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Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.

Roy W BeckRichard M BergenstalTonya D RiddlesworthCraig KollmanZhaomian LiAdam S BrownKelly L Close
Published in: Diabetes care (2018)
Based on these results, a compelling case can be made that TIR is strongly associated with the risk of microvascular complications and should be an acceptable end point for clinical trials. Although hemoglobin A1c remains a valuable outcome metric in clinical trials, TIR and other glycemic metrics-especially when measured with continuous glucose monitoring-add value as outcome measures in many studies.
Keyphrases
  • clinical trial
  • type diabetes
  • phase ii
  • cardiovascular disease
  • open label
  • glycemic control
  • double blind
  • phase iii
  • study protocol
  • randomized controlled trial
  • metabolic syndrome
  • skeletal muscle
  • red blood cell