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Clinical Trials/NCT04973644
NCT04973644CompletedNot Applicable

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

Second Affiliated Hospital of Nanchang University1 site in 1 country120 target enrollmentStarted: August 21, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
HbA1c concentration

Study Overview

Brief 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 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

HbA1c concentration

Time Frame: Baseline, Week 12, Week 24

HbA1c concentration reflects the average blood glucose level

Secondary Outcomes

  • Waist circumference(Baseline, Week 24)
  • BMI(Baseline, Week 24)
  • Serum uric acid(Baseline, Week 24)
  • FBG(Baseline, Week 24)
  • Fasting insulin(Baseline, Week 24)
  • Blood pressure(Baseline, Week 24)
  • Total cholesterol(Baseline, Week 24)
  • Triglycerides(Baseline, Week 24)
  • LDL-C(Baseline, Week 24)
  • HDL-C(Baseline, Week 24)
  • Weight(Baseline, Week 24)
  • Serum creatinine(Baseline, Week 24)
  • Urinary microalbumin / creatinine ratio(Baseline, Week 24)
  • Diabetes Treatment Satisfaction Questionnaire(Week 24)

Investigators

Sponsor
Second Affiliated Hospital of Nanchang University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

YunFeng Shen

professor

Second Affiliated Hospital of Nanchang University

Study Sites (1)

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