Accuracy of Blood Glucose Detection by Diabetes Alert Dogs
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 6 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | July 2014 |
| End Date: | March 2015 |
| Contact: | Jesse Grabman, B.A. |
| Email: | JHG5DQ@hscmail.mcc.virginia.edu |
| Phone: | 434-924-5316 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
