COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04723550
• Other study ID #: NO.2020QN80
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: January 2021
• Source: Xuzhou No.1 Peoples Hospital
• Contact: Wenwen Yin, MD.
• Phone: +86 18112008016
• Email: wenwen261621[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 5, 2022
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• Hospital telemedicine management system
Patients upload data of blood glucose, diet and exercise. Then doctors guide patients' diet, exercise and medication adjustment through the telemedicine system.

Other:
• Usual care
Outpatient/telephone follow-up:continued care, as usual, from their primary care provider through out duration of action 6 months intervention period

Locations

Country	Name	City	State
China	Department of Endocrinology, Xuzhou NO.1 Peoples Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Wenwen Yin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in scores measured by Self-rating Depression Scale	Self-rating Depression Scale includes 20 items in four dimensions of psychological disorders, namely, psychotic emotional symptoms, somatic disorders, psychomotor disorders, and depression. The maximum value of SDS is 50 points. A lower total score means a better situation in terms of depression and vice versa	Baseline, 22days,3 months and 6 months
Other	Number of hypoglycemia events	Hypoglycemia events for telemedicine group versus control group	6 months
Other	Cost effectiveness	The objectives are to compare the results of the study in terms of cost and cost-effectiveness of these two strategies	6 months
Primary	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	Change in FBG	Change in FBG among control and telemedicine groups from baseline to 6 months	Baseline, 22days,3 months and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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