Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322478
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2006-05-05
Brief Title:
Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes
Sponsor:
Diabetech
Organization:
Diabetech
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
This study is recruiting patients from throughout the USA including Hawaii and Alaska
Detailed Description:
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None