Twiist Postmarket Surveillance Study for Type 1 Diabetes
Recruiting now
Conditions studied: Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT07356089
- Run by
- Deka Research and Development
- People needed
- 1875
- Starts
- 2025-12-09
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-01-21
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Any form of diabetes other than T1D
- Receiving dialysis for end-stage renal disease
Where it is running
- Jaeb Center for Health Research — Tampa, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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