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 |
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| 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 |
|
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| 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 |
|
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| 2 | Diabetic foot ulcer | Change in physiologic stress response | Heart rate monitor | Heart rate variability |
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| 2 | Alzheimer's disease | Change in speech features from baseline to week 48 | Microphone (audio recordings) | Acoustic and linguistic language features |
|
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| 2 | COPD | Average change in pre-bronchodilator FEV1 from week 16 to week 24 | Home spirometer | FEV1 |
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| 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 |
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| 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].