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Accuracy of Blood Glucose Detection by Diabetes Alert Dogs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02126605
Recruitment Status : Unknown
Verified April 2014 by Linda Gonder-Frederick, University of Virginia.
Recruitment status was:  Not yet recruiting
First Posted : April 30, 2014
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Linda Gonder-Frederick, University of Virginia

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.

Condition or disease
Type I Diabetes Mellitus

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.

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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Blood Glucose Detection by Diabetes Alert Dogs
Study Start Date : July 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar




Primary Outcome Measures :
  1. Percent agreement between DAD alerts and glucose readings [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Psychosocial variables (quality of life, fear of hypo-/hyperglycemia, diabetes distress, self-efficacy, and DAD experiences) [ Time Frame: Baseline, 5 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetes Alert Dog (DAD) owners who have obtained their dogs from a specific training organization.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126605


Contacts
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Contact: Jesse Grabman, B.A. 434-924-5316 JHG5DQ@hscmail.mcc.virginia.edu
Contact: Jaclyn Shepard, Psy.D. 434-924-5314 JAS8RW@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Center for Behavioral Medicine Research
Charlottesville, Virginia, United States, 22908
Contact: Jesse Grabman, B.A.    434-924-5316    JHG5DQ@hscmail.mcc.virginia.edu   
Principal Investigator: Linda Gonder-Frederick, Ph.D.         
Sub-Investigator: Jaclyn Shepard, Psy.D.         
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Linda Gonder-Frederick, Ph.D. University of Virginia
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Responsible Party: Linda Gonder-Frederick, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02126605    
Other Study ID Numbers: 17296
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014
Keywords provided by Linda Gonder-Frederick, University of Virginia:
diabetes alert dogs
hypoglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases