Postmarket monitoring of twiist automated insulin delivery for people with Type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a postmarket observational surveillance following youth and adults (≥6 years) with Type 1 diabetes who began using the twiist AID system within 90 days of enrollment. Participants will allow twiist device data and any customer-support reports to be used and will complete a baseline survey and monthly surveys for 12 months. The study may request medical records for any hospitalizations and requires U.S. residency and regular cellular or weekly Wi‑Fi access for uploads. Data collection is coordinated with Jaeb Center for Health Research and the device sponsor to characterize real-world safety, device use patterns, and clinical outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.