NCT07325201尚未招募2 期
Mitigating Diabetic Ketoacidosis in People With T1D and Chronic Kidney Disease on an SGLT1&2 Inhibitor: Ketosis Risk Factor Determination and Incorporation Into an Enhanced Glucose Ketone Report
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in time in ketone range >1.5/mmol/L
研究概览
简要总结
The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to:
- Evaluate how ketone metrics differ between participants no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD in three time periods.
- Identify potentially modifiable ketosis risk factors.
- Use continuous dual ketone and glucose monitoring (DGK) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors and determine which factors in the Ketone Action Plan (KAP) were most valuable.
- Gather information on how participants and clinicians like and use the DGK reports.
Participants will be asked to:
- Meet with study investigators to determine if they are eligible
- Sign written informed consent
- Take a pregnancy test, if applicable
- Have blood taken to assess kidney function and hemoglobin A1c
- Take the study medication, following the study team instructions
- Wear the study provided sensor throughout participation.
- Complete 5 in person visits, and 11 phone check ins over a nine-month period
- Provide feedback on their experience, usefulness of CGM/CKM reports, and the most valuable factors of the Ketone Action Plan (KAP).
详细描述
Sodium-glucose cotransporter 2 (SGLT2) inhibitors and similar medications can prevent progression of heart and kidney disease but strategies to safely use these medications in people with type 1 diabetes (T1D) have not yet been developed. We will conduct an open-label trial of sotagliflozin (an SGLT 1/2 inhibitor) in 80 people with T1D with no chronic kidney disease (CKD), moderate risk CKD and high or very high risk CKD. Through the use of continuous ketone monitoring, we will characterize ketone levels in both individuals with chronic kidney disease (CKD) and T1D, compared to those with T1D without CKD, before and after starting sotagliflozin. We will improve our understanding of the risk factors for developing elevated ketone levels and optimize prevention of diabetes ketoacidosis through the development and refinement of an enhanced combined continuous glucose and ketone monitoring data visualization report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Males and females; Ages 18-
- •Diagnosis of type 1 diabetes, based on a clinical diagnosis with onset at least 3 months prior to screening.
- •Using an automated insulin delivery system (AID) or multiple daily injections (MDI), (defined by use of rapid analogue with meals and approved long-acting analogue (e.g. detemir or glargine)).
- •Most recent eGFR ≥25 (and within prior 12 months).
- •HbA1c 7-<-9%.
- •Have never used SGLT2i medications.
- •Must be willing and able to wear a DGK device and willing to follow the study protocol.
- •Must be able to read and speak English.
- •Use of adequate contraception for the duration of the study be the women of childbearing potential.
- •Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access).
排除标准
- •Pregnant, lactating, or planning to become pregnant or unwillingness to be on contraception during the trial.
- •Any form of diabetes other than T1D.
- •Any history of use of sodium-glucose cotransporter inhibitors and use of other non-insulin glucose lowering medication within the last 6 months.
- •Chronic systemic corticosteroids (>4 consecutive weeks) within 6 months before screening or planned use during the study period.
- •History of diabetic ketoacidosis within 3 months of screening or 2 or more episodes of DKA within the last year.
- •History of multiple (≥ 3 infections) genital mycotic or bacterial infections within 6 months of screening or any history of necrotizing fasciitis.
- •Hypotension at screening as 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) <25 mL/min/1.73m
- •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).
- •Active Hepatitis B or C, 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.
- •History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status, in the opinion of the investigator, including, but not limited to patients who have undergone organ or bone marrow transplantation. HIV positive patients who are on stable immunosuppressive therapy and have undetectable viral load may be eligible for inclusion in the study, subject to the investigator's discretion.
- •Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis.
- •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.
- •History of kidney transplant.
- •Chronic kidney disease (CKD) from a known cause other than T1D.
- •Current or clinically significant history of an eating disorder.
- •BMI <22 at time of screening.
- •Adherence to a very low carbohydrate or ketogenic diet (<100g carbohydrate /day) and unwilling to change during study participation.
- •History of foot amputation.
- •Non-healing wounds of extremities.
- •Documented medical adhesive allergy, as evaluated by investigator.
- •Inability to perform the study follow up or unwilling to wear the DGK device.
- •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.
- •Participation in another treatment or intervention study within the past six weeks.
- •Any condition or factor that would compromise the participant's safety or conduct of the study (for example: cognitive impairment, bipolar disorder, or eating disorder) or any other reason the PI deems that the patient should not be included.
研究组 & 干预措施
Sotagliflozin
Experimental
In this single arm trial, all patients will be started on sotagliflozin at a dose of 200mg/d. After 3 months of sotagliflozin 200 mg/d, patients who do not achieve good glycemic control (TIR >60%) and who have moderate or no CKD (eGFR >60) will be offered the option to increase sotagliflozin to 400mg/d. All other participants will continue taking 200 mg sotagliflozin daily.
干预措施: Sotagliflozin initiation (Drug)
结局指标
主要结局
Change in time in ketone range >1.5/mmol/L
时间窗: 3 months, 6 months, 9 months
Number of episodes of diabetic ketoacidosis (DKA)
时间窗: 6 months, 9 months
Change in % time in ketone range >1.5/mmol/L
时间窗: Baseline 3 months to 3 months following sotagliflozin initiation
Number of episodes of diabetic ketoacidosis
时间窗: 3 months following sotagliflozin initiation
ADA/EASD consensus on hyperglycemia definition of DKA will be used for the definition of DKA (must meet all 3 criteria: Glucose ≥200 mg/dL (11.1 mmol/L) OR prior history of diabetes; BHB concentration ≥3.0 mmol/L OR urine ketone strip 2+ or greater; pH \<7.3 and/or bicarbonate concentration \<18 mmol/L)
次要结局
- Change in mean ketone level(3 months, 6 months, 9 months)
- Highest ketone level in time period(6 months, 9 months)
- Number of severe hypoglycemia episodes(3 months, 6 months)
- Number of episodes (>=15 minutes) at >1.5 mmol/L(6 months, 9 months)
- Number of prolonged episodes (>=2 hours) at >1.5 mmol/L(6 months, 9 months)
- Change in time in ketone level >3.0/mmol/L(3 months, 6 months, 9 months)
- Number of episodes (>=15 minutes) at >3.0 mmol/L(6 months, 9 months)
- Number of prolonged episodes (>=2 hours) at >3.0 mmol/L(6 months, 9 months)
- Change in time in ketone level >2.5/mmol/L(3 months, 6 months, 9 months)
- Number of episodes (>=15 minutes) at >2.5 mmol/L(6 months, 9 months)
- Number of prolonged episodes (>=2 hours) at >2.5 mmol/L(6 months, 9 months)
- Change in time in ketone level >2.0/mmol/L(3 months, 6 months, 9 months)
- Number of episodes (>=15 minutes) at >2.0 mmol/L(6 months, 9 months)
- Number of prolonged episodes (>=2 hours) at >2.0 mmol/L(6 months, 9 months)
- Change in time in ketone level >1.0/mmol/L(3 months, 6 months, 9 months)
- Number of episodes (>=15 minutes) at >1.0 mmol/L(6 months, 9 months)
- Number of prolonged episodes (>=2 hours) at >1.0 mmol/L(6 months, 9 months)
- Change in time in ketone level >0.6/mmol/L(3 months, 6 months, 9 months)
- Number of episodes (>=15 minutes) at >0.6 mmol/L(6 months, 9 months)
- Number of prolonged episodes (>=2 hours) at >0.6 mmol/L(6 months, 9 months)
- Change in mean ketone level(Baseline 3 months to 3 months following sotagliflozin titration)
- Number of prolonged episodes of ketosis with >=120 minutes at >1.5 mmol/L(3 months following sotagliflozin titration)
- Highest ketone level observed(3 months following sotagliflozin titration)
- Number of episodes of ketosis with >=15 minutes at >1.5 mmol/L(3 months following sotagliflozin titration)
- Change in % time in ketone range >=3.0/mmol/L(Baseline 3 months to 3 months following sotagliflozin titration)
- Change in mean ketone level(Baseline 3 months to 3 months following sotagliflozin initiation)
- Highest ketone level observed(3 months following sotagliflozin initiation)
- Number of episodes of ketosis with >=15 minutes at >1.5 mmol/L(3 months following sotagliflozin initiation)
- Number of prolonged episodes of ketosis with >=120 minutes at >1.5 mmol/L(3 months following sotagliflozin initiation)
- Change in % time in ketone range >=3.0/mmol/L(Baseline 3 months to 3 months following sotagliflozin initiation)
研究者
研究点 (1)
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