RecruitingNCT07356089
Twiist Postmarket Surveillance Study for Type 1 Diabetes
Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes
Sponsor
Deka Research and Development
Enrollment
1,875 participants
Start Date
Dec 9, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 6 Years
Inclusion Criteria15
- 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 Criteria2
- Any form of diabetes other than T1D
- Receiving dialysis for end-stage renal disease
Interventions
DEVICEtwiist Automated Insulin Delivery System
twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07356089
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