Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DEVICERemote 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.
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c concentration | Baseline, Week 12, Week 24 | HbA1c concentration reflects the average blood glucose level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting insulin | Baseline, Week 24 | Insufficient insulin secretion or insulin resistance is a major cause of diabetes |
| Blood pressure | Baseline, Week 24 | Normal systolic blood pressure \<140mm Hg, diastolic blood pressure\<90mmHg in China. |
| Total cholesterol | Baseline, Week 24 | Total cholesterol refers to the sum of cholesterol contained by all lipoproteins in the blood.Normal Total cholesterol values \<5.17 mmol/L |
| Triglycerides | Baseline, Week 24 | Normal Triglycerides values Triglycerides\<1.7 mmol/L |
| LDL-C | Baseline, Week 24 | The level of LDL-C is correlated with the incidence and severity of cardiovascular disease |
| HDL-C | Baseline, Week 24 | The level of HDL-C is inversely associated with coronary heart disease. |
| FBG | Baseline, Week 24 | Normal FBG values are 3.9 to 6.1 mmol/L |
| Waist circumference | Baseline, Week 24 | Waist circumference is an important index to determine central obesity. |
| BMI | Baseline, Week 24 | 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. |
| Serum uric acid | Baseline, Week 24 | 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. |
| Serum creatinine | Baseline, Week 24 | 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. |
| Urinary microalbumin / creatinine ratio | Baseline, Week 24 | 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. |
| Diabetes Treatment Satisfaction Questionnaire | Week 24 | 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. |
| Weight | Baseline, Week 24 | Standard weight is one of the important signs to reflect and measure a person's health status |
Countries
China
Outcome results
None listed