NCT06604871已完成不适用
Safety Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM in Children 2-6 Years of Age
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 16
- 主要终点
- Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL)
研究概览
简要总结
The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects (2-6 years of age) in a home setting.
详细描述
This study is a multi-center, single arm study in insulin-requiring pediatric subjects with type 1 diabetes on the MiniMed 780G system using DS5. The run-in period and study period, together, will be approximately 130 days long.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-6 years at time of screening.
- •Has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
- •Parent(s)/guardian(s) is/are literate and able to read the language offered in the pump or pump materials.
- •Subject or parent(s)/guardian(s) is/are willing to provide informed consent for participation.
- •Is willing to perform fingerstick blood glucose measurements as needed.
- •Is willing to wear the system continuously throughout the study.
- •Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 6 units on average.
- •Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
- •Note: All HbA1c blood specimens will be collected via fingerstick and sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
- •Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.
- •Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study per manufacturers labeling:
- •Humalog (insulin lispro injection)
- •Authorized generic insulin lispro
- •NovoLog (insulin aspart injection)
- •Authorized generic insulin aspart
- •Admelog (insulin lispro injection) - for subjects aged 3 years and older only
- •Has 1 month or more of CGM experience at time of screening.
- •If subject has been diagnosed with hyperthyroidism or hypothyroidism, he/she must have a TSH within 3 months prior to screening or at time of screening.
排除标准
- •Has a history of 1 or more episodes of severe hypoglycemia during the 3 months prior to screening.
- •Has been hospitalized or has visited the emergency room (ER) in the 3 months prior to screening resulting with a primary diagnosis of uncontrolled diabetes.
- •Has had DKA in the last 3 months prior to screening visit.
- •Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
- •Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- •Has diagnosis of adrenal insufficiency.
- •Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
- •Is using hydroxyurea at time of screening or plans to use it during the study.
- •Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
- •Is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
- •Parent(s)/guardian(s) has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
- •Has elective surgery planned that requires general anesthesia during the course of the study.
- •Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
- •Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
- •Is diagnosed with current eating disorder such as anorexia or bulimia.
- •History of chronic renal disease or currently on hemodialysis
- •Has hemophilia or any other bleeding disorder.
- •Has celiac disease that is not adequately treated as determined by the investigator.
- •Has a cardiovascular condition which the investigator determines must exclude the subject.
- •Has hyperthyroidism or hypothyroidism that is not adequately treated as determined by the investigator.
- •Is an immediate family member of a Medtronic Diabetes employee.
结局指标
主要结局
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL)
时间窗: Last 6-7 weeks of study period.
Percent of Time in Range (TIR 70-180 mg/dL). Descriptive only.
Primary Safety Endpoints - Incidence of Adverse Events
时间窗: Through study completion, approximately 18 months.
The safety data associated with diabetes management will be summarized: * Serious Adverse Events (SAE) * Serious Adverse Device Effects (SADE) * Unanticipated Adverse Device Effects * Incidence of Severe Hypoglycemia * Incidence of Severe Hyperglycemia * Incidence of DKA The details of all AEs will also be presented under Reported Adverse Events in ClinicalTrials.gov.
次要结局
未报告次要终点
研究者
研究点 (16)
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