NCT00489879

Brief Summary

The purpose of this study is to determine whether cellular phone based health care system is effective in the treatment of diabetes and hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

Enrollment Period

3 months

First QC Date

June 20, 2007

Last Update Submit

May 19, 2008

Conditions

DiabetesHypertensionObesity

Keywords

Mobile Health UnitsChronic Disease

Outcome Measures

Primary Outcomes (1)

  • HbA1c, fasting blood glucose level, Weight change, Blood pressure level in the morning, lipid profiles

    baseline, 3months later

Secondary Outcomes (1)

  • exercise time during one week, self reported change in dietary habit, fat consumption ratio

    baseline, 3months later

Interventions

Mobile Health Care System (DrUB)DEVICE

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type II diabetes using only oral hypoglycemic agents
  • % \< HbA1c \< 10%
  • systolic blood pressure \> 130 or diastolic blood pressure \> 80
  • BMI \> 23
  • \< age \< 75

You may not qualify if:

  • type I diabetes or type II diabtes using insulin treatment
  • liver, renal or heart disease
  • recent change (within 1 month) in the type or dosage of anti-diabetic agent, anti-hypertensive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Korea University College of Medicine

Seoul, VD, 152-703, South Korea

Location

Related Publications (1)

  • Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004 Feb;27(2):478-83. doi: 10.2337/diacare.27.2.478.

    PMID: 14747232BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusHypertensionObesityChronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Kyung M Choi, MD

    Department of Internal Medicine, Korea University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

July 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 20, 2008

Record last verified: 2008-05

Locations

KR(1)