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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: FreeStyle Precision Neo-Meter

Detailed Description

The objectives of this study are to

1. Describe patients' and care providers' satisfaction associated with the use of the FreeStyle Precision Neo-Meter
2. Evaluate the uptake and use of the Meter
3. Describe the impact of the Meter on primary care diabetes consultation from care providers' perspectives.

In order to achieve the objectives of this study, diabetes healthcare providers and people with type 2 diabetes who have been using the Neo meter will be interviewed. Maximum variability will be sought for provider discipline and patient demographic characteristics. Sampling will continue until theme saturation is reached. A total of up to 20 (10 care providers and 10 people with diabetes) will be interviewed for this study.

Diabetes healthcare provider interview: Two care providers from each discipline including physicians, nurses, nurse educators and dietitians in Southwestern Ontario, Canada, who have been using the Neo meter will be recruited for interviews. Care providers satisfaction will be assessed after the use of the Meter with sample representation of sole and team based practices.

Patient interviews: Eligible patients who agreed to participate in the study will be provided with a Neo meter and test strips. Their care providers will provide them with instructions, guidance and support in using the device as part of their self-management activities. Patients will be interviewed 3 months after (post only) the use of the Meter to assess their satisfaction with its functionality, capacity, design and ease-of-use.

Interviews will take place at a location and time convenient for participants and will take approximately 45min-60min in Oct/Nov 2015. Interviews will be audio tape recorded to allow for a fluid discussion such that the interviewer does not need to stop the conversation to take notes. A letter of information and consent form will be provided to participants.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Neo meter; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Abbott
• Investigators: Principal Investigator: Stewart Harris, MD, The Western University

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Canada-IIS_ADC-OUS-IIS-14-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No