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Home Monitoring in the Management of Hypertension and Diabetes Mellitus

Primary Purpose

Hypertension, Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home monitoring
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring hypertension, type 2 diabetes, home monitoring

Eligibility Criteria

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

Inclusion Criteria:

  • Regardless of whether they are currently receiving antihypertensive therapy, systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg.
  • Whether or not use oral hypoglycemic agents or insulin injections, the fasting plasma is higher than 7.0 mmol/L, or postprandial blood glucose higher than 11.1 mmol/L.

Exclusion Criteria:

  • With life-threatening disease.
  • With the various effects of metabolic diseases such as hyperthyroidism, hypothyroidism, etc.
  • Stroke, myocardial infarction and other serious cardiovascular and cerebrovascular diseases occurred within 3 months.
  • Serum creatinine level higher than 176.8 mmol/L
  • Dementia or severe cognitive decline
  • Unable to do a long-term follow-up or do not agree to participate in this trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    no home monitoring

    Arm Description

    no automated measuring devices for patients use at home

    Outcomes

    Primary Outcome Measures

    blood pressure, blood glucose, body weight and visceral fat levels.

    Secondary Outcome Measures

    albuminuria

    Full Information

    First Posted
    August 28, 2009
    Last Updated
    August 28, 2009
    Sponsor
    Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00968786
    Brief Title
    Home Monitoring in the Management of Hypertension and Diabetes Mellitus
    Official Title
    A Trial of the Use of Multiple Automated Measuring Devices in the Management of Patients With Hypertension and Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    September 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The home monitoring of automated measuring devices may improve the management of the chronic diseases, and may decrease the incidence of fatal disease. The investigators conducted a small sample and short observation time research to explore the feasibility to carry out later large-scale research.
    Detailed Description
    Background: Approximately 40% of type 2 diabetes patients are also with hypertension. There are many risk factors in these patients, and so it's difficult to manage these patients. With the improvement of the accuracy of automated measuring devices, the patients can use these devices to monitor blood pressure, blood glucose, body weight, visceral fat and other indicators at home, and contribute their own participation in the management of there own diseases. The home monitoring may improve the management of this chronic disease, and may decrease the incidence of fatal disease such as stroke, myocardial infarction, heart failure, renal dysfunction and other serious diseases. Large-scale research will carry out to prove that whether home monitoring is valuable for preventing the incidence of fatal disease such as stroke, myocardial infarction, heart failure, renal dysfunction. And in the first, it is necessary to conduct a small sample (n = 100), short observation time (six months) research, to monitor blood pressure, blood glucose, body weight and other indicators of intermediate target detection, to explore the feasibility to carry out such large-scale research. Objective: In hypertensive and type 2 diabetes patients, conducted an open randomized controlled trial to explore the patient's own use blood pressure monitors, blood glucose meter and pedometer at home, and use the body composition measurement instruments in clinic, is to be more effective control of blood pressure, blood glucose, body weight, and reduce the risk of patients with albuminuria. Inclusion criteria: Regardless of whether they are currently receiving antihypertensive therapy, systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than90 mmHg. Whether or not use oral hypoglycemic agents or insulin injections, the fasting plasma is higher than 7.0 mmol/L, or postprandial blood glucose higher than 11.1 mmol/L. Exclusion criteria: with life-threatening disease. With the various effects of metabolic diseases such as hyperthyroidism, hypothyroidism, etc. stroke, myocardial infarction and other serious cardiovascular and cerebrovascular diseases occurred within 3 months. serum creatinine level hugher than 176.8 mol/L. Dementia or severe cognitive decline. unable to do a long-term follow-up study or do not agree to participate in this trial. Sample estimates and statistical analysis: In accordance with 6-month follow-up, the average difference between the two groups, systolic blood pressure 3 mmHg, glycated hemoglobin 0.2%, under the conditions of a= 0.05 and b= 0.10, the research needs of each group of about 50 patients, a total of 100. Major findings of the statistics using t test comparing the two groups after 6 months follow-up observations from the baseline change in the margin, and calculated 95% confidence interval. At the same time will also use non-parametric Wilcoxon test were compared blood pressure, blood glucose and so many follow-up results of repeated measurements.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Type 2 Diabetes Mellitus
    Keywords
    hypertension, type 2 diabetes, home monitoring

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    no home monitoring
    Arm Type
    No Intervention
    Arm Description
    no automated measuring devices for patients use at home
    Intervention Type
    Device
    Intervention Name(s)
    Home monitoring
    Intervention Description
    automated measuring devices for patients using at home
    Primary Outcome Measure Information:
    Title
    blood pressure, blood glucose, body weight and visceral fat levels.
    Time Frame
    3,6 months
    Secondary Outcome Measure Information:
    Title
    albuminuria
    Time Frame
    3 months, 6 months

    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: Regardless of whether they are currently receiving antihypertensive therapy, systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg. Whether or not use oral hypoglycemic agents or insulin injections, the fasting plasma is higher than 7.0 mmol/L, or postprandial blood glucose higher than 11.1 mmol/L. Exclusion Criteria: With life-threatening disease. With the various effects of metabolic diseases such as hyperthyroidism, hypothyroidism, etc. Stroke, myocardial infarction and other serious cardiovascular and cerebrovascular diseases occurred within 3 months. Serum creatinine level higher than 176.8 mmol/L Dementia or severe cognitive decline Unable to do a long-term follow-up or do not agree to participate in this trial.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiguang Wang, Doctor
    Organizational Affiliation
    Shanghai Jiao Tong University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Home Monitoring in the Management of Hypertension and Diabetes Mellitus

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