A Feasibility Study of a Novel Glucose Sensor for Continuous Glucose Monitoring in Type 1 Diabetes.

Not Applicable

Completed

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

• Registration Number: ACTRN12614000256673
• 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: 2014-03-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Participant is 21-70 years of age at time of screening.
2. A clinical diagnosis of type 1 diabetes, as determined by the Investigator.
3. Participant is using insulin to treat his/her diabetes.
4. Currently using a sensor or has experience with sensor use.
5. Preference will be given to subjects who have a history of hypoglycaemia
6. Participant is willing to comply with all requirements associated with the protocol.

Exclusion Criteria

1. Participant has a positive pregnancy screening test
2. Participant is female and plans to become pregnant during the course of the study.
3. Participant is unable to tolerate tape adhesive in the area of sensor placement.
4. Participant has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of sensor glucose data provided by the Investigational (Harmony) sensor with meter glucose and YSI glucose values as references. [Day 1, Day 4, Day 8 of the study];Descriptive comparison of sensor accuracy using sensor glucose data provided by investigational Harmony sensors in comparison to YSI glucose values and glucose meter values as references.<br>[0 - 168 hours]

Secondary Outcome Measures

Name	Time	Method
Device survival of the Harmony sensor determined by provision of glucose measurements from sensor to senor recorder.[0 - 168 hours];Sensor insertion site appearance of the Harmony sensors determined by visual assessment.[Day 8 of the study (after removal of sensors)]