As innovation accelerates across diabetes and endocrinology – particularly in areas like type 1 and type 2 diabetes, cell and gene therapies, and digital health integration – Sponsors must navigate increasing scientific and operational complexity. Success requires a partner with deep therapeutic expertise, integrated capabilities, and the ability to translate data into actionable insights.
At this year’s American Diabetes Association (ADA) Scientific Sessions, Medpace is bringing together experts across clinical operations, medical, and laboratory services to discuss how we’re supporting Sponsors across diabetes development. In this blog, our multidisciplinary team answers some of the most common questions we hear from Sponsors.
How Medpace Supports Complex Diabetes Programs
How is Medpace supporting the evolving pipeline in type 1 diabetes, including cell and gene therapy approaches?
Medpace understands the significant daily burden faced by people living with type 1 diabetes (T1D), from lifelong insulin therapy and continuous glucose monitoring to the constant treatment decisions required to manage the disease. As the therapeutic landscape evolves, we have seen a shift in focus in clinical research to include cell and gene therapy in the fight against T1D to replace destroyed pancreatic beta cells and protect them from the autoimmune attack which occurs in the disease process – with the ultimate goal of eliminating the need for daily insulin requirements.
To support these innovative programs, Medpace has built a dedicated and engaged team who understand the mechanism of action in treatments which have shown efficacy in T1D. Our global cell and gene therapy teams collaborate regularly to share operational insights, scientific learnings, and best practices across studies, helping Sponsors navigate the unique complexities associated with these trials.
Because these studies often involve highly specialized procedures, endpoints, and patient management considerations, Medpace places strong emphasis on protocol-specific education throughout the study lifecycle. Robust training sessions equip CRAs and study teams with the knowledge needed to support investigators, maintain data integrity, and ensure high-quality trial execution.
What operational considerations are most critical in early-phase diabetes studies today?
Identifying sites with access to the targeted patient population, along with established expertise in endocrinology, immunology, and transplant medicine, can significantly improve startup timelines, enrollment performance, and patient retention.
As cell and gene therapy approaches continue to expand within diabetes research, operational success depends on close collaboration between multidisciplinary teams. Medpace creates planned communication points throughout the study to keep investigators and site teams engaged and informed.
How does Medpace’s fully integrated model improve efficiency and data quality in diabetes trials?
Medpace’s fully integrated model strengthens both operational efficiency and data quality by closely aligning medical, operational, and clinical teams throughout the duration of the study. Our medical monitor and advanced clinical practitioner teams work collaboratively to develop protocol-specific training tailored to the unique demands of diabetes trials. These include baseline training on hypoglycemia, DKA, CGM devices, insulin pumps, and precise training on the protocol along with unique assessments such as Mixed Meal Tolerance Tests, Dried Blood Spots, and 24-hour urine collection.
How does Medpace manage continuous glucose monitoring (CGM) in clinical trials?
With the expanding use of diabetes technology in clinical trials, more studies in both type 1 and type 2 diabetes are utilizing CGM data for endpoint analysis. In response, the Medpace Core Laboratories (MCL) team collaborated with the Medpace endocrine/metabolic medical monitors and advanced clinical practitioners to develop ClinTrak Connect – a unique, customizable CGM data collection platform built specifically for clinical research.
ClinTrak Connect provides customizable, study-specific trend graphs with key CGM parameters, including data capture rates, hyperglycemia and hypoglycemia percentages, and site-level oversight of CGM collection and queries. By combining integrated technology with in-house CGM expertise, Medpace offers Sponsors a streamlined approach to collecting and managing CGM data to support high-quality clinical trial endpoints.
How does Medpace ensure consistency and quality across sites and regions?
Medpace drives consistency and quality across global studies through close collaboration between medical and operational teams, combined with continuous education and process improvement informed by years of clinical trial experience. Ongoing communication, training, and cross-functional alignment help ensure consistent study execution and high-quality data collection across sites and regions.
Connect with Medpace at ADA Scientific Sessions
As the diabetes landscape continues to evolve, the ability to combine scientific insight with operational execution is essential. At Medpace, our goal is to seamlessly execute clinical development, bringing together therapeutic expertise, integrated services, and advanced data capabilities to help Sponsors move confidently from study start to submission.
If you’re attending the ADA Scientific Sessions, we welcome the opportunity to connect. Visit our team at the booth #2332 or schedule a meeting to discuss how Medpace can support your upcoming diabetes programs.
