Diabetes Connected Health Study - Diabetes Clinical Tri...

Diabetes Connected Health Study

Diabetes Connected Health Study

This study is not yet open for participant recruitment.
Verified by Massachusetts General Hospital, December 2008
Sponsored by: Massachusetts General Hospital

Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00812539

Purpose
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 better blood glucose control, improved patient-provider interaction, and better patient satisfaction towards their care.

Condition Intervention
Diabetes Mellitus, Type 2
Device: Subject/Provider Collaborative portal (the "Diabetes Connected Health" tool)

MedlinePlus related topics: Diabetes
Drug Information available for: Dextrose
U.S. FDA Resources
Study Type:Interventional
Study Design:Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:A Randomized Clinical Trial of a Secure Website Shared Between Patients and Providers for Blood Glucose Monitoring in Type-2 Diabetes

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
The primary outcome being measured is the change in Hemoglobin A1c (HbA1c) levels from the beginning to the end of the trial. [ Time Frame: At the time of enrollment and on completion of the trial. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Blood glucose levels [ Time Frame: On completion of the trial. ] [ Designated as safety issue: No ]

Number of subjects under control (HbA1c levels < 7) [ Time Frame: On completion of the trial. ] [ Designated as safety issue: No ]

Number of Care Provider visits and medication changes during the duration of the trial. [ Time Frame: On completion of the trial ] [ Designated as safety issue: No ]

Prescription refill rates [ Time Frame: On completion of the trial ] [ Designated as safety issue: No ]

Subject and provider satisfaction with the intervention [ Time Frame: On completion of the trial ] [ Designated as safety issue: No ]
Subject knowledge of diabetes and motivation [ Time Frame: On completion of the trial ] [ Designated as safety issue: No ]

Utilization of glucometer (control and intervention) and Internet site (intervention) [ Time Frame: On completion of the trial ] [ Designated as safety issue: No ]

Estimated Enrollment:207
Study Start Date:January 2009
Estimated Study Completion Date:June 2010
Estimated Primary Completion Date:June 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Diabetes Connected Health Tool: Experimental Device: Subject/Provider Collaborative portal (the "Diabetes Connected Health" tool)
Subjects enrolled into the intervention arm will use a glucometer, a modem device which will upload the blood glucose readings to a secure, web-based portal (the "Diabetes Connected Health" tool) where they can view a 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 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 require the subject to enter comments regarding each critical reading.

Detailed Description:
The study will be carried out at multiple practices within Partners HealthCare system and will have one Intervention and one control arm.

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 6 months and the primary outcome measure will be a change in Hemoglobin A1C levels.

The specific aims along with hypothesis of the study are:

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.

To test the clinical 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

Increase patients' knowledge of their diabetes management plan.
Increase patients' satisfaction with their clinical care.
Increase patients' awareness of why they have high and/or low glucose readings.
Increase patients' satisfaction with patient-provider communication.
Provider Domains

Increase clinician satisfaction with clinical care.
Increase clinician knowledge of individual patient care issues.
Clinical Outcome Domains

Reduced incidence of out of range glucose results. (highs and lows)
Increase rate of medication intensification.
Lower mean HbA1c levels.
Eligibility
Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria
Eligibility Criteria for Partners HealthCare practices:

Manage type-2 Diabetes patients.
Have at least one non-Physician provider (nurse practitioner, nurse, diabetes educator) with responsibility for diabetes patient care
Inclusion Criteria for subject selection:

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.
Exclusion Criteria for subject selection:

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.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812539

Contacts
Contact: Ellen E. Murachver, MSW 617-643-0272 emurachver@partners.org

Locations
United States, Massachusetts
Partners HealthCare Hospitals/Clinics (Massachusetts General Hospital, Brigham and Womens Hospital)
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Richard W. Grant, MD, MPH Massachusetts General Hospital

Responsible Party:Massachusetts General Hospital ( Richard Grant, MD MPH )
Study ID Numbers:2008-P-001898/1; MGH
First Received:December 18, 2008
Last Updated:December 18, 2008
ClinicalTrials.gov Identifier:NCT00812539 [history]
Health Authority:United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Diabetes
Hemoglobin A1C (HbA1c)
Blood glucose monitoring
Internet

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders