Beta Bionics 2026 Update

A look at the company's dramatic share price drop, iLet patient numbers, CGM partnership with Abbott & the outlook for rollout in the UK/EU.

Image courtesy of Beta Bionics

Beta Bionics, maker of the iLet® Bionic Pancreas, has experienced a turbulent start to 2026 as its share price slid amid concerns over lower than expected numbers of new-starts and patient-reported safety patterns raising questions.

iLet user base & new patient starts

Adoption data from Beta Bionics show rapid early growth in its user base — a key indicator of future recurring sensor and pump consumables revenue:

By Q1 2025, Beta Bionics reported approximately 19,151 installed iLet users, a steep increase from about 4,901 installed users the prior year.
Quarterly new patient starts throughout 2025 steadily climbed: ~3,853 in Q1, ~4,934 in Q2, and ~5,334 in Q3, reflecting ongoing market interest.
According to industry reporting, by mid-2025 the iLet had reportedly reached >24,000 users, including a notable percentage of users with type 2 diabetes.

However, commentary from early 2026 noted that most recent new starts came in below expectations, contributing to Beta Bionics’ share price pressure as investors adjusted growth assumptions.

Investor unease

In January 2026, Beta Bionics’ share price dramatically dropped:

Shares fell more than 35 % in early January after the company reported that its key growth metric — new patient starts — came in below analyst forecasts, even though preliminary revenue results beat expectations.
Other reports show share price declines in the 30 – 43 % range in mid-January as markets reacted to slower expansion and broader market scrutiny.

The plunge has underscored investor concerns about Beta Bionics’ short-term growth trajectory and its ability to scale the business fast enough to justify prior valuations.

Legal and Analyst Pressure

Following the stock drop, law firms have launched investigations into whether the company adequately disclosed information about its patient start forecasts and other disclosures, reflecting rising legal risks for the company.
Analysts have responded to the softer leading indicators with downgrades and more cautious outlooks, citing valuation pressures and execution risks ahead of the company’s Q4 and full-year 2025 results.

Beta Bionics is due to release its fourth-quarter and full-year 2025 financial results on 17 February 2026, giving investors a clearer look at performance trends and guidance for the year ahead.

FreeStyle Libre CGM integration plan

One of Beta Bionics’ strategic product expansion goals has been to broaden the array of CGMs that can feed glucose data into the iLet system — increasing user choice and market appeal:

FreeStyle Libre 3 Plus CGM integration: Beta Bionics partnered with Abbott to integrate the FreeStyle Libre 3 Plus sensor with the iLet Bionic Pancreas. This integration was planned to launch in late 2024 and, once enabled via software/firmware updates, made iLet the first automated insulin delivery (AID) system in the U.S. capable of using the Libre 3 Plus.
The FreeStyle Libre 3 Plus sensor is now officially supported on iLet alongside the system’s existing compatibility with Dexcom G6 and G7 CGMs, giving users more choice for continuous glucose input.
Beta Bionics offers both software updates and app guidance to switch an iLet’s paired CGM to the FreeStyle Libre 3 Plus sensor when desired.
It’s important to note that the iLet currently supports only the FreeStyle Libre 3 Plus (and not earlier Libre 2/3 sensors) for CGM linkage; Abbott’s integration approvals are sensor-specific.

This collaboration with Abbott represents a meaningful step toward sensor flexibility for iLet users, especially in markets like the U.S. where multiple CGM options are widely prescribed.

Real-world signals & safety patterns

Independent trackers of FDA MAUDE data and patient narratives have pointed to a detectable pattern of reports featuring severe hypoglycaemia signals among some iLet users — a surveillance signal, not formal incidence data but something many in the diabetes tech community are watching closely alongside adoption metrics.

Plans for UK & Europe

Current Status

As of early 2026, the iLet Bionic Pancreas is commercially available only in the United States; it is not yet approved for use in the United Kingdom or EU markets.

Regulatory pathways — notably review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and CE/UKCA marking for Europe — are prerequisites for future launch, but no firm timelines have yet been confirmed.

Market Interest

Beta Bionics has signalled interest in pursuing approvals outside the U.S., including the UK, but these remain in development with timing uncertain. Access and reimbursement landscapes, particularly within NHS systems, will also shape the pace of uptake once approvals occur.

Beta Bionic's plans for 2026 & beyond

Beta Bionics entered 2026 with several strategic priorities:

🚀 Boost new patient starts — accelerating adoption to support long-term revenue expectations.

📈 Expand CGM choice — the FreeStyle Libre 3 Plus integration was designed to widen iLet’s appeal.

📊 Enhance algorithms & usability — ongoing updates to improve performance, reduce variability, and streamline onboarding.

🌍 Regulatory expansion — clear pathways toward UK/EU availability to broaden the addressable market.

🔬 Long-term innovation — work toward dual-hormone (insulin + glucagon) systems and other next-generation technologies continues to be part of Beta Bionics’ R&D narrative.

Mint– A Tubeless Patch Pump in Development

Beta Bionics is actively developing a new tubeless insulin delivery device known as Mint. This represents a significant expansion of its product range, beyond the traditional tubed iLet pump and will positions Beta Bionics to compete more directly in the patch pump segment with others such as Omnipod.

What’s known about Mint:

Form factor: A semi-reusable tubeless patch pump with a two-part design — a reusable controller module and a disposable insulin pod — similar in concept to Insulet’s Omnipod series but with Beta Bionics’ design logic.
Wear time & insulin capacity: Designed for 3-day wear with a 12-hour grace period and a 200-unit insulin reservoir, matching key expectations for a competitive patch pump.
Control & connectivity: Will be controlled via smartphone (iOS and Android) and not require a phone to perform site changes, eliminating Bluetooth re-pairing during pod swaps.
CGM support: Mint is expected to support both Dexcom G7 and FreeStyle Libre 3 Plus sensors at launch, aligning with Beta Bionics’ interoperable CGM approach.
Timeline: Analysts and company discussions have pointed to a potential commercial launch by late 2027, pending regulatory clearance.

The current picture

Beta Bionics has lots of potential to offer in terms of products for diabetes management, particularly for hybrid closed loop (ie. AID) with adaptive automation and expanding CGM compatibility. The addition of FreeStyle Libre 3 Plus sensor support is a notable advancement toward user choice (albeit not yet in the UK or Europe), but it for now it seems uncertain how investor sentiment, user patterns and safety concerns, together with regulatory progress will impact the company’s plans.

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Disclaimer

Blogs and publications on this website are independent of any involvement by medtech companies or diabetes related charities. To ensure there is no bias, we do not accept any products, freebies or other material from any medtech provider. Except where credited otherwise, all materials are copyright ©️What CGM.

What CGM is not associated or affiliated with Abbott or FreeStyle Libre. Content here and on our websitewww.whatcgm.com does not constitute medical advice or replace the relationship between you and healthcare professionals nor the advice you receive from them.

The author of this blog has type 1 diabetes and uses a CGM on NHS prescription.

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