I am conducting a research study and using the dexcom g6 continuous glucose monitor in my study of pregnant women with and at risk for gdm.Four of the participants in our study experienced sensor deployment failures (i.E., the sensor did not come off of the applicator as it should have) during our study visits conducted via (b)(6).This unanticipated malfunction did not harm our participants, thankfully, but we believed the fda should know.(b)(4).We have reported these malfunctions to dexcom.We describe approx mean values for these 4 research participants in completing this form (weight, etc.), to protect their confidentiality.Therapy start date: (b)(6) 2021.Therapy end date: (b)(6) 2021.Fda safety report id # (b)(4).
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