Continuous Glucose Monitoring Use in Clinical Trials for On-Market Diabetes Drugs

Abstract

Despite the growing momentum behind a movement to augment adoption of continuous glucose monitoring (CGM) in clinical practice and investigation, to the best of our knowledge, there are no published data on the historical and recent use of CGM in clinical trials of pharmacologic agents used in the treatment of diabetes. We analyzed 2,032 clinical trials of 40 diabetes therapies currently on the market with a study start date between 1 January 2000 and 31 December 2019. According to ClinicalTrials.gov listings, 119 (5.9%) of these trials used CGM. CGM usage in clinical trials has increased over time, rising from <5% before 2005 to 12.5% in 2019. However, it is still low given its inclusion in the American Diabetes’s Association’s latest guidelines and known limitations of A1C for assessing ongoing diabetes care.

Continuous glucose monitoring‐based time‐in‐range using insulin glargine 300 units/ml versus insulin degludec 100 units/ml in type 1 diabetes: The head‐to‐head randomized controlled InRange trial

“…The utility of CGM is therefore becoming clear, and during 2013-2019, CGM was used in 11% of clinical trials for BIs. 23 However, to date no RCTs have used TIR metrics as primary/secondary endpoints in head-to-head investigations of Gla-300 and IDeg-100.…”

“…Such a differential is probable to be magnified at night when some events will be undetected by the person with diabetes. The utility of CGM is therefore becoming clear, and during 2013‐2019, CGM was used in 11% of clinical trials for BIs 23 . However, to date no RCTs have used TIR metrics as primary/secondary endpoints in head‐to‐head investigations of Gla‐300 and IDeg‐100.…”