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Recruiting

NCT Number: NCT07356089

Twiist Postmarket Surveillance Study for 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.

Recruiting

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location status: Recruiting

Location contact

Research Manager

CONTACT

[email protected]

813-975-8690

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

twiist Automated Insulin Delivery System

Device

twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm

Primary outcomes

  1. 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

Secondary outcomes

  1. Severe hypoglycemia events associated with seizure or loss of consciousness

    Time frame: From enrollment to the end of participation at 12 months

  2. Diabetic ketoacidosis

    Time frame: From enrollment to the end of participation at 12 months

  3. Hospitalizations related to use of twiist

    Time frame: From enrollment to the end of participation at 12 months

  4. Unanticipated adverse device effects

    Time frame: From enrollment to the end of participation at 12 months

Sponsors and collaborators

Lead sponsor

Deka Research and Development

Industry

Collaborators

  • Jaeb Center for Health Research

Registry information

Official study title

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

Acronym: twiist-PS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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