NCT07356089 · Deka Research and Development
Twiist Postmarket Surveillance Study for Type 1 Diabetes
(twiist-PS)
What this study 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.
View original scientific description
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.
Interventions
DEVICE
twiist Automated Insulin Delivery System
twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm
Primary outcome measures
Severe hypoglycemia events
Time frame: From enrollment to the end of participation at 12 months
Severe hypoglycemia events with cognitive impairment sufficient to require the assistance of a third party for treatment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Tampa, Florida
Collaborators
Jaeb Center for Health Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations