CTRI/2024/07/070349尚未招募不适用
Impact of Insulin care and administration reinforcement education ICARE through WhatsApp messages on glycemic control among diabetes patients using insulin, attending Endocrinology OPD of a tertiary care center in Eastern India, A single blind placebo controlled parallel group block randomized trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- It will improve the glycemic controls, knowledge and skills related to insulin care and administration
研究概览
简要总结
It is a single blind placebo controlled parallel-group block randomized trial among Diabetes Mellitus patients who are on insulin therapy.
The study is expecting reduction in HbA1c level, total Insulin dose per day in patients with Diabetes Mellitus as well as expected to improve Glycemic control, knowledge and Insulin administration skills of experimental group who will receive WhatsApp messages on ICARE rather than the placebo group receiving the sham messages after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All consecutive patients attending the Endocrinology and Metabolism Outpatient Department of AIIMS, Kalyani, with a known history of Diabetes Mellitus who are on insulin therapy for minimum span of 3 months.
- •2.Age group: 30-50 yrs 3.BMI: 23-30 kg/m2 4.Patients having HbA1c level: 7.5-12.5% 5.Patients receiving Insulin at least twice a day 6.Patients who has access to WhatsApp.
排除标准
- •1.Patients with known psychiatric illness and/or currently on psychiatry medications.
- •2.Any underlying Endocrinological disorder causing secondary diabetes mellitus such as Cushing’s disease, Acromegaly, Hyperthyroidism, type 3c diabetes.
- •3.Patients having secondary diabetes related to drugs like steroids, chemotherapy etc.
- •4.Pregnant and lactating mother up to 6 months, patients suffering from cancer and/or had a history of radiation or chemotherapy 5.DM Patients with CLD, CKD, eGFR less than 15, heart failure, any hematological disorder like beta-thalassemia etc.
结局指标
主要结局
It will improve the glycemic controls, knowledge and skills related to insulin care and administration
时间窗: 1 year
次要结局
- i. Reduction in HbA1c level.(ii. Reduction of daily Insulin dose.)
研究者
研究点 (1)
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