Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by Diabetech
Sponsor:
Information provided by:
Diabetech
ClinicalTrials.gov Identifier:
NCT00322478
First received: May 5, 2006
Last updated: September 22, 2010
Last verified: September 2010
  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
Behavioral: Automated informatics driven education and social networking
Behavioral: Blood Glucose Notifications to Remote Caregivers
Behavioral: Frequency of Pattern Management
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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:
  • Blood Sugar Control [ Time Frame: Daily and Quarterly ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: Quarterly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A1c [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
  • Self-Test Frequency of SMBG [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Standard Deviation of A1c and SMBG [ Time Frame: Daily via MAGE if eligible for analysis ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2006
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GlucoMON-ADMS enabled
Patients who are equipped with the automated technology vs. standard/conventional care
Behavioral: Automated informatics driven education and social networking
The patient uses a self-contained wireless accessory to a standard blood glucose meter. This device manages the meter to ensure accurate time stamps and transmits the data to a centralized data management system. The system is then configured to assess the data and take automated steps to derive relevant diabetes education and/or send reports to a registered and authorized team.
Other Name: The GlucoMON GSM/GPRS Appliance - NSR Investigational Device
Behavioral: Blood Glucose Notifications to Remote Caregivers
When children with type 1 diabetes are at school they will connect their blood glucose meter to the GlucoMON appliance. The data from the meter is then transmitted to the central system followed by the most recent blood sugar being sent to the primary caregiver's email address(es) as a plain text message. The investigator is interested to better understand the behaviors that accompany the expectation of the message and actions taken subsequent to receipt of the message by the patient-centric team.
Other Name: School Day Diabetes Management
Behavioral: Frequency of Pattern Management
The behavioral intervention being studied involves the assessment of frequency of self-care in relation to the primary and secondary outcomes including overall blood sugar control and patient satisfaction.
Other Names:
  • Automated blood sugar pattern management
  • Day over Day blood sugar report

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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Kevin L McMahon, B.S. 877.My.Gluco kevin@diabetech.net

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

Responsible Party: Kevin McMahon, Diabetech
ClinicalTrials.gov Identifier: NCT00322478     History of Changes
Other Study ID Numbers: DIRB1-2006-1
Study First Received: May 5, 2006
Last Updated: September 22, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014