DYNAMIC APPROACHES TO IMPROVE GLYCEMIC CONTROL AND PRIMARY DIABETES CARE DYNAMIC APPROACHES TO IMPROVE GLYCEMIC Figure. CONTROL AND PRIMARY DIABETES CARE 1‑OR Characterizing Clinical Inertia in a Large, National Database CORI R. RATTELMAN, ANUPAMA ARORA, JOHN K. CUDDEBACK, ELIZABETH L. CIEMINS, Alexandria, VA Objective: To characterize clinical inertia in the treatment of diabetes using a large, geographically diverse clinical database. Study Design: A retrospective descriptive analysis was conducted in a clinical database containing 22 million patient records across 22 health care organizations (HCOs). Population Studied: A total of 281,000 patients aged 18-75 were included during the 5.5-year study period (1/2012-6/2017). Patients had an outpatient visit in the last 12 months of the study period, an HbA1c in the last 24-30 months (index A1c), and a diagnosis of type 2 DM on a claim or EHR prob- lem list at least 6 months prior to index A1c. A subset of 47,693 patients with an index A1c ≥8 and a prior A1c ≥8 or lack thereof, was observed for Supported By: National Institute of Diabetes and Digestive and Kidney Diseases four 6-month follow-up periods for actions including a new class of diabetes (T35DK104689); Yale University medication prescribed or an A1c <8. The absence of observable action fol- lowing index A1c suggests potential “clinical inertia.” Principal Findings: Six months following an index A1c≥8, 55% of patients 3‑OR received no observable clinical action ranging from 45-65% across HCOs Influence of Diabetes Complications on the Cost‑Effectiveness of and 18-96% across individual providers. A new diabetes prescription was A1c Treatment Goals in Older U.S. Adults observed in 35% of patients (7.5% moved into glycemic control, A1c<8) HUI SHAO, DEBORAH B. ROLKA, EDWARD W. GREGG, PING ZHANG, Atlanta, GA and 10% moved into glycemic control without a new prescription. Patient The American Diabetes Association (ADA) recommends glycemic man- characteristics associated with increased clinical inertia, i.e., no observable agement goals for older diabetes patients take into account the complexity action, during the 6- and 24-month follow-up periods included black race, of complications. Little information is available on how cost-effectiveness low-income insurance, normal body mass index, and being on bolus insulin (CE) of glycemic control goals relates to a patient’s level of complications. (all P<.01). Within 24 months, clinical inertia was reduced to 19%, ranging We examined the CE of intensive glycemic control (A1c <7.5%) compared to from 13-28% across HCOs. standard treatment (A1c <8.5%) among adults aged 65 years with type 2 Conclusions: Lack of clinical action in the 6 months following an A1c ≥8 diabetes having various complications. 2011-2016 National Health and Nutri- suggests clinical inertia vs. ADA guidelines. Greater rates in low-income tion Examination Survey data were used to generate nationally representa- insurance and race/ethnic minority adults suggests potential populations tive samples with various complications. The CDC-RTI diabetes simulation to target to ensure adequate treatment for diabetes. The decline in clinical model was used to project the long-term health and cost consequences of inertia within 24 months suggests either actions not seen in the data, or intensive/standard glycemic control. The CE of the intensive glycemic con- later interventions that were ultimately effective. trol was measured in costs (2017 USD) per quality adjusted life year (QALY). Supported By: Novo Nordisk Based on a $50,000/QALY threshold, intensive glycemic control was only marginally cost effective for patients with no complications or any micro- vascular complication (excluding renal failure) but was not cost-effective 2‑OR for patients with one or more macrovascular complications. Current ADA Cost‑Related Insulin Underuse Is Common and Associated with standards recommend intensive glycemic control among older adults with Poor Glycemic Control fewer than 3 complications. From a CE perspective, our results only support DARBY M. HERKERT, PAVITHRA VIJAYAKUMAR, JING LUO, JEREMY SCHWARTZ, the intervention among those with no complications or only microvascular TRACY L. RABIN, EUNICE M. DEFILIPPO, KASIA J. LIPSKA, New Haven, CT, Boston, complication. MA, West Haven, CT Insulin is an essential medicine for people with diabetes (DM), but increas- ing prices have threatened its affordability. We examined the prevalence of and factors associated with cost-related insulin underuse. We administered a cross-sectional survey to patients with DM prescribed insulin at Yale Diabetes Center (YDC). Our primary outcome was cost-related underuse in the past 12 months, defined by a positive response to any 1 of 6 questions: Did you … 1.) Use less insulin than prescribed 2.) Try to stretch ORALS out your insulin 3.) Take smaller doses of insulin than prescribed 4.) Stop insulin 5.) Not fill an insulin prescription 6.) Not start insulin … because of cost? We examined the association of cost-related underuse with HbA1c >9% using logistic regression controlling for age, sex, age, DM duration, and income. Out of 354 patients prescribed insulin who had YDC visit in July 2017, 199 (56.2%) completed the survey (50.8% female, 60.8% white, 41.7% type 1). Of these patients, 51 (25.5%) reported cost-related insulin underuse. Patients with cost-related underuse had lower income levels, variable drug coverage and employment (Figure), and 3-fold higher odds of HbA1c >9% (p = 0.03) than patients who did not report underuse. One in four patients at our urban diabetes center reported cost-related insulin underuse, and this was associated with poor glycemic control. These results highlight an urgent need to address high insulin prices in the U.S. ADA-Supported Research A1 DYNAMIC APPROACHES TO IMPROVE GLYCEMIC CONTROL AND PRIMARY DIABETES CARE 4‑OR 6‑OR The Clinical and Economic Effects of Switching Medicare Benefi‑ Management of Patients with Type 2 Diabetes Shared between a ciaries with Type 2 Diabetes from Analog to Human Insulin Specialized Outpatient Clinic and General Practice Was Noninfe‑ JING LUO, NAZLEEN F. KHAN, THOMAS MANETTI, JAMES J. ROSE, ANI rior to Mono Management in a Specialized Outpatient Clinic—A KALOGHLIAN, BALU GADHE, SACHIN H. JAIN, JOSHUA GAGNE, AARON KES- Prospective, Randomized, Noninferiority Trial SELHEIM, Boston, MA, Cerritos, CA LENE MUNCH, BIRGITTE B. BENNICH, DORTHE OVERGAARD, HANNE KONRAD- Objective: To evaluate the clinical and economic effects of a managed SEN, HELLE V. MIDDELFART, NIELS KAARSBERG, FILIP K. KNOP, TINA VILSBØLL, care organization’s conversion program switching Medicare beneficiaries MICHAEL RØDER, Gentofte, Denmark, Hellerup, Denmark, Copenhagen, Denmark, with type 2 diabetes mellitus from analog to human insulin. Huddinge, Sweden, Holte, Denmark Methods: A consecutive sample of 14,635 participants who filled insulin To ensure high-quality care for patients with type 2 diabetes (T2D), it is prescriptions between January 2014 and December 2016 were identified necessary to consider how clinical management is organized. We investi- from a Medicare Advantage and prescription drug plan operating in 4 U.S. gated if management of patients with T2D shared between a specialized states (CA, AZ, NV, VA). Outcomes were mean hemoglobin A1c (%), rates of outpatient clinic and primary health care has a non-inferior outcome of severe hypoglycemia or hyperglycemia events and risk of reaching the Part HbA1c compared to ‘mono’ management in a specialized outpatient clinic. D coverage gap. Data were analyzed using interrupted time series and seg- The study was a 12-month randomized controlled, non-inferiority trial. Non- mented regression with cut points at the beginning and end of 2015. inferiority margin for HbA1c was 4.4 mmol/mol. Patients with T2D and incipi- Results: 14,635 members (mean age=72.5) filled 221,866 insulin prescrip- ent complications were eligible for the study. The shared care intervention tions. Insulin conversion decreased the proportion of scripts filled by analog consisted of one annual comprehensive check-up at the outpatient clinic and insulins from 90% to 30%. The baseline mean hemoglobin A1c was 8.46% three quarterly visits at the primary health care physician. The control group and decreased at a rate of -0.02% per month during 2014. The beginning was offered four quarterly visits at the outpatient clinic, including an annual of the conversion program in 2015 was associated with a level change of comprehensive check-up. We randomized 140 patients (age: 65.0±0.9 years +0.14% (p<0.01) and a slope change of 0.02% (p<0.01). The baseline rate of (mean±SEM), BMI: 30.8±0.5 kg/m2, diabetes duration: 9.1±0.5 years, HbA1c: severe hypoglycemia was 4.21 per 1000-person years (py) and increased at a 51.9±0.8 mmol/mol, systolic blood pressure: 135.6±1.1 mmHg) with no sig- rate of 0.36/1000py during 2014. The baseline rate of severe hyperglycemia nificant baseline differences between the groups. Ninety-five (68%) patients was 22.33/1000py and increased at a rate of 0.30/1000py. For both hypogly- had peripheral neuropathy, 26 (19%) microalbuminuria, and 21 (15%) previ- cemia and hyperglycemia, the level and slope changes in the 12-month inter- ous major cardiovascular event. At end-of-trial, mean HbA1c change from vention and post-intervention segments were not statistically significant. baseline was 2.0 mmol/mol in the intervention group and 0.9 mmol/mol in The intervention reduced the risk of reaching the coverage gap by 55% (HR the control group. The between-group difference of 1.1 mmol/mol (95% con- 0.45, nominal 95% CI: 0.43-0.48, p<0.001). fidence interval: -2.0, 4.1) met the pre-specified non-inferiority criterion. Our Conclusions: Switching Medicare beneficiaries with diabetes from analog study shows that a shared care program is non-inferior to an established to human insulin did not change the rates of hospitalization for hypoglyce- program in a specialized outpatient clinic in maintenance of glycemic control mia or hyperglycemia, slightly increased mean A1c, and reduced the risk of of T2D patients with incipient complications.