COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes

NCT ID: NCT04723550

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2022-01-05

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Telemedicine

Diabetes education and support by telemedicine

Group Type: EXPERIMENTAL

Hospital telemedicine management system

Intervention Type: DEVICE

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

Usual care

Diabetes education and support in person

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Usual care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wenwen Yin

OTHER

Sponsor Role: lead

Responsible Party

Wenwen Yin

M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Endocrinology, Xuzhou NO.1 Peoples Hospital

Xuzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenwen Yin, MD.

Role: CONTACT

wenwen261621@163.com

+86 18112008016

Ning Ding, MD.

Role: CONTACT

961897477@qq.com

+86 17712987026

Facility Contacts

Wenwen Yin

Role: primary

wenwen261621@163.com

+86 18112008016

References

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.

Reference Type: DERIVED

PMID: 36174028 (View on PubMed)

Other Identifiers

NO.2020QN80

Identifier Type: -

Identifier Source: org_study_id