NCT07356089Recruiting
Twiist Postmarket Surveillance Study for Type 1 Diabetes
Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1875 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 9 Dec 2025
- Primary completion date
- 1 May 2027
- Lead sponsor
- Deka Research and Development
- Diseases
- Type 1 diabetes
- NCT number
- NCT07356089
What you commit to
- Study type: Observational
- Planned participants: 1875
- From 9 Dec 2025 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving dialysis for end-stage renal disease
Other illness
- Any form of diabetes other than T1D
Who the study is looking for
- 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
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jaeb Center for Health Research Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.