Effect of Mobile Communication With a Cellular Phone With a Glucometer on Glucose Control in Type 2 Diabetic Patients - Full Text View

Sponsored by:	The Catholic University of Korea
Information provided by:	The Catholic University of Korea
ClinicalTrials.gov Identifier:	NCT00412178

Purpose

Previously we demonstrated the beneficial effects of an Internet-based glucose-monitoring system (IBGMS) in people with type 2 diabetes mellitus. The

Diabetes Phone”, a cellular phone with a glucometer integrated in the battery pack, was launched in Korea in 2003. Here we test the short-term effectiveness of the diabetes phone for glucose control and compare it with that of IBGMS.

Condition	Intervention
Type 2 Diabetes Mellitus	Device: telecommunication based glucose monitoring system

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:

HbA1c

Secondary Outcome Measures:

Compliance

Estimated Enrollment:	80
Study Start Date:	December 2004
Estimated Study Completion Date:	April 2005

Detailed Description:

Various strategies using electronic technologies or educational programs have been proposed to improve the quality and efficiency of care for people with diabetes. In the previous study, we introduced a new bidirectional communication tool for diabetes management termed the Internet-Based Glucose Monitoring System (IBGMS), and demonstrated its short-term and long-term effects on glycemic control in type 2 diabetic patients. Other researchers have also showed the effectiveness of telecommunication between health-care providers and patients for maintaining appropriate blood glucose control. These systems allow patients to send data to doctors, identify specific problems and receive recommendations from health-care providers more frequently and with fewer time and place limitations than at traditional face-to-face outpatient clinics. With the IBGMS, physicians can monitor patients’ self-monitored blood glucose data at regular intervals, and patients can communicate with their physicians whenever they have any questions. Although bidirectional interactive communications between physicians and patients can be achieved with the IBGMS, there remain time and place limitations.

Patients must connect to the Internet using their personal computer to input their data or questions on the IBGMS, while physicians only visit the website at regular intervals unless they have received questions from patients. To improve the efficiency of communication, we linked the IBGMS to the short message service (SMS) delivered by cellular phone. The patients sent their data to doctors through the IBGMS and then received the doctors’ recommendations about adjustment of drug dosage and other related data on the cellular phone. This system improved the efficiency of communication and patients’ satisfaction also slightly increased. However, patients were still limited by place and time when sending questions and blood glucose-monitoring data. Recently, cellular phones have been developed that can measure blood glucose level and transmit data directly to a web server (Diabetes Phone). The combination of a glucometer with the cellular phone function makes it easier for patients to report their self-monitored blood glucose (SMBG) levels and receive feedback from their doctors. However, it was not known how effective this cellular phone glucose-monitoring system would be for control of blood glucose levels, compared to the IBGMS tested previously. We investigated the effectiveness of the diabetes phone for blood glucose control and compared it with that of the IBGMS.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with type 2 diabetes mellitus who were able to operate the Internet and to communicate through a mobile phone using the short message service

Exclusion Criteria:

Significant disease conditions such as symptomatic heart failure, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels more than twice the normal level, renal disease and creatinine level greater than 1.5 mg/dL.
Patients were also excluded if they participated in other programs that provided information or education about diabetes management from any Internet websites or by any cellular phones other than ours.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412178

Locations

Korea, Republic of
Kangnam St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 137-040

Sponsors and Collaborators

The Catholic University of Korea

Investigators

Study Director:

Jae-Hyoung Cho, Instructor

Kangnam St. Mary's Hospital, The Catholic University of Korea

More Information

Additional Information:

This is the web site which includes the internet-based glucose monitoring system. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CMC
Study First Received:	December 13, 2006
Last Updated:	December 14, 2006
ClinicalTrials.gov Identifier:	NCT00412178 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:

Internet
mobile communication
glucose monitoring

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009