mHealth Insulin Titration and Management (iSage)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of participants meeting HgbA1c <7%
研究概览
简要总结
The purpose of this study is to determine the benefits of using the iSage app for basal insulin titration and support. By doing this study the investigators hope to learn whether the app improves the participant's ability to follow his/her healthcare provider's instructions to adjust his/her insulin doses.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Type 2 Diabetes, based on the World Health Organization (WHO) criteria, treated with basal insulin
- •HbA1c 8-11% inclusive
- •Glomerular filtration rate (GFR) > 60 ml/min
- •Has an Android or iOS based compatible smartphone (iOS 9.0 or above, Android 4.4 or above)
- •Willing to perform at least 1 fasting finger stick glucose measurements every morning
- •English speaking
排除标准
- •Diagnosis of hypoglycemic unawareness
- •Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
- •Recent (within the last 6 months)/current use of non-topical steroids
- •Insulin requirements in excess of 1 U/kg per day
- •Use of pioglitazone or another thiazolidinedione (TZD)
- •In the opinion of the provider, HgbA1c goals should be adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.
研究组 & 干预措施
iSage for adjustment of insulin
The provider will prescribe the iSage app to the subject and choose a treatment algorithm within the app to make insulin dose adjustments.
干预措施: iSage (Other)
Conventional management
Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet.
结局指标
主要结局
Number of participants meeting HgbA1c <7%
时间窗: 90 days
The investigators will calculate the percent of patients achieving HgbA1c \<7% at day 90.
Concentration of HgbA1c
时间窗: 90 days
The investigators will compare changes in HgbA1c from baseline to day 90.
次要结局
- Hypoglycemia(90 days)
- Sustained use of the iSage app (iSage group only)(90 days)