Objective
Tekton's Wichita, KS site with lead PI Dr. Brandon Alleman was selected to support a recent clinical trial evaluating a continuous glucose monitoring (CGM) device in pregnant women with diabetes. Pregnancy introduces unique challenges in managing glucose levels, making CGM a vital tool for optimizing maternal and fetal health.
Challenge
The study presented unique challenges, including the need to recruit and retain pregnant patients within a narrow enrollment window across multiple diabetes diagnoses, including gestational, type 1, and type 2. In addition, the sponsor required rapid regulatory submission and site activation to align with aggressive study timelines. Throughout the trial, Tekton also needed to engage and support a diverse patient population while maintaining strict adherence to study protocols and compliance standards.
Solutions
Key Metrics
Goal: 5 | Enrolled: 12
Tekton’s centralized model ensured alignment across internal teams, sites, and sponsor stakeholders. By centralizing regulatory and IRB submissions, contracting, and budgeting processes, Tekton cut down on back-and-forth delays and launched with speed and confidence. The study was supported every step of the way by a single point of contact and real-time dashboards to monitor progress and compliance.
Tekton leveraged a pre-identified pool of qualified patients from Dr. Alleman's private practice and executed personalized, site-based outreach—supporting patients throughout the screening process and ensuring strong communication through final visits. The site and central teams remained focused on flexibility and empathy to meet the unique needs of pregnant participants managing diabetes.
Results
This study demonstrates Tekton’s ability to combine operational speed with thoughtful patient engagement, even in sensitive populations like pregnant women with diabetes. By exceeding enrollment goals and retaining every participant, Tekton reinforced its reputation as a trusted site partner capable of accelerating device development in complex clinical settings.
