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

• ClinicalTrials.gov Identifier: NCT00322478
• Recruitment Status: Completed
• First Posted: May 8, 2006
• Last Update Posted: November 3, 2015
• Sponsor: Diabetech
• Information provided by (Responsible Party): Kevin L. McMahon, Diabetech

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 432 participants
• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

Locations

United States, Texas

Diabetech

Dallas, Texas, United States, 75201

Sponsors and Collaborators

Diabetech

Investigators

• Principal Investigator: Kevin L McMahon, BS; Sponsor-Investigator

More Information

• Responsible Party: Kevin L. McMahon, Principal Investigator, Diabetech
• ClinicalTrials.gov Identifier: NCT00322478 History of Changes
• Other Study ID Numbers: DIRB1-2006-1
• First Posted: May 8, 2006
• Last Update Posted: November 3, 2015
• Last Verified: October 2015

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases