Actively Recruiting
Twiist Postmarket Surveillance Study for Type 1 Diabetes
Led by Deka Research and Development · Updated on 2026-01-21
1875
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
D
Deka Research and Development
Lead Sponsor
J
Jaeb Center for Health Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Twiist Postmarket Surveillance Study for Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent (or a parent or legally authorized representative)
- Age 6 years or older
- Diagnosis of type 1 diabetes
- Currently using twiist Automated Insulin Delivery system with start within 90 days of enrollment
- Willing to use only insulin approved for the pump
- Residing in the United States
- Willing to use twiist according to the user manual
- Agree to have twiist data and related information shared with Sequel Medtech, LLC or customer support
- Willing to complete surveys at study start and monthly for 12 months
- Agree to be contacted for clarification or more information about reported events
- Willing to provide medical records or sign release for hospitalizations
- Has cell service or access to Wi-Fi 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 provide HbA1c documentation obtained within 6 months before starting twiist
You will not qualify if you...
- Any form of diabetes other than type 1 diabetes
- Receiving dialysis for end-stage renal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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