COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Device: Hospital telemedicine management systemOther: Usual care
- Registration Number
- NCT04723550
- Lead Sponsor
- Wenwen Yin
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- BMI≥24
- Be able use smart phones and the Internet
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemedicine Hospital telemedicine management system Diabetes education and support by telemedicine Usual care Usual care Diabetes education and support in person
- Primary Outcome Measures
Name Time Method Glucose control (HbA1c levels) Baseline, 22days,3 months and 6 months Change in HbA1c among control and telemedicine groups from baseline to 6 months
- Secondary Outcome Measures
Name Time Method Change in Blood glucose 2 hours after breakfast Baseline, 22days,3 months and 6 months Change in Blood glucose 2 hours after breakfast among control and telemedicine groups from baseline to 6 months
Change in biological parameter: BUN Baseline, 22days,3 months and 6 months Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: BUN
Change in biological parameter: TC Baseline, 22days,3 months and 6 months Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TC
Change in FBG Baseline, 22days,3 months and 6 months Change in FBG among control and telemedicine groups from baseline to 6 months
Change in waist-to-hip ratio 6 months Comparison of waist-to-hip ratio changes among control and telemedicine groups from baseline to 6 months
Change in biological parameter: TG Baseline, 22days,3 months and 6 months Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TG
Change in biological parameter: HDL-C Baseline, 22days,3 months and 6 months Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: HDL-C
Change in biological parameter: e-GFR Baseline, 22days,3 months and 6 months Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: e-GFR
Body mass BMI changes Baseline, 22days,3 months and 6 months Comparison of BMI changes among control and telemedicine groups from baseline to 6 months
Change in Blood pressure Baseline, 22days,3 months and 6 months Change in Blood pressure among control and telemedicine groups from baseline to 6 months
Change in biological parameter: Scr Baseline, 22days,3 months and 6 months Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: Scr
Trial Locations
- Locations (1)
Department of Endocrinology, Xuzhou NO.1 Peoples Hospital
🇨🇳Xuzhou, Jiangsu, China