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Tracking the Sugar Rush: Incorporating Continuous Glucose Monitoring Into Multisite Early Clinical Research With Type

Sabina Paglialunga1, Bruce H Morimoto1, Amparo de la Peña2

  • 1Scientific Affairs, Celerion Inc, Tempe, AZ, USA.

Clinical Pharmacology in Drug Development
|February 15, 2018
PubMed
Summary

Continuous glucose monitoring (CGM) offers reliable data for diabetes management and clinical trials. This study confirms low daily variability in CGM results for type 2 diabetes mellitus patients, supporting its use in multisite drug development.

Keywords:
continuous glucose monitoringdiabetesearly clinical studiesglycemic excursionshyperglycemia

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Area of Science:

  • Endocrinology
  • Clinical Pharmacology
  • Biomedical Engineering

Background:

  • Continuous glucose monitoring (CGM) enhances diabetes mellitus management and patient safety.
  • CGM is increasingly used as a pharmacodynamic tool in early clinical drug development.
  • Limited studies have explored CGM in type 2 diabetes mellitus (T2DM) drug development, with concerns about subject variability.

Purpose of the Study:

  • To investigate the daily variation of CGM results in patients with T2DM.
  • To assess the practicality of using CGM in multisite early clinical research studies.
  • To evaluate CGM as a pharmacodynamic tool for drug development in T2DM.

Main Methods:

  • Collected CGM data from 24 patients with T2DM across multiple clinical research units.
  • Analyzed daily reproducibility of CGM measurements within individual patients.
  • Assessed the feasibility of implementing CGM in multisite studies.

Main Results:

  • Observed strong daily reproducibility in CGM results (Pearson R = 0.86, P < .0001).
  • Demonstrated that CGM is practical for multisite studies.
  • Found low daily variability, indicating reliability for monitoring.

Conclusions:

  • CGM exhibits low daily variability in patients with T2DM.
  • CGM is a practical and reliable pharmacodynamic tool for multisite clinical drug development.
  • CGM enhances drug efficacy and safety monitoring in T2DM therapeutic research.