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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322478
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : November 3, 2015
Information provided by (Responsible Party):
Kevin L. McMahon, Diabetech

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.

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2006
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Blood Sugar Control [ Time Frame: Daily and Quarterly ]
  2. Patient Satisfaction [ Time Frame: Quarterly ]

Secondary Outcome Measures :
  1. A1c [ Time Frame: Quarterly ]
  2. Self-Test Frequency of SMBG [ Time Frame: Daily ]
  3. Standard Deviation of A1c and SMBG [ Time Frame: Daily via MAGE if eligible for analysis ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00322478

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United States, Texas
Dallas, Texas, United States, 75201
Sponsors and Collaborators
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Principal Investigator: Kevin L McMahon, BS Sponsor-Investigator
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Responsible Party: Kevin L. McMahon, Principal Investigator, Diabetech Identifier: NCT00322478    
Other Study ID Numbers: DIRB1-2006-1
First Posted: May 8, 2006    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases