This study will be an open-label, cross-over study as subjects will be studied under both study conditions - suspension of subcutaneous insulin infusion via pump during treatment with insulin alone (control) vs. suspension of subcutaneous insulin via pump during treatment with insulin and canagliflozin.
The study will consist of 4 visits: an enrollment/screening visit, a control visit with pump suspension prior to treatment with canagliflozin, a visit with pump suspension while on canagliflozin and an end of study visit. Each of the pump suspension visits will be approximately 20-hour overnight admissions to the Hospital Research Unit (HRU).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
basal interruption with canagliflozin
basal interruption
Yale University School of Medicine
New Haven, Connecticut, United States
Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin
The primary outcome measure for this study will be differences in plasma glucose levels following the interruption of basal subcutaneous infusion of insulin under the two study conditions; i.e., control study during treatment with insulin alone vs. experimental study during treatment with insulin plus canagliflozin or other SGLT2 inhibitor.
Time frame: 20 hours
Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal
Time frame: 20 hours
Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion
Time frame: 20 hours
Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion
Time frame: 20 hours
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