The trial was intended to evaluate implant technique and CBGM’s safety and the company used a small sample size of sensors to determine device functionality during the study
Glucotrack has positive data for implantable CBGM. (Credit: Martin Büdenbender from Pixabay)
US-based medical device company GlucoTrack has reported positive early accuracy data from the first preclinical study of its implantable continuous blood glucose monitor (CBGM).
GlucoTrack’s CBGM is said to have a long sensor life, does not require a second wearable component, and only requires one calibration event.
The company has completed the initial and long-term preclinical testing of this implantable device.
The trial was intended to evaluate implant technique and CBGM’s safety. In addition, the company used a small sample size of sensors to determine device functionality during the study.
According to the findings, the sensor showed a Mean Absolute Relative Difference (MARD) of 8.1% on Day 30 and 4.5% on Day 60. The trial concluded without any major adverse effects.
GlucoTrack CEO Paul Goode said: “We are extremely pleased with these initial results demonstrating that the sensor is both safe and capable of a high level of accuracy.
“Because this study was performed using initial prototype devices, we expect to see similar results with improved prototypes that are manufactured using refined production techniques.
“So, we are very confident as we continue to advance our development programme and as we share more information about our novel approach.”
The implantable CBGM is designed to be put under the skin and attached to a lead that is inserted straight into a blood vessel using an intravascular technique.
GlucoTrack said that the method enables continuous blood glucose measurements with zero lag time in comparison to several continuous glucose monitoring (CGM) systems which measure glucose in the interstitial fluid.
This approach is based on design components, implant methodologies, and implant tools frequently employed for active implantable medical devices in the cardiovascular domain.
This preliminary preclinical study shows that this method enables a simple implant technique that takes about 20 minutes.
Additionally, the medical device firm started long-term preclinical testing on the implantable CBGM. The goal of the trial is to assess sensor accuracy and longevity with a refined prototype and a larger sample size.
GlucoTrack is also planning for first-in-human trials, which should begin later this year.