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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: Automated informatics driven education and social networking; Behavioral: Blood Glucose Notifications to Remote Caregivers; Behavioral: Frequency of Pattern Management

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 Type: Interventional
• Enrollment (Actual): 432
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75201
      • Diabetech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Sugar Control	Daily and Quarterly
Patient Satisfaction	Quarterly

Secondary Outcome Measures

Outcome Measure	Time Frame
A1c	Quarterly
Self-Test Frequency of SMBG	Daily
Standard Deviation of A1c and SMBG	Daily via MAGE if eligible for analysis

Collaborators and Investigators

• Sponsor: Diabetech
• Investigators: Principal Investigator: Kevin L McMahon, BS, Sponsor-Investigator

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 5, 2006
• First Submitted That Met QC Criteria: May 5, 2006
• First Posted (Estimate): May 8, 2006

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: DIRB1-2006-1