NL-OMON38939撤回不适用
A Pilot Study to Evaluate the Longevity, Accuracy and Safety of the Senseonics Continuous Glucose Monitoring System - CGM System Pilot study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Males and Females Aged * 18 years of age.
- •2. Clinically confirmed diagnosis of diabetes mellitus (for at least 1 year of
- •duration) on multiple daily injections (>2 injections per day) or on insulin
- •pump therapy.
- •3. Subject understands study procedures and risks, is willing to comply with
- •protocol requirements, and has signed an informed consent document.
排除标准
- •Subjects will be denied participation in the investigation if they meet any of the following key,
- •exclusion criteria:
- •1. History of severe hypoglycemia in the 6 months immediately prior to study start.
- •2. Severe diabetic Ketoacidosis in the past 6 months.
- •3. Females who are lactating, pregnant or intending to become pregnant during the course
- •of the investigation, defined as
- •3.1 Not postmenopausal for at least 1 year OR
- •3.2 Not surgically sterile, OR
- •3.3 If of child bearing potential, the subject is not practicing birth control, not willing to
- •avoid pregnancy for the period of study participation, has a positive urine pregnancy test
- •at screening or has a positive urine pregnancy test at the time of the Sensor insertion
- •4. Any condition preventing or complicating the placement, operation or removal of the
- •Sensor, including but not limited to:
- •4.1 Upper extremity deformities that would impede the placement of the Sensor or
- •application of the external Transmitter.
- •4.2 Any skin condition that may affect Sensor insertion or external Transmitter placement.
- •5. Any medical condition or illness that in the judgment of the investigator might interfere
- •with the procedures, results or compliance during the course of this investigation, or
- •increase the risk of induced hypoglycemia or repeated blood testing, including but not
- •limited to:
- •5.1 Anemia, defined as either:
- •5.1.1 Hemoglobin (Hgb) value for females of < 12.0 g/dl, for males < 13.0 g/dl OR
- •5.1.2 Abnormal red cell indices and iron deficiency.
- •5.2 History of hepatitis B, hepatitis C or HIV.
- •5.3 Symptomatic coronary artery disease, unstable angina, myocardial infarction or stroke
- •within 6 months of screening, uncontrolled hypertension, or congestive heart failure.
- •5.4 Any seizure disorder.
- •5.5 History of adrenal insufficiency.
- •5.6 Significantly impaired hepatic function
- •5.7 Renal failure, defined as any prior dialysis or an estimated glomerular filtration rate
- •(eGFR) below 60 mL/min per 1.73 m2 using CKD-EPI formula (Levey et al, 2009)
- •5.8 History of cardiac arrhythmia
- •6. Known microvascular (diabetic) complications, including active proliferative diabetic
- •retinopathy or macular edema, active non-proliferative retinopathy, diabetic nephropathy
- •including active retinopathy, gastroparesis or neuropathy.
- •7. Currently receiving any of the following therapies, or likely to need such treatment during
- •the follow-up period of this study:
- •7.1 Immunosuppressant therapy
- •7.2 Chemotherapy for any form of cancer
- •7.3 Anti-coagulant therapy (e.g. Plavix, LMW heparin, coumadin)
- •7.4. Chronic systemic glucocorticoids (excluding topical, optical or nasal, but including
- •7.5. Antibiotic treatment for chronic infection (e.g. osteomyelitis)
- •8. Magnesium <1.6 mg/dL at screening.
- •9. Potassium <3.4 mmol/L at screening.
- •10. Hematocrit >50% or <30% at screening.
- •11. Topical or local anesthetic allergy.
- •12. Known current or recent alcohol or drug abuse by subject history.
- •13. Participation in another clinical investigation within 30 days preceding screening, or
- •intention to participate in any other clinical investigation during the period of this study.
- •14. The presence of any other active implanted device, whether turned on or off. Passive
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研究者
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