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Table 2 Characteristics of outcomes measured using BMDs according to outcome type (nā€‰=ā€‰464). Primary outcomes were those that were explicitly reported as such in the published article or in the entry in a public clinical trial registry or, if none was explicitly reported, the outcome(s) stated in the sample size estimation. All other outcomes were considered secondary outcomes

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

Ā 

Primary outcomes (nĀ =ā€‰64)

Secondary outcomes (nĀ =ā€‰400)

Type of sensor used

ā€ƒInertial measurement unit sensors

25 (39)

108 (27)

ā€ƒElectrochemical sensors

29 (45)

237 (59)

ā€ƒPressure sensors (including smart cap bottles)

3 (5)

35 (9)

ā€ƒOptical sensor

0 (0)

10 (2)

ā€ƒElectrodes

5 (8)

9 (2)

ā€ƒTemperature sensors

2 (3)

1 (0.2)

Concept of interest assessed

ā€ƒDiabetes control

29 (45)

237 (59)

ā€ƒAssessment of diabetic foot complications

0 (0)

2 (0.5)

ā€ƒPhysical activity

19 (30)

68 (17)

ā€ƒBlood pressure control

3 (5)

29 (7)

ā€ƒAdherence to treatment

6 (9)

16 (4)

ā€ƒHeart rate variability

5 (8)

9 (2)

ā€ƒPulmonary capacity

0 ()

2 (0.5)

ā€ƒSleep disturbance

2 (3)

37 (9)

Prespecification of the outcome*

42 (66)

139 (34)

  1. *Prespecification was assessed by looking, for each included trial, for the corresponding entry in a public clinical trial registry (e.g., clinicaltrials.gov) by looking for the trial registration number reported in the articles on January 2020 (and June 2020 for articles added during peer-review)