Evaluation of a novel glucose sensor in type 1 diabetes

Not Applicable

Completed

• Conditions: Type 1 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614001163695
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Clinical diagnosis of type 1 diabetes, insulin treatment for diabetes, experience with glucose sensor use.

Exclusion Criteria

Pregnant, planned pregnancy within study period, inability to tolerate tape adhesive in the area of device placement, adverse skin condition in the area of device placement.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of the ORS versus ECS (assessed via accuracy and reliability of sensor data), with blood glucose levels as the reference.[0 to 168 hours]

Secondary Outcome Measures

Name	Time	Method
ORS versus ECS insertion site appearance (skin assessed as normal or abnormal; any skin abnormalities described and photographed).[168 hours post sensor insertion];ORS versus ECS device comfort and irritability (assessed via non-structured interview).[168 hours post sensor insertion]