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Table 4 Prespecification of outcomes measured with BMDs in the included trials (nā€‰=ā€‰464 outcomes). For each included trial, we looked 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)

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

Comparison between outcome definitions in published articles and entries in public trial registries

Number of outcomes (%)

Example

Impossible because the trial is not registered*

79 (17)

ā€“

Outcome definition is not clear enough for comparison

54 (14)**

In the trial [22]:

Published outcome: ā€œMVPA was calculated using 3 axes based on 60ā€‰s epochs. Freedson-VM cut-off points were used to distinguish between light, moderate and vigorous PA.ā€

Outcome registered: ā€œObjective physical activity (accelerometer data)ā€

Similar outcome definitions reported in the 2 sources

116 (30)**

In the trial [23]:

Published outcomes: ā€œtime with glucose concentration [ā€¦] hyperglycemic (>ā€‰10.0ā€‰mmol/L andā€‰>ā€‰16.7ā€‰mmol/L)ā€

Outcomes registered: ā€œTime spent above target glucose (10.0ā€‰mmol/l) (180ā€‰mg/dl) [Time Frame: 12-week intervention phase]ā€ and

ā€œThe time with glucose levels in the significant hyperglycemia (glucose levels >ā€‰16.7ā€‰mmol/l) (300ā€‰mg/dl) [Time Frame: 12ā€‰week intervention phase]ā€

Outcome definition was modified in the published article

11 (3)**

In the trial [24], time frames during which BMD outcome data analyzed were modified; published outcome: ā€œM-value (24ā€‰h [ā€¦], 08.00ā€“12.00ā€‰h [ā€¦], 12.00ā€“24.00ā€‰h [ā€¦], 00.00ā€“06.00ā€‰h [ā€¦])ā€

Outcomes registered: ā€œM-value (24:00, 8:00ā€“12:00, 12:00ā€“24:00, 0:00ā€“8:00)ā€

Outcome in the published article was not registered

204 (53)**

Among outcomes registered for the trial [25], only ā€œ% time within target range (3.9ā€“10ā€‰mmol/L)ā€ and ā€œIncidence rate of hypoglycemic eventsā€ were registered. Published article also reported:

ā€œ% time >ā€‰10ā€‰mmol/Lā€; ā€œ% time >ā€‰15ā€‰mmol/Lā€

ā€œ% time >ā€‰20ā€‰mmol/Lā€ and ā€œMean (SD) glucose valuesā€

  1. *Including one trial for which the registration number provided in the published article linked to a different study
  2. **Denominator is 385 outcomes for which comparison was possible (464ā€“79)