1. Designing Screening Protocols for Diabetes and Pre-diabetes Ron Horswell, PhD (PBRC) Gang Hu, MD PhD (PBRC) Study group: Jolene Johnson, MD (LSU HSC) Will Cefalu, MD (PBRC) Jay Besse, BS (LSU HCSD)

2. Reasons to Consider Screening 1.Reduce number of undiagnosed diabetics – Reduce complications 2.Diagnosis diabetes shortly after its onset – Reduce complications 3.Diagnosis pre-diabetes – Prolong time to development of diabetes Implication: possible need to screen for pre- diabetes as well as diabetes

3. Possible Screening Tools Risk factor assessment HbA1c Fasting glucose Oral Glucose Tolerance Test Note: LSU HCSD has tested a screening protocol that involves: Step 1: risk factor assessment Step 2: HbA1c test for those with 2+ risk factors Step 3: Confirm with fasting test if HbA1c above a set threshold

4. Specific Aims 1.Determine if risk factor assessment can be used to define relatively cost effective screening protocols. 2.Define and compare possible protocols on: sensitivity, specificity, and health care system cost per newly-identified diabetic patient and pre-diabetic patient. 3.Conduct cost effectiveness comparisons of candidate protocols versus each other and versus no screening.

5. This Study Will: 1.Recruit patients age 45-80 who are currently undiagnosed from LSU HCSD MedHm clinics 2.At the time of recruitment administer two multi- item risk factor instruments: ADA, FINDRISC 3.Have subjects return (fasting) for HbA1c, Fasting plasma glucose, 2-hr OGTT. 5.Categorize patients as “normal,” “pre-diabetic,” “diabetic” 6.Identify most cost effective longitudinal screening approach that can be constructed from the tests.

6. Timeline & Core Services Timeline Data gathering at clinics (4 months) – August through November Analysis – November and December Core services needed: – Design and analysis (Gang) – Informatics: (Ron, data base development) – NEST: Recruit at three sites over 4 months Anticipated articles: – Value of using risk factor screening – Results from protocol comparisons

7. Broader Objectives 1.Define a protocol to pilot in LSU HCSD clinics 2.Use data accumulated from implementation experience to further refine the protocol, as needed, over time. 3.Define how other provider systems could go about defining a protocol that is near-optimal for them. 4.Establish a pre-diabetes research registry based on screening results. (Prior results suggest: 58% normal, 35% pre-diabetes, 7% diabetes.) 5.Enable projects directed to feasible interventions for pre-diabetic patients.