{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T20:05:20Z","timestamp":1793045120900,"version":"4.5.0"},"reference-count":28,"publisher":"American Medical Association (AMA)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n There is a need for additional treatment options for people with type 2 diabetes treated with insulin. Given the limited data on the use of automated insulin delivery (AID) systems in type 2 diabetes, studies evaluating their safety and efficacy are important.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n \n To evaluate the association of AID with hemoglobin A\n 1c<\/jats:sub>\n (HbA\n 1c<\/jats:sub>\n ) levels in a diverse cohort of adults with type 2 diabetes.\n <\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This single-arm prospective trial was conducted at 21 clinical centers in the United States among individuals aged 18 to 75 years with type 2 diabetes who had been using insulin for at least 3 months prior to screening. Participants with AID system use were excluded. The study started with a 14-day standard therapy phase, followed by 13 weeks of treatment with the investigational device. The first participant was enrolled April 11, 2023, and the last participant follow-up visit was February 29, 2024.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Participants used the Omnipod 5 AID System for 13 weeks following the 14-day standard therapy phase.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n \n Primary outcome was change in HbA\n 1c<\/jats:sub>\n level at 13 weeks, tested sequentially for noninferiority (0.3% margin) and superiority, compared with baseline.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Among 305 participants (mean [SD] age, 57 [11] years; 175 [57%] female; 72 [24%] Black, 66 [22%] Hispanic or Latino, and 153 [50%] White), 289 (95%) completed the trial. At baseline, 223 (73%) were using multiple daily injections, 63 (21%) were using basal insulin without bolus, 17 (6%) were using an insulin pump, 188 (62%) were using continuous glucose monitoring, 168 (55%) were using glucagon-like peptide-1 receptor agonists (GLP-1RAs), and 134 (44%) were using sodium-glucose transport protein 2 inhibitors (SGLT-2is). Following AID use, HbA\n 1c<\/jats:sub>\n levels decreased from a mean (SD) of 8.2% (1.3) at baseline to 7.4% (0.9) at 13 weeks (mean difference, \u22120.8 [95% CI, \u22121.0 to \u22120.7] percentage points;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001 for noninferiority and superiority). Improvement was seen across various subgroups (age, sex, race and ethnicity, insurance), and notably with or without use of GLP-1RAs or SGLT-2is and regardless of pretrial mealtime insulin regimen. Time in target glucose range (70-180 mg\/dL) increased from a mean (SD) of 45% (25) to 66% (17) (mean difference, 20 [95% CI, 18 to 22] percentage points;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Percentage of time in hypoglycemic ranges of less than 54 mg\/dL and less than 70 mg\/dL was noninferior compared with standard therapy. There was 1 episode of severe hypoglycemia and none of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n \n In this nonrandomized clinical trial, HbA\n 1c<\/jats:sub>\n levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation, suggesting that AID may be a beneficial and safe option for people with type 2 diabetes using insulin.\n <\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05815342<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.59348","type":"journal-article","created":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T11:31:33Z","timestamp":1739532693000},"page":"e2459348","source":"Crossref","is-referenced-by-count":49,"title":["Automated Insulin Delivery in Adults With Type 2 Diabetes"],"prefix":"10.1001","volume":"8","author":[{"given":"Francisco 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Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lori M.","family":"Laffel","sequence":"additional","affiliation":[{"name":"Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulio R.","family":"Romeo","sequence":"additional","affiliation":[{"name":"Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Mathew","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine, Bronx, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristin N.","family":"Castorino","sequence":"additional","affiliation":[{"name":"Sansum Diabetes Research Institute, Santa Barbara, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davida F.","family":"Kruger","sequence":"additional","affiliation":[{"name":"Henry Ford Health, Detroit, 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