Type 1 Diabetes (T1D)Digital healthChildren's healthDevice
What this study is
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.
What's being tested
- twiist Automated Insulin Delivery System
Intervention · DEVICE
twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm
Study details
- Official title
- Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes
- Sponsor
- Deka Research and Development
- Conditions
- Type 1 Diabetes (T1D) · Type 1 Diabetes Mellitus
- Enrolling
- 1,875 people
- Starts
- 2025-12-09
- Est. completion
- 2028-05-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Any form of diabetes other than T1D
- Receiving dialysis for end-stage renal disease
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openJaeb Center for Health Research
Tampa, Florida, United States
- Research Manager · Contact813-975-8690twiistPS@jaeb.org
Recruiting
Study team
Sponsor
Deka Research and Development
Study ID DKPI-00741-001
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.