Tandem Freedom - Feasibility Trial 2

Sponsor
Tandem Diabetes Care, Inc.
Study ID
NCT06834568
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • t:slim X2 insulin pump with Tandem Freedom Algorithm — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 24, 2025
Status verified
Apr 2026
Primary completion
Apr 7, 2025
Completion
Apr 7, 2025

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tandem Freedom
    After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting. Participants will also perform exercise challenges.

Primary Outcome Measure

Number of Participants With One or More Severe Hypoglycemia Events [ Time Frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) ]

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