Home Monitoring in the Management of Hypertension and Diabetes Mellitus

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00968786
First received: August 28, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Hypertension
Type 2 Diabetes Mellitus
Device: Home monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Trial of the Use of Multiple Automated Measuring Devices in the Management of Patients With Hypertension and Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • blood pressure, blood glucose, body weight and visceral fat levels. [ Time Frame: 3,6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • albuminuria [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no home monitoring
no automated measuring devices for patients use at home
Device: Home monitoring
automated measuring devices for patients using at home

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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968786

Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Jiguang Wang, Doctor Shanghai Jiaotong University
  More Information

No publications provided

Responsible Party: Shanghai Institute of Hypertension
ClinicalTrials.gov Identifier: NCT00968786     History of Changes
Other Study ID Numbers: HTDM 01
Study First Received: August 28, 2009
Last Updated: August 28, 2009
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
hypertension
type 2 diabetes
home monitoring

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

ClinicalTrials.gov processed this record on April 17, 2014