Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2006 |
| End Date: | October 2015 |
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.
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. We also would
like to know whether this procedure can improve the frequency of glucose pattern management
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 and/or father 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.
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. We also would
like to know whether this procedure can improve the frequency of glucose pattern management
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 and/or father 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.
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.
We found this trial at
1
site
