November puts emphasis on diabetes: November 14th is World Diabetes Day and November in general is Diabetes Awareness Month in many countries including the United States.
According to the World Health Organization, approximately 347 million people suffer worldwide from diabetes – 90% of patients having Type II diabetes. Diabetes may very well be a leading cause of death by 2030. Diabetes can be treated and the consequences can be avoided with diet, physical activity, medication and regular screening.
When it comes to clinical research, there are numerous global trials for Type I, Type II and Gestational Diabetes (which occurs during pregnancy). Clinical research is being driven by a search for minimally or non-invasive products for testing blood glucose levels.
There are over 12,500 diabetes studies on the clinicaltrials.gov website.
What are some considerations for Sponsors conducting diabetes trials?
1. Ensuring efficient trial and protocol design will save Sponsors from “rescue studies” down the line. Rescue studies due to patient recruitment or protocol flaws can cost Sponsors millions of dollars per year.
2. Regulatory authorities are constantly placing more emphasis on the quality and transparency of trial data. Centralizing your data with one specialized vendor allows Sponsors to have complete biometrics oversight and follow a risk-based approach to trials as outlined by the ICH GCP E6(R2) guidelines. Consider a clinical analytics solution for Risk-Based Monitoring.
3. Ask your provider about eClinical solutions such as easy data collection and reporting via EDC systems and eCOA platforms that allow for the integration of a Glucose meter if necessary.