A Phase I Clinical Trial Testing the Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on Insulin Pump Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Overall MAD of ketone concentration of the CKM (active device) compared to ketone capillary-measurements (control) during the 8-hour insulin-suspension study.
研究概览
简要总结
The goal of this 14-day randomized pilot trial is to assess the accuracy of a continuous ketone monitoring (CKM) system when compared to standard point-of-care capillary ketone monitors in individuals with type 1 diabetes on insulin pump therapy. The main question it aims to answer is:
- Can a CKM system demonstrate equivalent ketone monitoring compared to a capillary ketone monitor with accuracy within a mean absolute difference of no more than ± 0.1 mmol/L.
Participants will be asked to wear the SiBio KS1 CKM system for 14-days while undergoing two sequential ketogenic diets which are interspaced by an inpatient insulin-suspension period.
详细描述
In this study, all study participants will wear the CKM system and collect multiple standard point-of-care capillary ketone measurements. Therefore, there will be two groups in terms of measurements methods, one acting as an active comparator (the CKM system) and, the other serving as a control (point-of-care capillary ketone measurements). Both groups of measurement methods will be assessed in all study participants for both the outpatient phase (sequential ketogenic diets) and, the inpatient phase (insulin-suspension period) of the study to evaluate the accuracy of the CKM system.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years of age.
- •A clinical diagnosis of type 1 diabetes (T1D) for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required).
- •On stable, commercial closed-loop pump therapy for the past 30 days.
- •Stable use of continuous glucose monitor system for the past 30 days.
- •Cellular phone with Android OS operating system 8.1 and above or iOS11 and above operating system, for data compatibility with continuous ketone monitor mobile app (SiCKM app).
- •Able to perform study related tasks.
排除标准
- •Current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (SGLT2) inhibitor medication (e.g. empagliflozin).
- •Current use of ascorbic acid (Vitamin C) as it may impair accuracy of the sensor.
- •Severe hypoglycemic episode within one month of admission, defined as an event where glucose was <4 mmol/L resulting in seizure, loss of consciousness, needing third party assistance, or need to present to the emergency department.
- •Diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month.
- •Planned or ongoing pregnancy or breastfeeding individuals.
- •Any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators.
结局指标
主要结局
Overall MAD of ketone concentration of the CKM (active device) compared to ketone capillary-measurements (control) during the 8-hour insulin-suspension study.
时间窗: 2 weeks
次要结局
- Overall mean absolute difference (MAD) of ketone CKM (active device) concentration compared to ketone capillary-measurements at home (control).(2 weeks)
- Mean difference (MD) of ketone CKM concentration compared to ketone capillary-measurements during the 8h insulin-suspension study.(2 weeks)
- MD of ketone CKM concentration compared to ketone capillary-measurements at home.(2 weeks)
- MAD & MD according to duration during outpatient period:(2 weeks)
- MAD & MD across ketone levels during insulin-suspension visit:(2 weeks)
- Number of participants experiencing ketones by both the CKM and capillary-ketone meter.(2 weeks)
- Glycemic and insulin outcomes will be compared between the very low-carbohydrate diet and the intermittent fasting diet.(2 weeks)
研究者
Melissa Rosina-Pasqua
Endocrinologist, McGill University Health Centre, Hygea Clinic
McGill University