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Completed

NCT Number: NCT04973644

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Treatment and study plan

Remote monitoring devices+Internet management platform

Device

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

Primary outcomes

  1. HbA1c concentration

    Time frame: Baseline, Week 12, Week 24

    HbA1c concentration reflects the average blood glucose level

Secondary outcomes

  1. FBG

    Time frame: Baseline, Week 24

    Normal FBG values are 3.9 to 6.1 mmol/L

  2. Fasting insulin

    Time frame: Baseline, Week 24

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

  3. Blood pressure

    Time frame: Baseline, Week 24

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

  4. Total cholesterol

    Time frame: Baseline, Week 24

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

  5. Triglycerides

    Time frame: Baseline, Week 24

    Normal Triglycerides values Triglycerides<1.7 mmol/L

  6. LDL-C

    Time frame: Baseline, Week 24

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

  7. HDL-C

    Time frame: Baseline, Week 24

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

  8. Weight

    Time frame: Baseline, Week 24

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

  9. Waist circumference

    Time frame: Baseline, Week 24

    Waist circumference is an important index to determine central obesity.

  10. BMI

    Time frame: Baseline, Week 24

    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.

  11. Serum uric acid

    Time frame: Baseline, Week 24

    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.

  12. Serum creatinine

    Time frame: Baseline, Week 24

    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.

  13. Urinary microalbumin / creatinine ratio

    Time frame: Baseline, Week 24

    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.

  14. Diabetes Treatment Satisfaction Questionnaire

    Time frame: Week 24

    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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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