Patients and Care Providers Perspectives and Experience With Decision Aid Tool for Self-monitoring of Blood Glucose

NCT02553408 | Completed

• 1 other identifier: Canada-IIS_ADC-OUS-IIS-14-07
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Putting the limited use of titration algorithms in the context of escalating diabetes prevalence rates, strategies and tools are urgently needed to help both patients and primary care providers efficiently initiate and continue basal insulin therapy. Basel insulin is considered to be the appropriate strategy after oral diabetic agent failure. This project could set the stage for the need for a blood glucose meter with built-in algorithms designed to support decision making by patients as well as care providers. Furthermore, the project will evaluate the uptake and use of the newly developed Meter by Abbott Diabetes Care, which was launched in Canada in October 2014, and its impact on primary care diabetes consultation.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Patient and Care provider satisfaction structured interview guide

  Patients and Care providers will be interviewed to assess their satisfaction associated with the use of the meter and its perceived impact on diabetes management.Results will be reported in a qualitative way with participants quotes and themes that will be emerged from the interviews.

  3 months after the use of the meter

Study Arms (1)

Neo meter

OTHER

This is a single arm purely qualitative (interview only) study with no comparator. All participants will use the FreeStyle Precision Neo-Meter for at least 3 months for self-monitoring of their blood glucose.

Device: FreeStyle Precision Neo-Meter

Interventions

FreeStyle Precision Neo-Meter DEVICE

Participants will receive a free glucose meter (Neo) and test strips from their care providers with education and instructions on how to use the meter to monitor their glucose level. Three months after the start of using the meter, participants will be interviewed on their experiences, likes and dislikes about the meter.

Neo meter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with type 2 diabetes and starting basal insulin
• Inadequately managed patients i.e. patients who require further insulin intensification
• Patients who have used the Meter for at least 3 months
• Individuals who are over the age of 17

You may not qualify if:

• Individuals with type 1 diabetes
• Individuals who are over the age of 80
• Patients with psychological disorder
• Refuse to use the Meter to test their blood sugar

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Abbott: collaborator

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stewart Harris, MD

  The Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 13, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)