COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: Hospital telemedicine management system; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • Recruiting
      • Department of Endocrinology, Xuzhou NO.1 Peoples Hospital
      • Contact: Wenwen Yin; Phone Number: +86 18112008016; Email: wenwen261621@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine; Diabetes education and support by telemedicine	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.
Active Comparator: Usual care; Diabetes education and support in person	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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of hypoglycemia events	Hypoglycemia events for telemedicine group versus control group	6 months
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

Collaborators and Investigators

• Sponsor: Wenwen Yin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Anticipated): November 5, 2021
• Study Completion (Anticipated): January 5, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; Obesity; Type 2 Diabetes Mellitus; COVID-19 lockdown; Young and middle-aged
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NO.2020QN80

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No