Although the workgroups from the ADA and the Endocrine. Society tried to address defining and reporting hypoglycemia with clinical practice guidelines and ...
The Variation in the Definition of Hypoglycemia in Randomized Controlled Trials (RCTs): A Systematic Review on RCTs Conducted for SGLT-2 Inhibitors S. Medeiros, N. Kassir, and P. Farahani University of Western Ontario, National University of Ireland, McMaster University
Hypoglycemia is a dangerous side effect associated with diabetes pharmacotherapy. It is a serious episode that can be an economic burden, decrease quality of life, cause accidents, injuries, coma, and even death.
Using PubMed, a systematic review was conductive by extracting data from RCTs on SGLT-2 inhibitors limited to the English language. Initial Search (n=161) SGLT-2 Inhibitor RCTs (May 2016)
Excluded Studies (n=6) 1. Non-English RCTs 2. Studies that were irrelevant and didn’t look at the effectiveness of the pharmacotherapy 3. Duplicates
Randomized controlled trials (RCTs) aim to determine whether one intervention is better than another in diabetes pharmacotherapy • In diabetic therapy RCTs, hypoglycemia is usually reported as an adverse event to evaluate the safety and efficacy of a drug
Defining Hypoglycemia • There is no definitive method of reporting or definition of hypoglycemia used in the medical field • Workgroups from the American Diabetes Association (ADA) and the Endocrine Society suggest to defining and reporting hypoglycemia as a multivariable and on a classification scale as follows1: Classification of Hypoglycemia Severe Hypoglycemia
Plasma Glucose Threshold None
Additional Conditions
Documented Symptomatic Hypoglycemia
≤3.9 mmol/L
Hypoglycemic symptoms presented
Asymptomatic Hypoglycemia
≤3.9 mmol/L
No hypoglycemic symptoms presented
Pseudo-Hypoglycemia
Approaching 3.9 mmol/L
Discussion
Methods
Introduction
Included in analysis of the potential variation in defining hypoglycemia (n=155)
Results
Conclusion
Many RCTs fail to report any definition or episodes of hypoglycemia
The implementation of a more comprehensive definition of hypoglycemia for all RCTs may result in less heterogeneity of the outcomes in evaluating safety and effectiveness of diabetic pharmacotherapy.
Requires assistance of another person
Report Hypoglycemia 100(65)
No report of Hypoglycemia 55(35)
Work Cited
Hypoglycemic symptoms presented
• The degree to which this has occurred has never been studied before
Sodium-glucose co-transport 2 (SGLT-2) inhibitors • Novel therapy for type 2 diabetics2 • Can be used as a way to analyze the progress these work groups have made as they are a novel therapy that should report in a fairly similar manner due to the fact that the workgroups involved and guidelines had already been formed
Objective & Hypothesis
Figure 1: Hypoglycemia was not reported or defined in 35% of the SGLT-2 inhibitor RCTS. Using PubMed, SGLT-2 inhibitor RCTs that explored effectiveness of pharmacotherpy were analyzed (n=155). Results are presented as n(%).
The variation in the definition of hypoglycemia in SGLT-2 inhibitor RCTs
