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. 2021 Sep 13;5(3):216–223. doi: 10.1159/000517885

Table 1.

Abbreviated list of digital endpoints [30]

Study phase
4
Indication Sickle cell anemia Endpoint
Change in total physical activity from baseline to weeks 10–12 and 22–24
Technology Activity monitor Measurement Activity count
4 Sickle cell anemia Change in mean nocturnal hemoglobin oxygen saturation percentage from baseline, week 10–12, and week 22–24 Pulse oximeter Overnight pulse oximetry

1 Menopause, depression, and anxiety Change in wake after sleep onset from beginning of study to weeks 4, 8, 12, and 16 Activity monitor Wake time after sleep onset

3 Parkinson's disease Change in PD symptoms as assessed by the Parkinson's KinetiGraph/personal KinetiGraph wearable device from baseline to week 12 Activity monitor Tremor, bradykinesia, dyskinesia, and daytime somnolence

4 Diabetes mellitus Percent time in euglycemia by a continuous glucose monitor during the final 14 days of each treatment Continuous glucose monitor Glycemic variability

2 Diabetic foot ulcer Change in physiologic stress response Heart rate monitor Heart rate variability

2 Alzheimer's disease Change in speech features from baseline to week 48 Microphone (audio recordings) Acoustic and linguistic language features

2 COPD Average change in pre-bronchodilator FEV1 from week 16 to week 24 Home spirometer FEV1

3 Chronic cough Percentage of participants with a ≥30% reduction from baseline in 24-h coughs per hour at week 24 Chest contact sensor with audio recording Cough count

4 Asthma Percentage of rescue-free days between month 4 and month 6 as determined by the rescue medication sensor Ingestible sensor Medication adherence

These examples were selected to demonstrate the broad set of contexts in which digital endpoints are employed and for their relatively recent initiation dates (between December 2017 and August 2020) [30].