NCT03980236终止不适用
Feasibility of Using the Insulia App in an Integrated Platform With Livongo for Patients With Type 2 Diabetes Treated With Basal Insulin [Pilot Study]
Livongo Health1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年5月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in A1c
研究概览
简要总结
The Livongo-Insulia Study App Pilot Study (LISA Pilot) is a 3-month, prospective, interventional study. The purpose of this pilot study is to evaluate the feasibility of using the Livongo-Insulia Study App for individuals with type 2 diabetes using basal insulin. This will be assessed by measuring the impact of the Livongo-Insulia Study App on glycemic control for these individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Lives in the U.S.
- •Able to speak, read and write in English
- •Diagnosed with type 2 diabetes
- •Currently treated with long-acting basal insulin analog (Lantus, Levemir, Toujeo, Basaglar, Tresiba U-100) and taking 1 injection per day
- •Takes a daily dose ≤ 0.75 units/kg
- •Estimated A1c ≥ 8% (based on existing Livongo data)
- •Has been enrolled in Livongo for at least 12 weeks
- •Uses an iPhone compatible with Insulia's compatibility matrix (iPhone 5 or higher; iOS 8 or newer)
- •Willing to complete study questionnaires
- •Willing to complete at-home A1c kits
- •Willing to check before breakfast blood glucose at least once per day
排除标准
- •Diagnosis of type 1 diabetes
- •Currently using a long-acting basal insulin analog that is not supported by Insulia
- •Currently using rapid-acting, short-acting, or intermediate-acting or premixed insulins
- •Currently pregnant or planning pregnancy
研究组 & 干预措施
Livongo-Insulia Study App Arm
Experimental
Participants will be asked to use the Livong-Insulia Study App for the 3 month study duration
干预措施: Livongo-Insulia Study App (Device)
结局指标
主要结局
Change in A1c
时间窗: 12 weeks
Change in A1c from baseline to 12 weeks
次要结局
未报告次要终点
研究者
Bimal Shah, MD
Co-Principal Investigator
Livongo Health
研究点 (1)
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