A-One: A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop | Premium 'On Track' in combination with Afrezza treatment on the glycemic control, treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) > 7.0% already prescribed an injectable rapid-acting insulin.
详细描述
Eligible participants (N=400) with an A1c > 7.0% already prescribed a rapid-acting insulin will be randomized to one of two groups: (1) One Drop | Premium 'On Track' (i.e., use the One Drop | Mobile app with in-app diabetes education accredited by the American Diabetes Association with supplemental Afrezza content and a live Certified Diabetes Educator messaging in the app, the 'Chrome' Bluetooth-connected blood glucose meter that uploads blood glucose values in the app, and 150 test strips per month) in combination with Afrezza treatment (n=200) or (2) One Drop | Premium 'On Track' plus their current rapid-acting insulin (n=200).
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
- 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
- •18-75 years of age
- •Self-reported diagnosis of T2D
- •Diagnosed with diabetes for at least 12 months
- •Prescribed a prandial rapid-acting insulin
- •Willing to take Afrezza rapid-acting insulin for 3 months instead of current rapid-acting insulin
- •Willing to get a physician's prescription for Afrezza
- •Self-reported A1c > 7.0% (later confirmed with a mail-in A1c laboratory test)
- •Owns and uses an iPhone or Android phone with an operating system compatible with the One Drop | Mobile app
- •Has successfully downloaded and used a smart phone application previously
排除标准
- •Currently pregnant or planning to become pregnant during the trial period
- •Cannot read or write in English
- •Currently in a diabetes education or coaching program
- •Had previously used One Drop | Premium or One Drop |
- •Experts coaching
- •Had previously used or is currently using Afrezza
- •Currently smokes (cigaretts, e-cigs, pipes, cigars, marijuana) or has smoked anytime in the past 6 months
- •Has chronic lung disease, e.g., COPD and asthma
研究组 & 干预措施
One Drop | Premium with Afrezza
干预措施: Afrezza plus One Drop | Premium (Drug)
One Drop | Premium without Afrezza
干预措施: One Drop | Premium (Other)
结局指标
主要结局
Hemoglobin A1c
时间窗: 3 months
3-month between-group change in A1c assessed by a central lab
次要结局
- Health-related Productivity(3 months)
- Health-related Quality of Life(3 months)
- Insulin Device Satisfaction(3 months)
- Treatment Adherence(3 months)
- Self-care(3 months)
研究者
Chandra Osborn, PhD, MPH
Vice President, Health & Behavioral Informatics
Informed Data Systems, Inc.