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Continuous Glucose Monitoring

Transform diabetes clinical development

Quintiles Continuous Glucose Monitoring (CGM) platform combines our leading operational and therapeutic expertise with industry-leading CGM technologies to capture and analyze glucose data better than before; CGM has the potential to improve patient safety, accelerate clinical development, and provide a basis for differentiated claims.

Continuous Glucose Monitoring

Quintiles is the first CRO with an end-to-end Continuous Glucose Monitoring offering

Advanced Technology that Delivers High Quality Data 

New technologies are enabling better tools to measure, analyze, and access medical data. The benefit of CGM is how it provides more robust glycemic data sets and glucose variability: CGM captures the larger story of a patient’s glucose control by continuously monitoring glucose levels instead of the traditional approaches using self-monitored blood glucose measures (SMBG) and glycated hemoglobin (HbA1c). This means that glucose variability, including low (hypo) or high (hyper) glucose events, are captured and reported continuously. Less volatility in glucose levels means more control, which leads to better clinical outcomes and patient safety. Traditional measures of glycemic control like HbA1c provide little to no insights into daily glycemic variability, which can represent relevant information to further differentiate a drug’s effect on glucose control and safety profile.

An end-to-end CGM Solution

By integrating advanced technology with over 30 years of clinical experience, we offer you the tools and resources to get results faster. Standalone or as a comprehensive solution, you get industry-leading CGM technologies used in clinical trials incorporated into a secure data environment, combined with operational, metabolic, and cardiovascular expertise:
  • Range of FDA-approved sensors that measure glucose continuously for up to 7 days
  • Dedicated, regionally based CGM project managers with therapeutic and device experience
  • 24/7 CGM lab operations and helpdesk with specialized CGM training
  • Site support, training, and device provisioning, including the knowledge and experience to get devices in different countries
  • Diabetes Center of Excellence with >70 medical, scientific and operational experts

Accelerating Diabetes Clinical Development

Improve your clinical outcomes by harnessing the powerful benefits of Quintiles’ CGM approach: 
  • Faster initiation of trials with quick deployment of CGM kits designed to shorten trial time
  • Substantially larger data sets on daily glucose measures which go beyond HbA1c
  • Shorter drug optimization period providing near real-time data to glucose responses based on meal and study parameters,  
  • This provides information that allows investigators to make quicker and safer titration decisions
  • Quick identification of safety issues allowing for changes in treatment decisions
  • Faster go/no go decisions based on more robust mechanisms for data capture 
  • Strategic, data-driven approach to help you make the right decisions
  • End-to-end CGM solution to support your needs in any phase of your clinical development pathway
 
By working with a leader in diabetes clinical development and digital health markets, you get the combined benefit of Quintiles clinical expertise with FDA-approved CGM technology.

Interested in learning more about how your clinical trial can benefit from our CGM capabilities? Contact us today at clinical@quintiles.com.


Project Management and Oversight   +

Reliable operational delivery to set you up for success

  • Industry-leading technology platform built to pharma specifications
  • Smart logistics and load balancing capabilities
  • 24/7 help desk with specialized CGM training
  • Team of global PMs and DMs to provide customers with one point of contact, who is accountable for your project’s success 
  • Proprietary 21 CFR part 11 compliant platform co-developed with a leading CGM manufacturer insures electronic source data integrity 
Robust Data Capture Mechanisms   +

Robust data sets improve your clinical study and patient safety

  • Metrics driven performance shared with sponsor on study progress
  • Robust data capture mechanisms tell the larger patient story
  • Data capture, cleaning, and acceptability reporting helps identify gaps/risks
  • Ongoing data reconciliations of the data with the customer database
  • Advanced user interface for device upload and data management
  • Electronic source data secured with a single vendor
Analytics to Drive Insight   +

Connecting insights to accelerate your clinical development
  • Customized reports with visualization tools for data acceptability, site performance, and trend analysis
  • 275 experienced staff biostatisticians ensure robust glycemic analyses including Ambulatory Glucose Profile (AGP), Mean Amplitude of Glycemic Excursions (MAGE), Mean of Daily Differences (MODD), imputed 14 day HbA1c, etc.
  • Glycemic control and variability analyses to evaluate patterns of hyper-and hypoglycemia
  • Assessment of pre and postprandial glycemic changes
  • Robust SAP preparation and execution
  • Leverage the insights gained from developing and/or commercializing 29 of 2014’s top 30 best-selling diabetes products

Proof in marketplace

Join forces with Quintiles to change the way you approach your diabetes clinical trial at any stage of development.