CTRI/2024/05/068043尚未招募Unknown
A prospective open-label, multi-centre study to evaluate the effectiveness of personalized coaching program when compared to the standard of care in the management of type 2 diabetes
Ragus Healthcare Private Limited4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月18日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- â—Improvement in HbA1c levels
研究概览
简要总结
| Diabetes mellitus poses a significant global healthcare challenge, with persistently high and increasing prevalence in India and worldwide. Maintaining effective glycemic control is crucial for preventing complications and improving the quality of life for individuals with diabetes. The American Diabetes Association suggests that achieving the reversal of Type 2 Diabetes Mellitus (T2DM) involves a structured and systematic approach that centers on the management of nutrition, fitness, and lifestyle. This study seeks to explore variations in diabetes management and outcomes, considering patient engagement in Sugar. Fit Diabetes Reversal and Management Program (SDRMP). |
SDRMP is a personalized intervention study that uses technology-enabled medical management, dedicated coach-led diabetes, and nutrition experts. The effectiveness of SDRMP will be analyzed by comparing it with a control group that involved individuals with T2DM managed by conventional pharmacotherapy but not participating in the SDRMP.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients with age group of above 18 years both men and women 2 Patients with history of diabetes with HbA1c greater than 7 with T2DM condition 3 Patients willing to sign an informed consent document 4 Patients who have not participated in any clinical study in the past 30 days.
排除标准
- •1.Patients diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis 2.Pregnant and lactating subjects 3.Patients with severe co-morbidities or disease conditions (Cardiac or Renal or Cancer) 4.End-stage renal disease or severe renal impairment (creatinine clearance more 30 ml per min).
结局指标
主要结局
â—Improvement in HbA1c levels
时间窗: 3 months
â—Improvement in FBS
时间窗: 3 months
â—Improvement in weight, waist, and hip circumference
时间窗: 3 months
次要结局
- â—Reduction in insulin resistance (HOMA IR C-peptide)(â—Reduction in visceral fat adiposity (BCA))
研究者
Dr Mudit Sabarwal
Dharma Diabetes & Metabolic Clinic
研究点 (4)
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