A New Era in Diabetes Care: How a Novel Therapy and Pharmacists are Reshaping the Fight Against Type 1 Diabetes

A groundbreaking approach to managing Type 1 diabetes (T1D) is emerging, focusing on early intervention rather than just clinical diagnosis. In a recent interview, Jennifer Goldman, PharmD, a seasoned clinical pharmacist and professor, highlighted the critical need to understand the disease’s progression through distinct stages and the revolutionary potential of teplizumab (Tzield), the first FDA-approved therapy designed to delay the onset of T1D. This new therapeutic strategy, combined with the pivotal role of pharmacists, aims to prevent the crisis-driven diagnoses that have long defined the start of the disease.

Understanding the Stages of Type 1 Diabetes

The standard understanding of T1D often begins at the point of a clinical diagnosis, but Dr. Goldman explains that the disease has a clear, three-stage progression that most people are unaware of:

Stage 1: The Asymptomatic Onset. This is the initial stage where the immune system begins its attack on the pancreas. A patient has two or more islet autoantibodies present, which are markers of this autoimmune attack, but their blood sugar levels remain normal. The patient experiences no symptoms and is completely unaware of the developing condition.
Stage 2: Impaired Glucose Tolerance. The autoimmune attack on the pancreas accelerates, leading to significant destruction of the beta cells. At this point, the patient’s glucose tolerance becomes impaired, meaning their blood sugar is no longer strictly normal after eating. Crucially, like Stage 1, this stage is still without outward symptoms, making screening the only way to detect it. This is the specific stage targeted by teplizumab.
Stage 3: Clinical Diagnosis. This is the stage most people recognize as diabetes. By this point, blood sugars are consistently high, and classic symptoms such as excessive thirst, frequent urination, and unexplained weight loss become evident. Many individuals reach this stage abruptly, often presenting in an emergency room with diabetic ketoacidosis (DKA), a life-threatening complication that can have lasting negative effects.

Teplizumab: A Proactive Approach to Disease Management

Teplizumab is a novel, disease-modifying therapy approved for use in individuals aged 8 and older who are in Stage 2 of Type 1 diabetes. Administered as a 14-day infusion, it works by modulating the T cells of the immune system to slow down the destruction of the pancreas’s beta cells.

The clinical significance of this therapy is profound. By delaying the progression to Stage 3, teplizumab gives patients and their families valuable time—an average of 2 to 3 years, and in some cases, up to 5 to 7 years. This “time to prepare” is invaluable, allowing families to educate themselves, mentally and physically prepare for insulin therapy, and avoid an emergency diagnosis with DKA. Furthermore, delaying the onset of Stage 3 helps preserve a patient’s natural beta-cell function for longer, which can reduce insulin needs and lead to better long-term glycemic control.

Debunking Key Misconceptions

Dr. Goldman addressed two critical misconceptions that often hinder early diagnosis and effective care. First, contrary to popular belief, T1D is not exclusively a childhood disease. While the peak age for clinical onset is 10 to 14, a large study found that 59% of cases occur in people over the age of 20, often between 20 and 40, and sometimes even later. Second, a high percentage of adults with T1D—about 40%—are initially misdiagnosed with Type 2 diabetes. This misdiagnosis leads to incorrect treatment plans and poor disease management from the start. These facts underscore the urgent need for widespread screening in both pediatric and adult populations, especially for individuals with a family history of T1D or other autoimmune conditions.

The Pharmacist’s Central Role in Proactive Care

With this new paradigm of proactive disease management, pharmacists are positioned to be essential partners in patient care. Dr. Goldman outlines their critical role at every step:

Identifying high-risk individuals: Pharmacists can help spot patients who should be screened based on personal or family medical history.
Patient and family education: They can provide crucial information about the stages of T1D and the benefits of early intervention to prevent a DKA crisis.
Screening and referral: Pharmacists can recommend at-risk individuals for screening and help navigate the process.
Infusion coordination: They can assist in coordinating the complex logistics of the 14-day teplizumab infusion.
Long-term follow-up: They are vital in ensuring ongoing monitoring and support after treatment.

By taking on these responsibilities, pharmacists can help unlock the potential of teplizumab and other future breakthroughs, effectively walking patients “through that door” to proactive, preventative diabetes care.