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Glycemic and safety outcomes of the insulin-only bionic pancreas in older adults and individuals with impaired awareness of Hypoglycemia: a post hoc analysis of a randomized pivotal trial.

Puguh Oktavian·Citrawati Dyah Kencono Wungu·Indah Mohd Amin·Sony Wibisono Mudjanarko
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Abstract

AIMS: Evaluate the efficacy and safety of iLet Bionic Pancreas (BP) in older adults and individuals with impaired awareness of hypoglycemia (IAH). METHODS: This post hoc analysis used individual participant-level data from the Insulin-Only Bionic Pancreas Pivotal Trial (n = 440; NCT04200313). Eligible participants (n = 96) with type 1 diabetes, aged ≥ 60 years and/or had IAH (Clarke score ≥ 4), were randomized to BP with aspart/lispro (BP-Asp/Lis; n = 45), BP with fast-acting aspart configuration (BP-Fiasp; n = 31), or standard care (SC; n = 20) for 13 weeks. RESULTS: Compared with SC, time-in-range (70-180 mg/dL) significantly increased by 7.49 % (95 % CI: 2.61 to 12.38; ∼1.8 h/day) with BP-Asp/Lis and by 8.28 % (95 % CI: 3.15 to 13.41; ∼2.0 h/day) with BP-Fiasp, driven by reduced hyperglycemia. No significant differences were observed in hypoglycemia exposure. Severe hypoglycemia occurred in four participants (four events) on BP-Asp/Lis and one participant (two events) on SC. One diabetic ketoacidosis event occurred on BP-Fiasp due to an infusion set failure. CONCLUSIONS: In high-risk, clinically vulnerable populations, the BP system significantly improved glycemic control while maintaining safety parity with respect to hypoglycemia risk, providing a resilient therapeutic alternative for vulnerable cohorts.

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HumansHypoglycemiaFemaleMaleAgedDiabetes Mellitus, Type 1Middle AgedBlood GlucoseInsulinHypoglycemic AgentsPancreas, ArtificialAwarenessInsulin Infusion SystemsClosed-loopDiabetesFrailHigh-riskHypoglycemia unawarenessOlderJournal ArticleRandomized Controlled Trial

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Puguh Oktavian, Citrawati Dyah Kencono Wungu, Indah Mohd Amin, Sony Wibisono Mudjanarko. 2026-08-30. Glycemic and safety outcomes of the insulin-only bionic pancreas in older adults and individuals with impaired awareness of Hypoglycemia: a post hoc analysis of a randomized pivotal trial.. https://doi.org/10.1016/j.diabres.2026.113542

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Journal Article; Randomized Controlled Trial resourceAged subjectBlood Glucose subjectDiabetes subjectFemale subjectHumans subjectJournal Article subjectMale subjectMiddle Aged subjectRandomized controlled trials study

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