Ketone Monitoring in T1D: effect of SGLT2i During Usual Care and With Insulin Deficiency

Authors
Category Primary study
Year 2022
The study will consist of 4 distinct segments that include routine testing of ketones during, usual care, during insulin deficiency, and while taking a SGLT2i in addition to usual care,, then with insulin deficiency after the SGLT2i has reached steady state and ingested that, morning. We will study 20 adults with T1D who are using Dexcom G6 continuous glucose monitor, (CGM), plus any form of insulin delivery. Study participants will be randomized to Group A or, Group B. Simultaneous ketone monitoring using a the Biosense® breath ketone analyzer (BKA), and capillary blood beta hydroxybutyrate (BOHB) measurement will be done 2-3 times daily for, 2 weeks during each of the outpatient segments. This will generate >800 data points comparing, breath acetone, measured in units called ACEs, versus capillary blood BOHB measurements for, each 2 week period. On days of insulin withdrawal, which will take place on the Washington, University Intensive Research Unit (IRU), frequent monitoring with capillary blood, measurements of BOHB (Precision Xtra®, Abbott) will be compared with breath BrAce, measurements (Biosense®, Readout) and laboratory measurements of BOHB and acetoacetate., Electrolytes and glucose will also be measured.
Epistemonikos ID: 8b4a465877523d0e96501e70b99662ecf2c4a6b0
First added on: Jul 02, 2024