Illustrates Domains
DX
DU
Illustrates Variables
DXPRESP
DXOCCUR
MIDS
RELMIDS
Content
This is an example aCRF used to collect information on the use of a pre-specified list of devices at the time of the DKA event. The sponsor decided to categorize the devices according to their use (i.e., devices used for management of glucose or ketones, devices used for management of insulin). The sponsor collected the information associated with each DKA event using the concept of contingency visits. Contingency visit numbers were included in the header records, but are not shown below. This CRF also includes the CDASH variable DXAENO. This variable was used by the sponsor to assign/derive the appropriate timing variables associated with the use of the SDTM TM and SM domains. These mapping instructions are not provided.
Sponsors may customize the CRF as needed to reflect the interests of the study.
Title: DKA Event - Diabetic Device Used at Time of the Event
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DXAENO Not submitted
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| Indicate if the subject was using a real-time continuous glucose monitor for glucose or ketones management at the time of the event. |
Was a real-time continuous glucose monitor in use at the time of the event?
LBDEV_CGM_DXOCCUR DXOCCUR where DXTRT = "REAL-TIME CONTINUOUS GLUCOSE MONITOR"
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<From NY codelist> |
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| Indicate if the subject was using a flash glucose monitor for glucose or ketones management at the time of the event. |
Was a flash glucose monitor in use at the time of the event?
LBDEV_FGM_DXOCCUR DXOCCUR where DXTRT = "FLASH GLUCOSE MONITOR"
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<From NY codelist> |
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| Indicate if the subject was using a glucose meter for glucose or ketones management at the time of the event. |
Was a glucose meter in use at the time of the event?
LBDEV_GM_DXOCCUR DXOCCUR where DXTRT = "GLUCOSE METER"
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<From NY codelist> |
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| Indicate if the subject was using a glucose/ketones meter for glucose or ketones management at the time of the event. |
Was a glucose/ketones meter in use at the time of the event?
LBDEV_GKM_DXOCCUR DXOCCUR where DXTRT = "GLUCOSE/KETONES MONITOR"
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<From NY codelist> |
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| Indicate if the subject was using a ketones meter for glucose or ketones management at the time of the event. |
Was a ketones meter in use at the time of the event?
LBDEV_KM_DXOCCUR DXOCCUR where DXTRT = "KETONES METER"
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<From NY codelist> |
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| Indicate if the subject was using an insulin inhaler for insulin management at the time of the event. |
Was an insulin Inhaler in use at the time of the event?
INSDEV_INH_DXOCCUR DXOCCUR where DXTRT = "INSULIN INHALER"
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<From NY codelist> |
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| Indicate if the subject was using an electronic insulin pump for insulin management at the time of the event. |
Was an electronic insulin pump in use at the time of the event?
INSDEV_EIP_DXOCCUR DXOCCUR where DXTRT = "ELECTRONIC INSULIN PUMP"
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<From NY codelist> |
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| Indicate if the subject was using a mechanical insulin pump for insulin management at the time of the event. |
Was a mechanical insulin pump in use at the time of the event?
INSDEV_MIP_DXOCCUR DXOCCUR where DXTRT = "MECHANICAL INSULIN PUMP"
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<From NY codelist> |
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| Indicate if the subject was using an automated insulin delivery system for insulin management at the time of the event. |
Was an automated insulin delivery system in use at the time of the event?
INSDEV_AUT_DXOCCUR DXOCCUR where DXTRT = "AUTOMATED INSULIN DELIVERY SYSTEM"
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<From NY codelist> |
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| If an automated insulin delivery system was in use at the time of the event, indicate whether it was in automatic or manual mode for insulin delivery. |
If Yes, what was the insulin delivery automation mode at the time of the event?
DUORRES DUORRES where DUTESTCD = "INDLAUMD"
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