Can diabetes alert dogs detect hypoglycemia in patients with type 1 diabetes?
| ISRCTN | ISRCTN90927134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90927134 |
| Protocol serial number | OHSU IRB00010881; Jaeb Center for Health Research PPQ#10061006829 |
| Sponsor | Jaeb Center for Health Research (USA) |
| Funder | Jaeb Center For Health Research (USA) |
- Submission date
- 22/04/2016
- Registration date
- 26/04/2016
- Last edited
- 26/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Trained dogs are increasingly being used to detect when people with type 1 diabetes have low blood sugar (glucose). No one knows how well these dogs work, yet patients are paying tens of thousands of dollars to purchase dogs from dog trainers. Doctors don't know what to tell their patients about the dogs because we don't know enough about them. The aim of this study is to find out how reliable trained dogs are at detecting low blood sugar levels. We will compare the dog alerts to blood sugar measurement tools that are already well-tested: fingerstick blood tests and a continuous glucose monitoring (CGM) device.
Who can participate?
Type 1 diabetes patients aged 2-80 who already use a trained dog to detect low blood sugar levels
What does the study involve?
The study lasts one week. Participants go about their usual lives while wearing a "blinded" CGM which measures glucose levels but the numbers are not visible to the participant. When their dog alerts, the participant carries out a fingerstick blood test and records any low blood sugar symptoms. Participants also complete a brief survey about low blood sugar and how well they think their dog works.
What are the possible benefits and risks of participating?
Participants will receive a copy of the CGM report at the end of their participation and will be paid for their time. Possible risks include problems with the CGM insertion including pain, bleeding or infection at the insertion site, or discomfort with extra fingerstick blood tests.
Where is the study run from?
Oregon Health & Science University (USA)
When is the study starting and how long is it expected to run for?
June 2014 to August 2015
Who is funding the study?
Jaeb Center For Health Research (USA)
Who is the main contact?
Dr Evan Los
Contact information
Scientific
Mail Code: CDRC-P
707 SW Gaines Street
Portland
97239
United States of America
 ORCID ID |
0000-0002-7567-0178 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot study exploring the test characteristics (sensitivity, positive predictive value) of a trained dog to detect hypoglycemia under real-life conditions. The study also explores patient perceptions of dog reliability and subjective value. |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Reliability of trained dogs to detect hypoglycemia in patients with type 1 diabetes |
| Study objectives | 1. Trained dogs will not be able to reliably detect and alert to hypoglycemia in patients with type 1 diabetes 2. Compared to a continuous glucose monitor (CGM) with established reliability data, trained dogs will provide inferior detection and alert capabilities in patients with type 1 diabetes 3. Trained dogs accurately alert to rate of change and absolute glucose values |
| Ethics approval(s) | Oregon Health & Science University Institutional Review Board, approved 31/03/2015, renewed 27/11/2015, IRB#00010881 |
| Health condition(s) or problem(s) studied | Type 1 diabetes |
| Intervention | Use of trained dog to detect and alert to hypoglycemia events. We assess and compare accuracy to measurement tools with known accuracy - capillary glucose and continuous glucose monitoring. Continuous glucose monitors are blinded to allow for detection of unrecognized hypoglycemia (by either subject or trained dog). Detailed event diaries allow assessment of dog alerts and compare to time stamp of continuous glucose monitor measurement and capillary blood glucose. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Rate of correct identification and alert to hypoglycemia event by trained dog: |
| Key secondary outcome measure(s) |
1. Mean and median time to alert after CGM <70 |
| Completion date | 19/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 8 |
| Key inclusion criteria | Age 2-80 years with diagnosis of type 1 diabetes and current user of dog formally trained to detect hypoglycemia |
| Key exclusion criteria | 1. Pregnancy 2. Unwilling to use blinded CGM device 3. Inability to speak, read, write and understand English language |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 19/08/2015 |
Locations
Countries of recruitment
- United States of America
Study participating centre
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
