Site-Level Strategies to Drive Better Clinical Research Outcomes in Type 2 Diabetes Trials

Conducting clinical trials in Type 2 Diabetes (T2D) presents a unique set of challenges at the site level. Sites are responsible for managing participant recruitment, ensuring adherence, maintaining data integrity, and addressing socioeconomic barriers that impact study outcomes. While sponsors and regulatory bodies set study protocols, sites play a crucial role in overcoming operational hurdles and ensuring successful execution. Below, we explore key challenges faced by research sites in T2D trials and some effective strategies to mitigate these obstacles at the clinical site and individual patient/participant levels.
 
Recruitment and Retention of Diverse Populations^1,2,3

One of the most pressing challenges in T2D trials is recruiting and retaining a diverse patient population. Despite the disproportionate burden of diabetes on Black, Hispanic, and Asian populations, these groups remain underrepresented in clinical research due to mistrust, limited awareness, logistical difficulties, and cultural or language barriers. Underrepresentation can skew study results and limit the generalizability of trial findings to real-world patient populations.
 
Mitigation Strategies:

• Identify clinical site networks with deep T2D therapeutic and patient population experience.
• Partner with local health organizations, faith-based groups, and patient advocacy networks to establish credibility and trust within underrepresented communities (and leverage your site network partners’ relationships with these resources).
• Develop bilingual educational materials and leverage community-based education programs to ensure messaging resonates with diverse populations.
• Utilize mobile screening units, telemedicine, and home visits to reduce travel burdens and increase participation rates among hard-to-reach groups.
• Encourage former or current study participants from diverse backgrounds to share their experiences and encourage others to enroll.

Patient Adherence to Study Protocols⁴

T2D trials often require participants to follow strict medication regimens, dietary modifications, and frequent monitoring, which can be overwhelming for individuals balancing work, family, and other health conditions. Low adherence rates lead to protocol deviations, reduced data reliability, and increased study timelines and costs.
 
Mitigation Strategies:

• Tap your clinical site network partners to provide one-on-one counseling, digital learning tools, and peer support networks to reinforce the importance of adherence.
• Deploy wearable devices, mobile health apps, and AI-driven patient monitoring tools to track real-time adherence and flag potential compliance issues.
• Offer telehealth visits, flexible scheduling, and at-home monitoring options to improve retention and adherence.
• Implement milestone rewards and public recognition of compliance efforts to influence patient behavior.

Complex Study Designs and Long Trial Durations⁵

Many T2D trials require long-term follow-up to assess treatment efficacy and safety, sometimes spanning several years. These extended timelines place considerable demands on site resources, patient commitment, and investigator engagement. As a result, patient dropout rates, site burnout, and inconsistent data collection remain significant concerns.
 
Mitigation Strategies:

• Implement personalized patient support programs, reminder systems, and regular check-ins to maintain site-level engagement throughout the study.
• Streamline site workflows with adaptive trial methodologies, centralized monitoring, and automated data capture can improve efficiency and reduce administrative burdens.
• Enhance staff training on patient engagement, compliance monitoring, and trial management tools can help staff navigate complex study requirements while maintaining high-quality data collection.

Measuring Disease Progression and Data Integrity^6,7

Accurate measurement of diabetes biomarkers such as HbA1c, fasting glucose levels, and other lab results is crucial for assessing treatment effectiveness. However, variability in laboratory practices, differences in testing equipment, and inconsistencies in patient-reported outcomes can introduce data integrity issues.
 
Mitigation Strategies:

• Ensure that all participating sites follow uniform guidelines for biomarker assessment and laboratory analysis.
• Leverage real-time data tracking and automated discrepancy detection tools can help identify errors.
• Offer regular training on data entry best practices, quality control measures, and regulatory compliance, to ensure consistency across sites.
• Utilize AI-powered analytics and centralized data review panels to help detect irregular patterns and inconsistencies in lab results.

Socioeconomic Factors and Comorbidities^8,9,10

Many T2D patients face financial hardships, limited healthcare access, and multiple chronic conditions such as hypertension, cardiovascular disease, and obesity. These factors complicate trial participation and require additional support to maintain engagement.
 
Mitigation Strategies:

• Offer transportation assistance, stipends, childcare support, and meal vouchers to reduce participation barriers and ease access to each clinical site location.
• Use patient stratification models to ensure a diverse and representative study population.
• Partner with endocrinologists, nutritionists, behavioral psychologists, and primary care providers to offer holistic patient support.
• Improve health literacy by offering plain-language study materials and culturally appropriate counseling sessions.

Data Collection and Analysis Challenges¹¹

T2D trials generate massive amounts of heterogeneous data, including dietary intake, physical activity levels, medication adherence, and biomarker measurements. Data accuracy, consistency, and meaningful analysis require sophisticated data management strategies.
 
Mitigation Strategies:

• Adopt wearable devices, real-time monitoring systems, and AI-powered data processing tools to enhance data accuracy and reduce manual entry errors.
• Implement automated alerts and reminders to ensure patients report health metrics, take medications, and attend study visits with digital reminders and push notifications.
• Train site teams on electronic data capture (EDC) systems, regulatory compliance, and quality assurance measures to enhance data reliability.
• Combine electronic health records, mobile app data, and lab reports to provide a more holistic view of patient health and trial progress.

Key Takeaway

Clinical sites are the frontline in ensuring the successful execution of T2D trials. While some challenges are beyond site control, proactive community engagement, patient-centered study designs, and innovative technology adoption can enhance trial operations. The Alliance Clinical Network is committed to supporting CROs, sponsors, and sites with innovative, data-driven solutions. Connect with our team to learn how we can support your diabetes trials.

1 American Diabetes Association. (2023). Improving equity and access to health care: How nontraditional organizations can help increase clinical trial diversity.
2 Gladson, B., & Akhtar, S. (2013). Type 2 diabetes community-based recruitment strategies. Applied Clinical Trials, 22(6).
3 G. Frank, “Current Challenges in Clinical Trial Patient Recruitment and Enrollment,” SoCRA Source, 2, 30–38 (2004).
4 Knowler, W. C., Fowler, S. E., Hamman, R. F., Christophi, C. A., Hoffman, H. J., Brenneman, A. T., … & Nathan, D. M. (2009). 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. The Lancet, 374(9702), 1677-1686.
5 National Research Council. (2010). Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. National Academies Press.
6 Sacks, D. B., Arnold, M., Bakris, G. L., Bruns, D. E., Horvath, A. R., Kirkman, M. S., … & Surks, M. I. (2011). Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clinical Chemistry, 57(6), e1-e47.
7 Applied Clinical Trials. (2018). The Basics of Clinical Trial Centralized Monitoring. Applied Clinical Trials.
8 Khan, T., Tsipas, S., & Wozniak, G. (2023). Socioeconomic factors associated with poor medication adherence among patients with type 2 diabetes: A systematic review. European Journal of Clinical Pharmacology, 79(2), 211–221.
9 Walker RJ, Strom Williams J, Egede LE. Influence of Race, Ethnicity and Social Determinants of Health on Diabetes Outcomes. Am J Med Sci. 2016 Apr;351(4):366-73. 
10 Petrie JR, Guzik TJ, Touyz RM. Diabetes, Hypertension, and Cardiovascular Disease: Clinical Insights and Vascular Mechanisms. Can J Cardiol. 2018 May;34(5):575-584.
11 U.S. Department of Health and Human Services. (n.d.). Telehealth technology for diabetes care. Telehealth.HHS.gov.