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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western University

London, Ontario, N6A 3K7, Canada

About this study

The objectives of this study are to

Describe patients' and care providers' satisfaction associated with the use of the FreeStyle Precision Neo-Meter
Evaluate the uptake and use of the Meter
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Patient and Care provider satisfaction structured interview guide

Time frame: 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.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

Abbott

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Sep 17, 2015
Registry last updated: Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed