ADAM: Advancing DiAbetes Management- Integration of Continuous Glucose Monitoring with Artificial Intelligence for Personalized Diet Interventions in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Phase 1-an optimization model will be developed to formulate dietary management guidelines aimed at achieving balanced glucose levels.
研究概览
简要总结
In 2021, global diabetes prevalence was 6.1%, projected to reach 10% by 2050 (1)Lifestyle management, including diet, is crucial in diabetes management(2). While carbohydrate restriction shows promise for glycemic control, practical implementation remains a challenge, especially in India.
NOVELTY: This study seeks to integrate cutting-edge technologies by combining continuous glucose monitoring (CGM) with an AI-powered Virtual Dietician (VD) to offer real-time personalized feedback and dietary advice, aiming to bridge the gap between clinical evidence and practical implementation in Type 2 DM management
Objectives:
1. Assessing the blood glucose response to a carbohydrate-restricted diet among Indian diabetes patients on oral hypoglycemic agents (OHA) to refine the diet tool
2. Evaluating the effectiveness of the AI Virtual Dietician in providing personalized dietary advice to achieve higher time in range (TIR) compared to usual care.
Methods :The study comprises two phases:
Phase 1 involves a longitudinal study on Type 2 DM patients aged 18-65. CGM devices will monitor blood glucose for 14 days, while dietary recall will be conducted using the Virtual Dietician app. Results will inform modifications to the VD’s diet optimization tool to enhance glucose control and prevent hypoglycemia while meeting personalized micronutrient requirements.
Phase 2 consists of an (RCT) comparing Usual Care to Enhanced Care groups, both using CGM. The Enhanced Care group will additionally receive the AI-based Virtual Dietician app for personalized dietary recommendations based on phase 1 optimizations.
Outcomes:
1 Differences in average blood glucose and TIR between groups, changes in HbA1c, BMI, Quality of Life (QoL), and neuropathy symptoms.
研究设计
- 研究类型
- Observational
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 2 diabetes mellitus on treatment with the same oral hypoglycemic agents for 3 months.
排除标准
- •patients with kidney disease patients with liver disease patients with any acute illness.
结局指标
主要结局
Phase 1-an optimization model will be developed to formulate dietary management guidelines aimed at achieving balanced glucose levels.
时间窗: Phase 1-an optimization model will be developed to formulate dietary management guidelines aimed at achieving balanced glucose levels. | Phase 2-The efficacy of the Virtual Dietician based intervention .
Phase 2-The efficacy of the Virtual Dietician based intervention and Change in BMI, QoL and onset or change in neuropathy symptoms.
时间窗: Phase 1-an optimization model will be developed to formulate dietary management guidelines aimed at achieving balanced glucose levels. | Phase 2-The efficacy of the Virtual Dietician based intervention .
次要结局
- Change in BMI, quality of life and neuropathy symptoms(3 months)
研究者
Anjali T M Ollapally
St Johns Medical College Hospital