Table 2.
DTxa clinical trial demographic data from the Digital Therapeutics Alliance Product Library—Propeller, Bluestar (randomized controlled trial), Bluestar (secondary analysis of the randomized controlled trial), and d-Nav.
| Digital Therapeutic Product | Propeller | Bluestar | Bluestar | d-Nav | ||||||||||
| Company | Propeller Inc | WellDoc | WellDoc | Hygeia | ||||||||||
| FDAb regulation | FDA-cleared Class II Medical Device | FDA-cleared Class II Medical Device | FDA-cleared Class II Medical Device | FDA-cleared Class II Medical Device | ||||||||||
| Study type | Randomized controlled trial | Randomized controlled trial | Secondary analysis of a cluster randomized controlled trialc | Randomized controlled trial | ||||||||||
| Name of study | A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients | WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction | Mobile diabetes intervention for glycemic control: impact on physician prescribing | Automated insulin dosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trial | ||||||||||
| Digital therapeutic clinical area of focus | COPDd/asthma | Type 1/type 2 diabetes | Type 1/type 2 diabetes | Type 2 diabetes | ||||||||||
| Prescription required? | No | No | No | Yes | ||||||||||
| Demographics | ||||||||||||||
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Sample size, n | 437 | 26 | 117 | 181 | |||||||||
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Age (years) | Mean 47 (SD 15.0) | Range 20-64 | Mean 52.7 (SD 8.2) | Mean 60.3 (SD 7.9) | |||||||||
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Sex, n (%) | |||||||||||||
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Male | 153 (35.0) | 9 (34.6) | 59 (50.4) | 93 (51.4) | ||||||||
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Female | 284 (65.0) | 17 (65.4) | 58 (49.6) | 88 (48.6) | ||||||||
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Race, n (%) | |||||||||||||
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Asian | 22 (5.0) | 0 (0) | 0 (0) | 7 (3.9) | ||||||||
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Black | 34 (8.0) | 10 (38.5) | 43 (36.8) | 38 (20.9) | ||||||||
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White | 373 (85.0) | 16 (61.5) | 65 (55.6) | 125 (69.1) | ||||||||
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Others | 0 (0) | 0 (0) | 9 (7.7) | 11 (6.1) | ||||||||
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Ethnicity, n (%) | |||||||||||||
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Hispanic | —e | — | — | 8 (4.4) | ||||||||
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Non-Hispanic | — | — | — | 145 (80.1) | ||||||||
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Education: some college or more, n (%) | — | — | 85 (72.6) | — | |||||||||
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Employment: employed at least half time n (%) | — | — | — | — | |||||||||
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Married, remarried, or partnered, n (%) | — | — | — | — | |||||||||
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Percentage of participants with private insurance (%) | — | 100 | 100 | — | |||||||||
aDTx: digital therapeutics.
bFDA: Food and Drug Administration.
cStudy reported Hispanic Ethnicity and Black/African American as one group under Race Demographic Category.
dCOPD: chronic obstructive pulmonary disease.
eData not available in study.