Laboratory Results Collected for each Diabetic Ketoacidosis Event

Illustrates Domains

Illustrates Variables

LBMETHOD
LBTESTCD
LBTEST
SPDEVID
RELMIDS
MIDSDTC

Content

For laboratory results obtained using a diabetic device, the SPDEVID variable was included in the LB dataset to indicate which device was used to obtain the measurements. The LBSPEC variable is populated with the specimen type associated with the reported result. The LBNAM variable is typically used to represent the name of the vendor or laboratory providing the result. When the subject's diabetic device was the source of the data, the LBNAM variable was left blank.

The disease milestone variables MIDS, RELMIDS, and MIDSDTC are included in the dataset and are populated on all records associated with the disease milestones. The value of the MIDS variable identifies the subject DKA milestone with which the record is associated. The start date of the DKA milestone is recorded in the MIDSDTC variable and the RELMIDS variable indicates when the result was obtained with respect to the DKA milestone. On all the records shown below, RELMIDS indicates that the result was obtained at the time of the DKA milestone.

Laboratory results that were collected for each DKA event were assigned contingent visit numbers.

Note that all expected variables are not shown to save space.

lb.xpt

Row 1:	Shows the plasma equivalent glucose value at the time of the first on-study DKA event for this subject. This plasma equivalent glucose result was obtained from the continuous glucose monitor (CGM) at the time of the event. The SPDEVID variable is populated with the assigned device identifier. In this case, the sponsor used the generic name of the device as the SPDEVID value. The MIDS value "DKA1" indicates that this result is associated with the first occurrence of the DKA milestone for the subject.
Row 2:	Shows a pH result that was determined from a specimen of arterial blood that was collected at the start of the subject's first DKA event. The value of the LBNAM variable indicates that this result was from the laboratory. The SPDEVID variable is blank, as no study device was used to obtain the result.
Row 3:	Shows the glucose value at the time of the second on-study DKA event for this subject. The glucose measurement was performed by the hospital lab using a sample that was collected at an unscheduled visit between visits 14 and 15. The MIDS variable populated with "DKA2" indicates that this is the second occurrence of the DKA disease milestone for the subject.
Row 4:	Shows the result of a urine ketones measurement that was performed at the start of the second DKA milestone event. The value of the SPDEVID variable indicates that this test was performed using a ketone meter device.
Rows 5-6:	Show the laboratory results for 2 more tests performed on a sample of venous blood that was collected at the start of the subject's second DKA milestone event.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	SPDEVID	LBSEQ	LBTESTCD	LBTEST	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	LBSPEC	LBNAM	LBMETHOD	LBDTC	VISITNUM	VISIT	MIDS	RELMIDS	MIDSDTC
1	T001	LB	001	Real-Time Continuous Glucose Monitor	1	GLUCPE	Plasma Equivalent Glucose	260	mg/dL	14.43	14.43	mmol/L	INTERSTITAL FLUID		CALCULATION	2013-09-01	99.1	DKA CONTINGENT VISIT 1	DKA1	AT TIME OF	2013-09-01
2	T001	LB	001		2	pH	pH	7.24		7.24	7.24		ARTERIAL BLOOD	Hospital X		2013-09-01	99.1	DKA CONTINGENT VISIT 1	DKA1	AT TIME OF	2013-09-01
3	T001	LB	001		3	GLUC	Glucose	300	mg/dL	16.65	16.65	mmol/L	BLOOD	Hospital X		2014-10-24	99.2	DKA CONTINGENT VISIT 2	DKA2	AT TIME OF	2014-10-24
4	T001	LB	001	Ketones Meter	4	KETONES	Ketones	LARGE		LARGE			URINE		TEST STRIP	2014-10-24	99.2	DKA CONTINGENT VISIT 2	DKA2	AT TIME OF	2014-10-24
5	T001	LB	001		5	pH	pH	7.12		7.12	7.12		VENOUS BLOOD	Hospital X		2014-10-24	99.2	DKA CONTINGENT VISIT 2	DKA2	AT TIME OF	2014-10-24
6	T001	LB	001		6	BICARB	Bicarbonate	9.4	mEq/L	9.4	9.4	mmol/L	VENOUS BLOOD	Hospital X		2014-10-24	99.2	DKA CONTINGENT VISIT 2	DKA2	AT TIME OF	2014-10-24