Can diabetes alert dogs detect hypoglycemia in patients with type 1 diabetes?

Completed

• Conditions: Type 1 diabetes; Nutritional, Metabolic, Endocrine; Type 1 diabetes mellitus

• Registration Number: ISRCTN90927134
• Lead Sponsor: Jaeb Center for Health Research (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-26
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Age 2-80 years with diagnosis of type 1 diabetes and current user of dog formally trained to detect hypoglycemia

Exclusion Criteria

1. Pregnancy
2. Unwilling to use blinded CGM device
3. Inability to speak, read, write and understand English language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Rate of correct identification and alert to hypoglycemia event by trained dog:<br>1.1. Rate of correct alert (CBG or CGM <70 mg/dL and dog alert prior to other measures)<br>1.2. Rate of delayed alert (CBG or CGM <70 mg/dL and dog alert after other measures)<br>1.3. Rate of missed alert (CBG or CGM <70 mg/dL and no dog alert)<br>1.4. Rate of incorrect alert (alert without the presence of hypoglycemia)

Secondary Outcome Measures

Name	Time	Method
1. Mean and median time to alert after CGM <70<br>2. Rate of change of CGM value at time of dog alert<br>3. Total duration of time with CGM value <70 mg/dL per 24 hours)<br>4. Subjective confidence of dog’s master in the trained dog’s ability to detect hypoglycemia<br>5. Rate of hypoglycemia events for which dog is not present/not available<br>6. Rate of correct identification and alert to hyperglycemia event by trained dog at threshold designated by dog’s master<br>