The goal of this study is to assess the functionality of an integrated predictive low glucose
suspend system designed to minimize the incidence and duration of hypoglycemia by suspending
insulin delivery if hypoglycemia is projected.
Device: t:slim insulin pump with predictive low glucose suspend
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Locations near you
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Full eligibility criteria for NCT02877771
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Diagnosis of type 1 diabetes requiring insulin therapy for at least 12 months
Insulin pump therapy for at least 6 months
Age ≥18.0 years
Subject demonstrates stable insulin regimen including basal rates, insulin sensitivity factor and insulin:carbohydrate ratio for at least 3 months
Pregnant (female subjects must have negative urine or serum pregnancy screening test)
Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
Diabetic ketoacidosis in the month prior to enrollment
A current condition that would prevent the use of a CGM sensor or insulin pump, or in the judgment of the investigator is a contraindication to study participation
Use of acetaminophen during study participation
Current use of any medication intended to lower glucose other than insulin including naturaceuticals, oral or non-insulin injectable medications
All locations for NCT02877771
United States (2)
Palo Alto, California, United States, 94304
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
View full eligibility
Tris trial is registered with FDA with number: NCT02877771. The sponsor of the trial is Tandem Diabetes Care, Inc. and it is looking for 10 volunteers for the current phase.
Official trial title:
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