Clinical trial NCT04973644: Combining Wearable Technology to Crate Internet+Digital Hospital-remote Home Type 2 Diabetes Follow-up Management Mode
Official title: Combining Wearable Technology to Crate Internet+Digital Hospital-remote Home Type 2 Diabetes Follow-up Management Mode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c concentration
timeFrame: Baseline, Week 12, Week 24
Secondary outcomes:
measure: FBG
timeFrame: Baseline, Week 24
measure: Fasting insulin
timeFrame: Baseline, Week 24
measure: Blood pressure
timeFrame: Baseline, Week 24
measure: Total cholesterol
timeFrame: Baseline, Week 24
measure: Triglycerides
timeFrame: Baseline, Week 24
measure: LDL-C
timeFrame: Baseline, Week 24
measure: HDL-C
timeFrame: Baseline, Week 24
measure: Weight
timeFrame: Baseline, Week 24
measure: Waist circumference
timeFrame: Baseline, Week 24
measure: BMI
timeFrame: Baseline, Week 24
measure: Serum uric acid
timeFrame: Baseline, Week 24
measure: Serum creatinine
timeFrame: Baseline, Week 24
measure: Urinary microalbumin / creatinine ratio
timeFrame: Baseline, Week 24
measure: Diabetes Treatment Satisfaction Questionnaire
timeFrame: Week 24
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
state: Jiangxi
Study officials:
References: