Connected Pens for Diabetes Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- CGM time in range
研究概览
简要总结
The objective of the study is to evaluate the impact of a wireless smart insulin pen and smartphone-based bolus advisor on clinical and psychosocial outcomes in insulin-treated diabetes mellitus patients after 3 months of use.
详细描述
The study is a prospective, randomized, controlled treatment design. The study device will be used for multiple daily injection (MDI) therapy of insulin. The participant will interact with the study device in the uncontrolled environment of the participant's daily life. The study protocol is designed to yield meaningful data to determine clinical and psychosocial benefits of using the study device. The study will evaluate the study device as an intervention versus a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants in the control arm will use a blinded device. All participants will be blinded to baseline time-in-range and HbA1c measures. Investigators will be blinded to professional CGM baseline time-in-range.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is ≥ 18 years of age
- •The participant has Type 1 OR Type 2 diabetes and is being treated with intensive insulin therapy via injection for ≥ 3 months. Intensive insulin therapy is defined as at least one long acting insulin dose and two or more short acting insulin doses per day.
- •Glycated hemoglobin (HbA1c) ≥ 7.5%).
- •The participant is a current iPhone user for over 30 days.
- •Participant adjusts meal insulin doses based on carbohydrate content of meals.
- •The participant is fluent in the English language.
- •The participant and the investigator understand participant obligations and agree that the participant is willing and able to complete the study visits.
- •Patients prandial insulin need must be <30 U per meal.
排除标准
- •The participant has been using unblinded CGM for less than 6 months.
- •The participant uses pre-mixed insulin.
- •Current use of a smart insulin pen.
- •Use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose results
- •Used systemic oral or inhaled steroids for more than 7 days within the last 3 months
- •Oral anti-diabetic agents, with the exception of metformin
- •Injectable anti-diabetic agents other than insulin
- •The participant is legally blind or has below specified best-corrected vision level.
- •Diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at Investigator's discretion)
- •The participant is pregnant, lactating, or plans to become pregnant in the next 6 months.
- •The participant is currently participating in another clinical study that may preclude the participant from meeting the obligations of this study.
- •The participant has any additional condition(s) (medical, social, or psychosocial) that in the investigator's opinion would warrant exclusion from the study or prevent the participant from completing or complying with the study requirements.
结局指标
主要结局
CGM time in range
时间窗: 3 months
Percent CGM time in range (70-180 mg/dL) at 90 days, measured over 14 day period
次要结局
- Change in patient reported outcomes - DTSQ(3 months)
- Change in patient reported outcomes - IDSS(3 months)
- Change in patient reported outcomes - HCS(3 months)
- Absolute change in HbA1c(3 months)
- Mean sensor glucose (mg/dL)(3 months)
- Percent CGM time spent in hypoglycemia (70-54 mg/dl, < 54 mg/dL)(3 months)
- Percent CGM time spent in hyperglycemic range (>180 mg/dl, >250 mg/dL)(3 months)
- Change in patient reported outcomes - ADDQoL(3 months)