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NCT07356089Recruiting

Twiist Postmarket Surveillance Study for Type 1 Diabetes

Deka Research and Development

Start Date

12/9/2025

Completion Date

5/1/2028

Summary

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.

Eligibility Criteria

Age Range: 6 years to No maximum

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

Interventions

DEVICE

twiist Automated Insulin Delivery System

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Type 1 Diabetes (T1D)Type 1 Diabetes Mellitus

Locations

Jaeb Center for Health Research

Tampa, Florida 33647

United States