Recruiting NCT07356089
Twiist Postmarket Surveillance Study for Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: twiist Automated Insulin Delivery System.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes
Overview
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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Jaeb Center for Health Research — Tampa
Identifiers
NCT: NCT07356089 · DKPI-00741-001