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临床试验/CTRI/2024/02/063351
CTRI/2024/02/063351尚未招募2 期

Augmentation Of Self Monitoring Of Blood Glucose With Digital Therapeutic Intervention In Patients With Type 2 Diabetes In Urban Aligarh: A Randomized Controlled Trial

Dr Chelsea1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
136
试验地点
1
主要终点
1)Attainment of glycemic control-FBS, PPBS, HbA1C

研究概览

简要总结

Diabetes mellitus, being one of the greatest contributors of global burden, has necessitated a holistic perspective for its treatment and prevention and not merely pharmacological therapy. Self monitoring of Blood glucose encompasses all the fundamental principles and approaches of Diabetic management and care. As digital revolution in the field of health is affecting and reshaping the healthcare system worldwide, application of novel digital innovation in SMBG can improve the quality of care. There is a need for continuous improvisation and research in this developing sector with multiple guidelines. Studies that had SMBG on a daily basis have had inconclusive findings and proved to be cumbersome while weekly SMBG had been found ineffective. By doing a thrice weekly study, the process is expected to be user-friendly as well as to mitigate the potential limitations found in the previous study.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All diabetic patients between 30-65 years, on treatment with diet and oral hypoglycemic agents (OHA) in the urban areas of Aligarh.
  • All those who will give consent.
  • Those who have compatible smartphones and literacy for application usage.

排除标准

  • Pregnant women
  • Those in immunocompromised state, palliative care and seriously ill patients.

结局指标

主要结局

1)Attainment of glycemic control-FBS, PPBS, HbA1C

时间窗: Baseline, 3 months and 6 months.

2)Lifestyle habits- Diet,physical activity, sleep, stress

时间窗: Baseline, 3 months and 6 months.

3)Adherence to treatment

时间窗: Baseline, 3 months and 6 months.

次要结局

  • 1)anthropometric parameter- BMI(2)prevention of hypoglycemia)

研究者

发起方
Dr Chelsea
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Chelsea

Jawaharlal Nehru Medical College, Aligarh Musim University

研究点 (1)

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