Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:41 AM
Study NCT ID:
NCT07421518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors
Sponsor:
AdventHealth Translational Research Institute
Organization:
Study Overview
Official Title:
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT2 Inhibitors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KARMA
Brief Summary:
The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). This special education plan is compared to a general education plan and considers the higher risk of DKA when using medicines like SGLT2 inhibitors.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: