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CeQur Simplicity wearable bolus patch

CeQur

A prescription, disposable US wearable for adults over 21 that replaces mealtime and correction injections, not basal insulin. The current commercial patch holds up to 200 units for four days and delivers a manual 2-unit bolus when both buttons are squeezed. FDA has also cleared seven-day wear and a separate 1-unit version, but CeQur has not said those variants are shipping.

Available nowRegulator-approvedpumppatchwearablebolus-onlymdi-adjunctmanualno-basalnon-connectedOfficial site ↗

The scorecard

Interoperability20

It works alongside a separately prescribed basal insulin regimen but has no CGM, app, algorithm, dose log, or open data connection.[1]

Reliability66

The FDA-cleared mechanical design has a commercial track record and a last-dose lockout, but the current four-day patch does not record doses or electronically confirm delivery.[1]

Form factor82

A 10 g, tubeless, water-resistant patch can replace repeated mealtime pen injections for up to four days; it still requires a separate basal injection and manual button squeeze for every bolus.[1]

Phone control0

Deliberately non-connected: every bolus is delivered by squeezing the two buttons on the patch, with no phone control or electronic dose history.[1]

Capacity68

Holds 100 to 200 units of Humalog or NovoLog U-100 for boluses only. The seven-day clearance may reduce changes, but usable wear still depends on how quickly the person uses the reservoir.[1]

Access & cost70

Available by US prescription with manufacturer-reported commercial and Medicare Part D coverage. The live FAQ still describes the four-day, 2-unit product; the newly cleared seven-day and 1-unit portfolio variants have no announced commercial date.[1]

The full picture

CeQur Simplicity sits between injections and a pump, but calling it a pump can mislead. It has no basal delivery, electronics, CGM connection, dose calculator, or automation. The current product is a disposable mechanical patch that holds 100 to 200 units of rapid-acting insulin. Squeezing both buttons delivers a 2-unit mealtime or correction bolus; basal insulin still comes from a separate long-acting injection.1

It is genuinely commercial in the United States. CeQur's current prescribing path and FAQ describe a four-day, prescription-only product for adults over 21, with Humalog or NovoLog U-100 and manufacturer-reported coverage through many commercial and Medicare Part D plans.1

Two regulatory updates need a careful status line. FDA cleared a 1-unit version in November 2024 and an up-to-seven-day version in April 2026. CeQur's June announcement says those clearances will enable expansion of the portfolio; it does not say the variants have launched. The live product FAQ still says four days and 2-unit increments, so that is the product counted as available here.234

The T1D evidence boundary is also important. The indication and current FAQ include adults with type 1 or type 2 diabetes who need mealtime insulin. But the randomized and CGM outcome publications CeQur cites in its June release studied type 2 diabetes, not type 1. Regulatory clearance and commercial use support the delivery claims; they do not establish a T1D-specific glycaemic benefit.

References

  1. CeQur. CeQur Simplicity HCP FAQs. https://myceqursimplicity.com/hcp-faq/ ↩ ↩2

  2. U.S. FDA. 510(k) summary — CeQur Simplicity 1-unit device (K243273) (13 November 2024). https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243273.pdf ↩

  3. U.S. FDA. 510(k) clearance — CeQur Simplicity extended wear (K252757) (10 April 2026). https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252757.pdf ↩

  4. CeQur. CeQur Announces Exciting Advancements: 2 Recent FDA Clearances and New Clinical Evidence to be Presented at ADA (4 June 2026). https://myceqursimplicity.com/wp-content/uploads/CeQur-Press-Release-ADA-June-4-2026.pdf ↩

What's next for this

  • →Commercial introduction of the FDA-cleared seven-day-wear version · not announced
  • →Commercial introduction of the FDA-cleared 1-unit version · not announced

Sources

  1. [1]CeQur Simplicity HCP frequently asked questions · manufacturer — Current commercial specifications: prescription use over age 21, four-day single-use patch, 2-unit increments, 100-to-200-unit capacity, Humalog or NovoLog U-100, no dose tracking, and manufacturer-reported pharmacy-plan coverage.
  2. [2]FDA 510(k) summary for CeQur Simplicity 1-unit version (K243273) · regulatory · 2024-11-13 — Clears a modified manual bolus pump delivering 1 unit per button depression. Clearance authorizes marketing but does not prove commercial launch.
  3. [3]FDA 510(k) clearance for CeQur Simplicity extended wear (K252757) · regulatory · 2026-04-10 — FDA clearance associated with the seven-day-wear modification; clearance is not evidence that this variant has reached pharmacies.
  4. [4]CeQur announces seven-day-wear and 1-unit FDA clearances · manufacturer · 2026-06-04 — Says the clearances will enable an expanded portfolio. It does not give a launch date, while the live FAQ continues to describe the four-day, 2-unit product.