Clinical trial NCT04723550: COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes
Official title: Impact of Telemedicine on Young and Middle-aged Obese Patients With Type 2 Diabetes Mellitus During COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
COVID-19 lockdown
Telemedicine
Obesity
Young and middle-aged
Lead sponsor: Xuzhou No.1 Peoples Hospital
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Glucose control (HbA1c levels)
timeFrame: Baseline, 22days,3 months and 6 months
Secondary outcomes:
measure: Change in FBG
timeFrame: Baseline, 22days,3 months and 6 months
measure: Change in Blood glucose 2 hours after breakfast
timeFrame: Baseline, 22days,3 months and 6 months
measure: Change in Blood pressure
timeFrame: Baseline, 22days,3 months and 6 months
measure: Body mass BMI changes
timeFrame: Baseline, 22days,3 months and 6 months
measure: Change in waist-to-hip ratio
timeFrame: 6 months
measure: Change in biological parameter: TC
timeFrame: Baseline, 22days,3 months and 6 months
measure: Change in biological parameter: TG
timeFrame: Baseline, 22days,3 months and 6 months
measure: Change in biological parameter: HDL-C
timeFrame: Baseline, 22days,3 months and 6 months
measure: Change in biological parameter: BUN
timeFrame: Baseline, 22days,3 months and 6 months
measure: Change in biological parameter: Scr
timeFrame: Baseline, 22days,3 months and 6 months
measure: Change in biological parameter: e-GFR
timeFrame: Baseline, 22days,3 months and 6 months
Other outcomes:
measure: Change in scores measured by Self-rating Depression Scale
timeFrame: Baseline, 22days,3 months and 6 months
measure: Number of hypoglycemia events
timeFrame: 6 months
measure: Cost effectiveness
timeFrame: 6 months
Locations:
city: Xuzhou
country: China
facility: Department of Endocrinology, Xuzhou NO.1 Peoples Hospital
state: Jiangsu
Study officials:
References:
citation: Yin W, Liu Y, Hu H, Sun J, Liu Y, Wang Z. Telemedicine management of type 2 diabetes mellitus in obese and overweight young and middle-aged patients during COVID-19 outbreak: A single-center, prospective, randomized control study. PLoS One. 2022 Sep 29;17(9):e0275251. doi: 10.1371/journal.pone.0275251. eCollection 2022.