Twiist Postmarket Surveillance Study for Type 1 Diabetes (twiist-PS)

January 20, 2026 updated by: Deka Research and Development

Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes

The goal of this surveillance study is to collect real-world data on adults and youth with type 1 diabetes (T1D) using twiist(TM) for insulin delivery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1875

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33647
        • Recruiting
        • Jaeb Center for Health Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
twiist users
Device: twiist Automated Insulin Delivery System
twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe hypoglycemia events
Time Frame: From enrollment to the end of participation at 12 months
Severe hypoglycemia events with cognitive impairment sufficient to require the assistance of a third party for treatment
From enrollment to the end of participation at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Severe hypoglycemia events associated with seizure or loss of consciousness
Time Frame: From enrollment to the end of participation at 12 months
From enrollment to the end of participation at 12 months
Diabetic ketoacidosis
Time Frame: From enrollment to the end of participation at 12 months
From enrollment to the end of participation at 12 months
Hospitalizations related to use of twiist
Time Frame: From enrollment to the end of participation at 12 months
From enrollment to the end of participation at 12 months
Unanticipated adverse device effects
Time Frame: From enrollment to the end of participation at 12 months
From enrollment to the end of participation at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deka Research and Development

Collaborators

Jaeb Center for Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DKPI-00741-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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