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Tandem Freedom Feasibility Study 1

NCT06428591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-11-18

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 1 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

Participants will use the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses.

Sponsors & Collaborators

  • Tandem Diabetes Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Jordan Pinsker, MD · Tandem Diabetes Care

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2024-06-10
Completion
2024-06-10
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 NCT06428591 on ClinicalTrials.gov