Actively Recruiting

Age: 6Years +
All Genders
NCT07356089

Twiist Postmarket Surveillance Study for Type 1 Diabetes

Led by Deka Research and Development · Updated on 2026-01-21

1875

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

Sponsors

D

Deka Research and Development

Lead Sponsor

J

Jaeb Center for Health Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Twiist Postmarket Surveillance Study for Type 1 Diabetes

Who Can Participate

Age: 6Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide informed consent (or a parent or legally authorized representative)
  • Age 6 years or older
  • Diagnosis of type 1 diabetes
  • Currently using twiist Automated Insulin Delivery system with start within 90 days of enrollment
  • Willing to use only insulin approved for the pump
  • Residing in the United States
  • Willing to use twiist according to the user manual
  • Agree to have twiist data and related information shared with Sequel Medtech, LLC or customer support
  • Willing to complete surveys at study start and monthly for 12 months
  • Agree to be contacted for clarification or more information about reported events
  • Willing to provide medical records or sign release for hospitalizations
  • Has cell service or access to Wi-Fi 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 provide HbA1c documentation obtained within 6 months before starting twiist
Not Eligible

You will not qualify if you...

  • Any form of diabetes other than type 1 diabetes
  • Receiving dialysis for end-stage renal disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Jaeb Center for Health Research

Tampa, Florida, United States, 33647

Actively Recruiting

Loading map...

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here