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

NCT04973644 | Completed

• 1 other identifier: DM202106
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c concentration

  HbA1c concentration reflects the average blood glucose level

  Baseline, Week 12, Week 24

Secondary Outcomes (14)

• FBG

  Baseline, Week 24

• Fasting insulin

  Baseline, Week 24

• Blood pressure

  Baseline, Week 24

• Total cholesterol

  Baseline, Week 24

• Triglycerides

  Baseline, Week 24

Study Arms (2)

Internet + Digital Hospital-remote home management mode

EXPERIMENTAL

Remote monitoring devices+Internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction.

Device: Remote monitoring devices+Internet management platform

the traditional management mode

NO INTERVENTION

Routine dietary and exercise recommendations, education as well as monitor in the clinic.

Interventions

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.

Internet + Digital Hospital-remote home management mode

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

Related Publications (1)

• 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.

  PMID: 38870076 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 22, 2021
• Study Start: August 21, 2021
• Primary Completion: June 23, 2022
• Study Completion: July 23, 2022
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

CN (1)