Use of the Guardian™ Connect System With Smart Connected Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 14
- 主要终点
- Percentage of Time in Hyperglycemia
研究概览
简要总结
The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitoring in subjects with insulin requiring diabetes 2-80 years of age.
详细描述
The study is a multi-center, prospective single-arm design without controls. All subjects will participate for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older will participate for up to 9 months (Phase 2). All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.
The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is 2-80 years of age at time of consent.
- •A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator for:
- •at least the last 6 months for subjects 2-6 years of age
- •at least the last 12 months for subjects 7-80 years of age
- •Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing and can afford to use insulin pen(s) and pen cartridge(s).
- •Subject is currently using or is willing to use the Guardian Connect system during the study.
- •Subject agrees to comply with the study protocol requirements.
- •For adult subjects: Subject is capable of providing legal consent without a legal authorized representative.
排除标准
- •Subject is using a syringe and unwilling or unable to use insulin pen(s).
- •Subject is using an insulin pump.
- •Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian Connect system during the study.
- •Subject is using hydroxyurea at time of screening or plans to use it during the study.
- •Subject will not tolerate tape adhesive in the area of device placement as assessed by a qualified provider.
- •Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection).
- •Subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), other than this study, wherein they have received treatment from an investigational drug or device.
- •Subject has a positive urine pregnancy test at time of screening.
- •Subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study.
- •Subject is unwilling to participate in study procedures.
- •Subject is directly involved in the study as research staff.
研究组 & 干预措施
Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens
All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.
干预措施: Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app (Device)
结局指标
主要结局
Percentage of Time in Hyperglycemia
时间窗: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in hyperglycemia (SG \> 180 mg/dL)
Percentage of Time in Hypoglycemia
时间窗: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in hypoglycemia (SG \< 70 mg/dL)
Percentage of Time in Euglycemia
时间窗: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in euglycemia (SG 70-180 mg/dL)
次要结局
未报告次要终点