twiist Automated Insulin Delivery System: twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm
Study 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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Severe hypoglycemia events — 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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