NCT02974816已完成不适用
The Glooko Diabetes Mobile Monitoring and Management Advantage Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Glooko
- 入组人数
- 197
- 试验地点
- 8
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
The purpose of this study is to compare HbA1c of insulin-treated subjects with type 2 diabetes managed via usual care alone and usual care augmented with remote monitoring using Glooko
详细描述
In this study, the investigator wants to evaluate if diabetes self-management supported by a mobile application, which captures a subject's blood glucose readings, lifestyle and medication information and shares it with the subject's certified diabetes educator (CDE) to enable remote monitoring, improves their glycemic control compared to standard of care.
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
- •Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act (HIPAA) or other privacy authorization prior to any participation in study.
- •Subject has self-reported type 2 diabetes.
- •Subject has HbA1c ≥ 7.5% and ≤ 12.5% measured within 30 days of screening visit.
- •Subject is on a stable diabetes therapeutic regimen of two or more diabetic medications (e.g., metformin plus one other antihyperglycemic agent) and/or insulin therapy for at least 2 months before screening visit. Dose changes or adjustments made within 2 months is acceptable as long as the patient has been on the medication regimen for 2 months or longer.
- •Subject is ≥ 18 and ≤ 75 years of age.
- •Subject is a male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- •If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study):
- •Condoms, sponge, diaphragm, or intrauterine device;
- •Oral or parenteral contraceptives for 3 months prior to screening visit;
- •Vasectomized partner;
- •Total abstinence from sexual intercourse
- •Subject is able to speak, read and write in English
- •Subject has a Glooko compatible smartphone/device with an active data plan or access to Wi-Fi and downloaded at least one mobile application on their phone on their own.
- •Subject has performed self-monitoring of blood glucose at least five (5) times within two (2) weeks prior to screening visit.
排除标准
- •Subject has type 1 diabetes.
- •Subject has advanced disease (physical or psychological) that would prevent them from being able to comply with study tasks and considered exclusionary by the study physicians.
- •Subject has been on medication or therapy within the last 2 months that severely affects blood glucose levels (e.g. corticosteroids).
- •Subject has visual impairment which severely limits his/her ability to see or use the mobile application.
- •Subject is a participant in another clinical study that has not been approved as a concomitant study by Glooko.
结局指标
主要结局
Change in HbA1c from baseline
时间窗: 24 weeks
Change in HbA1c from baseline
次要结局
- Number of ER visits(Change from baseline)(12 and 24 weeks)
- Bolus insulin dose(Change from baseline)(12 and 24 weeks)
- Number of hospitalizations(Change from baseline)(12 and 24 weeks)
- Percentage of patients achieving </=7%(12 and 24 weeks)
- Weight(Change from baseline)(12 and 24 weeks)
- Mean blood glucose concentration(Change from baseline)(12 and 24 weeks)
- Basal insulin dose(Change from baseline)(12 and 24 weeks)
- Change in HbA1c from baseline(12 weeks)
- Problem Areas in Diabetes score(Change from baseline)(12 and 24 weeks)
- Change in Total insulin dose(Change from baseline)(12 and 24 weeks)
- Self-monitoring blood glucose frequency(12 and 24 weeks)
- Rate of hypoglycemic events (blood glucose level <70mg/dL)(12 and 24 weeks)
研究者
研究点 (8)
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