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Purpose

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

Eligibility

Eligible Ages
Over 6 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
twiist users
  • Device: twiist Automated Insulin Delivery System
    twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm

Recruiting Locations

Jaeb Center for Health Research
Tampa 4174757, Florida 4155751 33647
Contact:
Research Manager
813-975-8690
twiistPS@jaeb.org

More Details

NCT ID
NCT07356089
Status
Recruiting
Sponsor
Deka Research and Development

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center