This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.
This is a double blinded cross-over study. Subjects will be asked to wear infusion set either a standard infusion set or an extended wear infusion set. They will wear each infusion set twice, and the order of infusion set wear will be randomized with the first infusion set wear and then alternated over 4 weeks. By performing a cross over study using both experimental infusion sets and standard infusion sets, the investigators hope to see whether there is a benefit to using an extended wear infusion set.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
For two of the 4 weeks the Extended Wear insulin infusion set will be used.
For two of the 4 weeks the Standard infusion set will be used
Stanford University
Palo Alto, California, United States
Time to an infusion set failure due to an occlusion
Glucose \>250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL, or ketones \> or = 0.6 mg/dL with a glucose reading of \>250 mg/dL (in the absence of illness), or a pump occlusion alarm
Time frame: within 1 week
signs of infection at insulin infusion site
erythema or induration of \> 1cm in diameter at injection site
Time frame: 1 week
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