NCT05562206招募中不适用
A 48hr Study to Test Feasibility of the Pacific Diabetes Technologies Continuous Glucose Monitor Infusion Set (CGMIS) Sensing Interstitial Glucose Continuously in the Immediate Vicinity of SQ Insulin Delivery in Adults With T1 Diabetes
Pacific Diabetes Technologies2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Accuracy
研究概览
简要总结
This is a single center, single arm non-randomized study of 48-hour CGMIS wear duration incorporating two meal-challenge tests to explore the performance of a single insertion combined glucose-sensing insulin delivery cannula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Type 1 diabetes, present for at least 6 months. If there is lack of clarity regarding the type of diabetes, the PI will make the final decision based on medical records.
- •Age 18-75
- •Currently using a Tandem T-Slim or Medtronic 523/723 or newer series insulin pump to treat their diabetes.
- •Hgb A1C between 5.8 and 10%
- •Willingness to follow all study procedures and to attend all clinic visits.
- •Willingness to sign informed consent and HIPPA documents.
排除标准
- •Need for MRI/CT/Diathermy during study participation
- •Current use of Hydroxyurea
- •History of chronic kidney disease
- •Inability to read pump or CGM display due to reduced visual acuity
- •History of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
- •History of chronic liver disease
- •Active infection such as HIV or hepatitis
- •Anemia defined by HCT at least 4 percentage points below lower limit of the reference range
- •Dementia, Schizophrenia or other untreated mental illness
- •Chronic substance abuse
- •Chronic alcohol abuse
- •Seizure disorder
- •Major surgical operation within 30 days prior to screening
- •History of bleeding disorder or treatment with anticoagulants.
- •Allergy to acrylate-based skin adhesives
- •Ongoing use of an investigational drug or device
- •Female of childbearing potential who is pregnant or intending to become pregnant
- •Diabetic ketoacidosis or hypoglycemia requiring hospitalization within the last 6 months
- •Insulin resistance as defined by insulin requirement of more than 200 units per day
- •Use of glucose-lowering medications other than insulin
- •Need for uninterrupted treatment with acetaminophen
- •Any other physical or mental condition judged by the PI as being exclusionary.
结局指标
主要结局
Accuracy
时间窗: First 48 hours
Sensor accuracy as determined by mean absolute difference (MAD) for reference YSI venous blood glucose values ≤75 mg/dL and mean absolute relative difference (MARD) for reference YSI venous blood glucose values \>75 mg/dL
次要结局
- Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia(First 48 hours)
- Results of tolerability questionnaire(First 48 hours)
- Results of Draize scale(Firts 48 hours)
- Visual Analog Scale (VAS) for site discomfort(First 48 hours)
研究者
研究点 (2)
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