Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
Tandem Diabetes Care, Inc.
Summary
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
Description
All participants will use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each. The 2 treatment arms are: Existing t:slim X2 Users: * t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods) * t:slim X2 insulin pump with SteadiSet (43 inches) with no side ports (3 wear periods) Existing Mobi Users: * Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods) * Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age 18 to 80 years old inclusive * Generally in good health, as determined by the investigator * Living in the United States with no plans to move outside the United States during the study * Diagnosis of T1D for at least 12 months * Currently using a Tandem pump * Current Dexcom CGM user * HbA1c \<9.0% in the last 6 months. * Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study * Willing to wear each investigational infusion set for up to 7 days during each of the wear periods in the study * Willing to perf…
Interventions
- DeviceSteadiSet Infusion Set
Participants will use the SteadiSet Infusion set with an enhanced filling process for three wear periods and the Steadiset Infusion Set only for three wear periods.
Location
- Stanford UniversityStanford, California