Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 30
- 主要终点
- 7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog
研究概览
简要总结
The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).
Participants will be asked to:
- Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
- Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour
详细描述
This is a multi-center, single-arm, prospective study of an extended wear infusion set in adults with Type 1 diabetes using a Tandem t:slim X2 insulin pump with Control-IQ technology with continuous Glucose Monitoring (CGM). Up to 300 participants across the United States age 18-80 will be enrolled in up to 20 investigational centers. Participants will change insulin cartridge every 48 to 72 hours as recommended by their health care provider. Participants will be expected to participate in the study for approximately 12-16 weeks.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Age 18 to 80 years old inclusive
- •Generally in good health, as determined by the investigator
- •Living in the United States with no plans to move outside the United States during the study
- •Diagnosis of T1D for at least 12 months
- •Minimum of 6 months of insulin pump experience and at least 3 months of current experience with a Tandem pump
- •Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment
- •Minimum of 14 days of Control-IQ data immediately preceding screening that demonstrate pump use compliance, including at least 85% of time with Control-IQ technology active
- •HbA1c <9.0% in the last 6 months.
- •Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study
- •Willing to wear each investigational infusion set for up to 7 days during each of the 12 consecutive wear periods in the study
- •Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips
- •Access to internet for required periodic uploads of study device data
- •BMI in the range 18-35 kg/m2, both inclusive
- •Currently using one of the following insulins with no expectation of a need to change insulin type during the study:
- •Humalog™* (insulin lispro)
- •NovoLog™* (insulin aspart)
- •Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 month at the time of enrollment
- •Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
- •Has routine access to a smart phone e.g., ability to receive text messages
- •Has the ability to understand and comply with protocol procedures and to provide informed consent (i.e., English proficient in both verbal and written communication)
排除标准
- •Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
- •Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception
- •Episodes of severe hypoglycemia in the last 6 months resulting in:
- •Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)
- •Loss of consciousness
- •One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization
- •Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, or intending to begin one during the study period
- •Known cardiovascular disease considered to be clinically relevant by the investigator
- •Known history of any of the following conditions:
- •Cushing's Disease
- •Pancreatic islet cell tumor
- •Lipodystrophy
- •Extensive lipohypertrophy, as assessed by the investigator
- •Currently undergoing treatment with:
- •Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening),
- •Thyroid hormones, unless use has been stable during the past 3 months
- •Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:
- •Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results
- •Current participation in another clinical drug or device study
- •Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is a study site personnel directly affiliated with this study or who is an employee of Capillary Biomedical
结局指标
主要结局
7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog
时间窗: 12 weeks
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Humalog.
7 Day Survival of Infusion Set for Primary Outcome Measure - Novolog
时间窗: 12 weeks
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Novolog.
7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog
时间窗: 12 weeks
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Humalog.
7 Day Survival of Infusion Set for Primary Outcome Measure - Novolog
时间窗: 12 weeks
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Novolog.
次要结局
未报告次要终点