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New insulin system under Real-World watch: will it keep diabetes patients safer?

NCT ID NCT07356089

Disease control Sponsor: Deka Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 1,875 people with type 1 diabetes (ages 6 and up) who are already using the Twiist automated insulin delivery system. Researchers are monitoring for severe low blood sugar events, diabetic ketoacidosis, and hospitalizations related to the device. The goal is to see how well the system works in everyday life, outside of a controlled clinic setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Twiist Automated Insulin Delivery System (insulin pump, CGM sensor, and algorithm)
What this could lead to
If successful, this study could confirm that the Twiist system is safe and effective for daily use, helping people with type 1 diabetes manage their blood sugar more easily.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove the device causes or prevents outcomes. Risks include severe hypoglycemia, diabetic ketoacidosis, and device-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,875 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants who are diagnosed with Type 1 Diabetes, are at least 6 years old, and have been prescribed and are currently using the twiist system.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Willing and able to provide informed consent (or a parent or other legally authorized representative) * Age ≥ 6 years old * Diagnosis of T1D * Currently using twiist AID system, with initiation of twiist within 90 days of enrollment * Willing to only use an insulin approved for the pump * Residing in United States * Willing to use twiist in accordance with the user manual * Willing to have the study use the twiist data and any information that has been provided to Sequel Medtech, LLC or customer support since twiist was started * Willing to complete surveys at the beginning of the study and then monthly for 12 months * Willing to be contacted if clarification or further information is needed for any events reported on a survey or to customer support * Willing to provide medical records or sign a record release for any hospitalizations * Has cell service or if not, will have access to WIFI at least once a week * For females, not pregnant or planning pregnancy in the next 12 months * Able to speak and read English * Able to obtain documentation of HbA1c result obtained within 6 months prior to twiist initiation Exclusion Criteria: * Any form of diabetes other than T1D * Receiving dialysis for end-stage renal disease

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes (T1D) Type 1 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jaeb Center for Health Research

    RECRUITING

    Tampa, Florida, 33647, United States

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