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Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes
This study is currently recruiting participants.
Study NCT00322478.   Last updated on May 8, 2006.
Information provided by Diabetech
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Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes
Non-Significant Risk Investigational Device Study of the Wireless GlucoMON™ Glucose Meter Accessory and Real-Time Blood Glucose Alerts as an Enabling Technology for People Who Team Manage Diabetes

Many people with diabetes have a desire to share blood glucose data with other members of their team. Using a unique wireless glucose meter device, real-time wireless alerts may be automatically sent to a specific team of interested caregivers whom the patient selects. Additionally, trending reports can be automatically delivered to any number of authorized patient caregivers to facilitate more frequent review of glycemic control.

This study is recruiting patients from throughout the USA including Hawaii and Alaska.

Previous research suggests that using wireless messaging to handle the values from finger-stick blood glucose testing and making the numbers available to both patients and their diabetes health care team may improve the management of diabetes. We would like to test the GlucoMON glucose meter accessory device and the real-time wireless alerts feature which automatically sends to a specific team of interested caregivers whom the patient selects and the effects of real-time alerts in the management of diabetes. Information gathered from your experience may help to ensure safety and effectiveness in a future commercial product. We also would like to know whether this procedure can improve your convenience as a patient and possibly reduce the costs of care required for frequent interactions between the patient and the diabetes care team.

In this study, we will compare a new wireless device and Internet-based automated data management system to existing methods of sharing data amongst an interested care team. Specifically, the research will answer the question, “How does the real-time alert feature of the GlucoMON device compare to people who regularly initiate telephone calls (notification) to interested members of the care team to report a) that a blood glucose test was performed; b) the numerical value of the blood glucose level; and, c) the time that the blood glucose test was performed?” In addition, the data collected during this study will be used to answer the larger question of whether the automated sharing of patient directed blood sugar information affects diabetes control positively or negatively and to what degree.

The GlucoMON device provided by Diabetech, LP is an automated, wireless blood glucose collection and reporting system that will be used to send encrypted glucose data through a secure Internet connection for review by the patient and the authorized diabetes care team. Preparing and delivering the glucose data in this manner will help the care team to know if the person with diabetes is testing or not and provide them with some level of information regarding current blood glucose control even though they cannot be with the patient.

The most obvious use of this feature of the automated diabetes management system is the delivery of a blood sugar text message to the mother of a child with type 1 diabetes attempting to provide remote assistance to their son or daughter at school. However, this is only one scenario in which the researchers anticipate patient feedback.

Phase II, Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Safety
Patient Satisfaction
A1c
Self-Test Frequency of SMBG
Standard Deviation of A1c and SMBG
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus, Gestational
Device: GlucoMON NSR Investigational Device
Behavioral: Real-Time Glucose Alerts to Remote Caregivers
 
Recruiting
1000
April 2006
December 2007

Inclusion Criteria:

  • Informed Consent/Assent Form Completion including signature(s) required prior to final enrollment
  • Previously diagnosed with diabetes (any type)
  • Participant must be willing to subsidize a portion of the cost of the research by agreeing to a participant fee

Exclusion Criteria:

  • Since the study device depends on nationwide wireless network coverage, only those patients who reside within the wireless network coverage area will be allowed to participate in this study. The Investigator will confirm adequate coverage based on zip code prior to enrollment.
Both
No
Contact: Kevin L McMahon, B.S. 877.My.Gluco kevin@diabetech.net
Contact: Stephen W Ponder, M.D. 361.694.4272 ponders@driscollchildrens.org
United States
 
NCT00322478
DIRB1-2006-1
Diabetech
Principal Investigator: Kevin L McMahon, BS Sponsor-Investigator
Diabetech
May 2006
May 5, 2006
May 8, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.