Type 1 Diabetes (T1D)twiist-PSNCT07356089
Twiist Postmarket Surveillance Study for Type 1 Diabetes
An observational study of Type 1 Diabetes (T1D) and Type 1 Diabetes Mellitus, run by Deka Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus
- What is being tested?
- twiist Automated Insulin Delivery System
- Type of treatment
- Medical device
- How many people
- 1,875 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to 1 May 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who are diagnosed with Type 1 Diabetes, are at least 6 years old, and have been prescribed and are currently using the twiist system.
Who may be able to join
- 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
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- 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 join
- Any form of diabetes other than T1D
- Receiving dialysis for end-stage renal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jaeb Center for Health Research
Tampa, Florida, 33647
Research Manager, 813-975-8690, twiistPS@jaeb.org
About this study
Official title: Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes
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
- Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus
- Being tested
- twiist Automated Insulin Delivery System
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
twiist Automated Insulin Delivery SystemDevice
twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm
| Study group | Role | What they receive |
|---|---|---|
| twiist users | Not described Receives: Device: twiist Automated Insulin Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe hypoglycemia events
Severe hypoglycemia events with cognitive impairment sufficient to require the assistance of a third party for treatment
Measured: From enrollment to the end of participation at 12 months
Secondary outcomes (4)
Severe hypoglycemia events associated with seizure or loss of consciousness
Measured: From enrollment to the end of participation at 12 months
Diabetic ketoacidosis
Measured: From enrollment to the end of participation at 12 months
Hospitalizations related to use of twiist
Measured: From enrollment to the end of participation at 12 months
Unanticipated adverse device effects
Measured: From enrollment to the end of participation at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start9 Dec 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,875 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Deka Research and Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356089
- Sponsor's protocol ID
- DKPI-00741-001
- Acronym
- twiist-PS
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07356089
- Acronym / sponsor ID
- twiist-PS / DKPI-00741-001
- Conditions
- Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,875 participants (estimated)
- Lead sponsor
- Deka Research and DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| twiist users | – | Device: twiist Automated Insulin Delivery System |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who are diagnosed with Type 1 Diabetes, are at least 6 years old, and have been prescribed and are currently using the twiist system.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- Any form of diabetes other than T1D
- Receiving dialysis for end-stage renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| twiist Automated Insulin Delivery Systemtwiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm | Device | twiist users |
Primary outcome
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
4 secondary outcomes
Severe hypoglycemia events associated with seizure or loss of consciousness
Time frame: From enrollment to the end of participation at 12 months
Diabetic ketoacidosis
Time frame: From enrollment to the end of participation at 12 months
Hospitalizations related to use of twiist
Time frame: From enrollment to the end of participation at 12 months
Unanticipated adverse device effects
Time frame: From enrollment to the end of participation at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes (T1D) and Type 1 Diabetes Mellitus, run by Deka Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe hypoglycemia events (time frame: From enrollment to the end of participation at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.