FreeStyle Libre potential in-reader correction study
Research type
Research Study
Full title
Effectiveness of a Potential In-reader Correction for FreeStyle Libre Sensor Glucose Data.
IRAS ID
230816
Contact name
Peter Dewland
Contact email
Sponsor organisation
Abbott Diabetes Care Ltd.
Duration of Study in the UK
0 years, 2 months, 0 days
Research summary
This is a single arm, prospective evaluation of the masked FreeStyle Libre Flash Glucose Monitoring System.
Twenty-seven people with Type I or Type II diabetes aged 18 and over will be enrolled.Participants will wear two masked (blinded) Sensors for up to 14 days consecutively; they will not be able to see the Sensor glucose data generated.
Sensors will be placed, one on the back of each arm. Up to three unique sensor lots will be evaluated in this study; each participant will wear sensors from one lot.
Participants will obtain at least four fingerstick readings per day whilst wearing the Sensors (using the built-in test strip port in the study Reader). Participants will scan each Sensor using the Reader immediately after obtaining a fingerstick reading. Blood Glucose results obtained from fingerstick will be visible to the participant.
Participants will make up to six visits to the clinical study site, including the Screening Visit (Visit 0) up to 28 days before Day 1.
There will be three in-clinic visits; of up to eight hours’ reference sampling at 15-minute intervals, from an IV port. The participant’s arm containing the IV insertion site will be heated to enhance blood flow during blood collection. Plasma reference samples will be analysed using the laboratory analyser (YSI).
Participants will return to the clinic at the end of the Sensor wear and the Reader data will be uploaded to a laptop.
One or two training participants may be enrolled for abbreviated study participation to train study staff on study procedures to ensure everyone is fully proficient on the system. Training participants’ data will be included in the safety data but not evaluated otherwise.
Each participant’s involvement in the study will be 15 days excluding the 28 day screening window.
REC name
HSC REC A
REC reference
17/NI/0156
Date of REC Opinion
11 Sep 2017
REC opinion
Further Information Favourable Opinion