SEARCH Summary Table of Measures

INSTRUMENT/MEASURE / SEARCH 1 2001-2005 / SEARCH 2 2006-2010 / SEARCH 3 2011-2015
Baseline / Follow-Up visit / Baseline IPV
'06 & '08 /
Registration
'07, '09,'10 / Base-line / Baseline IPV '12 /
Registration
'11, '13 -'15 / Follow-Up visit
PREV 01 / INC '02-'05 / INC '02-'05
FU-12 / INC '02-'05
FU-24 / INC '02-'05
FU-60 / INC '06 & '08 / INC '07, '09, '10 / PREV '09 / INC '12
Registry Study / INC '11, '13-'15
Registry Study / INC '02-'05, '06 & '08
Cohort Study
Case Registration (CR) / X / X / X / X / X / X / X
Core / X / X
Extended Core / X / X / X / X
Initial Patient Survey (IPS) / X / X / X / X / X / X / X
In Person Visit (IPV) / X / X / X / X / X / X / X / X
Physical Examination / X / X / X / X / X / X / X / X
Specimen Collection / X / X / X / X / X / X / X / X
Stimulated C-peptide / X / X / X / X / X
Blood and Urine Measures2 / X / X / X / X / X / X / X3 / X4
Health Questionnaire / X / X / X / X / X / X
Supplemental Health Questionnaire / X / X / X / X / X / X
Quality of Life (PedsQL) / X / X / X / X / X / X
Tanner Stage / X / X / X / X / X / X
Food Frequency Questionnaire (FFQ) / X / X / X / X / X
CESD / X / X / X / X / X / X
Family History / X / X / X
Medical Record Abstraction / X
Extended Typology / X / X
CVD Sub-study Measures / X / X
Quality of Care1 / X / X / X / X / X
Cardiac Measures (SphygmoCor)5 / X / X
Neuropathy Screening (MNSI)5 / X / X
Retinopathy Screening5 / X / X
Medication Inventory / X / X
Participating Relatives / X / X
Eye Vision History Form / X
Pediatric Diabetes Quality of Life Scale / X
Eating problems / X
Family Conflict / X
Low Blood Sugars / X
1. Quality of Care information gathered on sample of Prev 01 (10% NHW and all minorities), and selected elements were part of IPS for 06/08 cohort
2. Types of lab data collected differs between visits -see lab data table for measures collected
3. Registry Labs - Blood, 1st-morning urine, and spot urine. Diabetes autoantibodies (GAD65, IA2, ZnT8), HbA1c, fasting glucose, C-peptide, lipids, creatinine, and urinary albumin/creatinine. STORAGE: Serum, plasma, DNA and DNA repository, and urine
4. Cohort Labs - BLOOD: Fasting glucose, DAA (GAD65, IA2, ZnT8 [once assay is standardized]), fasting c-peptide, fasting lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides), A1c, ApoB, LDL particle size and density, Cystatin-C, CRP, IL-6, Fibrinogen, Adiponectin, Leptin, Creatinine. URINE: urinary albumin and creatinine (including first morning void and random sample at IPV). STORAGE: urine, serum, plasma, DNA and DNA repository.
5. Subsets of participants from SEARCH 1 completed CVD, neuropathy, and retinopathy measures

Collection Instruments/measurements per collection time period

Phase 1

[1] CR: Medical Record/Provider-based - ID, Age, DOB, gender, race/ethnicity, county of residence, zip code, diabetes validated (yes), method of validation (Medical record review/direct verification by a physician/ clinically verified database/death certificate/self-report), diabetes status (Prevalent/ Incident), date of diagnosis, secondary diabetes [diabetes caused by another source e.g., illness or medication] (Yes/No), residence eligibility (eligible/pending/not applicable), health plan eligibility (eligible/pending/not applicable), military eligibility (eligible, unknown), institutional eligibility (eligible, unknown), and date registered.

[1] IPS: Date of birth and gender, date of diagnosis, age at diagnosis, setting of diagnosis, approximate body size at diagnosis, past history concerning DKA and/or vomiting and insulin use, prescription medications and other medical history, status as active or dependent military or a college student, race/race/ethnicity of patient using Census 2000 categories, confirmation of residence during index year, (For local use only) Name and contact information.

[1] IPV: Physical Examination [anthropometric measures: height, weight, waist circumference, blood pressure, acanthosis nigricans (examination of neck)]; Specimen Collection [diabetes autoantibodies, fasting c-peptide and glucose, hgba1c lipid profile (fasting): total cholesterol, hdl, ldl, and triglycerides, urine albumin & creatinine, diabetes medications, stimulated c-peptide (possible second visit)]; Health Questionnaire [co-morbidities, clinical presentation and diagnosis, medication inventory(for age < 10 yrs), processes of care, socioeconomic status, family history, current family structure, general and diabetes specific quality of life (age-specific)]; Supplemental Health Questionnaire [health behaviors (e.g., diet, activity, sleep, smoking), medication inventory, pubertal development].

[1] MRM: Medical Record Abstraction (MRA) Diabetes autoantibodies, C-peptide, Clinical presentation, Selected acute and chronic diabetes complications, Selected co-morbidities, Medications, including insulin use, Processes of care, Diabetes-related genetic testing, and Pubertal development (subset). Diabetes Typology MRA (CORE) Patient gender, Race/ethnicity, Information for typology, Diagnosis, Diagnostician, Laboratory values, Insulin use, Height and Weight

[1] Survey: Quality of Care/Quality of Life survey; once only in Year 3 (10/07-9/08)

Phase 2

[1] CR: ID, age, date of birth, sex, race/ethnicity, county of residence, zip code, diabetes, validated, method of validation, date of diagnosis, type of diabetes indicated by provider

[1] MR: Characteristics related to typology, clinical presentation, complications, comorbidities, medications, health care utilization, diabetes education, Tanner Staging

[1] ECF: Sex, race/ethnicity, zip code, county/state of residence, date of diagnosis, provider type of diabetes, weight and height at diagnosis, presence of Acanthosis nigricans, insulin use, diabetes auto-antibody levels, c-peptide test results

[1] IPS(1): Sex, race/ethnicity, weight at birth, date of diagnosis, residence eligibility, health plan eligibility, military eligibility, institutional eligibility, provider type of diabetes, current insulin use, current weight/ height, DKA, Acanthosis nigricans, PCOS

[1] IPS(2): Family history of diabetes, health insurance, diabetes and personal health care providers, diabetes education, education and family income, contact information

[1] IPV: Physical Exam - Height, weight, waist, blood pressure, acanthosis; Blood/Urine Samples - DAA, FCP, lipids, glucose, HgbA1c, serum and plasma storage, and DNA and urine storage; Medication Inventory - List of current medications

Cohort year / Prev
2001 / Incident
2002 / Incident
2003 / Incident
2004 / Incident
2005 / Incident
2006 / Incident
2008 / 12-Month Follow-Up / 24-Month Follow-Up / 60-Month Follow-Up / Cohort visit / Incident2012
GAD65 / X / X / X / X / X / X / X / X / X / X / X / X
IA2 / X / X / X / X / X / X / X / X / X / X / X / X
ZnT81 / --- / X / X / X / X / X / X / X
HLA1 / X / X / X / X / X / X / X / X
MODY data1 / X / X / X / X / X / X
TCF7L21 / X / X / X / X / X / X
VNTR Class1 / X / X / X / X
PNDM1 / X / X / X / X / X / X / X
HDL / X / X / X / X / X / X / X / X / X / X / X / X
LDL / X / X / X / X / X / X / X / X / X / X / X / X
Triglycerides / X / X / X / X / X / X / X / X / X / X / X / X
Lp(a) 1 / X / X / X / X
ApoB1 / X / X / X / X / X
LDLRf1 / X / X / X / X / X
A1C / X / X / X / X / X / X / X / X / X / X / X / X
Albumin (urine) / X / X / X / X / X / X / X / X / X / X / X / X
Creatinine (urine) / X / X / X / X / X / X / X / X / X / X / X / X
Fasting Glucose / X / X / X / X / X / X / X / X / X / X / X / X
Fasting C-pep / X / X / X / X / X / X / X / X / X / X / X / X
Stim C-pep1 / X / X / X / X / X / X / X / X
Cystatin-C1 / X / X / X / X
Creatinine (blood) / X / X
Adiponectin1 / X / X / X / X / X
Leptin1 / X / X / X / X / X
CRP1 / X / X / X / X / X / X / X / X / X
IL-61 / X / X / X / X / X / X / X / X / X
Fibrinogen1 / X / X / X / X / X / X / X / X / X
  1. Subset on which data is collected varies across groups/visits (some subsets are very small)