Japan Clinical Informatization for Chronic Diseases Related to Lifestyle

In 2019, the Collaborative Committee of Clinical Informatization in Diabetes Mellitus (CCCIDM), a collaborative initiative involving six Japanese associations, published a special report in the Journal of Diabetes Investigation which identified core item sets (CIS) and self-managed item sets (SMIS) considered important data to be collected for diabetes mellitus and associated chronic diseases.

An initial project to perform a gap analysis to assess the feasibility of using the CDISC Study Data Tabulation Model (SDTM) for representing the 43 SMIS identified by the CCCIDM was completed in 2024. Building on this work, a second project was conducted and completed in 2025 resulting in the development of standalone SDTM examples illustrating all 43 items with supporting biomedical concepts.

Both projects are described in detail in the following white papers:

The SDTM examples and supporting biomedical concepts are now publicly available. The following table provides links to where each SMIS concept is represented in an SDTM example. All biomedical concepts may be found in the CDISC Biomedical Concepts Browser.

Item #	Japanese Collaborative Committee SMIS Item	Units / Expression	SDTM Domain	Example Link	Row Number
1	Height	cm	VS	Example 2	1
2	Weight	kg	VS	Example 2	2
3	Systolic blood pressure	mmHg	VS	Example 2	3
4	Diastolic blood pressure	mmHg	VS	Example 2	4
5	LDL-cholesterol	mg/dL	LB	Example 3a	1
6	HDL-cholesterol	mg/dL	LB	Example 3a	2
7	Smoking (including new types of tobacco)	Current/Former/Never	SU	Example 6	ALL
8	Serum creatinine	mg/dL	LB	Example 3a	5
9	Urine protein	–, ±, +, 2 +, 3 + or over	LB	Example 3a	15
10	Blood glucose	mg/dL	LB	Example 3a	8
11	Age or date diagnosed as diabetes mellitus	under 10y.o, 10's, 20's, ..., 70's, 80y.o. or over, Not yet, unknown	MH	Example 1a	5
12	HbA1c	%	LB	Example 3a	20
13	ALT	U/L	LB	Example 3a	10
14	Diabetic retinopathy	Yes/No/Unknown	MH	Example 1a	6
15	Age or date diagnosed as hypertension	under 10y.o, 10's, 20's, ..., 70's, 80y.o. or over, No, unknown or YYYY-MM-DD	MH	Example 1a	1
16	Serum potassium	mmol/L	LB	Example 3a	7
17	Abnormality on ECG	Yes/No/Unknown	MH and EG	Example 1a, Row 4; Example 4, Row 2
18	Triglyceride	mg/dL	LB	Example 3a	4
19	Age or date diagnosed as dyslipidemia	under 10y.o, 10's, 20's, ..., 70's, 80y.o. or over, No, unknown	MH	Example 1a	2
20	History of coronary disease	Yes (contrast), Yes (other), No, Unknown	MH	Example 1a	3
21	Age or date diagnosed as CKD	under 10y.o, 10's, 20's, ..., 70's, 80y.o. or over, No, unknown	MH	Example 1a	8
22	Serum albumin	g/dL	LB	Example 3a	9
23	Blood in Urine	–, ±, +, 2 +, 3 + or over; Macrohematuria	LB	Example 3a	17 (macro), 18 (occult)
24	Total cholesterol	mg/dL	LB	Example 3a	3
25	Urine albumin/creatinine	mg/gCre	LB	Example 3a	19
26	AST	U/L	LB	Example 3a	11
27	Waist	cm	VS	Example 2	5
28	Urine glucose	–, ±, +, 2 + or over	LB	Example 3a	16
29	y-GTP	U/L	LB	Example 3a	21
30	Diabetic neuropathy	Yes/No/Unknown	MH	Example 1a	7
31	Regular dental visit (≥ once/year)	Yes/No/Unknown	HO	Example 5	ALL
32	Urate	mg/dL	LB	Example 3a	22
33	Systolic BP at home	mmHg	VS	Example 2	6
34	Diastolic BP at home	mmHg	VS	Example 2	7
35	Family history of renal failure	Yes/No/Unknown	APMH	Example 1b	ALL
36	Urine protein/creatinine	g/gCre	LB	Example 3a	23
37	Urine protein/Day	g/Day	LB	Example 3a	14
38	Serum total protein	g/dL	LB	Example 3a	12
39	UN	mg/dL	LB	Example 3a	6
40	Hemoglobin	g/dL	LB	Example 3a	13
41	Cystatin C	mg/L	LB	Example 3a	24
42	Self-monitoring blood glucose	mmol/L	LB	Example 3b	ALL
43	Weight at home	kg	VS	Example 2	8

Japan Clinical Informatization for Chronic Diseases Related to Lifestyle

Item #

Japanese Collaborative Committee SMIS Item

Units / Expression

SDTM Domain

Example Link

Row Number