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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Remote monitoring devices+Internet management platform

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The Second Affiliated Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet + Digital Hospital-remote home management mode; Remote monitoring devices+Internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction.	Device: Remote monitoring devices+Internet management platform; Remote monitoring devices collects blood glucose, total cholesterol, serum ketones and serum uric acid,then upload data to the platform.
No Intervention: the traditional management mode; Routine dietary and exercise recommendations, education as well as monitor in the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c concentration	HbA1c concentration reflects the average blood glucose level	Baseline, Week 12, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FBG	Normal FBG values are 3.9 to 6.1 mmol/L	Baseline, Week 24
Fasting insulin	Insufficient insulin secretion or insulin resistance is a major cause of diabetes	Baseline, Week 24
Blood pressure	Normal systolic blood pressure <140mm Hg, diastolic blood pressure<90mmHg in China.	Baseline, Week 24
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	Baseline, Week 24
Triglycerides	Normal Triglycerides values Triglycerides<1.7 mmol/L	Baseline, Week 24
LDL-C	The level of LDL-C is correlated with the incidence and severity of cardiovascular disease	Baseline, Week 24
HDL-C	The level of HDL-C is inversely associated with coronary heart disease.	Baseline, Week 24
Weight	Standard weight is one of the important signs to reflect and measure a person's health status	Baseline, Week 24
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.	Baseline, Week 24
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.	Baseline, Week 24
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.	Baseline, Week 24
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.	Week 24
Waist circumference	Waist circumference is an important index to determine central obesity.	Baseline, Week 24
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.	Baseline, Week 24

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2021
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): July 23, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: DM202106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No