Clinical trial NCT02126605: Accuracy of Blood Glucose Detection by Diabetes Alert Dogs
Official title: Accuracy of Blood Glucose Detection by Diabetes Alert Dogs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type I Diabetes Mellitus
Keywords: diabetes alert dogs
hypoglycemia
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes Alert Dog (DAD) owners who have obtained their dogs from a specific training organization.

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.

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.

Eligibility 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

Primary outcomes:
measure: Percent agreement between DAD alerts and glucose readings
timeFrame: 5 weeks
Secondary outcomes:
measure: Psychosocial variables (quality of life, fear of hypo-/hyperglycemia, diabetes distress, self-efficacy, and DAD experiences)
timeFrame: Baseline, 5 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Behavioral Medicine Research
state: Virginia
Study officials:
affiliation: University of Virginia
name: Linda Gonder-Frederick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: