NCT03997331Unknown不适用
A Phase 1, Randomized Controlled Trial of the Chronicare Disease Management Program in Subjects With Type 2 Diabetes (Chronicare-T2D)
QuiO2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
This single-blind, single-center, randomized, controlled trial is designed to evaluate the utility of the Chronicare Disease Management Program in the management of subjects with T2D who are being treated with insulin glargine and metformin. The Chronicare Solution comprises connected devices (a Bluetooth-enabled insulin pen sensor, a Bluetooth-enabled medication container, and a Bluetooth-enabled glucometer), a mobile smartphone app (CRx Health), an automated support system (Intervention Engine), and a remote care application (CRx Care) used by a team of clinicians to monitor and support patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Male and female subjects between 18 and 75 years of age, inclusive, at Screening.
- •Diagnosed with T2D
- •Have a baseline HbA1c level between 7.5% and 10.0%, inclusive, while receiving insulin glargine and metformin.
- •Prescribed insulin glargine and an oral diabetes medication for ≥ 6 months prior to Screening.
- •The ability to follow an evening dosing schedule for insulin glargine.
- •Have an eGFR level >30 L/min, inclusive, according to their most recent measurement.
- •If female, must be post-menopausal or surgically sterile, or be established on (≥ 3 months prior to Screening) and agree to continue to use the same highly effective method of birth control throughout the study. Females must agree to avoid pregnancy during their participation in the study.
- •Able to comprehend and give informed consent.
- •Able to comply with the requirements of the study, which include being able to speak and read English, and to complete the full sequence of protocol-related procedures.
排除标准
- •Females who are pregnant (positive pregnancy test at Screening), lactating, or if having reproductive potential, are considered potentially unreliable with respect to contraceptive practice.
- •Have type 1 diabetes.
- •Have had or have a malignant neoplasm within the past five years.
- •Undergoing chronic or recurrent treatment with systemic corticosteroids or niacin treatment for hyperlipidemia.
- •Use of one or more of the following agents affecting glycemic control:
- •mifepristone, GLP-1RA, or any insulin other than insulin glargine.
- •Concurrent treatment with experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half-lives, whichever is greater, prior to study start.
- •Unable or unwilling to follow the evening insulin glargine regimen required by the titration protocol (once daily dose must be scheduled between 5pm and 12am).
- •Blood transfusions or severe blood loss in the last 3 months.
- •Any other unspecified reason that, in the opinion of the Investigator (or designee) or Sponsor, makes the subject unsuitable for enrollment.
- •Active diagnosis of hypoglycemic unawareness.
- •Hypoglycemia (blood glucose <70 mg/dl with or without symptoms) greater than one episode per week (on average)
结局指标
主要结局
Change in HbA1c
时间窗: Day 0 - Day 120
The primary endpoint is the difference in the reduction in HbA1c for each subject by treatment group (Intervention vs. Control), assessed by the mean reduction across all subjects in each treatment group.
次要结局
- Fasting Blood Glucose(Day 0 - Day 120)
- Mean Duration of Time to Reach Optimal Insulin Glargine Dose(Up to 120 days)
- Proportion of Patients Reaching Optimal Insulin Glargine Dose(Day 120)
- Median Adherence to Insulin Glargine(Day 0 - Day 120)
- Median Adherence to Metformin(Day 0 - Day 120)
研究者
研究点 (2)
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