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The glucagon-like peptide-1 receptor agonist dulaglutide has been approved for the treatment of type 2 diabetes in paediatrics. In addition, it was recently approved for the treatment of CVDs. Hence, this study aimed to assess the effect of dulaglutide compared with conventional insulin therapy on glycaemic metrics, pancreatic reserve, iron load and dyslipidaemia among adolescents with TDT-induced diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The open-label, parallel-group, randomised-controlled DIADEMA trial took place at the Paediatric Haematology Unit and the Paediatric and Adolescent Diabetes Unit, Paediatrics Hospital, Ain Shams University, Cairo, Egypt. Eligibility criteria were adolescents with TDT-induced diabetes aged 10\u201318 years, uncontrolled on metformin. The 80 participants were randomly assigned based on a computer-generated randomisation sequence to receive either subcutaneous dulaglutide (0.75 mg weekly) or conventional basal-bolus insulin therapy. Participants were followed up for 24 weeks with assessment of fasting blood glucose, HbA\n                      <jats:sub>1c<\/jats:sub>\n                      , fructosamine, fasting C-peptide, continuous glucose monitoring (CGM)-derived metrics, haemolysis markers, serum ferritin and lipid profile. The primary efficacy endpoint was the change in the CV as an index for glycaemic variability from baseline to week 24. People assessing the outcomes were masked (blind) to group assignment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Both groups were similar as regards baseline clinico-laboratory characteristics (\n                      <jats:italic>p<\/jats:italic>\n                      &gt;0.05). After 24 weeks, dulaglutide resulted in a significant decrease in CV (from 39.45\u00a0\u00b1\u00a03.97% to 35.05\u00a0\u00b1\u00a04.30%;\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.001), time above range, fasting blood glucose, HbA\n                      <jats:sub>1c<\/jats:sub>\n                      , fructosamine, total cholesterol and serum ferritin, with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.05). Although the glucose management indicator decreased in the insulin group after 24 weeks compared with baseline, the CV (from 39.85\u00a0\u00b1\u00a04.99% to 43.26\u00a0\u00b1\u00a05.75%;\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.001) and time above range were significantly increased (\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.001). The estimated standardised effect size for the between-group difference in the CV was 1.69 (95% CI 1.16, 2.22). No serious adverse event was reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\/interpretation<\/jats:title>\n                    <jats:p>The glucagon-like peptide-1 receptor agonist dulaglutide therapy was associated with greater improvements in glycaemic control and variability compared with insulin among adolescents with TDT-induced diabetes, without risk of hypoglycaemia or compromising safety. Moreover, dulaglutide might have a beneficial effect on iron overload, insulin secretion and lipid profile. These findings are exploratory and clinically provocative, warranting further investigation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Funding<\/jats:title>\n                    <jats:p>This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT07370922.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00125-026-06835-x","type":"journal-article","created":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T17:15:00Z","timestamp":1787159700000},"page":"3210-3220","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Dulaglutide vs insulin in adolescents with thalassaemia-induced diabetes: effect on metabolism and atherogenesis (DIADEMA)"],"prefix":"10.1007","volume":"69","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2309-9771","authenticated-orcid":false,"given":"Amira Abdel Moneam","family":"Adly","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1162-0171","authenticated-orcid":false,"given":"Eman Abdel Rahman","family":"Ismail","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed Salah Eldin Mohamed","family":"Abdel Kader","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manar Reda","family":"Sadeq","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6507-8835","authenticated-orcid":false,"given":"Nouran Yousef","family":"Salah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,8,19]]},"reference":[{"issue":"8","key":"6835_CR1","doi-asserted-by":"publisher","first-page":"e732","DOI":"10.1097\/HS9.0000000000000732","volume":"6","author":"D Farmakis","year":"2022","unstructured":"Farmakis D, Porter J, Taher A, Domenica Cappellini M, Angastiniotis M, Eleftheriou A (2022) Thalassaemia International Federation guidelines for the management of transfusion-dependent thalassemia. 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Access will be granted to qualified researchers to address research questions that are consistent with the scope of the original study and meet ethical and legal requirements.","order":1,"name":"Ethics","label":"Data availability","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).","order":2,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"The authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.","order":3,"name":"Ethics","label":"Authors\u2019 relationships and activities","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"AAA, EAI, MSA, MRS and NYS contributed equally to conceptualisation, study design, data collection, analysis and drafting of the manuscript. All authors have read and approved the final manuscript. NYS is responsible for the integrity of the work as a whole.","order":4,"name":"Ethics","label":"Contribution statement","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"The study protocol was approved by the Ethical Committee of Ain Shams University (approval number FMASU MS 794\/2024), and written informed consent was obtained from all participants and their legal guardians before participation.","order":5,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"No generative AI was used in the manuscript preparation.","order":6,"name":"Ethics","label":"Declaration of generative AI and AI-assisted technologies in the manuscript preparation process","group":{"name":"EthicsHeading","label":"Ethics"}}]}}