Objective
Our study aims to determine how safe and effective two new classes of diabetes medications—GLP-1 receptor agonists and SGLT2 inhibitors—are when used by people with type 1 diabetes. By analyzing a vast collection of electronic health records, we hope to learn whether these medications can help improve blood sugar control, support weight loss, and protect the heart and kidneys in individuals with type 1 diabetes, while also identifying any potential risks.
Background Rationale
People with type 1 diabetes rely almost entirely on insulin injections to manage their blood sugar levels. Although insulin is essential for survival, it can lead to challenges like weight gain and unpredictable blood sugar levels, which may increase the risk of heart, kidney, and other complications. In contrast, people with type 2 diabetes often benefit from additional medications that not only lower blood sugar but also offer benefits such as weight loss and improved heart and kidney health. Unfortunately, these newer treatments have not been well studied in the type 1 diabetes population. Our research seeks to fill that gap by examining how these drugs perform in people with type 1 diabetes.
Description of Project
Type 1 diabetes is a lifelong condition in which the body stops producing insulin, a hormone that helps control blood sugar. As a result, people with type 1 diabetes must rely on daily insulin injections to survive. However, while insulin is critical for managing blood sugar, it often comes with challenges such as weight gain and fluctuations in blood sugar levels, which can lead to serious complications like heart disease, kidney problems, and vision loss. Our study is focused on exploring new treatment options that might help address these challenges for people with type 1 diabetes.
In recent years, two new classes of diabetes medications have shown promising results in people with type 2 diabetes. One group, called GLP-1 receptor agonists, helps lower blood sugar, promotes weight loss, and protects the heart and kidneys. The other group, known as SGLT2 inhibitors, works by helping the body excrete excess sugar through the urine while also offering benefits for heart and kidney health. Although these medications have been well-studied in type 2 diabetes, their use in type 1 diabetes remains unclear. Many doctors have started prescribing them off-label (meaning for a use not officially approved) for type 1 diabetes, but we do not have enough evidence about their safety and effectiveness in this population.
Our study will use a massive nationwide database called EPIC COSMOS, which contains detailed electronic health records for a large portion of U.S. residents. By analyzing data from this database, we will identify people with type 1 diabetes who have used GLP-1 receptor agonists or SGLT2 inhibitors and compare their outcomes to those who have not used these medications. We will look at how these drugs affect important health outcomes such as heart and kidney health, blood sugar control, and weight. We will also carefully examine any potential side effects, such as diabetic ketoacidosis (a serious condition where the body produces too many acids called ketones) with SGLT2 inhibitors, or gastrointestinal problems and other risks with GLP-1 receptor agonists.
In addition, our research will use advanced statistical methods to make sure our comparisons are fair. This means we will adjust for differences between patients to get a clear picture of how well these medications work and how safe they are. Our goal is to create a detailed risk-benefit profile for these treatments in type 1 diabetes and develop a practical tool—a risk-benefit trade-off matrix—to help doctors make better treatment decisions.
Overall, this study has the potential to improve the lives of people with type 1 diabetes by identifying new treatment strategies that could reduce complications, improve blood sugar control, and support weight management, ultimately leading to better long-term health outcomes.
Anticipated Outcome
We expect our study to provide clear evidence on both the benefits and the risks of using these medications in type 1 diabetes. Our findings will show whether these drugs can safely help lower blood sugar, assist with weight loss, and protect vital organs like the heart and kidneys. Additionally, our research will identify any side effects, ensuring that doctors know which patients are most likely to benefit and which might be at increased risk.
Relevance to T1D
Type 1 diabetes is a lifelong condition where the body no longer produces insulin, forcing patients to rely on daily injections. Despite advancements in care, many people with type 1 diabetes continue to face issues like high blood sugar, weight gain, and serious complications affecting the heart and kidneys. By investigating these new treatment options, our study could lead to improved care strategies, better treatment decisions, and ultimately a higher quality of life for those living with type 1 diabetes.