Characterisation of sensor accuracy for CGM systems

• Research type

  Research Study

• Full title

  Characterisation of sensor accuracy performance for CGM systems

• IRAS ID

  355902

• Contact name

  Ivelin Trifonov

• Sponsor organisation

  Abbott Diabetes Care

• Duration of Study in the UK

  10 years, 0 months, 0 days

• Research summary

  This is a post-market, single arm study of multiple Continuous Glucose Monitoring (CGM) systems. The main purpose of this study is to characterise the accuracy performance of different CE-marked CGM systems and collect safety data during the study period. Abbott CGM systems that belong to the FreeStyle Libre family and non-Abbott CGM systems will be used in this study.

  Glucose monitoring is an integral part of diabetes management which have traditionally been performed through blood glucose meters for self-monitoring of blood glucose (SMBG). The strain of traditional SMBG testing for patients is well documented and has been associated with inconvenience, pain and low adherence. CGM systems measure glucose in the interstitial fluid, they are being increasingly adopted as a replacement for SMBG. CGMs provide useful information on treatment and lifestyle behaviours on daily changes in blood glucose levels.

  During this study 15-45 adult subjects with Type 1 or Type 2 Diabetes will wear between one and three sensors for a period of up to 31 days depending on each sensor's wear indications. At Visit 1, participants provide informed consent and are screened for study eligibility. The participant’s height, weight, demographic information, diabetes history and medications will be recorded. Participants will be trained and sensor(s) will be applied.

  During the period of sensor wear participants will go about their daily activities carrying the paired reading devices with them. Participants will be asked to perform at least four Blood Glucose fingerprick tests per day (before meals and bedtime). At Visit 2 sensors are removed and any AEs/DIs since last contact will be documented.

  Following device return, data from Abbott and/or non-Abbott sensors will be uploaded and transferred to ADC for analysis. Accuracy performance of the CGM system will be evaluated compared to capillary fingerstick blood glucose values.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  25/YH/0073

• Date of REC Opinion

  16 Apr 2025

• REC opinion

  Favourable Opinion