NCT01817595

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

March 21, 2013

Last Update Submit

December 3, 2014

Conditions

Keywords

Type 2 DiabetesInternet Blood Glucose Monitoringiphonemeter

Outcome Measures

Primary Outcomes (4)

  • Patient Satisfaction

    6 months

  • Frequency of SMBG testing

    6 months

  • Frequency of Reporting

    How often patient sends report in to endocrinologist

    6 months

  • Time required to teach meter/internet platform

    Measured at beginning of study

Study Arms (2)

BG Star (Conventional Meter)

ACTIVE COMPARATOR

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.

Other: BG Star Meter (Conventional) Internet Blood Glucose Reporting

IBG Star Group (iPhone)

ACTIVE COMPARATOR

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

Other: iBG Star (iphone) Internet Blood Glucose Method

Interventions

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

BG Star (Conventional Meter)

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

IBG Star Group (iPhone)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrine Research Society

Vancouver, British Columbia, V6E1M7, Canada

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 25, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations