COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hospital telemedicine management system
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, COVID-19 lockdown, Telemedicine, Obesity, Young and middle-aged
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
Sites / Locations
- Department of Endocrinology, Xuzhou NO.1 Peoples HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telemedicine
Usual care
Arm Description
Diabetes education and support by telemedicine
Diabetes education and support in person
Outcomes
Primary Outcome Measures
Glucose control (HbA1c levels)
Change in HbA1c among control and telemedicine groups from baseline to 6 months
Secondary Outcome Measures
Change in FBG
Change in FBG among control and telemedicine groups from baseline to 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
Change in Blood pressure
Change in Blood pressure among control and telemedicine groups from baseline to 6 months
Body mass BMI changes
Comparison of BMI changes among control and telemedicine groups from baseline to 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
Change in biological parameter: TC
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TC
Change in biological parameter: TG
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TG
Change in biological parameter: HDL-C
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: HDL-C
Change in biological parameter: BUN
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: BUN
Change in biological parameter: Scr
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: Scr
Change in biological parameter: e-GFR
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: e-GFR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04723550
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
November 5, 2021 (Anticipated)
Study Completion Date
January 5, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wenwen Yin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, COVID-19 lockdown, Telemedicine, Obesity, Young and middle-aged
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
Diabetes education and support by telemedicine
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Diabetes education and support in person
Intervention Type
Device
Intervention Name(s)
Hospital telemedicine management system
Intervention Description
Patients upload data of blood glucose, diet and exercise. Then doctors guide patients' diet, exercise and medication adjustment through the telemedicine system.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Outpatient/telephone follow-up:continued care, as usual, from their primary care provider through out duration of action 6 months intervention period
Primary Outcome Measure Information:
Title
Glucose control (HbA1c levels)
Description
Change in HbA1c among control and telemedicine groups from baseline to 6 months
Time Frame
Baseline, 22days,3 months and 6 months
Secondary Outcome Measure Information:
Title
Change in FBG
Description
Change in FBG among control and telemedicine groups from baseline to 6 months
Time Frame
Baseline, 22days,3 months and 6 months
Title
Change in Blood glucose 2 hours after breakfast
Description
Change in Blood glucose 2 hours after breakfast among control and telemedicine groups from baseline to 6 months
Time Frame
Baseline, 22days,3 months and 6 months
Title
Change in Blood pressure
Description
Change in Blood pressure among control and telemedicine groups from baseline to 6 months
Time Frame
Baseline, 22days,3 months and 6 months
Title
Body mass BMI changes
Description
Comparison of BMI changes among control and telemedicine groups from baseline to 6 months
Time Frame
Baseline, 22days,3 months and 6 months
Title
Change in waist-to-hip ratio
Description
Comparison of waist-to-hip ratio changes among control and telemedicine groups from baseline to 6 months
Time Frame
6 months
Title
Change in biological parameter: TC
Description
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TC
Time Frame
Baseline, 22days,3 months and 6 months
Title
Change in biological parameter: TG
Description
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TG
Time Frame
Baseline, 22days,3 months and 6 months
Title
Change in biological parameter: HDL-C
Description
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: HDL-C
Time Frame
Baseline, 22days,3 months and 6 months
Title
Change in biological parameter: BUN
Description
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: BUN
Time Frame
Baseline, 22days,3 months and 6 months
Title
Change in biological parameter: Scr
Description
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: Scr
Time Frame
Baseline, 22days,3 months and 6 months
Title
Change in biological parameter: e-GFR
Description
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: e-GFR
Time Frame
Baseline, 22days,3 months and 6 months
Other Pre-specified Outcome Measures:
Title
Change in scores measured by Self-rating Depression Scale
Description
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
Time Frame
Baseline, 22days,3 months and 6 months
Title
Number of hypoglycemia events
Description
Hypoglycemia events for telemedicine group versus control group
Time Frame
6 months
Title
Cost effectiveness
Description
The objectives are to compare the results of the study in terms of cost and cost-effectiveness of these two strategies
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenwen Yin, MD.
Phone
+86 18112008016
Email
wenwen261621@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Ding, MD.
Phone
+86 17712987026
Email
961897477@qq.com
Facility Information:
Facility Name
Department of Endocrinology, Xuzhou NO.1 Peoples Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenwen Yin
Phone
+86 18112008016
Email
wenwen261621@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
36174028
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.
Results Reference
derived
Learn more about this trial
COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes
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