Evaluation of Iphone Technology in Diabetes Treatment

Summary

Background

With the emergence of the internet, health care professionals are changing the way they approach diabetes management. Internet Blood Glucose Monitoring Systems (IBGMS) are aimed at keeping blood glucose levels normal or in the range of acceptable levels to prevent the complications associated with diabetes. The Principal Investigators have completed a randomized clinical trial supporting the efficacy of IBGMS (1,2).

Patient satisfaction of reporting platform is essential to encourage patient reporting and participation in IBGMS. In this study, we wish to compare two different types of meters which will be used to internet blood glucose monitoring: the BG Star Meter (Conventional Meter), and the iBG Star Group (iPhone Technology).

Purpose and Rationale

Patients who are more satisfied with their meter and internet reporting platform are more likely to participate in an internet monitoring system. Patients often lack the motivation to report to their endocrinologist. With increased reporting to their healthcare professional, patients are more likely to benefit from such a system. This study aims to compare two types of meters and their respective internet reporting platforms to encourage patient participation.

Objectives

Our main goal is to compare the two types of meters.

Primary Outcomes Include:

1. Patient Satisfaction as measured by the "Diabetes Treatment Satisfaction Questionnaire" (DTSQ)
2. Frequency of reporting to endocrinologist
3. Number of Self-Monitoring Blood Glucose (SMBG) tests
4. Time taken to teach each patient the platforms

Research Design/Methods

Sample Size: 50 patients will be randomized into two groups:

BG Star Group (Conventional Meter) 25 patients will use the (conventional) BG star meter in which patients will upload their readings onto a computer and send in their readings via email.

IBG Star Group (iPhone Technology) 25 patients will be randomized to the iBGstar system will upload their readings to their iPhone and send in their readings using the iPhone.

Patients will be recruited from a Physician's private office.

Both the (Conventional meter) BG star and iBG star (iPhone Technology) group will be asked to perform SMBG 3 or more times per day and to upload their metered glucose values online every 2 weeks to be reviewed by the doctor.

Inclusion criteria:

* Type 1s
* Type 2s, can be on insulin, oral antihyperglycemic agents, or in combination.
* Willingness to test blood glucose levels a minimum of 3 times daily
* Willingness to be randomized
* Trained in self-blood glucose monitoring
* Internet Access

Exclusion criteria: Patients who do not meet the above criteria or are not willing to participate will not be included in the study.

Conditions

• Type 2 Diabetes Mellitus

Interventions

OTHER

BG Star Meter (Conventional) Internet Blood Glucose Reporting

Patients in BG Star Meter Group will report using BG software through uploading information onto a computer and sending readings to their endocrinologist via email

OTHER

iBG Star (iphone) Internet Blood Glucose Method

25 patients will be randomized to the iBGstar system will upload their readings to their iPhone and send in their readings using the iPhone.

Sponsors & Collaborators

• Endocrine Research Society

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• Canada

Study Locations