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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: FreeStyle Precision Neo-Meter

• Registration Number: NCT02553408
• Lead Sponsor: Lawson Health Research Institute

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neo meter	FreeStyle Precision 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.

Primary Outcome Measures

Name	Time	Method
Patient and Care provider satisfaction structured interview guide	3 months after the use of the meter	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.

Trial Locations

Locations (1)

Western University; 🇨🇦 London, Ontario, Canada