Twiist Postmarket Surveillance Study for Type 1 Diabetes

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

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

Conditions3

Locations1 site

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