Sanofi, a global healthcare comapny, and T1D Exchange, a non-profit organization focused on type 1 diabetes, will collaborate on the TEENs registry study, which aims to provide the type 1 diabetes community with a better understanding of how children, adolescents and young adults are currently living with type 1 diabetes, and to deliver recommendations for better disease management and patients outcomes.
TEENs is a multinational, observational, cross-sectional study that will evaluate the percentage of type 1 diabetes patients between the ages of 8 and 25 with controlled glycemia, as measured by hemoglobin A1c (HbA1c). Secondary outcomes will include measurements of quality of life and emotional status, the relationship between glycemic control and quality of life, and the impact of factors such as medical care on these two measurements.
"To better understand how to treat young people with type 1 diabetes, we need to know how exactly they are living with the disease. Our goal with the TEENs study is to examine how clinical factors such as glycemic control impact the quality of life of this particularly vulnerable group of young people with diabetes," said Riccardo Perfetti, MD, vice president medical affairs, global diabetes, Sanofi. "TEENs is another example of Sanofi's ongoing commitment to further develop the understanding of optimal type 1 diabetes care."
The TEENs study will enroll more than 7,000 people with type 1 diabetes in 20 countries, with a sample representative of the typical medical care in the respective country. In the U.S., Sanofi works in partnership with T1D Exchange for the recruitment of the young study participants and for implementation of this study. Worldwide, Sanofi partners with various clinic centers, hospitals and healthcare professionals.
"We are excited to support Sanofi and the TEENs study with T1D Exchange's patient registry and extensive clinic network in the U.S. We are also honored to be designated by Sanofi as a clinical trial Center of Excellence," said Dana Ball, CEO and cofounder , T1D Exchange. "This collaboration demonstrates the unique efficiencies and capabilities that partnerships with foundation-driven clinical exchanges can create."
Data will be collected from healthcare professionals, parents or guardians and patients. Anticipated outcomes include: identification of predictive factors for glucose control and acute complications of type 1 diabetes, better understanding of unmet needs of young people with type 1 diabetes in different age groups, documentation of insulin regimens in young people with type 1 diabetes and description of the patient journey from pediatric to adult care services.
Results from the TEENs study will be presented at scientific congresses in 2013 and in 2014.