Diabetic Ketoacidosis From New SGLT2i: Can Genomics Estimate Risk

Launched by MOUNT SINAI HOSPITAL, CANADA · May 30, 2022

Keywords

ClinConnect Summary

The DANGER study is a clinical trial looking at how genetics might help predict the risk of a serious side effect called diabetic ketoacidosis (DKA) in people with type 2 diabetes who are taking a type of medication known as SGLT2 inhibitors. These medications are beneficial for many patients as they can lower the risk of heart problems and kidney failure, but they can also lead to DKA, which is a life-threatening condition. By understanding which patients are at higher or lower risk for DKA based on their genetics, doctors can better manage treatment and help those who can benefit most from SGLT2 inhibitors.

To participate in this study, you need to be 18 years or older and have been diagnosed with type 2 diabetes. You should either have been hospitalized due to DKA related to SGLT2 inhibitors or be taking an SGLT2 inhibitor without having DKA. If you decide to join, you will provide a saliva sample for genetic testing. The study is currently recruiting participants, and it is important to note that it does not include children or pregnant women since these medications are not approved for these groups. If you're interested or think you might be eligible, please talk to your healthcare provider for more information.

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Eligibility criteria

• Inclusion Criteria:
• To be considered eligible for participation in this study, a participant must meet each of the following criteria:
• • 1. Be 18 years or older and have a diagnosis of type 2 diabetes mellitus.
• • 2. Have been admitted to hospital with SGLT2 inhibitor-associated DKA (cases) or admitted to hospital on an SGLT2 inhibitor and not have DKA (controls).
• • 3. Be able to provide written consent (or, if patient is unable, have a substitute decision maker \[SDM\] available).
• Exclusion Criteria:
• A participant will be ineligible for participation in this study if he or she satisfies any one or more of the following criteria:
• • 1. Diagnosis of type 1 diabetes mellitus.
• • 2. Unable to spit 10mL into a vial.
• • 3. A first degree relative has already been recruited into the study.
• • 4. Had an alcohol binge before admission
• • 5. Had prolonged fasting (\>48 hours) prior to hospital admission
• • 6. Recently stopped their insulin (within the past 7 days prior to hospital admission)
• • Our study will not include children or pregnant women because SGLT2 inhibitors are not approved for use in either patient population.