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

December 14, 2006 updated by: The Catholic University of Korea
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.

Study Overview

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.

Study Type

Interventional

Enrollment

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c

Secondary Outcome Measures

Outcome Measure
Compliance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jae-Hyoung Cho, Instructor, Kangnam St. Mary's Hospital, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

December 13, 2006

First Submitted That Met QC Criteria

December 14, 2006

First Posted (Estimate)

December 15, 2006

Study Record Updates

Last Update Posted (Estimate)

December 15, 2006

Last Update Submitted That Met QC Criteria

December 14, 2006

Last Verified

December 1, 2006

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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