Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01817595
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2013-03-21
Brief Title:
Evaluation of Iphone Technology in Diabetes Treatment
Sponsor:
Endocrine Research Society
Organization:
Endocrine Research Society
Study Overview
Official Title:
Evaluation of Iphone Technology in Diabetes Treatment
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12
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 DesignMethods
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 Physicians 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
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 12
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 DesignMethods
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 Physicians 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:
BackgroundHypothesis
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 andor 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 12
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 DesignMethods
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 Physicians 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 UBCProvidence 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 meterplatform 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
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 andor 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 12
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 DesignMethods
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 Physicians 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 UBCProvidence 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 meterplatform 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None