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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
120
Patients upload data of blood glucose, diet and exercise. Then doctors guide patients' diet, exercise and medication adjustment through the telemedicine system.
Outpatient/telephone follow-up:continued care, as usual, from their primary care provider through out duration of action 6 months intervention period
Department of Endocrinology, Xuzhou NO.1 Peoples Hospital
Xuzhou, Jiangsu, China
RECRUITINGGlucose control (HbA1c levels)
Change in HbA1c among control and telemedicine groups from baseline to 6 months
Time frame: Baseline, 22days,3 months and 6 months
Change in FBG
Change in FBG among control and telemedicine groups from baseline to 6 months
Time frame: Baseline, 22days,3 months and 6 months
Change in Blood glucose 2 hours after breakfast
Change in Blood glucose 2 hours after breakfast among control and telemedicine groups from baseline to 6 months
Time frame: Baseline, 22days,3 months and 6 months
Change in Blood pressure
Change in Blood pressure among control and telemedicine groups from baseline to 6 months
Time frame: Baseline, 22days,3 months and 6 months
Body mass BMI changes
Comparison of BMI changes among control and telemedicine groups from baseline to 6 months
Time frame: Baseline, 22days,3 months and 6 months
Change in waist-to-hip ratio
Comparison of waist-to-hip ratio changes among control and telemedicine groups from baseline to 6 months
Time frame: 6 months
Change in biological parameter: TC
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TC
Time frame: Baseline, 22days,3 months and 6 months
Change in biological parameter: TG
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Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TG
Time frame: Baseline, 22days,3 months and 6 months
Change in biological parameter: HDL-C
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: HDL-C
Time frame: Baseline, 22days,3 months and 6 months
Change in biological parameter: BUN
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: BUN
Time frame: Baseline, 22days,3 months and 6 months
Change in biological parameter: Scr
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: Scr
Time frame: Baseline, 22days,3 months and 6 months
Change in biological parameter: e-GFR
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: e-GFR
Time frame: Baseline, 22days,3 months and 6 months