None listed
Conditions
Brief 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.
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
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.
Sponsors
Wellington Regional Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed