Twiist Postmarket Surveillance Study for Type 1 Diabetes

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

  • Type 1 Diabetes (T1D)
  • Type 1 Diabetes Mellitus

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

Status
Recruiting
Sponsor
Deka Research and Development

Study Contact