Concept: fully closed-loop extended-wear patch pump

This is not a product — it is a target: the insulin-delivery hardware a true artificial pancreas needs, assembled from pieces that mostly already exist but have never shipped in one box. A fully closed-loop, extended-wear patch pump would combine six properties: tubeless patch form factor; 7+ day wear; a large reservoir; ultra-fast-insulin compatibility; full phone control; and open interoperability so any algorithm — commercial or open-source — can drive it.¹²

Form factor: a patch, not a tube. The model is today's tubeless pumps — a small, waterproof Pod worn directly on the body with no tubing and no separate insulin line — but worn far longer than they currently last.¹ Tubing is the most visible burden of pump therapy; removing it is the single biggest quality-of-life upgrade a pump can offer, and this concept keeps that while extending wear.

Reservoir capacity and wear — where the gap is widest. Today's leading tubeless patch holds up to 200 units and is replaced about every 3 days (72 h).¹ Separately, the first and only infusion set cleared for up to 7 days of wear cut set changes from roughly 10 to 5 per month — but it is a tubed set, not a patch.³⁴ No tubeless pump yet reaches 7-day wear. The concept asks for both at once: a large reservoir (a developmental semi-durable patch pump already specs a 300-unit reservoir at 7-day wear) in a tubeless body.⁵

Infusion set, cannula and occlusion detection — the real unsolved problem. Extending wear is not just an adhesive challenge; it is a chemistry one. In a euglycemic-clamp study, insulin delivery fell about 24% from day 0 to day 7 of set wear, and other extended sets show glucose-infusion-rate area-under-curve dropping ~28% by day 7 even when the set never alarms.⁶⁷ In the largest 7-day trial, the set's day-7 survival rate was 77.8% (about one in five failed to last the week), though true occlusion-driven failure was very rare (0.1-0.4%).⁸ In a prototype set, 88% of sets were worn 7 days, yet glucose control deteriorated after day 3.⁹ So the honest engineering target is reliable, drift-free delivery and trustworthy occlusion detection out to day 7 — not just an adhesive that sticks.

Ultra-fast-insulin compatibility — a genuine tension. A true artificial pancreas wants the fastest possible insulin, but ultra-rapid formulations are harder on sets: in a randomized pump study, faster aspart (Fiasp) caused no confirmed occlusions but triggered premature set changes in 44% of users versus 16.7% on standard aspart.¹⁰ Designing a 7-day patch that tolerates ultra-rapid insulin is therefore a specific, named requirement — not a given.

Which CGMs, algorithms and DIY it would work with. The concept is open by design. The FDA already created the architecture: an ACE pump (alternate controller enabled) is cleared as a building block that any compatible interoperable CGM (iCGM) and any interoperable controller (iAGC) can drive.² That open-controller layer is real — Tidepool Loop was cleared in January 2023 as the first iAGC, an iPhone app able to drive any ACE pump using any iCGM.¹¹ The advocacy ask is a patch pump that fully embraces this: drivable by commercial algorithms and open-source/DIY loops, with an integrated CGM, rather than locked to one ecosystem.

Phone bolusing. Full bolus and settings control from a phone is part of the target — and is already proven on a tubeless pump, so this piece is achievable rather than speculative.¹

Access and cost by region. Undefined — no such integrated product exists, so there is no price, region, or coverage to report. By analogy to other novel integrated devices, a first mover would likely launch at premium pricing before competition or insurance coverage caught up.⁵

What's coming. The pieces are converging. A developmental semi-durable patch pump with a 300-unit reservoir and 7-day wear has been previewed, alongside other tubeless multi-component designs, though analysts expect nothing before roughly 2027.⁵ Extended-wear set chemistry keeps improving across multiple companies.⁸⁷ And the interoperability scaffolding — ACE pumps, iCGMs, and a cleared open iAGC — already exists to make an open patch pump legal.²¹¹ We keep this record as a placeholder concept so the editorial team can decide whether to feature it, and so every real pump is scored against the hardware we actually want.

References

1. Insulet (Omnipod). Omnipod 5 — product overview (tubeless waterproof Pod, up to 200 U U-100 insulin, ~72 h wear, smartphone bolusing). https://www.omnipod.com/what-is-omnipod/omnipod-5 ↩ ↩² ↩³ ↩⁴

2. U.S. Food & Drug Administration. FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices (ACE pump / alternate controller enabled interoperability pathway). https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-insulin-pump-intended-allow-patients-customize-treatment-through ↩ ↩² ↩³

3. Medtronic. Medtronic Secures FDA Clearance For First Ever Infusion Set That Can Be Worn Up To 7 Days By People With Diabetes (July 16, 2021; first set worn up to 7 days vs standard 2-3; new tubing connector improves insulin stability and reduces preservative loss). https://news.medtronic.com/featured-stories?item=231 ↩

4. Medtronic (MiniMed). Extended Infusion Set and Reservoir — product overview ("the only infusion set indicated for up to 7 days of wear"; ~5 vs ~10 set changes per month; tubed set). https://www.minimed.com/en-us/products/infusion-sets/extended-infusion-set/ ↩

5. Reuter E (MedTech Dive). ADA takeaways: Diabetes tech firms preview new patch pumps, glucose sensors (developmental semi-durable patch pump: 300-unit reservoir, 7-day wear; Beta Bionics Mint and other tubeless designs; ~2027 at earliest). https://www.medtechdive.com/news/ada-conference-diabetes-new-pumps-cgms/751482/ ↩ ↩² ↩³

6. Kastner JR, Bailey TS, Strange P, et al. Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear. Diabetes Technol Ther (2022); 25(2):143–147 (NCT04398030). According to PubMed: insulin AUC declined ~24% from day 0 to day 7. https://pmc.ncbi.nlm.nih.gov/articles/PMC9894594/ (DOI) ↩

7. Simic A, Schøndorff PK, Stumpe T, et al. Survival assessment of the extended-wear insulin infusion set featuring lantern technology in adults with type 1 diabetes by the glucose clamp technique. Diabetes Obes Metab (2021); 23(6):1402–1408. According to PubMed: 100% 7-day survival, but glucose-infusion-rate AUC fell 28% by day 7. https://pmc.ncbi.nlm.nih.gov/articles/PMC8251565/ (DOI) ↩ ↩²

8. Brazg R, Garg SK, Bhargava A, et al. Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial. Diabetes Technol Ther (2022); 24(8):535–543 (NCT04113694). According to PubMed: day-7 survival 77.8%; occlusion-driven failure 0.1-0.4%; no DKA. https://pmc.ncbi.nlm.nih.gov/articles/PMC9353978/ (DOI) ↩ ↩²

9. Kastner JR, Venkatesh N, Brown K, et al. Feasibility study of a prototype extended-wear insulin infusion set in adults with type 1 diabetes. Diabetes Obes Metab (2022); 24(6):1143–1149. According to PubMed: 88% of sets worn 7 days, but control deteriorated after day 3. https://doi.org/10.1111/dom.14685 (DOI) ↩

10. Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol (2017); 12(1):145–151. According to PubMed: no confirmed occlusions, but premature set changes in 44% vs 16.7% for standard aspart. https://pmc.ncbi.nlm.nih.gov/articles/PMC5761985/ (DOI) ↩

11. Tidepool. Tidepool Loop has received FDA Clearance (Jan 24, 2023; first iAGC — an iPhone app cleared to drive any ACE pump using any iCGM). https://www.tidepool.org/blog/tidepool-loop-has-received-fda-clearance ↩ ↩²