Beta Bionics Mint (iLet patch AID)
Beta Bionics
FDA-cleared patch pump and iOS/Android dosing software; full US pharmacy launch targeted for Q1 2027.
What it is
Beta Bionics’ tubeless patch automated insulin delivery system, combining the Mint ACE patch pump (FDA-cleared 11 September 2026 under K260001) with the updated iLet Dosing Decision Software on iOS and Android smartphones (K262763). Full US pharmacy launch is targeted for Q1 2027, with the separate 3D Intelligence multi-target algorithm under FDA review.
Editorial review: .
Most recent recorded citation date: 2026-09-14. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.
- Benefit or performance
- Time in range: Runs the FDA-cleared iLet autonomous dosing algorithm (K262763), which achieved 65% time-in-range in the 13-week NEJM pivotal trial (n=326, up from 54% at baseline) and ~67–71% in commercial real-world cohorts without carb counting.[4]
- Important harms and treatment burden
- Read the safety discussion and original sources. A missing summary does not establish safety.
- Approval and country access
- FDA-cleared ACE patch pump (K260001) and iOS/Android iLet Dosing Decision Software (K262763); full US pharmacy launch targeted for Q1 2027.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 70 × 20 + 78 × 20 + 85 × 10 + 88 × 20 + 70 × 5 + 70 × 5 + 50 × 5 + 42 × 5 = 6730; divide by total weight 90. Unrounded weighted result: 74.77777777777777. (Access & cost is excluded from the weighted score until commercial launch.)
Runs the FDA-cleared iLet autonomous dosing algorithm (K262763), which achieved 65% time-in-range in the 13-week NEJM pivotal trial (n=326, up from 54% at baseline) and ~67–71% in commercial real-world cohorts without carb counting.[4]
The iLet algorithm held time below 54 mg/dL to 0.33% vs 0.35% at baseline in the NEJM pivotal trial; FDA 510(k) K262763 clears the same autonomous dosing engine on iOS and Android paired with the Mint ACE patch pump.[4]
Initialized from body weight alone with zero carb ratios, basal rates, or correction factors — users announce meals only as "Usual for me", "More", or "Less" from the iLet App on iOS or Android.[2]
Fully tubeless two-piece patch pump (2-year reusable controller that never requires recharging + 200-unit 3-day+12h disposable cartridge with a 4.5 mm 90-degree stainless-steel cannula, K260001) controlled entirely from the iLet App on iOS and Android (K262763).[1]
The iLet algorithm reduced HbA1c from 7.9% to 7.3% (adjusted difference −0.5 percentage points, p<0.001) and mean sensor glucose to 164 mg/dL in the NEJM pivotal trial.[4]
Autonomous basal, correction, and meal-adaptation controllers smooth day-to-day glycemic excursions without manual carb counting.[4]
Current iLet Dosing Decision Software (K262763) does not include a dedicated user-settable exercise target; users manage activity with carbs or temporary disconnection, while the separate 3D Intelligence algorithm (under FDA review) proposes selectable target experiences.[2]
K262763 adds independent meal-type reset (allowing Breakfast, Lunch, or Dinner adaptation to be reset individually without wiping all therapy history) and a streamlined single therapy-reset flow; the separate 3D Intelligence algorithm with three clinician-selectable target experiences remains under FDA review.[2]
On the horizon — both the Mint ACE patch pump (K260001) and iOS/Android iLet Dosing Decision Software (K262763) were FDA-cleared on 11 September 2026, with full US commercial launch targeted for Q1 2027 through the pharmacy channel.[3]
AID default: 50% glucose outcomes and low-glucose protection, 40% daily experience, 10% access and cost. Freedom includes tubing, wearability, water-use limits and controller requirements. These are editorial priorities; studies and device generations differ. Check each scorecard for its evidence and limits.
The full picture
Overview
Beta Bionics Mint brings the autonomous, weight-initialized iLet Bionic Pancreas algorithm into a fully tubeless, smartphone-controlled patch pump. On 11 September 2026, the U.S. FDA cleared both the Mint ACE Pump (K260001) and the updated iLet Dosing Decision Software (K262763) running on the iLet App for iOS and Android for people with type 1 diabetes aged 6 years and older.12 Beta Bionics targets full US commercial availability in Q1 2027 through the pharmacy channel.3
What changes versus the tubed iLet
The original iLet Bionic Pancreas is a tubed durable pump whose mobile app is view-only (requiring meal announcements on the pump screen itself). Mint resolves both hardware limitations while keeping the same zero-carb-counting setup:
- Tubeless two-piece patch (
K260001): A reusable durable Controller (expected 2-year service life that never requires recharging) snaps onto a single-use disposable Cartridge housing the battery, pumping mechanism, 200-unit reservoir (20-unit minimum fill), and a 4.5 mm, 90-degree stainless-steel cannula, worn for up to 3 days (72 hours) plus a 12-hour grace period with NovoLog or Kirsty U-100 insulin aspart.1 - Full iOS and Android smartphone control (
K262763): The on-body patch has no screen; initialization, meal announcements ("Usual for me", "More", "Less"), and alerts run directly from the iLet App on compatible iOS and Android phones.2 - Independent meal-type reset (
K262763): Unlike the original iLet software (where resetting learned dosing wiped the entire therapy history),K262763introduces individual meal-type reset, allowing users or clinicians to reset learned meal dosing for Breakfast, Lunch, or Dinner independently, alongside a streamlined single therapy-reset flow.2 - CGM compatibility: Integrates with Dexcom G7, Dexcom G7 15-Day, and FreeStyle Libre 3 Plus.3
Separate 3D Intelligence algorithm submission
Beta Bionics has separately submitted its 3D Intelligence dosing algorithm to the FDA, which is designed to offer three clinician-selectable algorithm experiences (both on the tubed iLet as "iLet 3D" and on Mint as "Mint 3D").3 Because 3D Intelligence remains under FDA review, this record scores the already FDA-cleared K260001 + K262763 Mint system.
Coming soon
ETA · Full US commercialization targeted Q1 2027; 3D Intelligence algorithm under FDA review
- →Full US commercialization of Mint patch AID through the pharmacy channel · Q1 2027 company target
- →FDA review of the separate 3D Intelligence algorithm (three selectable target experiences) · Pending FDA review
Sources
- [1]FDA 510(k) Summary K260001 — Beta Bionics Mint ACE Pump (cleared 11 September 2026) · Regulatory decision · 2026-09-11 — Clears the Mint ACE Pump (21 CFR 880.5730, product code QFG) for ages 6+: two-piece reusable controller (2-year life) + single-use disposable cartridge (up to 3 days + 12-hour grace period, 200 U max / 20 U min fill, 4.5 mm 90-degree stainless-steel cannula, 5.0 U occlusion threshold, NovoLog and Kirsty U-100 insulin aspart).
U.S. Food & Drug Administration. 510(k) Summary K260001 — Beta Bionics Mint ACE Pump (cleared 11 September 2026; 21 CFR 880.5730, product code QFG; ages 6+; 200 U max / 20 U min reservoir; 3-day wear + 12-hour grace period; 2-year reusable controller; 4.5 mm 90-degree stainless-steel cannula; 5.0 U occlusion threshold; NovoLog and Kirsty U-100).
- [2]FDA 510(k) Summary K262763 — Beta Bionics iLet Dosing Decision Software (cleared 11 September 2026) · Regulatory decision · 2026-09-11 — Clears the updated iLet Dosing Decision Software (21 CFR 862.1356, product code QJI) to run on the iLet App for iOS and Android smartphones paired with the Mint ACE Pump, adding individual meal-type reset (Breakfast, Lunch, Dinner) and a single therapy-reset flow.
U.S. Food & Drug Administration. 510(k) Summary K262763 — Beta Bionics iLet Dosing Decision Software (cleared 11 September 2026; 21 CFR 862.1356, product code QJI; ages 6+; runs on iLet App for iOS and Android smartphones paired with Mint ACE Pump; adds individual meal-type reset for Breakfast/Lunch/Dinner and single therapy reset).
- [3]Beta Bionics announces FDA clearance of Mint patch pump and separate 3D Intelligence submission · Manufacturer · 2026-09-14
Beta Bionics. Beta Bionics Announces FDA Clearance of Mint, the Company's Patch Pump, and Separate 510(k) Submission for 3D Intelligence (14 September 2026).
- [4]Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes (NEJM 2022) · Peer-reviewed study · 2022-09-29