Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tandem Diabetes Care, Inc.
With
Jaeb Center for Health Research
This protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. The study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a Premarket Approval (PMA) application.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
