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Clinical Trials in the USA / NCT07356089
Recruiting Observational

Twiist Postmarket Surveillance Study for Type 1 Diabetes

NCT07356089 · tracked via the Priya Life Science USA tracker
Sponsor
Deka Research and Development
Phase
Observational
Started
2025-12-09
Last updated
2026-01-21

Condition(s) studied

Type 1 Diabetes (T1D)Type 1 Diabetes Mellitus

Investigational drug(s) / intervention(s)

twiist Automated Insulin Delivery System

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)

Trial sites (1)

FacilityCityRegionStatus
Jaeb Center for Health Research Tampa Florida Recruiting

Other trials for the same condition

Official registry record

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.

View NCT07356089 on ClinicalTrials.gov ↗ ← All trials in the USA