],"container-title":["Diabetic Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdme.14202","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dme.14202","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dme.14202","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dme.14202","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T18:57:23Z","timestamp":1694026643000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/dme.14202"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12,19]]},"references-count":15,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2020,5]]}},"alternative-id":["10.1111\/dme.14202"],"URL":"https:\/\/doi.org\/10.1111\/dme.14202","archive":["Portico"],"relation":{},"ISSN":["0742-3071","1464-5491"],"issn-type":[{"value":"0742-3071","type":"print"},{"value":"1464-5491","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12,19]]},"assertion":[{"value":"2019-12-04","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-12-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}