🏛️ Verified NIH Record • Updated 2026-02-17

Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors (NCT07421518)

Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT2 Inhibitors

🟡 Not Yet Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: AdventHealth Translational Research Institute

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (22 items).

Location: AdventHealth Translational Research Institute — Orlando, Florida

Age range: 18 Years to 40 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Pregnancy, lactation or planning to become pregnant
  • Any form of diabetes other than T1D
  • People with T1D using weekly insulin (when approved)
  • Use of sodium-glucose cotransporter 2 inhibitors within 4 weeks prior to screening
  • Chronic systematic corticosteroids (\>4 consecutive weeks) within 6 months before screening
  • History of diabetic ketoacidosis within 6 months of screening
  • History of multiple (≥ 3 infections) genital mycotic infections within 6 months of screening
  • Hypotension at screening is defined as systolic blood pressure \< 90 and diastolic blood pressure \< 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations)
  • History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening
  • Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening
  • New York Heart Association Class IV heart failure

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • AdventHealth Translational Research Institute — Orlando, Florida

📞 Contact the Study Coordinator

Phone: (407) 303-7100

Email: CFD.TRI.Recruitment@AdventHealth.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗