This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Stanford University
Stanford, California, United States
7 Day Survival of Infusion Set for Primary Outcome Measure
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised)
Time frame: 6 weeks
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