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Diabetes Mellitus, Type 2NCT04973644

Combining Wearable Technology to Crate Internet+Digital Hospital-remote Home Type 2 Diabetes Follow-up Management Mode

A study testing Remote monitoring devices+Internet management platform in people with Diabetes Mellitus, Type 2, run by Second Affiliated Hospital of Nanchang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study intends to combining wearable technology to crate Internet+Digital Hospital-remote Home Type 2 Diabetes follow-up management mode.To preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of DM can improve the management objectives and patient… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Remote monitoring devices+Internet management platform
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
21 Aug 2021to 23 Jul 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with type 2 diabetes according to the World Health Organization criteria;
  • Aged between 18 and 70 years;
  • Glycosylated haemoglobin (HbA1C%) between 7% and 9%.

Who cannot join

  • Type 1 diabetes;
  • Gestational diabetes;
  • Other special types of diabetes;
  • Moderate-severe insufficiency of heart , liver, kidney and lung;
  • Complicated with acute disease or stress status.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330000

Other trials in China

About this study

This study intends to combining wearable technology to crate Internet+Digital Hospital-remote Home Type 2 Diabetes follow-up management mode.To preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of DM can improve the management objectives and patient satisfaction of T2DM and reduce medical costs. The study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future.

Read the detailed description

Background:The prevalence of T2DM in Chinese adults has exceeded 10%, and the prevalence of abnormal glucose metabolism has exceeded 40% in people older than 18 years. This will lead to a significant increase in the prevalence of DM complications in the next decade, and the disability and death caused by complications will also seriously affect the quality of life of patients and bring a huge social and economic burden.This randomized controlled trial intends to combining wearable technology to crate Internet+Digital Hospital-remote Home T2DM follow-up management mode.To preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of DM can improve the management objectives and patient satisfaction of T2DM and reduce medical costs. The study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future.

Methods:The study was a parallel-group, randomised, controlled trial. the number of cases planned to be included in 200 cases. Participants were randomly assigned to the intervention or control group.The intervention group receives Internet + Digital Hospital-remote home management mode,including remote monitoring devices+Internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction, etc.The control group receives the traditional management mode, including routine dietary and exercise recommendations, education as well as monitor in the clinic.

Being tested
Remote monitoring devices+Internet management platform
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Remote monitoring devices+Internet management platformDevice

    Remote monitoring devices collects blood glucose, total cholesterol, serum ketones and serum uric acid,then upload data to the platform.

Study groups in NCT04973644
Study groupRoleWhat they receive
Internet + Digital Hospital-remote home management modeExperimentalRemote monitoring devices+Internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction.
Receives: Device: Remote monitoring devices+Internet management platform
the traditional management modeNo interventionRoutine dietary and exercise recommendations, education as well as monitor in the clinic.

What is being measured

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

  1. HbA1c concentration

    HbA1c concentration reflects the average blood glucose level

    Measured: Baseline, Week 12, Week 24

Secondary outcomes (14)

  1. FBG

    Normal FBG values are 3.9 to 6.1 mmol/L

    Measured: Baseline, Week 24

  2. Fasting insulin

    Insufficient insulin secretion or insulin resistance is a major cause of diabetes

    Measured: Baseline, Week 24

  3. Blood pressure

    Normal systolic blood pressure <140mm Hg, diastolic blood pressure<90mmHg in China.

    Measured: Baseline, Week 24

  4. Total cholesterol

    Total cholesterol refers to the sum of cholesterol contained by all lipoproteins in the blood.Normal Total cholesterol values <5.17 mmol/L

    Measured: Baseline, Week 24

  5. Triglycerides

    Normal Triglycerides values Triglycerides<1.7 mmol/L

    Measured: Baseline, Week 24

  6. LDL-C

    The level of LDL-C is correlated with the incidence and severity of cardiovascular disease

    Measured: Baseline, Week 24

  7. HDL-C

    The level of HDL-C is inversely associated with coronary heart disease.

    Measured: Baseline, Week 24

  8. Weight

    Standard weight is one of the important signs to reflect and measure a person's health status

    Measured: Baseline, Week 24

  9. Waist circumference

    Waist circumference is an important index to determine central obesity.

    Measured: Baseline, Week 24

  10. BMI

    BMI is an internationally used measure of how fat and thin a person is and whether they are healthy or not.The calculation formula is: BMI= weight/height^2.

    Measured: Baseline, Week 24

  11. Serum uric acid

    Serum uric acid is the end product of purine catabolism.Is excreted by the kidney with urine.Serum uric acid measurement is a sensitive marker for the diagnosis of severe renal impairment.

    Measured: Baseline, Week 24

  12. Serum creatinine

    Clinically detecting serum creatinine is one of the main methods to understand renal function, and it is an important indicator of kidney function, and an elevated serum creatinine means the damage of kidney function.

    Measured: Baseline, Week 24

  13. Urinary microalbumin / creatinine ratio

    Urinary microalbumin /creatinine ratio is the test used clinically to judge microalbuminuria, examine early renal lesions, and is more commonly used clinically for early diabetic nephropathy.

    Measured: Baseline, Week 24

  14. Diabetes Treatment Satisfaction Questionnaire

    Comments on the distribution of treatment satisfaction scores measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ).There are 8 items in total, including three dimensions of treatment satisfaction, self-perceived hyperglycemia and self-perceived hypoglycemia.The minimum and maximum values are 0 and 36 ,respectively.Higher scores mean a better outcome.

    Measured: Week 24

Timeline

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

  1. First posted22 Jul 2021
  2. Study start21 Aug 2021
  3. Primary completion23 Jun 2022
  4. Study completion23 Jul 2022

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973644
Sponsor's protocol ID
DM202106
Status last verified
Apr 2025
First submitted
7 Jul 2021
Last updated
24 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Peng P, Shen Y, Xiong H. Wearable monitoring device based on an internet management platform improves metabolic parameters in type 2 diabetes patients: a prospective pilot study. Postgrad Med. 2024 Jun;136(5):523-532. doi: 10.1080/00325481.2024.2366156. Epub 2024 Jun 13.

    PubMed 38870076

Questions about this trial

What is this clinical trial studying?

A study testing Remote monitoring devices+Internet management platform in people with Diabetes Mellitus, Type 2, run by Second Affiliated Hospital of Nanchang University 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 3 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: finished, as of the sponsor's last update on 24 Apr 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c concentration (time frame: Baseline, Week 12, Week 24). 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 NCT04973644, 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 24 Apr 2025.

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