(P-563) A New United States Database for Pharmacoepidemiology Studies in Type 2 Diabetes Mellitus: The IMEDS Distributed Database

Background: The Innovation in Medical Evidence Development and Surveillance System Distributed Database (IMEDS-DD) is a subset of the Food and Drug Administration Sentinel Distributed Database, a national system for active surveillance of medical product safety. The IMEDS-DD includes healthcare data of 117 million patient-lives across 9 health plan partners. Generalizability of IMEDS-DD findings on Type 2 diabetes mellitus (T2DM) to the general T2DM population is unknown.

Objectives: 1) To assess data relevancy and data quality of the IMEDS-DD for diabetes research; 2) to evaluate comparability of the IMEDS-DD T2DM cohort to the general T2DM population.

Methods: A retrospective study was conducted using the IMEDS-DD. Eligible members were adults with ≥ 1 encounter from 4/1/2018 to 3/31/2019 (index period) and ≥ 6 months of medical plus prescription drug use history available. T2DM (≥ 1 Type 2 and no Type 1 or gestational diabetes mellitus diagnoses) and comorbid conditions were determined using all data available from 4/1/2016 to the most recent encounter (index date). Patient characteristics, comorbidities and hemoglobin A1c (HbA1c) values were summarized and compared to those of the general T2DM population established in national benchmarks and literature.

Results: T2DM prevalence was 12.6% in the IMEDS-DD. Of the 414,672 T2DM patients, 52.8% were male and the mean age was 65.0 (SD 13.3) years, with 24.1% over 75 years of age. The common comorbidity included hypertension (84.5%), hyperlipidemia (82.8%), obesity (45.3%), and cardiovascular disease (CVD, 44.7%). Moderate-to-severe chronic kidney disease (CKD) was observed in 20.2% patients. The most common T2DM treatment on the index date was metformin (35.7%), followed by sulfonylureas (14.8%) and insulin (9.9%). One-half (48.9%) had an HbA1c value recorded; among those, 36.3% had most recent HbA1c ≥7.0%. These findings align with estimates from the Centers for Disease Control and Prevention and those reported for T2DM patients identified within other large databases broadly used for diabetes research (T2DM US prevalence 13.0%; mean age 60.9-66.4 years; male 52.5-56.4%; CVD 25.1-45.2%; CKD 18.9-24.1%).

Conclusions: Despite the limitations related to HbA1c data, findings from the study indicate that the IMEDS-DD contains robust information on key data elements to conduct pharmacoepidemiology studies in diabetes, including member demographic and clinical characteristics and health services utilization. This is further demonstrated by the notable similarity in patient characteristics between the IMEDS-DD T2DM population and the T2DM population identified within other large databases.