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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

• 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

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
• 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
• 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
• Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites, or hepatic encephalopathy), and/or known diagnosis of cirrhosis
• 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
• 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)
• Inability to perform the study follow up/ unwilling to wear the investigational device
• People who are unwilling to consume at least 20% of calories from carbohydrates

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• AdventHealth Translational Research Institute — Orlando

Identifiers

NCT: NCT07421518 · 2289759

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗