InPen User Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Endpoints are exploratory and descriptive related to time in glycemic range.
研究概览
简要总结
The purpose of this study is to evaluate the user experience of InPen™ with InPen™ Diabetes Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of a future pivotal study.
详细描述
This study is a multi-center, single arm study in insulin-requiring adult subjects with type 1 diabetes treated with MDI (basal and bolus) therapy.
The total study duration will be approximately 10 weeks long for each participant.
The study consists of a run-in (phase 1) and study phases 2, 3 and 4.
Phase 1:
The purpose of the run-in phase is to collect baseline HbA1c and blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current MDI therapy.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged 18-75 years at time of screening
- •Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥1 year prior to screening
- •Subject has a clinical diagnosis of type 1 diabetes for 1 year prior to screening
- •Subject has a Glycosylated hemoglobin (HbA1c) less than 10% as assessed by local lab <15 days prior to screening or at time of screening visit
- •Subject is on MDI therapy with
- •Continuous Glucose Monitoring (CGM), or
- •Intermittent Scanning CGM (iscCGM)
- •Subject is willing to upload data from a BG meter, must have internet access and a compatible computer system that meets the requirements for uploading data at home.
- •Subject is willing and able to sign and date informed consent, comply with all study procedures, and wear all study devices, as required during the study.
- •Subject is willing to take or switch to one of the following insulins:
- •Humalog™* (insulin lispro injection)
- •NovoLog™* (insulin aspart)
排除标准
- •Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
- •Women who are breastfeeding.
- •Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- •Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.
- •Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
- •Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- •Subject is legally incompetent, illiterate or vulnerable person.
- •Research staff involved with executing the study.
结局指标
主要结局
Endpoints are exploratory and descriptive related to time in glycemic range.
时间窗: Above endpoints will be categorized by daytime and night-time and overall (24hour).
Percentage of Time spent within range with sensor glucose (SG) between 70-180 mg/dL (3.9-10.0 mmol/L)
次要结局
未报告次要终点