On July 21, the Clinical Chemistry and Clinical Toxicology Devices Panel Advisory Committee of the US Food and Drug Administration (FDA) voted in favor of the proposed non-adjunctive indication for a CGM system as a replacement to self-monitoring blood glucose meters (SMBG) glucose testing for diabetes treatment decisions.
“The proposed changes to the CGM indication would allow patients to use glucose information provided through CGM devices to make real-time treatment decisions to better manage their diabetes,” Sam Osman, Head of Cardiac Safety Services & Connected Devices at Quintiles told Outsourcing-Pharma.com.
As opposed to traditional approaches, such as using SMBG and glycated hemoglobin (HbA1c), GCM is able to capture a “larger story” of a patient’s glucose control.
“CGM is the equivalent of automatically taking a finger stick every 5 minutes and providing patients with the information to make better treatment decisions,” explained Osman. “This means that glucose variability, including low (hypo) or high (hyper) glucose events, are captured and reported continuously.”
According to Osman, traditional measures of glycemic control like HbA1c provide “little to no insights into daily glycemic variability,” which is often needed to assess a drug’s effect on glucose control and safety profile.
“When used in clinical research, CGM provides investigators with access to a myriad of customized data analytics and performance reports,” he added.
Additionally, these optimized glycemic data sets can be analyzed more efficiently to uncover trends, such as non-compliance, and potential safety triggers faster than traditional diabetes monitoring models.
“In the clinical trial setting, this comprehensive and timely glucose visibility has the potential to improve patient safety and accelerate clinical development,” added Osman.
According to Osman, the offering enables investigators to make informed decisions in a timely, safe manner for patients in a study.
“CGM can provide a variety of in-depth measures from diabetes patients – information that can be used to enhance the way patients are treated for diabetes and why this new offering is so critical,” he added.
For example, CGM can provide up to 288 data points a day (every 5 minutes for 24 hours), allowing investigators to analyze glucose levels after meals, while a patient is sleeping or while they are exercising. It also allows researchers to better understand rates of glucose change. “This data is key to helping drugmakers optimize dosing and monitor safety,” said Osman.
He added, “We believe that this new technology solution incorporating biosensors and wearables, which can be used across all drug development phases, has the potential to improve the way the industry tracks and improves diabetes care for patients worldwide.”