Study to Evaluate the Efficacy of a Doctor-led Digital Diabetes Program Aided by a Data-driven Coaching Intervention Process in Achieving Better Glycemic Control in Uncontrolled Type II Diabetics
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the glycaemic levels (HbA1c, FBG, PPBG) in uncontrolled type II diabetes patients being managed by conventional treatment compared to those being managed nutritional ketosis using a connected digital health platform
研究概览
简要总结
Type II Diabetes is a lifestyle relateddisease that is fast becoming an epidemic in India with 69.1 million affectedpeople in 20151.With a cost of 94.9 USD per person1this disease is poised to become a big economic burden for the not onlyindividuals but also society at large. Achieving better glycaemic control andavoiding complications remains one of the most relevant goals of any diabetesmanagement program. In this fast evolving world of digital technologies,chronic disease care is also poised for a revolution. In the field of diabetescare also several studies have shown that mobile phone interventions led tostatistically significant improvement in glycaemic control and self- managementprogram. Despite advances in treatment of diabeteslike novel drugs and insulin analogues for the treatment of diabetes, thecomplications that arise due to diabetes have not reduced. Diet is one of themost crucial elements in the management of diabetes. Nutritional ketosis as adietary intervention has shown promise to help with diabetes control. Butfollowing through with a keto diet requires constant support from amultidisciplinary team of clinical nutritionists and medical doctors for it tobe adequately safe. Connected digital technology has been shown to improve carecoordination and provide a continuum of care while making real-time dataavailable for decision making. Through this study, we evaluate if a structurednutritional ketosis program delivered through a digital health platform iseffective in reducing HbA1c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Type II Diabetes Mellitus subjects of either sex aged 18 to 65years.
- •HbA1c value greater than 7.0%.
- •Subjects able to provide written informed consent.
- •Subjects using android mobile.
- •Agree to follow Keto/T2DM diet and use Keto calculator app.
- •If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable for past 3 months prior to baseline and throughout the study.
排除标准
- •Subjects with deteriorating health status at the time of enrolment; rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhoea, gastro-intestinal disease, irritable bowel syndrome).
- •Recent blood donation (within 3 months from the date of screening).
- •Immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection).
- •Pregnant or breast feeding women.
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.
- •Any contraindication to blood sampling.
结局指标
主要结局
To compare the glycaemic levels (HbA1c, FBG, PPBG) in uncontrolled type II diabetes patients being managed by conventional treatment compared to those being managed nutritional ketosis using a connected digital health platform
时间窗: 3 months
次要结局
- To compare weight loss, Body mass index changes, Insulin and medication requirement, compliance to prescribed medication, visit and lab test schedule between the above two groups at the end of a three-month period(3 months)