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

February 17, 2026 updated by: AdventHealth Translational Research Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Translational Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Men and nonpregnant women ≥18 years and older
  2. Diagnosis of T1D according to American Diabetes Association (ADA) criteria
  3. HbA1c < 9 %
  4. Participants treated with multiple daily injections of insulin, insulin pump, or advanced insulin delivery systems
  5. Has provided written informed consent to participate in the study.
  6. Must be willing to wear the investigational device
  7. Use of adequate contraception for the duration of the study by women of childbearing potential

Exclusion Criteria:

  1. Pregnancy, lactation or planning to become pregnant
  2. Any form of diabetes other than T1D
  3. People with T1D using weekly insulin (when approved)
  4. Use of sodium-glucose cotransporter 2 inhibitors within 4 weeks prior to screening
  5. Chronic systematic corticosteroids (>4 consecutive weeks) within 6 months before screening
  6. History of diabetic ketoacidosis within 6 months of screening
  7. History of multiple (≥ 3 infections) genital mycotic infections within 6 months of screening
  8. 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)
  9. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening
  10. Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening
  11. New York Heart Association Class IV heart failure
  12. CKD-EPI estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²
  13. Impairment of systems and organs that may increase their risk of participating in the intervention study or compromise the results (for example: end stage kidney disease, active liver dysfunction, gastroparesis, anemia, ), organ transplant.
  14. Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening
  15. Active Hepatitis B or C, acquired immunodeficiency syndrome (HIV infection controlled with suppressive medications is allowed) or tuberculosis
  16. Abnormal liver function at screening defined as any of the following: aspartate aminotransferase (AST) >2X upper limit of the normal reference range (ULN), ALT >2X ULN, serum total bilirubin (TB) >1.5X ULN
  17. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites, or hepatic encephalopathy), and/or known diagnosis of cirrhosis
  18. Heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week) at screening, history of alcohol use disorder or binge drinking
  19. Any condition or factor that would compromise the participant's safety or the scientific integrity of the study (cognitive impairment, bipolar disorder, or history of eating disorder)
  20. Inability to perform the study follow up/ unwilling to wear the investigational device
  21. People who are unwilling to consume at least 20% of calories from carbohydrates

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: People with Type 1 Diabetes
Drug: SGLT-2 inhibitor (Sotagliflozin)
Participants will be asked to take the SGLT-2 inhibitor.
Other Names:
  • Inpefa
Other: Insulin withdrawal test (IWT)
An Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L
Time Frame: 6 months
Number of ketone events with BOHB > 1.5 mmol/L for 15 consecutive minutes, as measured by the DGK. The event will end when BOHB is < 1.5 for 15 consecutive minutes. These events will be measured during the risk mitigation phase (Period 3 and Period 4) of the study.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Richard Pratley, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2289759

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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