> At a Glance
> – PreEvnt Isaac reads blood-sugar-related biomarkers in a single breath
> – Indiana University trials pit the disc against standard finger-stick and CGM readings
> – FDA “de novo” review slated for later this year
> – Why it matters: Millions of diabetics-especially kids and seniors-could ditch painful daily finger pricks
A gadget no bigger than a quarter stole attention at CES 2026 by doing what Apple still hasn’t achieved: measuring glucose without breaking the skin. The PreEvnt Isaac detects volatile organic compounds-acetone in particular-on your breath and links rising levels to blood-glucose events.
How the Isaac Works
Users blow onto the disc; internal sensors log volatile compounds and the companion app converts the data into a glucose-style reading. A necklace loop keeps the device within reach for toddlers or adults who struggle with traditional kits.
- Sample type: Exhaled breath
- Size: Approximately one U.S. quarter
- Connectivity: Bluetooth to iOS/Android app
- Extra: Emergency-contact alerts for low-sugar episodes
Clinical Path & FDA Timeline
After a 2025 CES preview, Indiana University began head-to-head trials comparing Isaac readings against finger sticks and continuous glucose monitors. Adolescents with type 1 diabetes enrolled first; adults with type 2 followed. Data collected this year will feed a de novo FDA submission intended for 2026 review.
Fredrick Brooks, PreEvnt’s director of health technologies, said:
> “This is a de novo application, so we’re educating the FDA as we’re working with them. They’ve been very interested and understanding.”
Current App Features (Beta)
| Feature | Status |
|---|---|
| Real-time breath analysis | Functional |
| Glucose-style numeric | Functional |
| Emergency contact alert | Functional |
| Food logging timeline | Final-stage dev |
Market Context
Wearables long ago mastered step counts, sleep stages, even atrial-fibrillation alerts, but optical or electrochemical glucose without needles remains elusive. Apple, Garmin, Oura and others continue internal R&D; meanwhile GLP-1-fuelled interest has pushed non-diabetic consumers toward CGMs for weight management. Isaac keeps the focus on medical necessity first-quality-of-life gains for people who must track glucose every few hours.
Key Takeaways
- First public demo of a consumer-friendly, breath-based glucose tracker happened at CES 2026
- Indiana University study could pave the way for FDA clearance under the agency’s de novo pathway later this year
- If approved, the Isaac would offer a painless alternative for children and elderly patients who find skin-penetrating sensors difficult or distressing
After years of vaporware promises from tech giants, a pocketable disc may finally deliver the needle-free future diabetics have been waiting for.
