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Clinical Research Coordinator Analysis

SMBG Data Collection and Participant Compliance

Finding: The protocol requirement (Section 6.2.2, page 34) for participants to perform Self-Monitored Blood Glucose (SMBG) 4 times daily for 3 consecutive days immediately prior to Randomization (Visit 2) and Visits 4, 5, and 6, presents a significant participant burden and a high risk of incomplete or inaccurately recorded data. This intensive schedule, coupled with the need to bring the meter and diary to each study visit for review, can be challenging for consistent adherence, especially for individuals not accustomed to such frequent monitoring. Recommendation:

1. Develop a site-specific "SMBG Success Kit" for participants. This kit should include a simplified visual guide illustrating the 3-day monitoring schedule relative to their visit dates, a pre-formatted section in their diary or a separate log sheet for these specific intensive monitoring periods, and concise, easy-to-understand tips for accurate meter use and data recording.

2. Implement a structured, multi-touchpoint reminder and support system:

* During the visit immediately preceding an intensive SMBG collection period (e.g., at Screening for the pre-Randomization collection), the CRC should verbally review the upcoming requirement in detail, provide the "SMBG Success Kit," and address any participant questions or concerns.

* With participant consent and preference, send a reminder (e.g., phone call, secure SMS/email) approximately 4-5 days before the start of each 3-day SMBG collection window, prompting them to prepare and begin.

3. At each visit where SMBG data is due for review (Visits 2, 4, 5, 6), CRCs should allocate dedicated time to meticulously cross-reference the participant's handwritten diary entries with the glucose meter's stored memory. This allows for immediate clarification of discrepancies, reinforcement of correct procedures, and supportive feedback to the participant.

Rationale: Proactively addressing this demanding aspect of the protocol will significantly enhance participant understanding, engagement, and adherence. This, in turn, improves the completeness and reliability of crucial SMBG data, which is vital for safety monitoring (e.g., detection of hypoglycemia) and potentially for evaluating secondary or exploratory endpoints. This approach also helps minimize source data discrepancies and subsequent eCRF queries, streamlining data management processes.