NCT00322478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

9.5 years

First QC Date

May 5, 2006

Last Update Submit

October 30, 2015

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

  • Blood Sugar Control

    Daily and Quarterly

  • Patient Satisfaction

    Quarterly

Secondary Outcomes (3)

  • A1c

    Quarterly

  • Self-Test Frequency of SMBG

    Daily

  • Standard Deviation of A1c and SMBG

    Daily via MAGE if eligible for analysis

Study Arms (1)

GlucoMON-ADMS enabled

OTHER

Patients who are equipped with the automated technology vs. standard/conventional care

Behavioral: Automated informatics driven education and social networkingBehavioral: Blood Glucose Notifications to Remote CaregiversBehavioral: Frequency of Pattern Management

Interventions

Automated informatics driven education and social networkingBEHAVIORAL

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.

Also known as: The GlucoMON GSM/GPRS Appliance - NSR Investigational Device
GlucoMON-ADMS enabled
Blood Glucose Notifications to Remote CaregiversBEHAVIORAL

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.

Also known as: School Day Diabetes Management
GlucoMON-ADMS enabled
Frequency of Pattern ManagementBEHAVIORAL

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.

Also known as: Automated blood sugar pattern management, Day over Day blood sugar report
GlucoMON-ADMS enabled

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetech

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kevin L McMahon, BS

    Sponsor-Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 8, 2006

Study Start

April 1, 2006

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-10

Locations

US(1)