NCT07421518尚未招募2 期
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT2 Inhibitors
AdventHealth Translational Research Institute1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
People with Type 1 Diabetes
Other
干预措施: SGLT-2 inhibitor (Sotagliflozin) (Drug)
People with Type 1 Diabetes
Other
干预措施: Insulin withdrawal test (IWT) (Other)
结局指标
主要结局
Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (1)
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