{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T09:33:03Z","timestamp":1792056783324,"version":"4.4.0"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T00:00:00Z","timestamp":1766102400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Endocrinol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>This study evaluated 6-month effectiveness and safety of automated insulin delivery (AID) in comparison with multiple daily injections (MDI) in pediatric and adult type 1 diabetes (T1D).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>Individuals with T1D, aged 2\u201380 years, were enrolled across 32 international centers (in the United States, Europe, Canada, and New Zealand) and randomized 1:1 to AID intervention (MiniMed\u2122 670G or 770G system) or MDI with or without continuous glucose monitoring. Primary endpoints were change in mean HbA1c for participants with a baseline HbA1c &amp;gt;8.0% (Group 1) and percentage of time spent below 70 mg\/dL (%TBR &amp;lt;70 mg\/dL [&amp;lt;3.9 mmol\/L]) for participants with baseline HbA1c \u22648.0% (Group 2), to show superiority of AID intervention versus MDI. Safety endpoints including rates of severe hypoglycemia and diabetic ketoacidosis (DKA), and difference in diabetes treatment satisfaction score were assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>For Group 1, N = 56 participants (aged 29.4 \u00b1 17.0 years) were randomized to AID intervention and N = 54 participants (aged 36.8 \u00b1 19.6 years) were randomized to MDI. For Group 2, N = 73 (aged 37.4 \u00b1 21.0 years) and N = 69 (aged 39.2 \u00b1 19.3 years), respectively, were randomized to AID and MDI. Change in HbA1c (mean [95% CI] difference of \u22120.7% [\u22121.1, \u22120.3], P = 0.0002) and difference in %TBR &amp;lt;70 mg\/dL (4.8% [\u22126.4, \u22123.1], P&amp;lt;0.001) favored AID intervention versus MDI. Rates of severe hypoglycemia (AID: 1.82\/100 patient-years) and DKA (MDI: 3.52\/100 patient-years) were low and met preestablished success criteria for safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This large, international, multicenter randomized controlled trial demonstrates safety of the MiniMed\u2122 670G\/770G systems. AID significantly improved HbA1c and time spent in hypoglycemia when compared with MDI, in both youth and adults living with T1D.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:related-object>\n                      <jats:ext-link>https:\/\/clinicaltrials.gov\/<\/jats:ext-link>\n                      , identifier NCT02748018.\n                    <\/jats:related-object>\n                  <\/jats:sec>","DOI":"10.3389\/fendo.2025.1716587","type":"journal-article","created":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T12:12:01Z","timestamp":1766146321000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["Automated basal insulin delivery versus multiple daily injections in type 1 diabetes: results from a randomized parallel controlled trial"],"prefix":"10.3389","volume":"16","author":[{"given":"Johan H.","family":"Jendle","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satish K.","family":"Garg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Thivolet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth S.","family":"Weinstock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irl B.","family":"Hirsch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Evans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kurt J.","family":"Griffin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Athena","family":"Philis-Tsimikas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin J.","family":"Wheeler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark\u00a0S.","family":"Kipnes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders L.","family":"Carlson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce A.","family":"Buckingham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anuj","family":"Bhargava","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce W.","family":"Bode","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret L.","family":"Lawson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy B.","family":"Criego","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet B.","family":"McGill","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John \u201cChip\u201d H.","family":"Reed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gnanagurudasan","family":"Prakasam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Grunberger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Girelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Asunci\u00f3n","family":"Martinez-Brocca","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark P.","family":"Christiansen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin I.","family":"de Bock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yogish C.","family":"Kudva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott W.","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Yovanovich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John J.","family":"Shin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toni L.","family":"Cordero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer J. F.","family":"McVean","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Vigersky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,12,19]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1159\/000543266","article-title":"International Society for Pediatric and Adolescent Diabetes clinical practice consensus guidelines 2024: glycemic targets","volume":"97","author":"de Bock","year":"2024","journal-title":"Horm Res Paediatr"},{"key":"B2","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1007\/s00125-022-05744-z","article-title":"Automated insulin delivery: benefits, challenges, and recommendations. A consensus report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association","volume":"66","author":"Sherr","year":"2023","journal-title":"Diabetologia"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-023-01394-5","article-title":"A systematic review of commercial hybrid closed-loop automated insulin delivery systems","volume":"14","author":"Peacock","year":"2023","journal-title":"Diabetes Ther"},{"key":"B4","doi-asserted-by":"publisher","first-page":"783","DOI":"10.3390\/life13030783","article-title":"Automated insulin delivery (AID) systems: use and efficacy in children and adults with type 1 diabetes and other forms of diabetes in Europe in early 2023","volume":"13","author":"Bassi","year":"2023","journal-title":"Life"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1136\/bmjdrc-2021-002633","article-title":"HbA1c, and less hypoglycemia in closed-loop insulin system in patients with type 1 diabetes: A meta-analysis","volume":"10","author":"Jiao","year":"2022","journal-title":"BMJ Open Diabetes Res Care"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1089\/dia.2022.0421","article-title":"Improved glycemia with hybrid closed-loop versus continuous subcutaneous insulin infusion therapy: results from a randomized controlled trial","volume":"25","author":"Garg","year":"2023","journal-title":"Diabetes Technol Ther"},{"key":"B7","doi-asserted-by":"publisher","first-page":"750","DOI":"10.1016\/j.jcjd.2021.02.006","article-title":"Real-world patient experience of long-term hybrid closed-loop insulin pump use","volume":"45","author":"Wang","year":"2021","journal-title":"Can J Diabetes"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.2337\/dc20-1447","article-title":"Six months of hybrid closed-loop versus manual insulin delivery with fingerprick blood glucose monitoring in adults with type 1 diabetes: A randomized, controlled trial","volume":"43","author":"McAuley","year":"2020","journal-title":"Diabetes Care"},{"key":"B9","doi-asserted-by":"publisher","first-page":"66","DOI":"10.1089\/dia.2023.0438","article-title":"The health economics of automated insulin delivery systems and the potential use of time in range in diabetes modeling: A narrative review","volume":"26","author":"Mathieu","year":"2024","journal-title":"Diabetes Technol Ther"},{"key":"B10","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1089\/dia.2023.0364","article-title":"Two years with a tubeless automated insulin delivery system: A single-arm multicenter trial in children, adolescents, and adults with type 1 diabetes","volume":"26","author":"Criego","year":"2024","journal-title":"Diabetes Technol Ther"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1002853","article-title":"Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes","volume":"363","author":"Bergenstal","year":"2010","journal-title":"N Engl J Med"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2008.0068","article-title":"Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study","volume":"10","author":"Hirsch","year":"2008","journal-title":"Diabetes Technol Ther"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.2337\/dc09-0750","article-title":"Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the realTrend study","volume":"32","author":"Raccah","year":"2009","journal-title":"Diabetes Care"},{"key":"B14","doi-asserted-by":"publisher","first-page":"CD008101","DOI":"10.1002\/14651858.CD008101.pub2","article-title":"Continuous glucose monitoring systems for type 1 diabetes mellitus","volume":"1","author":"Langendam","year":"2012","journal-title":"Cochrane Database Syst Rev"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2025.1563410","article-title":"Fear of hypoglycemia is linked to poorer glycemic control and reduced quality of life in adults with type 1 diabetes","volume":"16","author":"Mesa D\u00edaz","year":"2025","journal-title":"Front Endocrinol"},{"key":"B16","doi-asserted-by":"publisher","first-page":"19322968241290259","DOI":"10.1177\/19322968241290259","article-title":"Twelve-month real-world use of an advanced hybrid closed-loop system versus previous therapy in a Dutch center for specialized type 1 diabetes care","author":"Dekker","year":"2024","journal-title":"J Diabetes Sci Technol"},{"key":"B17","doi-asserted-by":"publisher","DOI":"10.1111\/dom.15023","article-title":"Real-world performance of the MiniMed 780G advanced hybrid closed loop system in latin america: substantial improvement in glycaemic control with each technology iteration of the MiniMed automated insulin delivery system","volume":"25","author":"Grassi","year":"2023","journal-title":"Diabetes Obes Metab"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2019.0400","article-title":"Prospective analysis of the impact of commercialized hybrid closed-loop system on glycemic control, glycemic variability, and patient-related outcomes in children and adults: A focus on superiority over predictive low-glucose suspend technology","volume":"22","author":"Beato-V\u00edbora","year":"2020","journal-title":"Diabetes Technol Ther"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.1007\/s00592-021-01789-5","article-title":"Improved satisfaction and sleep quality with Medtronic MiniMed\u00ae Advanced hybrid closed-loop delivery compared to predictive low glucose suspend in people with type 1 diabetes in a randomized crossover trial","volume":"59","author":"Wheeler","year":"2022","journal-title":"Acta Diabetol"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2021.0319","article-title":"Safety and glycemic outcomes during the MiniMedTM advanced hybrid closed-loop system pivotal trial in adolescents and adults with type 1 diabetes","volume":"24","author":"Carlson","year":"2022","journal-title":"Diabetes Technol Ther"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2023.0255","article-title":"Safety and glycemic outcomes during the MiniMedTM advanced hybrid closed-loop system pivotal trial in children and adolescents with type 1 diabetes","volume":"25","author":"Pihoker","year":"2023","journal-title":"Diabetes Technol Ther"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(22)00212-1","article-title":"Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): A randomised controlled study","volume":"10","author":"Choudhary","year":"2022","journal-title":"Lancet Diabetes Endocrinol"},{"key":"B23","doi-asserted-by":"publisher","DOI":"10.1111\/jns.70026","article-title":"Advanced hybrid closed-loop insulin delivery is associated with improved glycemic indicators and normalization of small nerve fibre structure in adults with type 1 diabetes","volume":"30","author":"Gad","year":"2025","journal-title":"J Peripher Nerv Syst JPNS"},{"key":"B24","doi-asserted-by":"publisher","first-page":"395","DOI":"10.1089\/dia.2024.0522","article-title":"Glycemic control across the menstrual cycle in women with type 1 diabetes using the MiniMed 780G advanced hybrid closed-loop system: the 780MENS prospective study","volume":"27","author":"Monroy","year":"2025","journal-title":"Diabetes Technol Ther"},{"key":"B25","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-025-01698-8","article-title":"Advanced hybrid closed loop algorithm use in type 1 diabetes: the french MiniMedTM glycemic control and quality of life study","volume":"16","author":"Kessler","year":"2025","journal-title":"Diabetes Ther Res Treat Educ Diabetes Relat Disord"},{"key":"B26","doi-asserted-by":"publisher","first-page":"17","DOI":"10.1089\/dia.2023.0446","article-title":"A peek under the hood: explaining the MiniMedTM 780G algorithm with meal detection technology","volume":"26","author":"Grosman","year":"2024","journal-title":"Diabetes Technol Ther"},{"key":"B27","unstructured":"National Diabetes Statistics Report\n          \n          \n          \n          2025"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-1770","article-title":"Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin HbA1c levels in T1D exchange clinic registry participants","volume":"36","author":"Miller","year":"2013","journal-title":"Diabetes Care"},{"key":"B29","doi-asserted-by":"publisher","first-page":"66","DOI":"10.1089\/dia.2018.0384","article-title":"State of type 1 diabetes management and outcomes from the T1D exchange in 2016-2018","volume":"21","author":"Foster","year":"2019","journal-title":"Diabetes Technol Ther"}],"container-title":["Frontiers in Endocrinology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fendo.2025.1716587\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T12:12:03Z","timestamp":1766146323000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fendo.2025.1716587\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,19]]},"references-count":29,"alternative-id":["10.3389\/fendo.2025.1716587"],"URL":"https:\/\/doi.org\/10.3389\/fendo.2025.1716587","relation":{},"ISSN":["1664-2392"],"issn-type":[{"value":"1664-2392","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,19]]},"article-number":"1716587"}}