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Tandem Freedom - Feasibility Trial 2

NCT06834568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-05

Study results available
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Summary

This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a one week run-in, then will use Tandem Freedom in a supervised hotel setting.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

t:slim X2 insulin pump with Tandem Freedom Algorithm

t:slim X2 insulin pump with Tandem Freedom System consists of the Tandem t:slim X2 insulin pump and the Freedom algorithm embedded in the pump. Participants will also use the Dexcom G6 continuous glucose monitoring system.

Sponsors & Collaborators

  • Tandem Diabetes Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Jordan Pinsker, MD · Tandem Diabetes Care, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2025-04-07
Completion
2025-04-07
FDA Device
Yes

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06834568 on ClinicalTrials.gov