Twiist Postmarket Surveillance Study for Type 1 Diabetes

NCT07356089 | Recruiting FDA Device

• 1 other identifier: DKPI-00741-001
• Study Type: observational
• Target: 1,875
• Locations: 1 country
• Sites: 1

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 Mellitus; Type 1 Diabetes (T1D)

Outcome Measures

Primary Outcomes (1)

• Severe hypoglycemia events

  Severe hypoglycemia events with cognitive impairment sufficient to require the assistance of a third party for treatment

  From enrollment to the end of participation at 12 months

Secondary Outcomes (4)

• Severe hypoglycemia events associated with seizure or loss of consciousness

  From enrollment to the end of participation at 12 months

• Diabetic ketoacidosis

  From enrollment to the end of participation at 12 months

• Hospitalizations related to use of twiist

  From enrollment to the end of participation at 12 months

• Unanticipated adverse device effects

  From enrollment to the end of participation at 12 months

Study Arms (1)

twiist users

Device: twiist Automated Insulin Delivery System

Interventions

twiist Automated Insulin Delivery System DEVICE

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

twiist users

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are diagnosed with Type 1 Diabetes, are at least 6 years old, and have been prescribed and are currently using the twiist system.

You may qualify if:

• 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

You may not qualify if:

• Any form of diabetes other than T1D
• Receiving dialysis for end-stage renal disease

Sponsors & Collaborators

• Deka Research and Development: lead
• Jaeb Center for Health Research: collaborator

Study Sites (1)

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 21, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)