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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04973644
• Other study ID #: DM202106
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 21, 2021
• Est. completion date: July 2022

Study information

• Verified date: September 2021
• Source: Second Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed with type 2 diabetes according to the World Health Organization criteria;

• Aged between 18 and 80 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c concentration	HbA1c concentration reflects the average blood glucose level	Baseline, Week 12, Week 24
Secondary	FBG	Normal FBG values are 3.9 to 6.1 mmol/L	Baseline, Week 24
Secondary	Fasting insulin	Insufficient insulin secretion or insulin resistance is a major cause of diabetes	Baseline, Week 24
Secondary	Blood pressure	Normal systolic blood pressure <140mm Hg, diastolic blood pressure<90mmHg in China.	Baseline, Week 24
Secondary	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
Secondary	Triglycerides	Normal Triglycerides values Triglycerides<1.7 mmol/L	Baseline, Week 24
Secondary	LDL-C	The level of LDL-C is correlated with the incidence and severity of cardiovascular disease	Baseline, Week 24
Secondary	HDL-C	The level of HDL-C is inversely associated with coronary heart disease.	Baseline, Week 24
Secondary	Weight	Standard weight is one of the important signs to reflect and measure a person's health status	Baseline, Week 24
Secondary	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 36
Secondary	WHR	Waist-hip ratio is an important index to determine central obesity. WHR= Waist circumference/Hip circumference	Baseline, Week 24
Secondary	Blood ketone	Blood ketone is a product of human metabolism.Blood ketones will be elevated in diabetic ketoacidosis.	Baseline, Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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