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

NCT07421518 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 2289759
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L

  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

Study Arms (1)

People with Type 1 Diabetes

OTHER

Drug: SGLT-2 inhibitor (Sotagliflozin); Other: Insulin withdrawal test (IWT)

Interventions

SGLT-2 inhibitor (Sotagliflozin) DRUG

Participants will be asked to take the SGLT-2 inhibitor.

Also known as: Inpefa

People with Type 1 Diabetes

Insulin withdrawal test (IWT) OTHER

An Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored.

People with Type 1 Diabetes

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• CKD-EPI estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m²
• 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.
• 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
• Active Hepatitis B or C, acquired immunodeficiency syndrome (HIV infection controlled with suppressive medications is allowed) or tuberculosis

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

Related Links

• AdventHealth Translational Research Institute

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Richard Pratley, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JaWanda Thacker

CONTACT

407-303-7100; CFD.TRI.Recruitment@AdventHealth.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 19, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)