Diabetes Connect: Patients and Providers Use of a Secure Website for Blood Glucose Monitoring in Type-2 Diabetes
NCT ID: NCT00812539
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2009-02-28
2009-10-31
Brief Summary
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Detailed Description
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Subjects enrolled into the intervention arm will use a OneTouch Ultra2 glucometer and an iMetrikus modem device which will upload the blood glucose readings to a secure, login-enabled web-based portal. Subjects will be given login information to access to their own individual Internet site, where they can view their readings and detailed graphical representation of their blood glucose levels over time, read educational material regarding diabetes management and receive personalized tips and feedback from their physicians (who will also have access to their patients' information on the web portal).
Subjects enrolled into the control arm will have access to the same glucometer and modem, and will have access to another individual internet website (the "Basic Site") which will show their glucose readings and graphical representation of glucose levels. Each patient will be enrolled for 3 months. and the primary outcome measure will patient and provider satisfaction with the Diabetes Connected Health tool.The specific aims along with hypothesis of the study are:
1. To develop a web-based application ("Diabetes Connected Health") that will enable home-based glucose monitoring results to be readily incorporated into clinical glycemic management.
Hypothesis: We hypothesize that through a development process incorporating interactive feedback loops between software developers, patients, clinicians, and other stakeholders, we can create a web-based clinical application that will be adopted by clinical practices.
2. To test the impact of the "Diabetes Connected Health" tool in a randomized clinical trial.
Hypothesis: We hypothesize that implementation of the tool will have a beneficial impact relative to control patients in several critical domains:
Patient Domains
1. Increase patients' knowledge of their diabetes management plan.
2. Increase patients' satisfaction with their clinical care.
3. Increase patients' awareness of why they have high and/or low glucose readings.
4. Increase patients' satisfaction with patient-provider communication.
Provider Domains
1. Increase clinician satisfaction with clinical care.
2. Increase clinician knowledge of individual patient care issues.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Diabetes Connected Health Tool "Deluxe"
Subjects enrolled into the intervention arm will measure their glucose levels by using a glucometer. An iMetrikus modem will upload the blood glucose readings to a secure, web-based portal. Participants will be given login information to access this portal, where they can view their glucose readings and detailed graphical representation of their blood glucose levels over time, read educational material regarding diabetes management and receive personalized tips and feedback from their physicians (who will also have access to these subjects' information on the web portal).
Subject/Provider Portal "Diabetes Connected Health" tool - Deluxe
Subjects enrolled into the "Deluxe"intervention will use a glucometer, a modem to upload the blood glucose readings to a secure, web-based portal ("Diabetes Connected Health" tool) where they can view detailed graphical representation of their blood glucose levels over time, educational material regarding diabetes management and receive personalized tips and feedback from their physicians (who will also have access to their subjects' information on the web portal and contact them by an embedded messaging system). Subjects with new high or low readings will be flagged. Providers can initiate messages to subjects regarding symptoms or medications. A medication summary and log of all readings uploaded with date/time will be displayed on the website as well as a graphical display of all uploaded glucose readings over time and will allow subjects to enter comments regarding each critical reading.
Diabetes Connected Health Tool "Basic"
Control group will measure their glucose levels by using a glucometer. An iMetrikus modem will upload the blood glucose readings to a secure, web-based portal. Participants will be given login information to access this portal. where they can view their glucose readings in tabular form. Their physicians will not have access to this information.
Subject only Portal "Diabetes Connected Health Tool" Basic
Patients enrolled in the Diabetes Connect "Basic" intervention will use a glucometer, a modem which will upload the blood glucose readings to a secure, web-based portal (the "Diabetes Connected Health" tool) where they can view their readings in a less detailed/journal fashion. No detailed graphical representation of their blood glucose levels over time is available to this group, nor is any educational material regarding diabetes management. Their physicians will not have access to these subjects' information on the web portal and will not have the ability to contact them by an embedded messaging system.
Interventions
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Subject/Provider Portal "Diabetes Connected Health" tool - Deluxe
Subjects enrolled into the "Deluxe"intervention will use a glucometer, a modem to upload the blood glucose readings to a secure, web-based portal ("Diabetes Connected Health" tool) where they can view detailed graphical representation of their blood glucose levels over time, educational material regarding diabetes management and receive personalized tips and feedback from their physicians (who will also have access to their subjects' information on the web portal and contact them by an embedded messaging system). Subjects with new high or low readings will be flagged. Providers can initiate messages to subjects regarding symptoms or medications. A medication summary and log of all readings uploaded with date/time will be displayed on the website as well as a graphical display of all uploaded glucose readings over time and will allow subjects to enter comments regarding each critical reading.
Subject only Portal "Diabetes Connected Health Tool" Basic
Patients enrolled in the Diabetes Connect "Basic" intervention will use a glucometer, a modem which will upload the blood glucose readings to a secure, web-based portal (the "Diabetes Connected Health" tool) where they can view their readings in a less detailed/journal fashion. No detailed graphical representation of their blood glucose levels over time is available to this group, nor is any educational material regarding diabetes management. Their physicians will not have access to these subjects' information on the web portal and will not have the ability to contact them by an embedded messaging system.
Eligibility Criteria
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Inclusion Criteria
Age 18 years or older
English speaking/able to read English
Last measured Hemoglobin A1c (HbA1c) \> 7.5 % in the last 12 months.
Prescribed glucose self-monitoring, and either currently self monitoring or willing to monitor their blood glucose, as prescribed by their care provider, using the OneTouch Ultra2 portable glucometer.
Access to the Internet for the 6 months the study will run.
Access to a compatible analog telephone line at either their work place or home such that the subjects are able to upload the glucometer readings to the website.
Access to an active email account.
Receiving diabetes care primarily within the practice.
Exclusion Criteria
Subjects are not candidates for guideline-based diabetes care.
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Joseph C. Kvedar
Director, Center for Connected Health
Principal Investigators
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Richard W. Grant, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Partners HealthCare Hospitals/Clinics (Massachusetts General Hospital, Brigham and Womens Hospital)
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2008-P-001898/1; MGH
Identifier Type: -
Identifier Source: org_study_id