2021
DOI: 10.2337/cd20-0049
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Continuous Glucose Monitoring Use in Clinical Trials for On-Market Diabetes Drugs

Abstract: To the best of our knowledge, there are no published data on the historical and recent use of CGM in clinical trials of pharmacological agents used in the treatment of diabetes. We analyzed 2,032 clinical trials of 40 antihyperglycemic therapies currently on the market with a study start date between 1 January 2000 and 31 December 2019. According to ClinicalTrials.gov, 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.… Show more

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Cited by 6 publications
(5 citation statements)
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“…CGM data are now frequently collected in T1D clinical trials, commonly as a part of exploratory objectives and potentially as an outcome measure (16)(17)(18)(19). In contrast to self-measured glucose using a fingerstick, CGM can provide continuous real-time measurement of glucose levels in an ambulatory setting, with the assessment of glycemic variability, comprehensive measurement of hyperglycemic and hypoglycemic exposure, and safety alerts for glycemic extremes.…”
Section: Introductionmentioning
confidence: 99%
“…CGM data are now frequently collected in T1D clinical trials, commonly as a part of exploratory objectives and potentially as an outcome measure (16)(17)(18)(19). In contrast to self-measured glucose using a fingerstick, CGM can provide continuous real-time measurement of glucose levels in an ambulatory setting, with the assessment of glycemic variability, comprehensive measurement of hyperglycemic and hypoglycemic exposure, and safety alerts for glycemic extremes.…”
Section: Introductionmentioning
confidence: 99%
“…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.…”
Section: Introductionmentioning
confidence: 99%
“…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.…”
Section: Introductionmentioning
confidence: 99%
“…However, the use of CGM data in BI research has been increasing in recent years, which is in line with the overall increase in CGM usage in clinical trials. From 2013-2019, 10.7% of BI clinical trials used CGM data, which is an increase from 4.8% from 200-2006 and 8.8% from 2007-2012 (74). No major adverse events were reported, and the safety profile was in line with prior models (73).…”
Section: Dexcom G6mentioning
confidence: 63%