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Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes
This study is currently recruiting participants.
Verified by Diabetech, May 2006
First Received: May 5, 2006   Last Updated: May 8, 2006   History of Changes
Sponsored by: Diabetech
Information provided by: Diabetech
ClinicalTrials.gov Identifier: NCT00322478
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Diabetech:

Primary Outcome Measures:
  • Safety
  • Patient Satisfaction

Secondary Outcome Measures:
  • A1c
  • Self-Test Frequency of SMBG
  • Standard Deviation of A1c and SMBG

Estimated Enrollment: 1000
Study Start Date: April 2006
Estimated Study Completion Date: December 2007
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. 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322478

Contacts
Contact: Kevin L McMahon, B.S. 877.My.Gluco kevin@diabetech.net
Contact: Stephen W Ponder, M.D. 361.694.4272 ponders@driscollchildrens.org

Locations
United States, Texas
Diabetech Recruiting
Dallas, Texas, United States, 75201
Principal Investigator: Kevin L McMahon, B.S.            
Sponsors and Collaborators
Diabetech
Investigators
Principal Investigator: Kevin L McMahon, BS Sponsor-Investigator
  More Information

No publications provided

Study ID Numbers: DIRB1-2006-1
Study First Received: May 5, 2006
Last Updated: May 8, 2006
ClinicalTrials.gov Identifier: NCT00322478     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Pregnancy Complications
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Diabetes, Gestational
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Pregnancy Complications
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Diabetes, Gestational
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009