NCT00925080已完成不适用
Pivotal Study of the Intravenous Blood Glucose (IVBG) System, In-Clinic Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels < 75 mg/dL, and within ±20% at YSI glucose levels >75 mg/dL).
研究概览
简要总结
The purpose of this study is to evaluate safety and accuracy of the IVBG System (the "System") when used to track blood glucose in insulin treated subjects with diabetes mellitus in an in-clinic setting for up to 72 hours (per subject). Reference blood glucose measurements will be collected across the entire reportable range of the System (e.g., 40 400 mg/dL) with adequate sampling at the upper and lower ends of this range. IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels < 75 mg/dL, and within ±20% at YSI glucose levels >75 mg/dL).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age 18 years or older;
- •Willing to participate in one 72-hour in-clinic session during which up to 72 venous blood samples drawn for YSI measurement of glucose concentration (maximum sampling frequency of 4 per hour), a fingerstick blood glucose measurement will also be performed at the time of each YSI blood draw;
- •If instructed, be willing not to perform any activities that would result in submersion of the Sensor/Potentiostat in water or willing to wear a waterproof covering when submerging the Sensor/Potentiostat;
- •Have been diagnosed with insulin-requiring diabetes mellitus and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
- •Able to speak, read, and write English.
排除标准
- •Have skin conditions or existing (or planned) medical instrumentation and/or dressings that preclude wearing the IVBG Sensor (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, or surgical dressings at the proposed wear site);
- •Are pregnant (as demonstrated by a positive pregnancy test within 72-hours of device insertion);
- •Have a contraindication to placement of a dedicated peripheral IV line;
- •Have a known history of heparin-induced thrombocytopenia;
- •Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
- •Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).
结局指标
主要结局
IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels < 75 mg/dL, and within ±20% at YSI glucose levels >75 mg/dL).
时间窗: 72-hours
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 DiabetesDiabetes Mellitus, Type 2NCT03509324Sun Yat-sen University67
已完成
3 期
An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant AntigensEnd-Stage Renal DiseaseKidney TransplantationNCT00000935National Institute of Allergy and Infectious Diseases (NIAID)100
已完成
3 期
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency DisordersPrimary Immunodeficiency Diseases (PID)Immune Thrombocytopenic Purpura (ITP)Kawasaki SyndromeNCT00157079Baxalta now part of Shire61
已完成
不适用
Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes MellitusDiabetesNCT01729546Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm114
已完成
不适用
Comparison Evaluation of Blood Glucose Meter Systems in a Clinical SettingDiabetesNCT01614613Ascensia Diabetes Care146