Accuracy of Blood Glucose Detection by Diabetes Alert Dogs

NCT02126605 | Unknown DMC

• 1 other identifier: 17296
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type I Diabetes Mellitus

Keywords

diabetes alert dogs; hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Percent agreement between DAD alerts and glucose readings

  5 weeks

Secondary Outcomes (1)

• Psychosocial variables (quality of life, fear of hypo-/hyperglycemia, diabetes distress, self-efficacy, and DAD experiences)

  Baseline, 5 weeks

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Center for Behavioral Medicine Research

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Linda Gonder-Frederick, Ph.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse Grabman, B.A.

CONTACT

434-924-5316; JHG5DQ@hscmail.mcc.virginia.edu

Jaclyn Shepard, Psy.D.

CONTACT

434-924-5314; JAS8RW@hscmail.mcc.virginia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 30, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

US (1)