Recruiting

twiist(TM)

Sponsor:

Deka Research and Development

Code:

NCT07356089

Conditions

Type 1 Diabetes (T1D)

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

twiist Automated Insulin Delivery System

Study Details

Brief 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.

Conditions

Type 1 Diabetes (T1D)

Type 1 Diabetes Mellitus

Study ID

NCT07356089

Start date

Dec 9, 2025

Status verified date

Jan, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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

Enrollment

1875 participants

Anticipated

Interventions and Outcome Measures

Arms

twiist users

Interventions

twiist Automated Insulin Delivery System

twiist(TM) system includes a novel insulin pump, a CGM sensor, and the glycemic-control algorithm

Primary outcome measure

  • Severe hypoglycemia events [ Time Frame: From enrollment to the end of participation at 12 months ]

Central Contacts and Locations

Locations

Jaeb Center for Health Research

Recruiting

Tampa, Florida, United States, 33647

Contacts

Research Manager

813-975-8690twiistPS@jaeb.org

More Information

Sponsor

Deka Research and Development

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Deka Research and Development on 2026-01-21.