RightFit
RecruitingPhase not listed

Twiist Postmarket Surveillance Study for Type 1 Diabetes

Twiist Postmarket Surveillance Study in Adults and Youth With Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects data on how people use twiist to deliver insulin in everyday life. It is for adults and children age 6 and older with type 1 diabetes who recently started using twiist.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 6 or older, have type 1 diabetes, and live in the United States.
  • Be using the twiist automated insulin delivery system and have started it within 90 days before joining.
  • Be willing and able to agree to join, or have a parent or other legally authorized person agree for you.
  • Use only insulin approved for the pump and follow the twiist user manual.
  • Allow the study to use your twiist data and information shared with Sequel Medtech or customer support since starting twiist. Provide hospital records or permission to get them for any hospital stays.
  • Complete surveys when you join and each month for 12 months. Agree to be contacted for more details about events reported in surveys or to customer support.
  • Speak and read English. Have cell service or access to Wi-Fi at least once a week.
  • If female, not be pregnant or plan pregnancy in the next 12 months. Have a record of an HbA1c test, which measures average blood sugar, done within 6 months before starting twiist.

Who can't join

  • Have any type of diabetes other than type 1.
  • Receive dialysis, a treatment that filters blood, for kidney failure.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

FL