Type 1 and Type 2 Mellitus Validation Report
In April, 2016 a report was conducted at the request of the FDA that would test an alternative
strategy to validating diagnostic algorithms for diabetes mellitus (DM) that would avoid medical record
validation. The report derived data from five Mini-Sentinel Data Partners that are also SUPREME-DM
DataLink sites.
In the report, the Data was linked to find variables found in both (probabilistic match) and using
patient health record numbers. A total of 737,122 adults were linked.
The Algorithm used diagnoses, laboratory tests results, and medication criteria. Using the SUPREME-
DM DalaLink Algorithm the gold standard for Any DM in adults, the sensitivity was determined and
positive predictive value was set to other Any DM Algorithms. To evaluate the impact of laboratory
criteria on case ascertainment, tests were done on modified SUPREME-DM DataLink Algorithm without
laboratory criteria, with just diagnoses and medication only.
Numbers and proportions were compared and cases identified. T1DM and T2DM’s cases were testes
