Combining Wearable Technology to Crate Internet+Digital Hospital-remote Home Type 2 Diabetes Follow-up Management Mode
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
YunFeng Shen
professor
Second Affiliated Hospital of Nanchang University