NCT07356089 Twiist Postmarket Surveillance Study for Type 1 Diabetes
| NCT ID | NCT07356089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Deka Research and Development |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,875 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,875 participants in total. It began in 2025-12-09 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07356089 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07356089 currently recruiting?
Yes, NCT07356089 is actively recruiting participants. Visit ClinicalTrials.gov or contact Deka Research and Development to inquire about joining.
Where is the NCT07356089 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT07356089 clinical trial?
NCT07356089 is sponsored by Deka Research and Development. The trial plans to enroll 1,875 participants.
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