Home Monitoring in the Management of Hypertension and Diabetes Mellitus

Hypertension Clinical Trial

Official title:

A Trial of the Use of Multiple Automated Measuring Devices in the Management of Patients With Hypertension and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00968786
• Other study ID #: HTDM 01
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 28, 2009
• Last updated: August 28, 2009
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: August 2009
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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:

1. Regardless of whether they are currently receiving antihypertensive therapy, systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than90 mmHg.

2. 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:

1. with life-threatening disease.

2. With the various effects of metabolic diseases such as hyperthyroidism, hypothyroidism, etc.

3. stroke, myocardial infarction and other serious cardiovascular and cerebrovascular diseases occurred within 3 months.

4. serum creatinine level hugher than 176.8 mol/L.

5. Dementia or severe cognitive decline.

6. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

Device:
• Home monitoring
automated measuring devices for patients using at home

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure, blood glucose, body weight and visceral fat levels.		3,6 months	Yes
Secondary	albuminuria		3 months, 6 months	Yes