Diabetes Connect: Patients and Providers Use of a Secure Website for Blood Glucose Monitoring in Type-2 Diabetes
A Randomized Clinical Trial of a Secure Website Shared Between Patients and Providers for Blood Glucose Monitoring in Type-2 Diabetes
1 other identifier
interventional
20
1 country
1
Brief Summary
Currently, diabetic patients who receive their care at the diabetes clinic self monitor their blood glucose using a portable glucometer, under the direction of care providers at the clinic. We propose to conduct a randomized controlled trial to examine the effect of the "Diabetes Connected Health" tool, which is a secure website shared between patients of Type-2 Diabetes and their providers and displays (subjects') blood glucose values in graphical format. The study will be carried out through multiple primary care practices within the Partners/PCHI Network. We hypothesize that implementation of the Diabetes Connected Health Tool will result in overall better Diabetes Care, in terms of improved patient-provider interaction, and better patient satisfaction towards their care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Feb 2009
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedAugust 2, 2013
August 1, 2013
8 months
December 18, 2008
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subject and provider satisfaction with the intervention.
Upon completion of the trial.
Secondary Outcomes (1)
Subject knowledge of diabetes and motivation
On completion of the trial
Study Arms (2)
Diabetes Connected Health Tool "Deluxe"
EXPERIMENTALSubjects 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).
Diabetes Connected Health Tool "Basic"
ACTIVE COMPARATORControl 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.
Interventions
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.
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
You may qualify if:
- Diagnosis of type 2 diabetes
- 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.
You may not qualify if:
- Subjects having mental health, cognitive or physical impairments that would preclude the set up and use of the modem, glucometer or computer.
- Subjects are not candidates for guideline-based diabetes care.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Partners HealthCare Hospitals/Clinics (Massachusetts General Hospital, Brigham and Womens Hospital)
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard W. Grant, MD, MPH
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Center for Connected Health
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 22, 2008
Study Start
February 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 2, 2013
Record last verified: 2013-08