Postmarket monitoring of twiist automated insulin delivery for people with Type 1 diabetes
Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes
This project will collect real-world data from people age 6 and older with Type 1 diabetes who recently started using the twiist automated insulin delivery system to see how it works for them over 12 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1875 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Deka Research and Development Industry-sponsored |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT07356089 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are U.S. residents age 6 or older with a diagnosis of Type 1 diabetes who started using the twiist system within the prior 90 days, are willing to share device and support data, complete monthly surveys for 12 months, and are not pregnant or planning pregnancy.
Not a fit: People younger than 6, those not using twiist or who started twiist more than 90 days before enrollment, non-U.S. residents, or those unwilling to share device data or complete monthly surveys are unlikely to benefit from this surveillance.
Why it matters
Potential benefit: If successful, this could show whether twiist helps people with Type 1 diabetes manage glucose control, is safe in everyday use, and is user-friendly.
How similar studies have performed: Other automated insulin delivery systems have shown improvements in time-in-range and fewer hypoglycemia events in clinical and real-world studies, but twiist-specific postmarket evidence is currently limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida
- Jaeb Center for Health Research — Tampa, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.