Diabetes Mellitus, Type 1Phase 2/3NCT00322478
Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes
A Phase 2/3 study testing Automated informatics driven education and social networking, Blood Glucose Notifications to Remote Caregivers and Frequency of Pattern Management in people with Diabetes Mellitus, Type 1, run by Diabetech at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Automated informatics driven education and social networking, Blood Glucose Notifications to Remote Caregivers and Frequency of Pattern Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Oct 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Automated informatics driven education and social networking, Blood Glucose Notifications to Remote Caregivers, Frequency of Pattern Management
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated informatics driven education and social networkingBehavioural
Also called The GlucoMON GSM/GPRS Appliance - NSR Investigational Device
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.
Blood Glucose Notifications to Remote CaregiversBehavioural
Also called School Day Diabetes Management
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.
Frequency of Pattern ManagementBehavioural
Also called Automated blood sugar pattern management, Day over Day blood sugar report
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.
| Study group | Role | What they receive |
|---|---|---|
| GlucoMON-ADMS enabled | Other | Patients who are equipped with the automated technology vs. standard/conventional care Receives: Behavioral: Automated informatics driven education and social networking; Behavioral: Blood Glucose Notifications to Remote Caregivers; Behavioral: Frequency of Pattern Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Sugar Control
Measured: Daily and Quarterly
Patient Satisfaction
Measured: Quarterly
Secondary outcomes (3)
A1c
Measured: Quarterly
Self-Test Frequency of SMBG
Measured: Daily
Standard Deviation of A1c and SMBG
Measured: Daily via MAGE if eligible for analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startApr 2006
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Kevin L. McMahon, Diabetech
- Investigators
- Kevin L McMahon, BS, Principal investigator, Sponsor-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322478
- Sponsor's protocol ID
- DIRB1-2006-1
- Status last verified
- Oct 2015
- First submitted
- 5 May 2006
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00322478
- Acronym / sponsor ID
- DIRB1-2006-1
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- DiabetechIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GlucoMON-ADMS enabled | Other | Behavioral: Automated informatics driven education and social networking, Behavioral: Blood Glucose Notifications to Remote Caregivers, Behavioral: Frequency of Pattern ManagementPatients who are equipped with the automated technology vs. standard/conventional care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated informatics driven education and social networkingAlso: The GlucoMON GSM/GPRS Appliance - NSR Investigational DeviceThe 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. | Behavioural | GlucoMON-ADMS enabled |
| Blood Glucose Notifications to Remote CaregiversAlso: School Day Diabetes ManagementWhen 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. | Behavioural | GlucoMON-ADMS enabled |
| Frequency of Pattern ManagementAlso: Automated blood sugar pattern management, Day over Day blood sugar reportThe 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. | Behavioural | GlucoMON-ADMS enabled |
Primary outcome
Blood Sugar Control
Time frame: Daily and Quarterly
Patient Satisfaction
Time frame: Quarterly
3 secondary outcomes
A1c
Time frame: Quarterly
Self-Test Frequency of SMBG
Time frame: Daily
Standard Deviation of A1c and SMBG
Time frame: Daily via MAGE if eligible for analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin L McMahon, BS principal investigator
Sponsor-Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Automated informatics driven education and social networking, Blood Glucose Notifications to Remote Caregivers and Frequency of Pattern Management in people with Diabetes Mellitus, Type 1, run by Diabetech at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Sugar Control (time frame: Daily and Quarterly). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.