Table 1 Overview of timing of enrolment, interventions and assessments in the CRISTAL study
STUDY PERIOD | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
TIMEPOINTS | Screening | Baseline run-in (within 1 week after screening) | Randomisation | Training 780G HCL system or masked CGM (within 1 week after run-in) | Study visit 1 (if screening < 8 weeks) | Study visit 2 | Study visit 3 | Study visit 4 | Study visit 5 | Delivery and early postpartum | |
ENROLMENT | Eligibility screen | X | |||||||||
Informed consent | X | ||||||||||
Allocation | X | ||||||||||
INTERVENTIONS | (masked) CGM for 10 days | X | |||||||||
(masked) CGM for 21 days | X | X | X | X | X | ||||||
780G HCL system | X | X | X | X | X | X | X | ||||
ASSESSMENTS | Outcomes collected from medical records: | ||||||||||
Demographic data | X | ||||||||||
Medical and obstetrical history | X | ||||||||||
Clinical and biochemical outcomes: | |||||||||||
Physical examination | X | X | X | X | X | X | |||||
HbA1c | X | X | X | X | X | X | |||||
Future analyses of new bio-markers and metabolomics | X | X | X | X | X | X | |||||
CGM metrics | X | X | X | X | X | X | X | ||||
(S)AEs and DDs | X | X | X | X | X | X | X | ||||
Other relevant health data | X | X | X | X | X | X | X | ||||
C-peptide | X | ||||||||||
Future analyses of new bio-markers and metabolomics in umbilical cord blood | X | ||||||||||
Sum of skinfolds | X | ||||||||||
Neonatal body fat mass | X | ||||||||||
Patient-reported outcomes: | |||||||||||
Self-administered questionnaires | X | X | X | X | X | X | |||||
Data for health-economic evaluation | X | X | X | X | X | X | X | ||||
Medication use | X | X | X | X | X | X | X | ||||