CeQur Simplicity wearable bolus patch
CeQur
What it is
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.
Editorial review: .
Most recent recorded citation date: 2026-06-04. 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
- Reliability: 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]
- Important harms and treatment burden
- Read the safety discussion and original sources. A missing summary does not establish safety.
- Approval and country access
- Country-specific approval and access are not summarized in this record.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.
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: 20 × 20 + 66 × 20 + 82 × 20 + 0 × 15 + 68 × 10 + 70 × 15 = 5090; divide by total weight 100. Unrounded weighted result: 50.9.
It works alongside a separately prescribed basal insulin regimen but has no CGM, app, algorithm, dose log, or open data connection.[1]
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]
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]
Deliberately non-connected: every bolus is delivered by squeezing the two buttons on the patch, with no phone control or electronic dose history.[1]
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]
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.
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]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.
CeQur. CeQur Simplicity HCP FAQs.
- [2]FDA 510(k) summary for CeQur Simplicity 1-unit version (K243273) · Regulatory decision · 2024-11-13 — Clears a modified manual bolus pump delivering 1 unit per button depression. Clearance authorizes marketing but does not prove commercial launch.
U.S. FDA. 510(k) summary — CeQur Simplicity 1-unit device (K243273) (13 November 2024).
- [3]FDA 510(k) clearance for CeQur Simplicity extended wear (K252757) · Regulatory decision · 2026-04-10 — FDA clearance associated with the seven-day-wear modification; clearance is not evidence that this variant has reached pharmacies.
U.S. FDA. 510(k) clearance — CeQur Simplicity extended wear (K252757) (10 April 2026).
- [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.
CeQur. CeQur Announces Exciting Advancements: 2 Recent FDA Clearances and New Clinical Evidence to be Presented at ADA (4 June 2026).