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
About this trial
This is an interventional prevention trial for Hypertension focused on measuring hypertension, type 2 diabetes, home monitoring
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.
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
NCT ID
NCT00968786
First Posted
August 28, 2009
Last Updated
August 28, 2009
Sponsor
Shanghai Jiao Tong University School of Medicine
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
We'll reach out to this number within 24 hrs