Fit-One: A Randomized Waitlist Controlled Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The Fit-One trial involves three prospective, randomized waitlist-controlled studies. These studies evaluate the effects of One Drop's digital therapeutics solution with and without Fitbit devices on the social cognitive, behavioral, and health outcomes of people with diabetes. Fit-One is being tested on adults with type 1 diabetes (T1D) of all weights, and adults with type 2 diabetes (T2D) or pre-diabetes that are overweight or obese (BMI ≥ 25).
详细描述
Sub-study 1 (T2D). Eligible participants (N=300) with T2D, an A1c above 7.0% and Body Mass Index (BMI) ≥ 25 will be randomized to one of three groups. Participants assigned to group 1 (n=100) get One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=100) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch. Finally, participants assigned to group 3 (n=100) are asked to manage their diabetes without an app, coach, or activity tracker for 3 months. After 3 months, group 3 gets One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic smartwatch (n=100).
Sub-study 2 (T1D). Eligible participants (N=100) with T1D and an A1c above 7.0% will be randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's digital therapeutics solution (app, meter, and 'On Call' in-app coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch.
Sub-study 3 (Pre-diabetes). Eligible participants (N=100) with pre-diabetes, an A1c between 5.7-6.4% and a BMI ≥ 25 will be randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's digital therapeutics solution ('Revive' in-app coaching) and a Fitbit Charge 2 and are asked to use both for 3 months. Participants assigned to group 2 (n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Charge 2.
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
- •U.S. residency and mailing address
- •Self-reported diagnosis of T1D, T2D, or pre-diabetes
- •For people with a diabetes diagnosis, diagnosed for 1+ years
- •For people with a diabetes diagnoses, self-reported A1c ≥ 7.0% (later confirmed with a mail-in A1c laboratory test)
- •For people with a pre-diabetes diagnoses, self-reported A1c 5.7-6.4% (later confirmed with a mail-in A1c laboratory test)
- •For people with T2D or pre-diabetes, BMI ≥ 25
- •Owns and uses an iPhone or Android phone
- •No cardiovascular problems
- •No neuromuscular problems
- •No orthopedic problems
- •Doctor is ok with increased physical activity
- •English-speaking
- •Naïve to One Drop's digital therapeutics solution
- •Naïve to all Fitbit products
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
- •Previously downloaded the One Drop | Mobile app
- •Owns or previously used Fitbit products
研究组 & 干预措施
T1D: One Drop without Fitbit Ionic
干预措施: One Drop | Experts On Call (Behavioral)
PD: One Drop with Fitbit Charge 2
干预措施: One Drop | Experts Revive (Behavioral)
PD: One Drop without Fitbit Charge 2
干预措施: One Drop | Experts Revive (Behavioral)
T2D: One Drop with Fitbit Ionic
干预措施: One Drop | Experts On Track (Behavioral)
T2D: One Drop without Fitbit Ionic
干预措施: One Drop | Experts On Track (Behavioral)
T2D: Waitlist Control
T1D: One Drop with Fitbit Ionic
干预措施: One Drop | Experts On Call (Behavioral)
结局指标
主要结局
Hemoglobin A1c
时间窗: 3 months
Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months.
次要结局
- Physical Activity(3 months (12 months for Sub-study 3))
- Medication Adherence(3 months (12 months for Sub-study 3))
- Healthcare Utilization(3 months (12 months for Sub-study 3))
- Weight(3 months (12 months for Sub-study 3))
- Diet(3 months (12 months for Sub-study 3))
- Self-Monitoring of Blood Glucose(3 months)
研究者
Chandra Osborn, PhD, MPH
VP, Health & Behavioral Informatics
Informed Data Systems, Inc.