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临床试验/NCT04723550
NCT04723550Unknown不适用

Impact of Telemedicine on Young and Middle-aged Obese Patients With Type 2 Diabetes Mellitus During COVID-19 Pandemic

Wenwen Yin1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Glucose control (HbA1c levels)

研究概览

简要总结

At present, in order to cope with the global pandemic of the COVID-19 virus, governments have introduced corresponding measures, COVID-19 lockdown is one of the most important measures. However, lockdown makes the management of chronic diseases (such as type 2 diabetes) more difficult, and telemedicine may be one of the solutions. We hope to explore the effect of telemedicine on blood glucose control and other prognostic indicators of young and middle-aged obese patients with type 2 diabetes who will experience isolation control.

详细描述

We recruit patients with type 2 diabetes who need to be isolated due to the COVID-19 epidemic, Our study will include young and middle-aged obese patients. The lockdown period is 21 days. The patients will be randomly divided into two groups with a total follow-up time of 6 months. One group is the telemedicine intervention group, and the other group is the routine follow-up control group. The intervention group used the hospital telemedicine management system to upload blood glucose values (fasting and 2h after three meals), food intake of three meals, and exercise volume (Data collection frequency: first three months, 4 times/week; 4-6 Month, 2 times/week).Doctors will collect data from hospital telemedicine management system to guide patients on diets, exercise, and medication adjustments. The control group will be followed up by telephone/outpatient clinic every 1 week. (only telephone follow-up will be conducted during the lockdown period) Then doctors will collect their blood glucose values.(fasting and 2h after three meals) Based on the data collected, The doctors will provide lifestyle guidance to the patients on the telephone or face to face. The clinical data of the two groups of patients will be collected at baseline, 22 days, 3 months, and 6 months respectively. (HbA1c, fasting blood glucose(FBG), blood glucose 2 hours after breakfast, blood pressure, Body Mass Index(BMI), waist-to-hip ratio, total cholesterol(TC), triglyceride(TG), high-density lipoprotein cholesterol(HDL-C), low-density lipoprotein cholesterol(LDL-C), Blood Urea Nitrogen(BUN), serum creatinine(Scr), e-GFR, Self-rating Depression Scale, frequency of hypoglycemia,and Cost effectiveness) The clinical data will be statistically analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Physician diagnosis of Type 2 diabetes for more than 6 months
  • 7.0%<HbA1c<10.0%
  • Quarantine for 21 days due to COVID-19 outbreak related reasons
  • age: 18 ~ 55 yrs
  • Be able use smart phones and the Internet

排除标准

  • Insulin pump users
  • For female subjects: pregnancy or lactation, or subject may become pregnant during the study
  • Patient who underwent obesity surgery to the exclusion of a gastric band, loosened or removed for more than a year
  • Patients diagnosed with COVID-19 infection
  • Have severe complications (chronic heart disease, cerebrovascular disease, diagnosed HIV/AIDS, cancer, emphysema, chronic liver or kidney disease) that would affect the subjects' ability to follow the tailored advice

结局指标

主要结局

Glucose control (HbA1c levels)

时间窗: Baseline, 22days,3 months and 6 months

Change in HbA1c among control and telemedicine groups from baseline to 6 months

次要结局

  • Change in Blood glucose 2 hours after breakfast(Baseline, 22days,3 months and 6 months)
  • Change in biological parameter: BUN(Baseline, 22days,3 months and 6 months)
  • Change in biological parameter: TC(Baseline, 22days,3 months and 6 months)
  • Change in FBG(Baseline, 22days,3 months and 6 months)
  • Change in waist-to-hip ratio(6 months)
  • Change in biological parameter: TG(Baseline, 22days,3 months and 6 months)
  • Change in biological parameter: HDL-C(Baseline, 22days,3 months and 6 months)
  • Change in biological parameter: e-GFR(Baseline, 22days,3 months and 6 months)
  • Body mass BMI changes(Baseline, 22days,3 months and 6 months)
  • Change in Blood pressure(Baseline, 22days,3 months and 6 months)
  • Change in biological parameter: Scr(Baseline, 22days,3 months and 6 months)

研究者

发起方
Wenwen Yin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wenwen Yin

M.D.

Xuzhou No.1 Peoples Hospital

研究点 (1)

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