Considerations for practical use of tree-based scan statistics for signal detection using electronic healthcare data: a case study with insulin glargine.

Background: Hypothesis-free signal detection (HFSD) methods such as tree-based scan statistics (TBSS) applied to longitudinal electronic healthcare data (EHD) are increasingly used in safety monitoring. However, challenges may arise in interpreting HFSD results alongside results from disproportionality analysis of spontaneous reporting.

Research Design And Methods: Using the anti-diabetes drug insulin glargine (Lantus®) we apply two different tree-based scan designs using TreeScan™ software on retrospective EHD and compare the results to one another as well as to results from a disproportionality analysis using SRD.

Role of Fenugreek in the prevention of type 2 diabetes mellitus in prediabetes.

Background: It is hypothesized that dietary supplementation with Fenugreek modulates glucose homeostasis and potentially prevents diabetes mellitus in people with prediabetes. The objective of present study is to determine whether Fenugreek can prevent the outcome of T2DM in non diabetic people with prediabetes.

Methods: A 3-year randomized, controlled, parallel study for efficacy of Fenugreek (n = 66) and matched controls (n = 74) was conducted in men and women aged 30-70 years with criteria of prediabetes.