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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote monitoring devices+Internet management platform
Sponsored by
Second Affiliated Hospital of Nanchang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated Hospital Of Nanchang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet + Digital Hospital-remote home management mode

the traditional management mode

Arm Description

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

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

Outcomes

Primary Outcome Measures

HbA1c concentration
HbA1c concentration reflects the average blood glucose level

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2021
Last Updated
September 5, 2021
Sponsor
Second Affiliated Hospital of Nanchang University
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1. Study Identification

Unique Protocol Identification Number
NCT04973644
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Nanchang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet + Digital Hospital-remote home management mode
Arm Type
Experimental
Arm Description
Remote monitoring devices+Internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction.
Arm Title
the traditional management mode
Arm Type
No Intervention
Arm Description
Routine dietary and exercise recommendations, education as well as monitor in the clinic.
Intervention Type
Device
Intervention Name(s)
Remote monitoring devices+Internet management platform
Intervention Description
Remote monitoring devices collects blood glucose, total cholesterol, serum ketones and serum uric acid,then upload data to the platform.
Primary Outcome Measure Information:
Title
HbA1c concentration
Description
HbA1c concentration reflects the average blood glucose level
Time Frame
Baseline, Week 12, Week 24
Secondary Outcome Measure Information:
Title
FBG
Description
Normal FBG values are 3.9 to 6.1 mmol/L
Time Frame
Baseline, Week 24
Title
Fasting insulin
Description
Insufficient insulin secretion or insulin resistance is a major cause of diabetes
Time Frame
Baseline, Week 24
Title
Blood pressure
Description
Normal systolic blood pressure <140mm Hg, diastolic blood pressure<90mmHg in China.
Time Frame
Baseline, Week 24
Title
Total cholesterol
Description
Total cholesterol refers to the sum of cholesterol contained by all lipoproteins in the blood.Normal Total cholesterol values <5.17 mmol/L
Time Frame
Baseline, Week 24
Title
Triglycerides
Description
Normal Triglycerides values Triglycerides<1.7 mmol/L
Time Frame
Baseline, Week 24
Title
LDL-C
Description
The level of LDL-C is correlated with the incidence and severity of cardiovascular disease
Time Frame
Baseline, Week 24
Title
HDL-C
Description
The level of HDL-C is inversely associated with coronary heart disease.
Time Frame
Baseline, Week 24
Title
Weight
Description
Standard weight is one of the important signs to reflect and measure a person's health status
Time Frame
Baseline, Week 24
Title
BMI
Description
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.
Time Frame
Baseline, Week 36
Title
WHR
Description
Waist-hip ratio is an important index to determine central obesity. WHR= Waist circumference/Hip circumference
Time Frame
Baseline, Week 24
Title
Blood ketone
Description
Blood ketone is a product of human metabolism.Blood ketones will be elevated in diabetic ketoacidosis.
Time Frame
Baseline, Week 24
Title
Serum uric acid
Description
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.
Time Frame
Baseline, Week 24
Title
Serum creatinine
Description
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.
Time Frame
Baseline, Week 24
Title
Urinary microalbumin / creatinine ratio
Description
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.
Time Frame
Baseline, Week 24
Title
Diabetes Treatment Satisfaction Questionnaire
Description
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.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Second Affiliated Hospital Of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China

12. IPD Sharing Statement

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

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