Diabetes Connect: Patients and Providers Use of a Secure Website for Blood Glucose Monitoring in Type-2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomized Clinical Trial of a Secure Website Shared Between Patients and Providers for Blood Glucose Monitoring in Type-2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812539
• Other study ID #: 2008-P-001898/1; MGH
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: August 1, 2013
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: August 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Partners HealthCare Hospitals/Clinics (Massachusetts General Hospital, Brigham and Womens Hospital)	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject and provider satisfaction with the intervention.		Upon completion of the trial.	No
Secondary	Subject knowledge of diabetes and motivation		On completion of the trial	No