Accuracy of Blood Glucose Detection by Diabetes Alert Dogs

April 28, 2014 updated by: Linda Gonder-Frederick, University of Virginia
Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as a way to monitor blood glucose in type 1 diabetes (T1D), no scientific studies have confirmed the ability of DADs to accurately detect extreme high and low blood sugar. The current project is the first preliminary investigation into the accuracy of DADs, using scientifically rigorous research methods similar to those required to demonstrate accuracy in blood glucose meters. The primary aim of the project is to test the hypotheses that DADs are accurate at detecting extreme blood sugar levels in adults and children with T1D. The proposed project has several other secondary aims, which include determining: 1) the glycemic thresholds and time course for hypo- and hyperglycemic DAD alerts, 2) the degree to which alert accuracy is consistent across different DADs, and 3) whether or not DAD owners appear to experience better psychosocial status and quality of life compared to other individuals with T1D.

Study Overview

Status

Unknown

Conditions

Detailed Description

In the proposed project, DAD alerts will be compared to blood glucose (BG) readings from a continuous glucose monitoring (CGM) device, as well as a BG meter. CGM, BG meter, and DAD alert data will be collected over a 4-wk period. CGM devices will be "blinded" so that BG readings will not be shown. This will allow for a direct comparison between objective glucose readings generated by approved BG monitoring devices and DAD alerts. This study will also utilize two methods for measuring DAD alerts: (1) use of the event recorder mechanism of the CGM device, and (2) collection of more detailed and qualitative data on DAD alerts using diaries (Daily DAD Diaries) to collect information concerning the occurrence, timing, and type of DAD alerts.

Study Type

Observational

Enrollment (Anticipated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Center for Behavioral Medicine Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetes Alert Dog (DAD) owners who have obtained their dogs from a specific training organization.

Description

Inclusion Criteria:

  • The participant must have had type 1 diabetes for at least 1 year and been taking insulin since diagnosis
  • The participant must have a DAD placed in their home for a minimum of 6 months.
  • Participants must not currently be using a continuous glucose monitor (CGM) in their diabetes management.
  • Participants must be capable of performing all tasks involved in the study protocol, including filling out questionnaires and diaries in English.
  • Participants must have an internet-connected computer compatible with study software.
  • Willingness to avoid consumption of acetaminophen-containing products for the duration of the study.

Exclusion Criteria:

  • Pregnant women-self reported
  • Current use of a CGM
  • History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent agreement between DAD alerts and glucose readings
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychosocial variables (quality of life, fear of hypo-/hyperglycemia, diabetes distress, self-efficacy, and DAD experiences)
Time Frame: Baseline, 5 weeks
Baseline, 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Linda Gonder-Frederick, Ph.D., University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

April 30, 2014

Last Update Submitted That Met QC Criteria

April 28, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17296

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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