When entering data in the Electronic Data Forms (EDC) or the paper administered Questionnaires, please keep in mind the following information.
Item #1 – Questionnaires:
For the patient administered Questionnaires (all versions), HFS II, Adult Low Blood Sugar Survey, Question 2. Tried to keep my blood sugar above 150. This value is in mg/dl; if the unit of measure is in mmol/L in your country, please remember to convert the value in this question for the patient.
Item #2 – EDC:
Delivery Form – if the participant delivers prior to 34 gestational weeks, please ensure that HbA1c sample collected for the central lab is collected within 2 days of delivery.
Item #3 – HbA1c collection:
a) After Randomization – if the participant miscarries, please ensure that you collect the HbA1c (within 2 days) even if she miscarries as little as a few days after randomization. This blood sample collection is the primary outcome for the trial.
b) After At Confirmed Pregnancy – again ensure that the HbA1c sample is collected after confirmed pregnancy. This will be considered the sample for the primary outcome.
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