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Sponsored by: |
Diabetech |
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Information provided by: | Diabetech |
ClinicalTrials.gov Identifier: | NCT00322478 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational |
Device: GlucoMON NSR Investigational Device Behavioral: Real-Time Glucose Alerts to Remote Caregivers |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 1000 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2007 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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, Texas | |
Diabetech | Recruiting |
Dallas, Texas, United States, 75201 | |
Principal Investigator: Kevin L McMahon, B.S. |
Principal Investigator: | Kevin L McMahon, BS | Sponsor-Investigator |
Study ID Numbers: | DIRB1-2006-1 |
Study First Received: | May 5, 2006 |
Last Updated: | May 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00322478 |
Health Authority: | United States: Food and Drug Administration |
Pregnancy Complications Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Diabetes, Gestational Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |