RecruitingACTRN12618001516279

Using the Freestyle Libre Continuous Glucose Monitor on Alternative Sites

The perceived and actual reliability of an alternative Freestyle Libre Continuous Glucose Monitoring application site in people with Type 1 & 2 Diabetes

Sponsor

Wellington Regional Hospital

Enrollment

20 participants

Start Date

Dec 10, 2018

Study Type

Interventional

Conditions

Flash glucose monitoring Blood glucose monitoring Diabetes Mellitus

Summary

Monitoring blood glucose levels is crucial to good control of Diabetes Mellitus (DM) however the inconvenience and discomfort associated with capillary blood glucose testing limits its use. The Freestyle Libre continuous glucose monitor (CGM) is new technology for monitoring subcutaneous interstitial fluid glucose concentration. This technology has recently been introduced to New Zealand and there is considerable interest amongst those with DM. The manufacturer advises that the sensor device has only been licenced to be sited on the back of the arm, although a few studies have assessed the accuracy and precision of placing the sensor in other body sites. We aim to demonstrate in that using a Freestyle Libre sensor on the chest or flank are comparable with the manufacturer's recommended site on the back of the arm.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Managing blood sugar levels is one of the most important tasks for people living with diabetes, but finger-prick blood tests are inconvenient and uncomfortable, so many people do not test as often as they should. The Freestyle Libre is a continuous glucose monitoring device — a small sensor worn on the skin that measures glucose levels automatically without finger pricks — and it has recently become available in New Zealand. The manufacturer recommends the Freestyle Libre sensor be worn on the back of the upper arm, but this location can be inconvenient for some people. This study tests whether wearing the sensor on the chest or flank (side of the body) gives readings that are as accurate and consistent as the recommended arm placement, potentially offering more comfortable and discreet alternatives for daily use. To be eligible you need to have Type 1 or Type 2 diabetes. People who regularly take aspirin (which can interfere with interstitial glucose monitoring) or who have allergies to medical adhesive tape are not eligible. The study involves wearing multiple sensors simultaneously on different body locations and comparing the readings over time — no additional medications or procedures are required.

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Interventions

Potential participants will be identified and contacted by a diabetes nurse from the Endocrine, Diabetes & Research Centre, and provided with the information sheet. Participants will be recruited from patients attending the diabetes clinic who are currently using a Freestyle Libre or intending to use in the next 3 months. We plan to recruit equal proportions of patients, who are aged 18 years and over, with Type 1 or Type 2 DM, who are using insulin therapy. 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. Those who express interest will be invited to attend the research centre for 3 visits. The summer student will provide further details, answer any questions and provide an information and consent sheet on the initial visit. After recruitment, three Freestyle Libre sensors will be placed by a summer medical student under the close supervision of a medical practitioner or Clinical Nurse Specialist. Participants will be instructed to regularly scan (at least once) within an 8 hour period for the 14 day trial period (- to upload and store the recorded data. Activity logs (record books) will be continued to be maintained over the 2 week period. The back of upper arm (the comparator) on anterior chest wall, and the flank region posteriorly above the ilium worn simultaneously. The data will be analysed at the end of the 28 days.