This section highlights FDA-related milestones and regulatory updates for drugs developed by GlucoTrack (GCTK).
Over the past two years, GlucoTrack has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Continuous and Subclavian. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Continuous Blood Glucose Monitor - FDA Regulatory Timeline and Events
Continuous Blood Glucose Monitor is a drug developed by GlucoTrack for the following indication: Concept among people with insulin-requiring diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Continuous Blood Glucose Monitor
- Announced Date:
- August 15, 2024
- Indication:
- Concept among people with insulin-requiring diabetes.
Announcement
Glucotrack, Inc. announced new findings from a recent market research study evaluating the acceptance of its new Continuous Blood Glucose Monitor (CBGM) concept among people with insulin-requiring diabetes.
AI Summary
Glucotrack, Inc. recently shared market research results on its new Continuous Blood Glucose Monitor (CBGM) concept. This innovative, implantable device is designed for people with insulin-requiring diabetes and offers continuous, accurate blood glucose readings without the need for calibration or a wearable component. The study, conducted with 757 respondents including both current and non-users of continuous monitoring systems, revealed that over 50% of participants were open to using the new CBGM. Key features that attracted interest were its long-term sensor life, with testing conducted for up to 2 years, and its ability to deliver real-time glucose data without any on-body attachments.
The research highlights a strong market potential for Glucotrack’s device, confirming that many people with diabetes are looking for more convenient and less intrusive monitoring options. These insights will help guide future improvements in the technology as Glucotrack works to enhance diabetes management.
Read Announcement
Subclavian - FDA Regulatory Timeline and Events
Subclavian is a drug developed by GlucoTrack for the following indication: Vein-Based Continuous Glucose Monitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Subclavian
- Announced Date:
- February 4, 2025
- Indication:
- Vein-Based Continuous Glucose Monitor
Announcement
Glucotrack, Inc. announced the successful completion of its first in human clinical study, marking a significant milestone in continuous glucose monitoring.
AI Summary
Glucotrack, Inc. announced a major milestone with the successful completion of its first in-human clinical study for its continuous blood glucose monitoring (CBGM) sensor. This study tested a new real-time device that directly measures blood glucose by placing the sensor lead in the subclavian vein, offering an alternative to traditional monitors that measure interstitial fluid. The short-term, four-day hospital study focused on the safety, placement, use, and removal of the sensor. It involved six diabetic patients and was successfully conducted by interventional cardiologists, with no serious adverse events reported during the study period. The results confirmed that the CBGM sensor lead performed as expected, matching the accuracy levels observed in previous animal studies. These promising findings bring the technology one step closer to providing a less intrusive and more continuous method of blood glucose monitoring for people with diabetes.
Read Announcement
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