NCT04723550

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2022

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

January 21, 2021

Last Update Submit

January 23, 2021

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusCOVID-19 lockdownTelemedicineObesityYoung and middle-aged

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in FBG

    Baseline, 22days,3 months and 6 months

  • Change in Blood glucose 2 hours after breakfast

    Baseline, 22days,3 months and 6 months

  • Change in Blood pressure

    Baseline, 22days,3 months and 6 months

  • Body mass BMI changes

    Baseline, 22days,3 months and 6 months

  • Change in waist-to-hip ratio

    6 months

  • +6 more secondary outcomes

Other Outcomes (3)

  • Change in scores measured by Self-rating Depression Scale

    Baseline, 22days,3 months and 6 months

  • Number of hypoglycemia events

    6 months

  • Cost effectiveness

    6 months

Study Arms (2)

Telemedicine

EXPERIMENTAL

Diabetes education and support by telemedicine

Device: Hospital telemedicine management system

Usual care

ACTIVE COMPARATOR

Diabetes education and support in person

Other: Usual care

Interventions

Hospital telemedicine management systemDEVICE

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

Telemedicine
Usual careOTHER

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

Usual care

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Physician diagnosis of Type 2 diabetes for more than 6 months
  • %\<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

You may not qualify if:

  • Insulin pump users
  • For female subjects: pregnancy or lactation, or subject may become pregnant during the study
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Xuzhou NO.1 Peoples Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36174028DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Wenwen Yin, MD.

CONTACT

+86 18112008016wenwen261621@163.com

Ning Ding, MD.

CONTACT

+86 17712987026961897477@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 25, 2021

Study Start

January 5, 2021

Primary Completion

November 5, 2021

Study Completion

January 5, 2022

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

CN(1)