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Home Monitoring in the Management of Hypertension and Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00968786
Recruitment Status : Unknown
Verified August 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Enrolling by invitation
First Posted : August 31, 2009
Last Update Posted : August 31, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Hypertension Type 2 Diabetes Mellitus Device: Home monitoring

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : August 2008
Primary Completion Date : August 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. blood pressure, blood glucose, body weight and visceral fat levels. [ Time Frame: 3,6 months ]

Secondary Outcome Measures :
  1. albuminuria [ Time Frame: 3 months, 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00968786


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

Responsible Party: Shanghai Institute of Hypertension
ClinicalTrials.gov Identifier: NCT00968786     History of Changes
Other Study ID Numbers: HTDM 01
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: August 31, 2009
Last Verified: August 2009

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

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