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)
Reasons to Consider Screening • Reduce number of undiagnosed diabetics • Reduce complications • Diagnosis diabetes shortly after its onset • Reduce complications • Diagnosis pre-diabetes • Prolong time to development of diabetes Implication: possibleneed to screen for pre-diabetes as well as diabetes
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
Specific Aims • Determine if risk factor assessment can be used to define relatively cost effective screening protocols. • Define and compare possible protocols on: sensitivity, specificity, and health care system cost per newly-identified diabetic patient and pre-diabetic patient. • Conduct cost effectiveness comparisons of candidate protocols versus each other and versus no screening.
This Study Will: • Recruit patients age 45-80 who are currently undiagnosed from LSU HCSD MedHm clinics • At the time of recruitment administer two multi-item risk factor instruments: ADA, FINDRISC • Have subjects return (fasting) for HbA1c, Fasting plasma glucose, 2-hr OGTT. • Categorize patients as “normal,” “pre-diabetic,” “diabetic” • Identify most cost effective longitudinal screening approach that can be constructed from the tests.
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
Broader Objectives • Define a protocol to pilot in LSU HCSD clinics • Use data accumulated from implementation experience to further refine the protocol, as needed, over time. • Define how other provider systems could go about defining a protocol that is near-optimal for them. • Establish a pre-diabetes research registry based on screening results. (Prior results suggest: 58% normal, 35% pre-diabetes, 7% diabetes.) • Enable projects directed to feasible interventions for pre-diabetic patients.