COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes

Study Overview
=================
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.

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Hospital telemedicine management system
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>Diabetes education and support by telemedicine | Device: Hospital telemedicine management system<br>* Patients upload data of blood glucose, diet and exercise. Then doctors guide patients' diet, exercise and medication adjustment through the telemedicine system.<br>|
| Active Comparator: Usual care<br>Diabetes education and support in person | Other: Usual care<br>* Outpatient/telephone follow-up：continued care, as usual, from their primary care provider through out duration of action 6 months intervention period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose control (HbA1c levels) | Change in HbA1c among control and telemedicine groups from baseline to 6 months | Baseline, 22days,3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FBG | Change in FBG among control and telemedicine groups from baseline to 6 months | 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 | 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 | 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 | 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 | 6 months | 
| Change in biological parameter: TC | Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TC | Baseline, 22days,3 months and 6 months | 
| Change in biological parameter: TG | Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TG | 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 | 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 | 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 | 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 | Baseline, 22days,3 months and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes Mellitus, COVID-19 lockdown, Telemedicine, Obesity, Young and middle-aged