Tandem Freedom Feasibility Study 1

Sponsor
Tandem Diabetes Care, Inc.
Study ID
NCT06428591
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
    Participants will use the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses.

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 1 week run-in, then will use Tandem Freedom in a supervised hotel setting.

Key Dates

Start date
May 29, 2024
Status verified
Nov 2025
Primary completion
Jun 10, 2024
Completion
Jun 10, 2024

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 used the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses. Participants performed meal and exercise challenges in a supervised hotel setting.

Primary Outcome Measure

Severe Hypoglycemia Events [ Time Frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus ]

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