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. 2024 Oct 21;13:e59423. doi: 10.2196/59423

Table 1.

Study outcomes and covariates for phase 2, proof-of-concept randomized controlled trial.

Outcome variable Data source Collection timepoint


Baseline 36-38 weeks gestation Delivery 6-weeks post partum
Maternal outcomes

Fasting and 2-hour blood glucose Medical record


Gestational weight gain Medical record



Glucose readings during gestation GDM-DHa app and medical record (intervention group); medical record (standard care group)



Initiation of insulin therapy Medical record



Induction of labor Medical record



Cesarean delivery Medical record


Neonatal outcomes

Birth weight Medical record



Apgar score Medical record



NICUb admission Medical record



Neonatal hypoglycemia Medical record


Usability and acceptability outcomes

Oxford Maternity Diabetes Treatment Satisfaction Questionnaire [56] Survey (self-report)


Variables measured in the intervention group only

App usage GDM-DH app





Time spent on the app




Self-monitoring compliance (observed vs expected number of entries) GDM-DH app





Carbohydrate intake





Blood glucose entries






Blood pressure entries






Weight entries





mHealthc App Usability Questionnaire [57] Survey (self-report)



System Usability Scale [54] Survey (self-report)


Covariates

Sociodemographics Survey (self-report)



Prepregnancy weight Survey (self-report)


aGDM-DH: gestational diabetes mellitus-Dhulikhel Hospital.

bNICU: neonatal intensive care unit.

cmHealth: mobile health.