Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors

Part of paid clinical trials in Orlando, Florida.

Sponsor
AdventHealth Translational Research Institute
Study ID
NCT07421518
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • SGLT-2 inhibitor (Sotagliflozin) — DRUG
    Participants will be asked to take the SGLT-2 inhibitor.
  • Insulin withdrawal test (IWT) — OTHER
    An Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Other: People with Type 1 Diabetes

Primary Outcome Measure

Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AdventHealth Translational Research InstituteOrlandoFlorida32804-

Find similar trials in Orlando, FL

Related Studies