twiist (Sequel)
Sequel Med Tech (hardware by DEKA Research & Development)
What it is
US tubed pump with a 300-unit cassette, weighing under 2 oz. Its pump-resident twiist Loop controller automates basal insulin; correction boluses require confirmation. A compatible iPhone is required, with optional Apple Watch control. Current pairings include Libre 3 Plus and Eversense 365; the controller is indicated for T1D ages 6+, while Eversense is limited to adults 18+. The pump is splash-resistant, not suitable for swimming.
Editorial review: .
Most recent recorded citation date: 2026-09-08. 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.See the linked studies and their populations →
- Benefit or performance
- Reliability: Acoustic sensing checks delivered volume. The manufacturer’s up-to-ninefold occlusion comparison uses other devices’ manuals and differing test rates, rather than a clinical head-to-head trial. Detection time varies with delivery rate.[3]
- 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.
Score limitations. Editorial pump ratings have not been recalibrated in this targeted safety and compatibility correction. Confirm current labeling for each sensor and phone; planned integrations are not current choices.
Default calculation: 72 × 20 + 78 × 20 + 58 × 20 + 90 × 15 + 76 × 10 + 70 × 15 = 7320; divide by total weight 100. Unrounded weighted result: 73.2.
Pump-resident twiist Loop works with Libre 3 Plus and adult-only Eversense 365. A DBLG2 integration is a planned future option, not an available algorithm choice. Commercial compatibility does not establish DIY access.[4]
Acoustic sensing checks delivered volume. The manufacturer’s up-to-ninefold occlusion comparison uses other devices’ manuals and differing test rates, rather than a clinical head-to-head trial. Detection time varies with delivery rate.[3]
Round and remarkably light (under 2 oz / ~57 g), but still a tubed pump worn on the hip or in a pocket, so it trades discretion against true patch pumps.
Compatible iPhone and optional Apple Watch control include bolusing. A physical pump-button bolus is available only when enabled in Settings; it is not a full on-pump screen interface.[4]
300-unit cassette matches the largest tubed reservoirs, swapped about every 3 days; rechargeable batteries are swapped at each cassette change.
US pharmacy access is documented. Current commercial guidance requires an iPhone; an Android modification has FDA clearance but the FAQ still describes Android as in development. Cost and insurance coverage vary.[4]
The full picture
The twiist is a tubed insulin pump with an unusual round shape and an even more unusual party trick: it physically measures the insulin it sends, rather than just assuming the motor pushed the expected amount.7 It is made by Sequel Med Tech, with the hardware engineered by DEKA Research.8
Form factor and wear. The tubed pump weighs under 2 oz and holds up to 300 units. The current user guide specifies IP24 splash protection with the cassette attached and says not to use the pump while swimming. The earlier 12-feet-for-one-hour claim was incorrect for this pump.34
Reservoir and infusion set. A bladder-style "cassette" holds up to 300 units of insulin — matching the largest tubed reservoirs — and is changed roughly every 3 days.4 Power comes from small rechargeable lithium-ion batteries that you hot-swap at each cassette change; the starter kit ships with four batteries and two chargers, so the pump runs continuously.49 It connects to standard infusion sets such as the Smiths Medical Cleo 90, Unomedical Comfort, and Medtronic MiniMed Silhouette/Quick-Set.10
Occlusion detection. iiSure acoustic sensing checks delivered insulin volume. Sequel’s up-to-ninefold comparison uses published specifications from other pumps, with differing test rates; it is not a clinical head-to-head safety comparison. The manual shows that time to an occlusion alarm varies with insulin delivery rate.43
Algorithm, CGM, and phone bolusing. The pump-resident twiist Loop controller automates basal delivery; correction boluses require user confirmation. Current commercial guidance specifies a compatible iPhone, with optional Apple Watch control. A physical pump-button bolus is available when enabled in Settings. Libre 3 Plus and Eversense 365 pairings are available, but the Eversense combination is for adults 18+, even though the controller’s T1D indication starts at age 6.54
Access. The manufacturer documents US pharmacy availability. Current commercial guidance requires a compatible iPhone; Android received FDA clearance in June 2026 but the FAQ still describes it as in development. FDA clearance alone does not establish commercial launch or insurance coverage.46
Type 2 diabetes data — separate population. Sequel’s ADA 2026 report described 307 adults enrolled and 286 completing 13 weeks. Mean HbA1c fell by 0.7 percentage points from 8.1%, and TIR increased from 57% to 73%. No severe hypoglycemia occurred; one DKA event was judged unrelated to the device. This company-reported, single-arm type 2 study does not establish T1D effectiveness or a type 2 indication.1
What's coming. Diabeloop and Sequel plan to integrate DBLG2 into twiist, targeting a US launch in 2027. This is a future algorithm option, not a currently shipping choice. Abbott separately expects a Libre Duo 10 Day pairing by the end of 2026; that is a company plan, not current compatibility or evidence of ketone-driven insulin dosing.1112
What's next for this
- →Sequel reported a 13-week type 2 study at ADA 2026: 307 enrolled, 286 completed, no severe hypoglycemia and one DKA event judged unrelated to the device. This population does not establish T1D outcomes or a type 2 indication.
- →Diabeloop and Sequel plan to integrate the FDA-cleared DBLG2 algorithm into twiist; this is not a currently available algorithm choice. · US launch targeted 2027 for the DBLG2 integration
- →Abbott Libre Duo 10 Day (FDA De Novo 25 August 2026) — Abbott expects twiist pairing by the end of 2026. Company plan, not a shipping AID pairing, and not a loop that doses from ketones.
- →Dexcom CGM support — specific pairing unconfirmed · in development
- →Body-worn adhesive (tubeless-style) options · in development
Sources
- [1]Sequel reports its ADA 2026 twiist type 2 pivotal study · Manufacturer · 2026-06-08
- [2]Real-World Data from U.S. Commercial Users of the 365-Day Implantable Eversense Continuous Glucose Monitoring System, Including with the Twiist Automated Insulin Delivery System Integration · Peer-reviewed study · 2026-09-08 — Retrospective manufacturer-authored analysis; 12,360 open-loop sensors and 153 sensors paired with twiist, not necessarily unique people; mixed diabetes types. No safety assessment or head-to-head comparison.
- [3]twiist AID System User Guide, revision 1.17 · Manufacturer
- [4]
- [5]FDA decision summary K234055: DEKA Loop · Regulatory decision
- [6]FDA K261672: twiist Android app modification · Regulatory decision · 2026-06-17
- [7]
Sequel Med Tech. Sequel's twiist Automated Insulin Delivery System Receives FDA 510(k) Clearance. GlobeNewswire (2024). https://www.globenewswire.com/news-release/2024/03/18/2847675/0/en/Sequel-s-twiist-Automated-Insulin-Delivery-System-Receives-FDA-510-k-Clearance.html
- [8]
Buckley S. Sequel fully launches twiist automated insulin pump in US. Drug Delivery Business News (2026). https://www.drugdeliverybusiness.com/sequel-fully-launches-twiist-pump-us/
- [9]
American Diabetes Association. twiist — insulin pump specifications. ADA Consumer Guide (2026). https://consumerguide.diabetes.org/products/insulin-pumps/twiist
- [10]
twiist Automated Insulin Delivery (AID) System review — specifications. Diabetesnet.com (2026). https://www.diabetesnet.com/diabetes-technology/automated-insulin-delivery-systems/twiist-automated-insulin-delivery-aid-system/
- [11]
Diabeloop and Sequel announce a planned DBLG2 integration. https://www.diabeloop.com/media-press/press-releases/dbl-sequel-pr-en
- [12]
Abbott. Abbott receives FDA authorization for world's first dual glucose-ketone sensing technology for people with diabetes (expects twiist and iLet pairings by end of 2026). Abbott Media Room (25 August 2026). https://abbott.mediaroom.com/2026-08-25-Abbott-receives-FDA-authorization-for-worlds-first-dual-glucose-ketone-sensing-technology-for-people-with-diabetes