Low Dose Empagliflozin in Adults With Type 1 Diabetes on Closed Loop Insulin System
Status:
Recruiting
Trial end date:
2021-08-30
Target enrollment:
Participant gender:
Summary
A closed-loop insulin system, also referred to as the "artificial pancreas" (AP), is made up
of an insulin pump, a continuous glucose monitor, and an application communicating between
the two to adjust insulin administration based on glucose control. This is meant for the
treatment of type 1 diabetes. The McGill Artificial Pancreas (MAP) has been used previously
in type 1 diabetes with significant benefits. Though prior studies have shown significant
benefit with this system, some challenges still exist.
Empagliflozin is used in type 2 diabetes; it allows for glucose to be removed through the
urine. Though its use is not approved in type 1 diabetes in North America, it (along with
similar drugs) has been used in studies as adjunctive therapy with insulin with benefits on
blood sugar control.
The purpose of our study is to see if a small dose of empagliflozin (2.5 mg and 5 mg) is
enough to help those who cannot achieve adequate glucose control on a closed-loop insulin
system.
The primary hypotheses of the study are the following:
1. The use of empagliflozin 2.5 mg daily will increase time in range compared to placebo
for those on the closed-loop system.
2. The use of empagliflozin 5 mg daily will increase time in range compared to placebo for
those on the closed-loop system.