Summary
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1 Sample Definition And Size
The study retrospectively analyzed the first 600 patients with type 2 diabetes using insulin (via pens or syringes) who were prescribed the AI-driven d‑Nav insulin titration program at a community-based endocrinology center in Greenville, North Carolina, USA. The cohort had a mean age of 67.1 ± 11.5 years, mean diabetes duration of 19.8 ± 11.0 years, and mean duration on insulin of 11.9 ± 10.0 years. Retention was 82%, with withdrawals occurring at a mean of 4.8 ± 3.1 months. The study also included a comparison group of 1,103 insulin-using patients not on d‑Nav for baseline demographic comparison.
2 Study Type
This was a retrospective, real‑world observational implementation study (clinical implementation report) of an AI‑driven autonomous insulin titration program, using de‑identified data collected during routine clinical care between October 2022 and September 2023.
3 Conflicts Of Interest
I.H. is cofounder and medical director of Hygieia PC.; E.B. is cofounder and CEO of Hygieia, Inc.; M.W. and M.H. are part of an institutional partnership with Hygieia PC.; R.M.B. has received research support, consulting fees, or advisory board roles from multiple diabetes‑related companies including Hygieia. The study was funded by Hygieia, Inc.
4 Results Summary
Patients used d‑Nav for 8.2 ± 3.0 months. Baseline HbA1c was 8.6% ± 2.1%, with 29.3% having HbA1c > 9%. After 6 months, HbA1c decreased to 7.3% ± 1.2% (P < 0.0001), with only 5.7% > 9%. During the first 3 months, total daily insulin dose decreased in 21% of patients to reduce hypoglycemia risk; overall insulin dose increased by 60.6% from 69.3 to 111.3 units, particularly in those with baseline weekly mean glucose >150 mg/dL. Hypoglycemia (<54 mg/dL) occurred at 0.4 ± 0.6 events/month; severe hypoglycemia occurred at 1.7 events per 100 patient‑years. In a CGM subgroup (n=80), time‑in‑range improved from 47.7% ± 25.5% pre‑d‑Nav to 65.4% ± 17.1% on d‑Nav (P = 0.003). Patient satisfaction was high (mean score 3.8/4).