Type 1 diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus
Conditions
Interventions
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
Sponsors
Jaeb Center for Health Research (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 2-80 years with diagnosis of type 1 diabetes and current user of dog formally trained to detect hypoglycemia
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Unwilling to use blinded CGM device 3. Inability to speak, read, write and understand English language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rate of correct identification and alert to hypoglycemia event by trained dog: 1.1. Rate of correct alert (CBG or CGM <70 mg/dL and dog alert prior to other measures) 1.2. Rate of delayed alert (CBG or CGM <70 mg/dL and dog alert after other measures) 1.3. Rate of missed alert (CBG or CGM <70 mg/dL and no dog alert) 1.4. Rate of incorrect alert (alert without the presence of hypoglycemia) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean and median time to alert after CGM <70 2. Rate of change of CGM value at time of dog alert 3. Total duration of time with CGM value <70 mg/dL per 24 hours) 4. Subjective confidence of dog’s master in the trained dog’s ability to detect hypoglycemia 5. Rate of hypoglycemia events for which dog is not present/not available 6. Rate of correct identification and alert to hyperglycemia event by trained dog at threshold designated by dog’s master | — |
Countries
United States of America
Outcome results
None listed