NCT00968786

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2008

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 31, 2009

Status Verified

August 1, 2009

Enrollment Period

1 year

First QC Date

August 28, 2009

Last Update Submit

August 28, 2009

Conditions

HypertensionType 2 Diabetes Mellitus

Keywords

hypertensiontype 2 diabeteshome monitoring

Outcome Measures

Primary Outcomes (1)

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

    3,6 months

Secondary Outcomes (1)

  • albuminuria

    3 months, 6 months

Study Arms (1)

no home monitoring

NO INTERVENTION

no automated measuring devices for patients use at home

Device: Home monitoring

Interventions

Home monitoringDEVICE

automated measuring devices for patients using at home

no home monitoring

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jiguang Wang, Doctor

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

August 1, 2008

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

August 31, 2009

Record last verified: 2009-08