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
In brief
Bionic pancreas adds roughly two extra hours of target glucose per day
In a post-hoc analysis of 96 type 1 diabetes participants aged 60 or older or with impaired hypoglycemia awareness, the iLet bionic pancreas increased time-in-range by about 7.5-8% (≈1.8-2 hours daily) versus standard care, without raising overall hypoglycemia risk. Severe hypoglycemia was rare and safety was comparable, suggesting the device may be a viable option for high-risk, vulnerable patients.
- Journal
- Diabetes research and clinical practice (Q1)
- Published
- 30 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Puguh Oktavian, Citrawati Dyah Kencono Wungu, Indah Mohd Amin, Sony Wibisono Mudjanarko
- PMID
- 42669381
- DOI
- 10.1016/j.diabres.2026.113542
Why clinicians should know about it
- Picked for Internal Medicine (top studies of the week, 6 September 2026): Bionic pancreas improves glycemic control in vulnerable adults
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.