2015 ADA Posters 929-1473.Indd
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CLINICAL THERAPEUTICS/NEW TECHNOLOGY—GLUCOSECATEGORY MONITORING AND SENSING Table 1. Difference Between CES-D and DFCS Between Team Clinic and Standard Diabetes Clinic. Team Clinic Standard Diabetes Clinic p-value CES-D positive 13% 17% 0.77 CES-D score (±SD) 13.4±10.1 13.7±11.5 0.90 DFCS score (±SD) 27.7±10.4 30.4±11.1 0.18 Supported By: National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases 931-P Comorbid Depression and Diabetes Before and During the “Great 929-P Recession” of 2008 Patient Responses to Interim Data from Cardiovascular Outcomes EESHWAR K. CHANDRASEKAR, MOHAMMED K. ALI, KAI MCKEEVER BULLARD, Trials: Results from an Online Patient Survey Atlanta, GA MANU V. VENKAT, RICHARD S. WOOD, ADAM S. BROWN, PHIN YOUNGE, LISA Prior studies indicated that prescription rates of antidepressants in- S. ROTENSTEIN, KELLY L. CLOSE, San Francisco, CA, Boston, MA creased during the economic recession of 2008. However, estimates vary The disclosure of interim data from ongoing clinical trials is usually regarding the prevalence of depression among people with diabetes melli- discouraged, as it can alter participant behavior and threaten trial integ- tus (DM) around this time period. We used national data to estimate preva- rity. Current U.S. regulatory guidance requires long-term cardiovascular lence of depressive symptoms among persons with normal glycemic sta- outcomes trials (CVOTs) for new T2DM drugs, but allows interim data tus, pre-DM, and DM during 2005-2008 and 2009-2012. We analyzed data to be disclosed to support approval. The purpose of this study was to from 21,618 adults aged ≥18 years from the 2005-2012 National Health and examine how such disclosure could influence enrollment dynamics in Nutrition Examination Surveys. Using the Patient Health Questionnaire-9 a CVOT. An online survey from the diabetes market research company (PHQ-9), we defi ned clinically-signifi cant depressive symptoms, or “de- dQ&A was distributed to a panel of adult T2DM patients. Of the 1,984 pression”, as PHQ-9 score ≥10 or use of antidepressants. We categorized total respondents with T2DM, 1,542 reported a history of CVD and/or participants’ glycemic status using HbA1c: normal glycemic status (<5.7%), being told by their healthcare provider that they are at elevated CVD pre-DM (5.7-6.4%), and DM (self-report of diagnosis or HbA1c ≥6.5%). We POSTERS risk. This represents a patient subgroup that is targeted for enrollment Therapeutics used logistic regression to compute predicted prevalence adjusted for age, in most diabetes CVOTs. In the survey, respondents were described a Clinical Diabetes/ sex, body mass index, race/ethnicity, poverty-to-income ratio, and aware- hypothetical CVOT. Next, they were randomized to receive scenarios in ness of DM or pre-DM. In 2009-2012, the crude prevalence of depression which evidence of either an increase or decrease in CVD incidence was among adults was 1.6 times higher for those with DM (22.9% [20.1-25.9]) disclosed during the trial. In both scenarios, the drug was approved. All than those with normal glycemic status (14.5% [13.0-16.1]) and 1.4 times participants selected one of four choices regarding their subsequent ac- higher than those with pre-DM (16.5% [14.4-18.9]). Crude prevalence in tions (see table below). each glycemic group remained relatively stable since 2005-2008, during Table 1. Patient Responses to the Disclosure of Interim CVOT Data. which the prevalence of depression among individuals with DM, pre-DM Interim data indicates Interim data indicates and normal glycemic status was 23.8% [21.3-26.5], 15.1% [13.0-17.4], and increased CVD risk decreased CVD risk 14.1% [12.9-15.3], respectively. In 2005-2008, adjusted prevalence ratios (n=816) (n=723) (normal glycemic status = reference) were 1.12 (0.93-1.34) for DM and 0.95 Remain in trial without any 26% 51% (0.82-1.09) for pre-DM. In 2009-2012, adjusted prevalence ratios (nor- major reservations mal glycemic status = reference) were 1.04 (0.83-1.31) for DM and 1.02 Remain in trial, ask doctor 41% 29% (0.87-1.92) for pre-DM. During 2005-2012, the prevalence of depressive about leaving trial during next symptoms remained stable across all glycemic groups. The prevalence of scheduled visit depressive symptoms did not increase around the “Great Recession” of Leave trial immediately, ask 4% 8% 2008. doctor to prescribe the newly approved therapy Leave trial immediately, return 30% 12% CLINICAL THERAPEUTICS/NEW TECHNOLOGY— to original diabetes therapy GLUCOSE MONITORING AND SENSING Our results indicate that interim data disclosure can meaningfully alter the behavior of T2DM patients enrolled in a CVOT, in ways that could endanger Guided Audio Tour: Glucose Monitoring—New Methods and Applications the trial’s integrity. Future work could examine the impact of interim data (Posters: 932-P to 939-P), see page 17. disclosure from real-world CVOTs. & 932-P 930-P Glycemic Effects of SGLT2 Inhibitor Canaglifl ozin in Type 1 Diabetes WITHDRAWN Using Dexcom G4 Platinum CGM NICHOLAS B. ARGENTO, KATHERINE NAKAMURA, Columbia, MD, San Diego, CA Limited information is available on the chronic use of sodium-glucose transporter 2 inhibitors in type 1 diabetes (T1D). We report on the glycemic, weight and systolic blood pressure (SBP) effect of canaglifl ozin 100 mg daily in T1D in a group of experienced Dexcom CGM (DCGM) users. In this retro- spective review, we examined records of T1D patients on DCGM > 1 yr (mean 4.6 yr) who were prescribed canaglifl ozin (CANA) and had a baseline DCGM 30 day download prior to and a second download after at least 1 month taking oral CANA 100 mg daily. 26 were identifi ed, 17 men, 25 white, T1D duration 12-48 yr average 30.3, 20 on pump and 6 on injections. All patients had an eGFR at baseline of 60 ml/min/1.73 m2 or higher. Average number of days/30 DCGM was worn was 29.3. Of the 26 patients, A1c data was avail- able in 25, and 22 had a baseline A1c of 7 or higher. The table shows results of selected outcomes. Total daily insulin dose (TDD) from pump downloads was available in 18 patients. In these patients, there was a reduction in TDD from 58.3 to 51.3 units (p=0.00012). There was no signifi cant change in serum creatinine or eGFR. Three females developed genital mycotic infections but continued therapy. Study concluded that the use of CANA in T1D resulted in signifi cant- ADA-Funded Research & Guided Audio Tour poster For author disclosure information, see page A810. A235 CLINICAL THERAPEUTICS/NEW TECHNOLOGY—GLUCOSECATEGORY MONITORING AND SENSING ly improved glycemic control with greater time in target, less hyperglycemia, due to chance, a large, pragmatic trial evaluating the effi cacy of intermittent and lower variability, with minimal increase in hypoglycemia, lower weight masked CGM in non-insulin treated patients with T2D is warranted. and SBP, and lower insulin use. Table. Table 1. Selected Outcomes of Baseline and Post CANA. CGM (N=17) SMBG (N=18) P-Value (Mean ± SD) Baseline Post p values Observed Mean (SD) CANA (paired t-tests) Baseline 7.7 (0.6) N=17 8.2 (0.5) N=18 DCGM mean glucose, mg/dL 169 ± 22 148 ± 16 <0.0001 Visit 5 Day 90 6.9 (0.6) N=14 7.2 (0.7) N=16 percent DCGM readings above 38 ± 12 25 ± 10 <0.0001 180 mg/dL Visit 10 Day 187 6.9 (0.7) N=15 7.5 (1.4) N=13 percent DCGM readings in target, 58 ± 12 69 ± 9 <0.0001 LOCF 6.9 (0.7) N=15 7.5 (1.3) N=16 70-180 mg/dL ANCOVA Least Squares percent DCGM below 70 mg/dL 4.1 ± 2.1 5.3 ± 3.7 0.0369 Mean (SE) Change from Baseline* DCGM standard deviation, mg/dL 67 ± 14 57 ± 11 <0.0001 Visit 5 Day 90 -1.03 (0.20) -0.73 (0.19) 0.271 Hemoglobin A1c,% 7.7 ± 0.9 7.2 ± 0.8 <0.0001 Visit 10 Day 187 -0.80 (0.33) -0.15 (0.39) 0.177 systolic blood pressure 122 ± 13/ 114 ± 15/ 0.0128/ LOCF -0.99 (0.31) -0.38 (0.31) 0.179 (mmHg)/weight (pounds) 206 ± 45 201 ± 46 0.0002 * Adjusting for baseline and site. Supported By: Medtronic, Inc. & 933-P Triple-Goal Achievement in Patients with Type 2 Diabetes Mellitus & 935-P (T2DM) Improves Clinical Outcomes The Performance of an Orthogonally Redundant Glucose Sensor QIAN SHI, LIZHENG SHI, VIVIAN FONSECA, New Orleans, LA Compared with a Simply Redundant Electrochemical Glucose Sen- The impact of achieving 3 ADA goals: HbA1c (<7%) and LDL-C (<100 mg/dl) sor in Adults with Type 1 Diabetes and BP < 130/85 mmHg, has not been adequately evaluated in clinical trials, SYBIL A. MCAULEY, TRI T. DANG, JODIE C. HORSBURGH, ANUBHUTI BANSAL, POSTERS GLENN M. WARD, ALICIA J. JENKINS, RICHARD J. MACISAAC, RAJIV V. SHAH, Therapeutics which usually examine only one or two. We therefore retrospectively exam- Clinical Diabetes/ ined the incremental reduction of complication events in patients with T2DM DAVID N. O’NEAL, Melbourne, Australia, Northridge, CA achieving all 3 goals, compared with those achieving <3 goals. We identifi ed Orthogonally redundant sensors (ORS) integrating two distinct glucose 68,083 T2DM patients from the Veterans Affairs VISN 16 data warehouse sensing technologies, electrochemical and fl uorescence-based optical, with (2004-2011). Long-term outcomes were compared triple-goal achievers with independent failure modes potentially improve continuous glucose monitor- dual-goal, single-goal, and no-goal achievers (Table).