Evaluation of Iphone Technology in Diabetes Treatment
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Detailed description: 
      Background/Hypothesis

      Management of diabetes is an evolving challenge to health care professionals. The
      fluctuations of glucose levels over the lifetime of patients with diabetes can lead to
      complications such as nephropathy, neuropathy, retinopathy and cardiovascular diseases.
      Although diabetes is a chronic disease, it can be controlled with use of medications (oral
      agents or insulin), and/or changes in life-style and diet.

      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 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.

      Confidentiality According to the guidelines of the University of British Columbia
      (UBC)/Providence Health Care Research Ethics Boards, the identity of participants will be
      kept confidential.

      Data for each patient will be collected from the Clinical Research Coordinator and the
      Internet based glucose monitoring system. These data will only be accessed by the
      investigators and will be inputted into an Excel® spreadsheet where each patient will be
      given a unique identifier. All data pertaining to individual patients will be kept locked in
      the office of the study investigators.

      Calculations and Statistics Statistical analysis will be performed on site by the
      researchers. Each group will complete the DTSQ. Questions revolve around satisfaction of
      treatment and are to be answered on a scale of 1 (very dissatisfied) to 6 (very Satisfied).
      Frequency of reporting will be determined through number of reports sent in per month. Total
      strip count will be recorded for each group. Time will be measured for the time it takes to
      train each patient in their respective meter/platform. All outcome measurements will be
      analysed using independent samples t-tests. Participants will only be identified by coded
      initials and a number to protect privacy.
    

Intervention name(s): BG Star Meter (Conventional) Internet Blood Glucose Reporting; iBG Star (iphone) Internet Blood Glucose Method
Intervention type(s): Other; Other
Intervention description(s): 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; 25 patients will be randomized to the iBGstar system will upload their readings to their iPhone and send in their readings using the iPhone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 2 Diabetes; Internet Blood Glucose Monitoring; iphone; meter