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Empagliflozin 2.5 mg + closed-loop insulin system for Type 1 Diabetes (CL-LoDE Trial)
CL-LoDE Trial 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: The use of empagliflozin 2.5 mg daily will increase time in range compared to placebo for those on the closed-loop system. The use of empagliflozin 5 mg daily will increase time in range compared to placebo for those on the closed-loop system.
- Type 1 Diabetes
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Outcome measures can provide a clearer picture of what you can expect from a treatment.CL-LoDE Trial Design
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