{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T10:46:09Z","timestamp":1783421169840,"version":"3.54.6"},"reference-count":26,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T00:00:00Z","timestamp":1740960000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100007028","name":"Leona M. and Harry B. Helmsley Charitable Trust","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007028","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabet Med"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>Evidence on outcomes of treating type 1 diabetes (T1D) with long\u2010acting basal insulins in low\u2010resourced settings is lacking. This study aimed to evaluate the impact of switching children and youth with T1D in the low\u2010income country of Mali from human insulin via syringe to long\u2010acting biosimilar insulin glargine delivered by reusable pens combined with short\u2010acting insulin via syringe.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A two\u2010group parallel design randomised trial was conducted enrolling 260 youth aged &lt;25\u2009years, diagnosed with T1D for \u226512\u2009months without prior use of analogue insulin. Youth were randomised 1:1 to either continue receiving current therapy or switch to analogue insulin. The primary outcome was HbA1c, collected at baseline and 3\u2010monthly for 12 months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Primary outcome data were available for 130 (100%) youth in the intervention group and 128 (98.5%) in the control group. Over the 12\u2010month study period, mean HbA1c decreased from 103 to 65\u2009mmol\/mol (11.6%\u20138.1%) (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) in the intervention group and from 101 to 93\u2009mmol\/mol (11.4% to 10.7%) in the control group (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01), an absolute difference of 30\u2009mmol\/mol (95% CI: \u221237, \u221224) (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). The proportion of participants with HbA1c \u2265130\u2009mmol\/mol (\u226514%) decreased from 38.5% to 0% in the intervention group, versus 40.6% to 21.9% in the control group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Switching to a basal\u2010bolus insulin regimen including biosimilar glargine resulted in marked improvements in HbA1c and diabetic ketoacidosis episodes. With relevant training, resources, and support, use of long\u2010acting analogue insulin for treating T1D in Mali was feasible and acceptable to participants and healthcare professionals.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dme.70007","type":"journal-article","created":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T22:24:11Z","timestamp":1741127051000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Marked improvement in <scp>HbA1c<\/scp> following introduction of biosimilar insulin to treatment regimen of children and youth with type 1 diabetes in Mali: A randomised controlled\u00a0trial"],"prefix":"10.1111","volume":"42","author":[{"given":"St\u00e9phane","family":"Besan\u00e7on","sequence":"first","affiliation":[{"name":"Sant\u00e9 Diab\u00e8te  Bamako Mali"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aveni","family":"Haynes","sequence":"additional","affiliation":[{"name":"Life for a Child Program Diabetes Australia  Glebe New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amagara Domon","family":"Togo","sequence":"additional","affiliation":[{"name":"H\u00f4pital du Mali Yirimadio  Bamako Mali"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica Lynn","family":"Sandy","sequence":"additional","affiliation":[{"name":"Life for a Child Program Diabetes Australia  Glebe New South Wales Australia"},{"name":"Institute of Endocrinology and Diabetes The Children's Hospital at Westmead  Westmead New South Wales Australia"},{"name":"Faculty of Medicine and Health University of Sydney  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jayanthi","family":"Maniam","sequence":"additional","affiliation":[{"name":"Life for a Child Program Diabetes Australia  Glebe New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asa Traor\u00e9","family":"Sidibe","sequence":"additional","affiliation":[{"name":"H\u00f4pital du Mali Yirimadio  Bamako Mali"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylla","family":"Dj\u00e9neba","sequence":"additional","affiliation":[{"name":"H\u00f4pital du Mali Yirimadio  Bamako Mali"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carine","family":"de Beaufort","sequence":"additional","affiliation":[{"name":"Pediatric Clinic Centre Hospitalier de Luxembourg  Luxembourg Luxembourg"},{"name":"Faculty of Science, Technology and Medicine University of Luxembourg  Esch\u2010Belval Luxembourg"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Montserrat Castellsague","family":"Perolini","sequence":"additional","affiliation":[{"name":"Division of Tropical and Humanitarian Medicine Geneva University Hospitals  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giacomo","family":"Gastaldi","sequence":"additional","affiliation":[{"name":"Department of Medicine Geneva University Hospitals  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7229-3920","authenticated-orcid":false,"given":"David","family":"Beran","sequence":"additional","affiliation":[{"name":"Faculty of Medicine University of Geneva  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecile","family":"Eigenmann","sequence":"additional","affiliation":[{"name":"Life for a Child Program Diabetes Australia  Glebe New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham David","family":"Ogle","sequence":"additional","affiliation":[{"name":"Life for a Child Program Diabetes Australia  Glebe New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,3,3]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/pedi.13442"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/pedi.12801"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-020-05375-2"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgh-2019-001410"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1210\/endrev\/bnaa015"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.23.8.1137"},{"issue":"12","key":"e_1_2_11_8_1","article-title":"(Ultra\u2010)long\u2010acting insulin analogues for people with type 1 diabetes mellitus","volume":"2019","author":"Hemmingsen B","year":"2019","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0194801"},{"key":"e_1_2_11_10_1","unstructured":"World Health Organization.World Health Organization model list of essential medicines 21st list 2019.2019. 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