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Type 2 Diabetes MellitusNCT04723550

COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes

A study testing Hospital telemedicine management system in people with Type 2 Diabetes Mellitus, run by Wenwen Yin at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Hospital telemedicine management system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
5 Jan 2021to 5 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Wenwen Yin, MD. contact

+86 18112008016

wenwen261621@163.com

Ning Ding, MD. contact

+86 17712987026

961897477@qq.com

China1 site, 1 recruiting

  • Department of Endocrinology, Xuzhou NO.1 Peoples Hospital

    Xuzhou, Jiangsu, 221000

    Wenwen Yin, +86 18112008016, wenwen261621@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Hospital telemedicine management system, Usual care
Keywords
Type 2 Diabetes Mellitus, COVID-19 lockdown, Telemedicine, Obesity, Young and middle-aged
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Usual careOther

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

Study groups in NCT04723550
Study groupRoleWhat they receive
TelemedicineExperimentalDiabetes education and support by telemedicine
Receives: Device: Hospital telemedicine management system
Usual careActive comparatorDiabetes education and support in person
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose control (HbA1c levels)

    Change in HbA1c among control and telemedicine groups from baseline to 6 months

    Measured: Baseline, 22days,3 months and 6 months

Secondary outcomes (11)

  1. Change in FBG

    Change in FBG among control and telemedicine groups from baseline to 6 months

    Measured: Baseline, 22days,3 months and 6 months

  2. 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

    Measured: Baseline, 22days,3 months and 6 months

  3. Change in Blood pressure

    Change in Blood pressure among control and telemedicine groups from baseline to 6 months

    Measured: Baseline, 22days,3 months and 6 months

  4. Body mass BMI changes

    Comparison of BMI changes among control and telemedicine groups from baseline to 6 months

    Measured: Baseline, 22days,3 months and 6 months

  5. Change in waist-to-hip ratio

    Comparison of waist-to-hip ratio changes among control and telemedicine groups from baseline to 6 months

    Measured: 6 months

  6. Change in biological parameter: TC

    Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TC

    Measured: Baseline, 22days,3 months and 6 months

  7. Change in biological parameter: TG

    Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TG

    Measured: Baseline, 22days,3 months and 6 months

  8. Change in biological parameter: HDL-C

    Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: HDL-C

    Measured: Baseline, 22days,3 months and 6 months

  9. Change in biological parameter: BUN

    Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: BUN

    Measured: Baseline, 22days,3 months and 6 months

  10. Change in biological parameter: Scr

    Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: Scr

    Measured: Baseline, 22days,3 months and 6 months

  11. Change in biological parameter: e-GFR

    Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: e-GFR

    Measured: Baseline, 22days,3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2021
  2. Study start5 Jan 2021
  3. Primary completion5 Nov 2021 (estimated)
  4. Study completion5 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04723550
Sponsor's protocol ID
NO.2020QN80
Status last verified
Jan 2021
First submitted
21 Jan 2021
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 36174028

Questions about this trial

What is this clinical trial studying?

A study testing Hospital telemedicine management system in people with Type 2 Diabetes Mellitus, run by Wenwen Yin at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wenwen Yin, MD. (+86 18112008016, wenwen261621@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose control (HbA1c levels) (time frame: Baseline, 22days,3 months and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04723550, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.

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