{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T15:00:35Z","timestamp":1785942035902,"version":"3.56.0"},"reference-count":32,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T00:00:00Z","timestamp":1785715200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100003710","name":"Korea Health Industry Development Institute","doi-asserted-by":"publisher","award":["HR21C0885"],"award-info":[{"award-number":["HR21C0885"]}],"id":[{"id":"10.13039\/501100003710","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Diabetes Sci Technol"],"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>We evaluated whether the frequency of algorithm-generated coaching events, a decision support system (DSS) integrated with a smart insulin pen (SIP), differed according to glycemic outcomes, thereby establishing the algorithmic foundation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This retrospective analysis evaluated continuous glucose monitoring (CGM) and SIP data from a 12-week randomized controlled trial (NCT06406439) involving individuals with diabetes managed with multiple daily injections (MDI). A total of 338 biweekly CGM profiles from 58 participants were analyzed. For each 14-day period, the coaching event frequency was calculated across 9 predefined coaching categories.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Frequencies of hyperglycemia-related coaching (time in range [TIR]: 18.8 vs 34.8; time above range [TAR\u2009&gt;\u2009180\u2009mg\/dL]: 18.3 vs 33.8) and missed bolus events (TIR: 7.6 vs 11.2; TAR: 7.0 vs 11.1) were significantly higher in profiles not meeting hyperglycemia-related CGM targets (all\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u2009.001). Both coaching categories demonstrated good discrimination for TIR and TAR target achievement (all area under the curve [AUC]\u2009&gt;\u20090.7). Frequency of missed basal detection also showed significant associations with achievement of TIR and TAR targets (all\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u2009.05). The hypoglycemia coaching group effectively discriminated the absence of nocturnal time below range &lt;54\u2009mg\/dL (AUC\u2009=\u20090.740). Basal insulin titration coaching frequencies were associated with nocturnal mean glucose changes (all\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u2009.005). Real-time insulin and correction factor reduction recommendations were independently associated with deterioration in TIR and TAR metrics (all\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u2009.05).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>The frequency of algorithm-based coaching events served as a robust indicator of glycemic control. These findings validate Stage 5 SIP-integrated DSS and suggest its potential utility in identifying unresolved glycemic issues in individuals treated with MDI.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/19322968261471490","type":"journal-article","created":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T11:27:28Z","timestamp":1785756448000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Retrospective Validation of a Stage 5 Decision Support Algorithm Using Clinical Trial Data From Stage 4 Smart Insulin Pens"],"prefix":"10.1177","author":[{"given":"Jee Hee","family":"Yoo","sequence":"first","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine, Chung-Ang University Gwangmyeong Hospital, Chung-Ang University College of Medicine, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seohyun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences &amp; Technology, Sungkyunkwan University, Seoul, Republic of Korea"},{"name":"Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Younghoon","family":"Kim","sequence":"additional","affiliation":[{"name":"Glucometrics Inc., Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang-Man","family":"Jin","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5001-963X","authenticated-orcid":false,"given":"Jae Hyeon","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences &amp; Technology, Sungkyunkwan University, Seoul, Republic of Korea"},{"name":"Glucometrics Inc., Seoul, Republic of Korea"},{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,8,3]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.4093\/dmj.2022.0271"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2020.0618"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2018.0384"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc22-1915"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2024.0586"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2415948"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.26353"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.4093\/dmj.2024.0804"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2025.0129"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.4093\/dmj.2022.0346"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1210\/endrev\/bnac022"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2021.0196"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2021.0262"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc26-S007"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.19975"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.7444"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1177\/19322968241306136"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2022.109209"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2019.0411"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.4093\/dmj.2025.0112"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.2337\/cd22-0068"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1177\/19322968241274796"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1177\/1932296820984490"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.3803\/EnM.2025.2579"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.1111\/dme.13142"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2022.0252"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc23-2176"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1177\/19322968221104142"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-025-63671-0"},{"key":"e_1_3_3_31_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.8910"},{"key":"e_1_3_3_32_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc21-0838"},{"key":"e_1_3_3_33_2","doi-asserted-by":"publisher","DOI":"10.1111\/dom.16249"}],"container-title":["Journal 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