Taking people in United StatesNo phase
Follows people with type 1 diabetes using the twiist insulin delivery device
Collects real-world data on adults and children with type 1 diabetes using twiist insulin delivery.
Key facts
- Who runs it
- Deka Research and Development
- Where
- Tampa, United StatesSee the site
- Trial code
- Registry title
- Twiist Postmarket Surveillance Study for Type 1 Diabetes
- Status
- Recruiting
- People taking part
- 1,875 people, planned
- Started
- 9 Dec 2025
- Expected to end
- 1 May 2028
- Type of study
- Observational
- Treatments tested
- twiist Automated Insulin Delivery System
- Record updated
- 21 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with type 1 diabetes who have recently started the twiist insulin pump system and will answer surveys for 12 months.
- Age
- 6 years or older
- Sex
- All sexes can join.
- Disease stage
- Diagnosis of type 1 diabetes (T1D).
- Earlier treatment
- Must currently use the twiist system, started within 90 days of enrolling. Must use only an insulin approved for the pump.
- Biomarker or test result
- A documented HbA1c result from within 6 months before starting twiist.
Main reasons for not taking part
- Any form of diabetes other than type 1 diabetes
- Receiving dialysis for end-stage renal disease
- Pregnant or planning pregnancy in the next 12 months
- Not living in the United States
- Cannot speak and read English
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Receiving dialysis for end-stage renal disease
- Any form of diabetes other than T1D
Where in United States
- Jaeb Center for Health ResearchTampa, United StatesContact: Research ManagerTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- twiist users
Treatment: twiist Automated Insulin Delivery System
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes
- Plain-language title
- Follows people with type 1 diabetes using the twiist insulin delivery deviceGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 21 January 2026