A Pilot Study on the effectiveness of using Automated Mobile Phone Text Messaging in improving Glycaemic Control among Newly Detected Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 5
- 主要终点
- Improvement in glycaemic outcome measured by HbA1c(less than or equal to 7.0% (53mmol/mol))
研究概览
简要总结
This study is a multicentre, randomized, open label, pilot study on the effectiveness of using automated mobile phone text messaging in improving glycaemic control among newly detected type 2 diabetic patients. Control arm will be receiving Standard care (Advice on physical activity, healthy diet habits, medication adherence and diabetes awareness plus physicians prescribed drugs during every visit) and Intervention arm will be receiving standard care plus automated text messages weekly thrice on lifestyle modification (Increased physical activity and healthy diet habits), medication adherence and diabetes awareness for 24 months.121 patients with newly diagnosed type 2 diabetes will be enrolled in each arm. The study will be conducted in five centres across India. The primary outcome measures the improvement of glycaemia (HbA1c less than or equal to 7.0% (53mmol/mol)) in the intervention group in comparison with standard care. The secondary outcomes are reduction of BMI, changes in blood pressure, fasting, postprandial plasma glucose and lipid profile, improvement of quality of life and acceptance of text messages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Newly diagnosed Type 2 Diabetes patients not receiving any medication for diabetes.
- •2.Patients who consent to participate in the study.
- •3.Both sexes of age 20 to 60 years.
- •4.Having HbA1c level greater than or equal to 6.5% (48 mmol/mol) on diagnosis.
- •5.Willing to report periodically for investigations during the study period
- •Ability to read and understand messages.
排除标准
- •1.Type 1 Diabetes 2.Major illness.
- •such as Cancer, Cardiovascular Disease, Chronic liver or kidney disease and complications related with diabetes on diagnosis of diabetes. 3.Disorders with cognitive impairment, severe depression or mental imbalance. 4.Physical disability that would prevent regular physical activity. 5.Participants unwilling to participate in the study. 6.Participants who do not possess a mobile phone. 7.Participants not able to read and understand text messages. 8.Participants below the age of 20 years and above the age of 60 years.
结局指标
主要结局
Improvement in glycaemic outcome measured by HbA1c(less than or equal to 7.0% (53mmol/mol))
时间窗: 12 and 24 months
次要结局
- Reduction in Blood Pressure(12 and 24 months)
- Changes in Fasting and Post postprandial plasma glucose(12 and 24 months)
- Changes in Lipid Profile(12 and 24 months)
- Improvement in quality of life(12 and 24 months)
- Acceptance of text messaging(12 and 24 months)
- Changes in BMI(12 and 24 months)