Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review

[1] Elenko E(2015)Defining digital medicine Nat Biotechnol 33 456-461

[2] Underwood L(2016)Mobile health: the power of wearables, sensors, and apps to transform clinical trials Ann N Y Acad Sci 1375 3-18

[3] Zohar D(2018)A two-stage model for wearable device data Biometrics 74 744-752

[4] Munos B(2018)Selection of and evidentiary considerations for wearable devices and their measurements for use in regulatory decision making: recommendations from the ePRO Consortium Value Health 21 631-639

[5] Baker PC(2018)Use of mobile devices to measure outcomes in clinical research, 2010-2016: a systematic literature review Digit Biomarkers 2 11-30

[6] Bot BM(2018)Closed-loop insulin delivery for glycemic control in noncritical care N Engl J Med 379 547-556

[7] Bai J(2018)Use of wearable, mobile, and sensor technology in cancer clinical trials JCO Clin Cancer Inform 2 1-11

[8] Sun Y(2018)Digital technologies as biomarkers, clinical outcomes assessment, and recruitment tools in Alzheimer’s disease clinical trials Alzheimers Dement (New York, N Y) 4 234-242

[9] Schrack JA(2018)Brain monitoring devices in neuroscience clinical research: the potential of remote monitoring using sensors, wearables, and mobile devices Clin Pharmacol Ther 104 59-71

[10] Crainiceanu CM(2017)Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem Nat Rev Drug Discov 16 736-667

[1] Elenko E(2015)Defining digital medicine Nat Biotechnol 33 456-461

[2] Underwood L(2016)Mobile health: the power of wearables, sensors, and apps to transform clinical trials Ann N Y Acad Sci 1375 3-18

[3] Zohar D(2018)A two-stage model for wearable device data Biometrics 74 744-752

[4] Munos B(2018)Selection of and evidentiary considerations for wearable devices and their measurements for use in regulatory decision making: recommendations from the ePRO Consortium Value Health 21 631-639

[5] Baker PC(2018)Use of mobile devices to measure outcomes in clinical research, 2010-2016: a systematic literature review Digit Biomarkers 2 11-30

[6] Bot BM(2018)Closed-loop insulin delivery for glycemic control in noncritical care N Engl J Med 379 547-556

[7] Bai J(2018)Use of wearable, mobile, and sensor technology in cancer clinical trials JCO Clin Cancer Inform 2 1-11

[8] Sun Y(2018)Digital technologies as biomarkers, clinical outcomes assessment, and recruitment tools in Alzheimer’s disease clinical trials Alzheimers Dement (New York, N Y) 4 234-242

[9] Schrack JA(2018)Brain monitoring devices in neuroscience clinical research: the potential of remote monitoring using sensors, wearables, and mobile devices Clin Pharmacol Ther 104 59-71

[10] Crainiceanu CM(2017)Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem Nat Rev Drug Discov 16 736-667