Table 3.
DTxa clinical trial demographic data from the Digital Therapeutics Alliance Product Library—Leva, Propeller, Daylight, and EndeavorRx.
| Digital Therapeutic Product | Leva | Propeller | Daylight | EndeavorRx | ||||||
| Company | Renovia | Propeller Inc | Big Health | Akili Interactive | ||||||
| FDAb regulation | FDA-cleared Class II Medical Device | FDA-cleared Class II Medical Device | —c | FDA-authorized Class II Medical Device | ||||||
| Study type | Randomized controlled trial | Randomized controlled trial | Randomized controlled trial | Randomized controlled trial | ||||||
| Name of study | Multicenter randomized controlled trial of pelvic floor muscle training with a motion-based digital therapeutic device versus pelvic floor muscle training alone for treatment of stress-predominant urinary incontinence | The impact of patient self-monitoring via electronic medication monitor and mobile app plus remote clinician feedback on adherence to inhaled corticosteroids: a randomized controlled trial | Efficacy of digital cognitive behavioral therapy for moderate‐to‐severe symptoms of generalized anxiety disorder: a randomized controlled trial | A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial | ||||||
| Digital therapeutic clinical area of focus | Female urinary incontinence | COPDd/asthma | Generalized anxiety disorder | ADHDe | ||||||
| Prescription required? | Yes | No | No | Yes | ||||||
| Demographics | ||||||||||
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Sample size, n | 77 | 100 | 256 | 348 | |||||
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Age (years), mean (SD) | 52.1 (14.0) | 48.5 (12.3) | 30.9 (10.7) | 9.7 (1.3) | |||||
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Sex, n (%) | |||||||||
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Male | 0 (0) | 20 (20.0) | 77 (30.1) | 248 (71.3) | ||||
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Female | 77 (100.0) | 80 (80.0) | 179 (69.9) | 100 (28.7) | ||||
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Race, n (%) | |||||||||
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Asian | 0 (0) | 6 (6.0) | 7 (2.7) | — | ||||
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Black | 10 (13.0) | 26 (26.0) | 10 (3.9) | — | ||||
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White | 52 (67.5) | 68 (68.0) | 215 (84.0) | — | ||||
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Others | 8 (10.4) | 0 (0) | 24 (9.4) | — | ||||
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Ethnicity, n (%) | |||||||||
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Hispanic | 5 (6.5) | 5 (5.0) | — | — | ||||
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Non-Hispanic | 72 (93.5) | 95 (95.0) | — | — | ||||
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Education: some college or more, n (%) | — | 87 (87) | 212 (82.8) | — | |||||
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Employment: employed at least half time, n (%) | — | — | — | — | |||||
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Married, remarried, or partnered, n (%) | — | — | 112 (43.6) | — | |||||
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Percentage of participants with private insurance | — | — | — | — | |||||
aDTx: digital therapeutics.
bFDA: Food and Drug Administration.
cData not available in study.
dCOPD: chronic obstructive pulmonary disease.
eADHD: attention-deficit hyperactivity disorder.