Clinical trial NCT01817595: Evaluation of Iphone Technology in Diabetes Treatment
Official title: Evaluation of Iphone Technology in Diabetes Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes
Internet Blood Glucose Monitoring
iphone
meter
Lead sponsor: Endocrine Research Society
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 6 months
measure: Frequency of SMBG testing
timeFrame: 6 months
measure: Frequency of Reporting
timeFrame: 6 months
measure: Time required to teach meter/internet platform
timeFrame: Measured at beginning of study
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Endocrine Research Society
state: British Columbia
Study officials:
References:
citation: Tildesley HD, Mazanderani AB, Ross SA. Effect of Internet therapeutic intervention on A1C levels in patients with type 2 diabetes treated with insulin. Diabetes Care. 2010 Aug;33(8):1738-40. doi: 10.2337/dc09-2256.