A Prospective, Single Arm, Open-label, Interventional Study to Evaluate the Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With Type 1 Diabetes
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- i-SENS, Inc.
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Accuracy of the glucose concentration measurements
概览
简要总结
This is a prospective, single arm, open-label, interventional, pilot study to evaluate the accuracy and precision of the continuous glucose monitoring (CGM) system of i-SENS, Inc., CareSens Air 3, in adult patients with type 1 diabetes.
详细描述
Participants will wear two CareSens Air 3 and one Libre 3 Plus for 16 days without access to glucose values from the CareSens Air 3 devices while maintaining their original diabetes mellitus treatment. The participants will draw capillary blood at least 8 times a day using the SMBG system between study visits.
Between insertion and removal of the CareSens Air 3 the participants will be in the clinic 4 times to obtain accurate glucose reading from the reference device under carefully controlled circumstances including induction of low and high blood glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The CareSens Air 3 data will neither be available to the investigational site nor the participants during the course of the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who are 18-65 years of age, inclusive
- •Patients with type 1 diabetes who use intensive insulin therapy (multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) including users of systems with continuous glucose monitoring (CGM) driven automatic adjustment of insulin doses for at least 3 months
- •Patients who voluntarily decide to participate in the study and provide written informed consent
排除标准
- •The following abnormal skin or skin diseases or skin alterations at the CGM sensor attachment or insertion site: Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash, Staphylococcus aureus infection.
- •Allergic contact dermatitis to medical adhesives.
- •History of frequent catheter abscesses associated with pump therapy.
- •Severe hypoglycemia events within 3 months prior to screening. Severe hypoglycemia is defined as loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia.
- •Hypoglycemia unawareness.
- •Conditions that predispose to hypoglycemia including inadequately treated thyroid and adrenal disease.
- •Participants with diabetic ketoacidosis within 3 months prior to screening.
- •History of epilepsy or syncope within 6 months prior to screening.
- •Unstable vascular diseases (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy, including: Stroke, transitory cerebral ischemia, ischemic heart disease, peripheral vascular disease, and serious arrhythmia.
- •Patients with anemia (hemoglobin below normal range).
研究组 & 干预措施
CareSens Air 3 primary insertion site
CareSens Air 3 primary insertion site
干预措施: CareSens Air 3 primary insertion (Device)
CareSens Air 3 secondary insertion site
CareSens Air 3 secondary insertion site
干预措施: CareSens Air 3 secondary insertion (Device)
结局指标
主要结局
Accuracy of the glucose concentration measurements
时间窗: 16 days
percentage of iCGM values in the measuring range less than 70 mg/dL (3.9 mmol/l) within +/- 15 mg/dL (0.83 mmol/l) of the reference venous glucose measurement by YSI analyzer
次要结局
- Precision of the glucose measurements(16 days)