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Trial record 65 of 661 for:    applied AND web-

The Effect of Remote SMBG Combined With the Application of APP on the Improvement of T2DM Management in the Community

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ClinicalTrials.gov Identifier: NCT03588000
Recruitment Status : Active, not recruiting
First Posted : July 17, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Yuwen Zhang, Ruijin Hospital

Brief Summary:
To investigate whether strengthen community diabetes patients self-monitoring of blood glucose can improve the patient's blood glucose control under Chinese guidelines for the prevention and treatment of diabetes (CDS 2017) and whether this intervention produces health and economic benefits.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Strengthen self-monitoring of blood glucose Not Applicable

Detailed Description:
This project is a cohort intervention study for randomized controlled trials. Community health service centers are the main body of implementing treatment and community diabetes patients are the objects of intervention. 1000 T2DM patients with poor blood glucose control (7%<HbA1c≤9.5%) from 4 different community health service centers will be randomized into two groups (strengthen group and control group). Strengthen self-monitoring of blood glucose by APP is the intervention and its duration is 12 months. Follow-up time of this study is 24 months (12 months after the intervention stopped). The diabetes treatment of patients from both groups follows Chinese guidelines (CDS 2017).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Remote Self-monitoring of Blood Glucose (SMBG) Combined With the Promotion and Application of Internet Mobile Terminal (APP) on the Improvement of the Staged Type 2 Diabetes Mellitus (T2DM) Management and the Success Rate of Blood Glucose in the Community
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Strength group
Strengthen self-monitoring of blood glucose by Internet mobile terminal (APP)
Other: Strengthen self-monitoring of blood glucose
Strengthen self-monitoring of blood glucose by Internet mobile terminal(APP).

No Intervention: Control group
Voluntary self-monitoring of blood glucose



Primary Outcome Measures :
  1. change in HbA1c [ Time Frame: baseline, 6 months, 12 months, 24months ]
    change in HbA1c from baseline measure


Secondary Outcome Measures :
  1. change in fasting blood glucose [ Time Frame: baseline, 12 months, 24 months ]
    change in fasting blood glucose from baseline measure

  2. change in postprandial blood glucose [ Time Frame: baseline, 12 months, 24 months ]
    change in postprandial blood glucose from baseline measure

  3. change in Health-related Quality of Life [ Time Frame: baseline, 12 months, 24 months ]
    36-Item Short Form Survey. This survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  4. change in health economics index [ Time Frame: baseline, 12 months, 24 months ]
    change in the total cost of diabetes drugs per year which represents the indicators of health economics index


Other Outcome Measures:
  1. change in diabetes medication [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months, 24 months ]
    change in diabetes medication type or dose from baseline measures

  2. change in urinary microalbumin and microalbumin/creatinine ratio [ Time Frame: baseline, 12 months, 24 months ]
    change in urinary microalbumin and microalbumin/creatinine ratio from baseline measures

  3. change in fasting insulin [ Time Frame: baseline, 12 months, 24 months ]
    change in fasting insulin from baseline measure

  4. change in postprandial insulin [ Time Frame: baseline, 12 months, 24 months ]
    change in postprandial insulin from baseline measure

  5. change in fasting C-Peptide [ Time Frame: baseline, 12 months, 24 months ]
    change in fasting C-Peptide from baseline measure

  6. change in postprandial C-Peptide [ Time Frame: baseline, 12 months, 24 months ]
    change in postprandial C-Peptide from baseline measure

  7. change in body mass index (BMI) [ Time Frame: baseline, 3months, 6 months, 9 months, 12 months, 24 months ]
    change in BMI from baseline measure

  8. change in systolic pressure [ Time Frame: baseline, 3months, 6 months, 9 months, 12 months, 24 months ]
    change in systolic pressure from baseline measure

  9. change in diastolic pressure [ Time Frame: baseline, 3months, 6 months, 9 months, 12 months, 24 months ]
    change in diastolic pressure from baseline measure

  10. change in weight [ Time Frame: baseline, 3months, 6 months, 9 months, 12 months, 24 months ]
    change in weight from baseline measure

  11. change in waist circumference [ Time Frame: baseline, 3months, 6 months, 9 months, 12 months, 24 months ]
    change in waist circumference from baseline measure

  12. change in waist-to-hip ratio [ Time Frame: baseline, 3months, 6 months, 9 months, 12 months, 24 months ]
    change in waist-to-hip ratio from baseline measure

  13. change in blood lipids [ Time Frame: baseline, 12 months, 24 months ]
    change in levels of blood lipids from baseline measures

  14. change in uric acid [ Time Frame: baseline, 12 months, 24 months ]
    change in level of uric acid from baseline measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 2 Diabetes
  • Between 18 and 79 years old
  • 7.0%<HbA1c ≤ 9.5%
  • Routinely uses a smart phone
  • Capability of operating the designated APP
  • Long-time residents in Jiading District, Shanghai, China
  • Subordinated to Shanghai medical insurance
  • Contracted residents of community in Jiading District, Shanghai, China
  • Being cognitively able to participate
  • Provision of written informed consent

Exclusion Criteria:

  • Type 1 diabetes, gestational diabetes mellitus or other types of diabetes mellitus
  • Currently pregnant or contemplating pregnancy within the next 24 months
  • Lactating women
  • Was not able to insist until the end (24 months)
  • Cognitive impairment
  • Migrant population

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588000


Locations
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China
Community Health Service Center of Malu Town, Jiading District
Shanghai, China, 201801
Community Health Service Center of Nanxiang Town, Jiading District
Shanghai, China, 201802
Community Health Service Center of Zhenxin, Jiading District
Shanghai, China, 201824
Community Health Service Center of Juyuan New District, Jiading District
Shanghai, China, 201899
Sponsors and Collaborators
Yuwen Zhang

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Responsible Party: Yuwen Zhang, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03588000     History of Changes
Other Study ID Numbers: 16CR4020A
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases