sing the Freestyle Libre Continuous Glucose Monitor on Alternative Sites

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus; Flash glucose monitoring; Metabolic and Endocrine - Diabetes; Blood glucose monitoring

• Registration Number: ACTRN12618001516279
• Lead Sponsor: Wellington Regional Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-10
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

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

Inclusion Criteria

Type 1 & 2 diabetes

Exclusion Criteria

Potential participants will not be recruited if they require regular Asprin use as it interferes with interstitial glucose monitoring, or if they have an allergy to medical tape/ sticking plaster and will stop participation if they develop an allergy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the proportion of time spent in the range of 4 to 8 mmol/L which will provide an estimation of the mean bias between the comparator site and the two other sites. This will be assessed by the analysis of the data retrieved from each of the sensor downloads.[Participants will have 3 visits to the study centre. On the first they will be recruited and 3 sensors will be placed on the back of arm, upper chest and flank. They will be instructed to scan each sensor at least once in an 8 hour period [to upload sensor data] then the sensor will downloaded at the third visit after 14 days. The next day (or soon after) they will return for their second visit for physiological testing. After 14 days they will return for the final rescanning and removal.]

Secondary Outcome Measures

Name	Time	Method
Comparison of sites with venous glucose measurements using a YSI anaylser during meal test and exercise activities. Venous samples will be obtained at 10 minute intervals throughout the moderate intensity 'stationary bicycle' exercise for 30 minutes and for a further 30 minutes after the end of the exercise completion.<br><br> [Participants will be asked to return on the second day (for four hours) after the insertion of the sensors and will be asked to fast for 10 hours. The medical student will insert intravenous cannula and take a fasting blood sample. Participants will then administer their individualised bolus dose of insulin (using a 20% reduction) and given a standard meal.]