TEENs, also known as the "Glycemic control and quality of life in children, adolescents, and young adults with type 1 diabetes mellitus described in a worldwide, cross-sectional study in 2012," 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 US, 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 US. We are also honored to be designated by Sanofi as a clinical trial Center of Excellence," said Dana Ball, CEO and Cofounder of the 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.
Diabetes is a chronic disease that occurs as type 1 diabetes, which is an autoimmune disease characterized by the lack of insulin (the hormone that regulates blood glucose concentrations) production by the pancreas, and type 2, a metabolic disorder in which there are two main biological defects: a deficient production of insulin and reduced ability of the body to respond to the insulin being produced. Type 1 and type 2 diabetes are characterized by an increase in blood glucose concentrations (hyperglycemia). Over time, uncontrolled hyperglycemia leads to the macrovascular and microvascular complications of diabetes. Macrovascular complications, which affect the large blood vessels, include heart attack, stroke and peripheral vascular disease. Microvascular complications affect the small blood vessels of the eyes (retinopathy), kidney (nephropathy) and nerves (neuropathy). More than 18 million people worldwide are living with type 1 diabetes. And, the incidence of type 2 diabetes is growing at an alarming rate, with nearly 348 million people worldwide living with the condition today.
About T1D Exchange
T1D Exchange is a non-profit organization with the mission to improve outcomes of people touched by type 1 diabetes by accelerating the discovery of new approaches to research and development. It connects the disparate stakeholders in the type 1 diabetes community by combining the critical components of traditional clinical research with the expanding fields of health information technology and social networking.
T1D Exchange evolved as a solution to mitigate barriers and inefficiencies for type 1 diabetes research and development. It is a personalized exploration platform anchored in health informatics: T1D Exchange consists of Glu, an interactive website with mobile capabilities for patients and caregivers; a network of 69 clinics across the United States; and a biorepository comprising clinically annotated patient biological samples. T1D Exchange was founded in 2011 through a grant from The Leona M. and Harry B. Helmsley Charitable Trust.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 receptor agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral antidiabetic agents.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).