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Sequel twiist

Sequel Med Tech; pump and controller developed by DEKA, powered by Tidepool

What it is

US hybrid AID with a tubed 300-unit pump, pump-resident twiist Loop algorithm and iPhone/optional Apple Watch control. It automates basal insulin; correction boluses require confirmation. Libre 3 Plus and adult-only Eversense 365 pairings are available. Direct T1D evidence now includes an ongoing FDA postmarket cohort.

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

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Available nowModerate evidencehybrid-closed-looptubedphone-controlOfficial site ↗

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
Time in range: FDA’s ongoing T1D postmarket study reports interim TIR 78.1%. It lists 351 enrolled and zero completed; the summary does not give the analyzed denominator or observation window for each metric. This cannot establish superiority over another system.[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. Ratings are editorial. Direct twiist evidence includes interim observational T1D results; historical open-source Loop cohorts and mixed-diabetes Eversense data are not head-to-head twiist results. Scores have not been recalibrated into comparative treatment effects.

Default calculation: 75 × 20 + 78 × 20 + 64 × 10 + 74 × 5 + 68 × 5 + 70 × 5 + 80 × 5 + 56 × 10 + 62 × 20 = 6960; divide by total weight 100. Unrounded weighted result: 69.6.

Time in range75

FDA’s ongoing T1D postmarket study reports interim TIR 78.1%. It lists 351 enrolled and zero completed; the summary does not give the analyzed denominator or observation window for each metric. This cannot establish superiority over another system.[3]

Hypo protection78

Interim FDA T1D data report 2.6% below 70 mg/dL and 0.24% below 54 mg/dL, alongside six severe-hypoglycemia events requiring assistance (8.44 per 100 person-years). Low sensor glucose exposure does not mean severe events are eliminated.[3]

Automation level64

Automatically increases, decreases or suspends basal insulin. Correction boluses require user confirmation, and users enter meal carbohydrates; the earlier claim of automatic correction boluses was inaccurate.[2]

Average glucose74

Interim FDA T1D data report GMI 6.59% and mean glucose 141.4 mg/dL. These observational figures have incompletely specified analysis duration and denominator; they are not measured HbA1c or a cross-system comparison.[3]

Low variability68

Interim FDA T1D data report glucose CV 33.1%. The public summary lacks detailed subgroup and follow-up information; this editorial score is not a validated conversion of CV into a ranking.[3]

Exercise handling70

A user-activated Workout Preset uses a configurable 87–250 mg/dL range. This provides flexibility but is not evidence that exercise hypoglycemia is prevented or that the setting is suitable for every activity.[1]

Customizability80

Correction ranges of 87–180 mg/dL can use up to 48 daily segments, with adjustable carbohydrate absorption entries and presets. The score reflects these documented options, not proven superiority in lived experience.[1]

Access & cost56

Commercial guidance currently specifies US pharmacy access and a compatible iPhone with iOS 18+. The current FAQ describes Android as in development, so commercial Android availability is not confirmed.[5]

Freedom (form factor)62

Pump under 2 oz, phone and optional Watch interaction, and an enabled pump-button bolus can reduce handling. It remains tubed; the assembled pump is IP24 splash-resistant and the manual says not to swim with it.[1]

AID default: 50% glucose outcomes and low-glucose protection, 40% daily experience, 10% access and cost. Freedom includes tubing, wearability, water-use limits and controller requirements. These are editorial priorities; studies and device generations differ. Check each scorecard for its evidence and limits.

The full picture

How it works. twiist Loop runs inside the tubed pump and adjusts basal insulin using CGM predictions. Correction boluses are recommended for the user to confirm; meal carbohydrates still need entry. It is a commercial, FDA-cleared controller derived from Tidepool Loop, not an interchangeable copy of every DIY Loop version.2

Daily use. The pump holds up to 300 units and weighs under 2 oz. Current commercial guidance requires a compatible iPhone with iOS 18 or newer; an Apple Watch with watchOS 11 or newer is optional. With Loop on and CGM data available, basal automation continues if the phone is off or disconnected. A pump-button bolus is available when enabled in settings.5

Water and maintenance. With its cassette attached, the pump has IP24 splash protection. The manual says not to use it while swimming. Battery and cassette changes remain part of daily life; the manufacturer describes a charged battery lasting 72 hours.15

Personalization. Correction ranges can be set from 87–180 mg/dL (4.8–10.0 mmol/L) in up to 48 daily segments. The Workout Preset allows a separate range up to 250 mg/dL (13.9 mmol/L), and meal entries include absorption-time options. These choices may matter to users who want more control; they do not prove better outcomes than another system.1

Direct T1D evidence. The FDA’s ongoing postmarket study reports 351 enrolled participants, 341 active, 10 early terminations and none completing follow-up at the reported interim point. Its summary gives TIR 78.1%, GMI 6.59%, CV 33.1%, time below 70 mg/dL 2.6% and below 54 mg/dL 0.24%. Six severe-hypoglycemia events requiring assistance were reported (8.44 per 100 person-years), with zero DKA. The public summary does not specify the analyzed denominator and observation window for each glucose metric. These are interim observational findings, not randomized comparative effects.3

Eversense pairing. The US combination launched in February 2026. twiist Loop is indicated for T1D from age 6, but Eversense 365 is for adults 18 or older; FreeStyle Libre 3 Plus is the other listed CGM partner. An implanted sensor can last up to a year, reducing insertions, but still needs an external transmitter, calibration and clinical insertion/removal. It is not adhesive-free care.257

A September 2026 manufacturer-authored study analyzed 153 Eversense sensors paired with twiist for more than 30 days; 65% were recorded as T1D. Mean TIR was 76.1% and GMI 6.78%. Sensor counts are not necessarily unique participants, the population mixes diabetes types, and the study did not collect safety outcomes or randomize users. These results cannot supply a T1D-only comparative ranking.4

Other evidence and plans. Sequel’s ADA 2026 type 2 report enrolled 307 adults and reported 286 completing 13 weeks. In that single-arm study TIR rose from 57% to 73%; there was no severe hypoglycemia and one DKA event reported as unrelated to the device. Those results do not establish T1D efficacy or a type 2 indication for twiist Loop. Android received FDA clearance in June 2026, but its commercial release is not confirmed by current guidance. Abbott’s expected Libre Duo pairing by year-end 2026 also remains a plan.8569

Occlusion claims. Acoustic sensing checks delivered insulin volume. The manufacturer’s “up to nine times faster” blockage claim compares specifications from different pump manuals, including different basal rates; it is not a head-to-head clinical safety result. The twiist manual itself shows that detection time varies with delivery rate.51

What's next for this

  • →Android app modification FDA-cleared 17 June 2026; commercial availability remains unconfirmed because current manufacturer guidance still specifies iPhone.
  • →Type 2 pivotal results were company-reported at ADA 2026; current twiist Loop labeling remains T1D age 6+.
  • →Abbott expects Libre Duo 10 Day pairing by the end of 2026. This is a company plan, not a shipping integration.

Sources

  1. [1]
  2. [2]
  3. [3]
  4. [4]
  5. [5]
  6. [6]
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  9. [9]