#DiabetesAwareness Week: Meeting the Needs of Diabetes Clinical Trials

DiabetesThis week, June 14-20th, is known as Diabetes Awareness Week throughout the UK to raise awareness about the causes and treatments of diabetes, and social media has been buzzing with information.

The diabetes market has proven to be a desirable market as some of the world’s largest pharmaceutical companies are battling over market domination – in the U.S., Europe and emerging markets. What does this mean for clinical research? CROS NT looks at the growing diabetes market and what is driving innovation in this sector.

Approximately 347 million people worldwide suffer from diabetes – 90% of patients having Type II diabetes.  The World Health Organization estimates that diabetes will be among the leading causes of death by 2030. There has also been huge market growth for Type II diabetes treatments due to aging populations and the growing obsession with controlling obesity. More patients are being screened for and being diagnosed with diabetes, cases which were previously undetected.

The global diabetes care market – including drug and device development – is set to reach $25.3 billion USD by 2018 with an annual growth rate of 5.2%. The main drivers of this market are glucose monitoring devices and insulin delivery devices.

Clinical research is being driven by a search for minimally or non-invasive products for testing blood glucose levels rather than pricking the skin. This means an increase in diabetes medical device trials. With more patients being diagnosed, pharmaceutical companies will also be looking to develop more cost-effective solutions for anti-diabetic drugs.

How can Sponsors of diabetes drugs and devices get their product to market efficiently and in a cost-effective manner?

The most prevalent outsourcing strategy among drug development companies remains the use of different full service CROs. Using a variety of full service CROs to obtain the right therapeutic expertise and geographic locations can result in dispersed clinical data across a program of studies. An alternative, which is gaining increased popularity, is to continue using such CROs but to centralize the data with one specialized vendor for all studies related to a single product or compound. The benefit is standardized data formats, improved traceability, greater leverage of work from one study to the next, and most importantly, a significant reduction in costs.

If one study team is assigned to trial design, data management, data analysis and medical communications from the start, common data standards can be applied throughout the drug development process. Continuity of team members creates consistency and accessibility in reporting, better interpretation of data and a consistent style of medical       communications. All data are stored in a central data warehouse and/or archive which avoids having to keep track of multiple repositories.

Technology Considerations

One significant approach to keeping studies on track is using electronic methods for data collection in order to increase patient compliance, increase the speed with which data is collected and analyze data in real time.

An integrated EDC/ePRO solutions would specifically benefit diabetes clinical trials. Integrating an intuitive ePRO device – such as smartphones (iOS, Android, etc) or tablet, with a glucose meter can electronically capture and deliver blood glucose levels for analysis. 

Patients are identified with a user ID and password. Data is securely transferred and does not remain on the device. Communication is encrypted and data protection is ensured.

CROS NT and Diabetes Studies

stethoscopeCROS NT has provided statistical analysis, clinical data management, medical writing and technology services for numerous diabetes studies and in various indications such as: Type I and Type II Diabetes, Self-monitoring of blood glucose observational studies, Diabetic Foot, Diabetic Complications and Type II Diabetes Mellitus.

CROS NT has also consulted on several diabetes trials evaluating markers for the ability of the body to deal with processing of sugars in the blood.

CROS NT also has technology partners for conducting diabetes trials using an integrated eClinical platform with EDC/ePRO/IWRS/CTMS.

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