A Randomized Trial of Preventive Care System Application Effectiveness on the Treatment of Diabetic Patients in Bandung
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- PT Bio Farma
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- HbA1C Changes
研究概览
简要总结
Randomized, unblinded, controlled, two arms parallel group, prospective intervention study
详细描述
The objective of the study is to compare the progression of HbA1c in diabetic patients after applying a Medwell digital application in addition to regular diabetes treatment (treatment arm) with regular diabetes treatment of diabetic subjects alone (control arm).
The primary endpoint will be measured as the difference between 3 months HbA1c relative to baseline in eligible subjects. Normally, HbA1c in each subject is expected to either stable or slightly increase overtime. In this study we are interested in measuring the difference in HbA1c 3 months post randomization. It is expected that in the experimental arm, HbA1c will slightly decrease, while in the standard arm, HbA1c will either remain the same or will slightly increase after 3 months in the study. Previous study shows that the standard deviation of the difference in HbA1c within 1 year is 0.97%.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are in the diabetes type 2 status (based on Perkeni standard) HbA1c is ≥6.5%
- •Aged 18 - 60 years old
- •Have compatible smartphone (minimum android 8 or iOS 13) and internet connection
- •Receiving regular diabetes treatment
- •Giving consent and commitment to participate in the study until finish
- •Located in Bandung Area within the treatment period (up to 3 month after receiving the treatment)
- •Subject is determined to be able to complete daily physical activities.
排除标准
- •Pregnant (based on test pack)
- •Participation in other weight loss program
- •Use of other tracking application
- •Having any abnormalities that affecting blood erythrocyte age defined by laboratory examination
- •Have other severe diabetic complications that prevent subjects from participating in the prescribed program (Such as stroke, cardiac diseases (CHF stage III-IV), COPD or asthma with acute exacerbation and other respiratory diseases, peripheral artery disease, CKD stage 3-5) and other severe diseases that by the investigator's judgment, could not participate in this study
结局指标
主要结局
HbA1C Changes
时间窗: 3 months
Change in HbA1c from baseline to month 3 for all groups. Change in HbA1c from baseline to month 3 for all groups. Change in HbA1C from baseline to moth 3 of all group
次要结局
- Drug Adherence(3 months)
- Anthropometry II (Body Fat)(3 months)
- Lab outcome II (2 hours post prandial glucose)(3 months)
- Lab outcome V (high density lipoprotein)(3 months)
- Lab outcome VI (triglyceride)(3 months)
- Lab outcome I (Fasting glucose)(3 months)
- Anthropometry III (Muscle Mass)(3 months)
- Lab outcome III (total cholesterol)(3 months)
- Lab outcome IV (low density lipoprotein)(3 months)
- Anthropometry I (BMI)(3 months)
- Evaluate the exercise(3 months)