NCT02897557已完成不适用
A Prospective Early Feasibility Study to Assess the Performance of the Insulet Artificial Pancreas (AP) System Using the OmniPod® Insulin Management System and the Dexcom G4® Share™ AP System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Percentage of time in hypoglycemic range (defined as <70 mg/dL)
研究概览
简要总结
The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be included in the study:
- •Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years
- •Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.
- •Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day and A1C > 6% at screening
- •Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump for at least 6 months prior to start of study
- •Willing to use the study CGM device for one week prior to study start and for the duration of the study
- •Willing to use the OmniPod® Insulin Management System during the study
- •Willing to perform all SMBG testing with the study-approved glucose meter at the frequency specified in the study protocol
- •Willing to abide by meal recommendations for breakfast, lunch and dinner during the study
- •Willing to refrain from use of acetaminophen, pseudoephedrine, and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study
- •Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF. Subjects aged ≥ 8 years will be asked to sign an assent form.
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •A1c >10% at the Screening visit
- •One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
- •Hypoglycemic unawareness as determined by a score of 4 or more "R" responses on the Clarke Questionnaire
- •One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
- •Used non-insulin anti-diabetic medication within last 30 days
- •Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
- •Dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor on the abdomen
- •Known history of myocardial infarction (MI) or stroke within the past 6 months
- •Known history of seizure disorder
- •Known history of adrenal insufficiency
- •Current renal or hepatic disease
- •Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)
- •Currently undergoing cancer treatment
- •Currently undergoing systemic treatment with steroids or immunosuppressive medication
- •History of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants
- •Current illness that would interfere with participation in the study
- •Untreated or inadequately treated mental illness
- •Current alcohol abuse per investigator's judgment
- •Electrically-powered implants that may be susceptible to RF interference
- •Currently participating in another clinical study testing an investigational drug or device or participation in a clinical study during which an investigational drug was used within the preceding 30 days
- •Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.
研究组 & 干预措施
Single Cohort in CRC
Experimental
This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting.
干预措施: Insulet Artificial Pancreas (AP) System (Device)
结局指标
主要结局
Percentage of time in hypoglycemic range (defined as <70 mg/dL)
时间窗: 36 hours
Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL)
时间窗: 36 hours
次要结局
- Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL)(36 hours)
- Percentage of time < 50 mg/dL(36 hours)
- Percentage of time >/= 300 mg/dL(36 hours)
- Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL)(36 hours)
- Mean glucose(36 hours)
- Percentage of time < 60 mg/dL(36 hours)
- Percentage of time > 180 mg/dL(36 hours)
- Standard deviation and coefficient of variation of CGM values(36 hours)
研究者
研究点 (4)
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