A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
Randomized, controlled, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.
详细描述
The study intervention, BT-001 (the App), will be dispensed at enrollment to the Immediate Intervention App Use arm of the trial. Patients randomized to the Delayed Intervention App Use arm will be provided a "control App" with diabetes control, and then the BT-001 App after 180 days. Each participant is assigned to one 90-day treatment cycle of BT-001. Over the 12-month intervention period, study participants will be able to opt into up to 3 additional treatment cycles of BT-001. Study schema is included at the end of this section
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
盲法说明
open label
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
- •Current (within 3 months prior to enrollment) HbA1c >=7.01%
- •Possession of and ability to use Android or iPhone mobile phone
- •Speaks and reads in English
- •Willing to measure frequent fasting finger glucose measurements as part of the App utilization
排除标准
- •Current use of insulin other than a long-acting insulin analogue or human NPH insulin
- •HbA1c >=11%
- •Cognitive impairment or degenerative neuropsychiatric condition (e.g. Alzheimer's, dementia, mixed dementia, other significant memory loss, schizophrenia), or any other condition that in the Investigator's opinion may prevent patient from completing study activities
- •Any terminal medical condition with life expectancy of < 1 year.
结局指标
主要结局
Change in HbA1c
时间窗: Baseline and Day 180
Change in HbA1c from baseline (enrollment) to 6 months after enrollment between groups.
次要结局
- Change in HbA1c(Baseline and day 180, 365)
- Significant change in HbA1c(Baseline and Day 365)