Number Of Diabetes Medications Research Articles

The impact of grip strength, waist circumference, and body mass index on Hemoglobin A1c value: Cross-sectional study using outpatient clinical data in Japanese elderly patients with type 2 diabetes mellitus.

Grip strength (GS) as a surrogate for muscular strength, waist circumference (WC) as a surrogate marker of visceral fat, and body mass index (BMI) as a surrogate marker of obesity should also be considered markers for the management of risks associated with type 2 diabetes mellitus (T2DM). However, in terms of the management of T2DM in elderly patients, the accentuated heterogeneity of sarcopenic change might modify the associations between those factors and glycemic control. In this cross-sectional study, we aimed to clarify the impact of GS, WC, and BMI on hemoglobin A1c (HbA1c) in elderly Japanese patients with T2DM. GS, WC, and BMI were measured in 327 patients. Odds ratios (ORs) and 95% confidence intervals (CIs) for good glycemic control (HbA1c < 7.0%) were investigated to analyze the three variables as numerical values by dividing them into tertiles. All results were expressed after adjustment was made for the confounders of age, sex, and number of diabetes medications being used by the study participants. The ORs of GS, WC, and BMI for well-controlled HbA1c were 1.056 (95% CI, 1.016-1.098), 0.986 (95% CI, 0.960-1.013), and 1.032 (95% CI, 0.959-1.111), respectively. The OR of 3.726 (95% CI, 1.831-7.581) in the high tertile for GS was significantly higher than the OR in the low tertile, and no differences were observed among the tertiles for WC and BMI. Based on that result, GS was found to have more potential as an effective marker of glycemic control than WC or BMI among elderly Japanese patients with T2DM. Geriatr Gerontol Int 2024; 24: 410-414.

The Impact of Hypoglossal Nerve Stimulation on Secondary Health Outcomes.

Objectives: Obstructive sleep apnea (OSA) is a prevalent sleep disorder that can increase the risk of hypertension, diabetes, obesity, and cardiovascular diseases. Hypoglossal nerve stimulation (HGNS) is an alternative therapy for OSA in patients who cannot tolerate continuous positive airway pressure. Understanding the impact of HGNS on blood pressure, hemoglobin A1C (A1C), and body mass index (BMI) currently remains limited. Methods: A retrospective review study of HGNS outcomes at a single practice from January 2020 to November 2022 was conducted. Inclusion/exclusion criteria were based on HGNS eligibility and postoperative titration study. Statistical analysis and data management were performed using statistical software, R (v.4.2.1; R Core Team). Paired Student's T test, Fisher's exact test, and McNemar's exact test were utilized for statistical analysis. P values less than .05 were considered statistically significant. Results: Sixty-three patients were included in this study. A significant decrease in mean apnea-hypopnea index was noted following HGNS (mean change -28; P < .0001). Similar significant decreases were also seen in mean arterial pressures (mean change -8.4, P < .0001). There was a significant change in overall antihypertensive medication requirements and in requirements ≥3 medications (P < .0005, P = .03). There was a trend toward reduction in A1C; however, there was no change in BMI or number of diabetes medications taken. Conclusions: Our results reinforce previous findings that HGNS is an effective treatment option for carefully selected patients with OSA. In addition, our findings suggest that HGNS may improve patients' quality of life while minimizing OSA associated morbidity.

The association between microvascular and macrovascular diseases and diabetes remission after bariatric surgery.

Type-2 diabetes mellitus (T2DM) results in detrimental vascular complications including both microvascular and macrovascular diseases. Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective weight-loss therapies that enhance T2DM remission. However, limited data are present regarding the association between diabetes-associated diseases before RYGB and SG with T2DM remission. This is a retrospective cohort study in patients with T2DM who underwent RYGB or SG. We collected data on preoperative microvascular (i.e., retinopathy, nephropathy, and neuropathy) and macrovascular (coronary artery disease, cerebrovascular accidents, and peripheral artery disease) diabetes-associated diseases. Our end points included assessment of association and cumulative effect of diabetes-associated diseases and disease remission. We also performed a multivariate logistic regression to evaluate the parameters associated with T2DM remission. A total of 536 patients (67% female, 94% White) were included in this study. Patients without diabetes-associated diseases had an OR of 2.72 (95% CI 1.92 to 3.88) to achieve T2DM remission compared to patients with diabetes-associated diseases (27.9% vs 59.4%; p < 0.001). Importantly, there was an additive effect of the number of diabetes-associated diseases on the T2DM remission (p < 0.001). We demonstrate a significant association between HbA1c (p < 0.001), number of diabetes medications (p < 0.001), T2DM duration (p < 0.001), surgery type (p = 0.009), and insulin use (p = 0.04) with T2DM remission. Patients with presurgical diabetes-associated diseases had a lower remission rate after RYGB and SG. Not only do these complications represent a more practical and consistent variable to predict T2DM remission, but also help planning a multidisciplinary management of patients with more severe T2DM.

Association of Metformin, Dipeptidyl Dipeptidase-4 Inhibitors, and Insulin with Coronavirus Disease 2019–Related Hospital Outcomes in Patients with Type 2 Diabetes

ObjectiveThe effects of diabetes medications on COVID-19 hospitalization outcomes have not been consistent. We sought to determine the effect of metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), and insulin on admission to the intensive care unit (ICU), need for assisted ventilation, development of renal insufficiency, and mortality in patients admitted with COVID-19 infection after controlling for clinical variables and other relevant diabetes-related medications in patients with type 2 diabetes mellitus (DM). MethodsThis was a retrospective study of patients hospitalized with COVID-19 from a single hospital system. Univariate and multivariate analyses were performed that included demographic data, glycated hemoglobin, kidney function, smoking status, insurance, Charlson comorbidity index, number of diabetes medications, and use of angiotensin-converting enzyme inhibitors and statin prior to admission and glucocorticoids during admission. ResultsA total of 529 patients with type 2 DM were included in our final analysis. Neither metformin nor DPP4i prescription was associated with ICU admission, need for assisted ventilation, or mortality. Insulin prescription was associated with increased ICU admission but not with need for assisted ventilation or mortality. There was no association of any of these medications with development of renal insufficiency. ConclusionsIn this population, limited to type 2 DM and controlled for multiple variables that have not been consistently studied (such as a measure of general health, glycated hemoglobin, and insurance status), insulin prescription was associated with increased ICU admission. Metformin and DPP4i prescriptions did not have an association with the outcomes.

Validation of the individualized metabolic surgery score for bariatric procedure selection in the merged data of two randomized clinical trials (SLEEVEPASS and SM-BOSS).

LSG and LRYGB are globally the most common bariatric procedures. IMS score categorizes T2D severity (mild, moderate, and severe) based on 4 independent preoperative predictors of long-term remission as follows: T2D duration, number of diabetes medications, insulin use, and glycemic control. IMS score has not been validated in a randomized patient cohort. To assess the feasibility of individualized metabolic surgery (IMS) score in facilitating procedure selection between laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) for patients with severe obesity and type 2 diabetes (T2D). Merged individual patient-level 5-year data of 2 large randomized clinical trials (SLEEVEPASS and SM-BOSS [Swiss Multicenter Bypass or Sleeve Study]). IMS score was calculated for study patients and its performance was analyzed. One hundred thirty-nine out of 155 patients with T2D had available preoperative data to calculate IMS score as follows: mild stage (n = 41/139), moderate stage (n = 77/139), severe stage (n = 21/139). At 5 years, 135 (87.1%, 67 LSG/68 LRYGB) were available for follow-up and 121 patients had both pre- and postoperative data. Diabetes remission rates according to preoperative IMS score were as follows: mild stage 87.5% (n = 14/16) after LSG and 85.7% (n = 18/21) after LRYGB (P = .999), moderate stage 42.9% (n = 15/35) and 45.2% (n = 14/31) (P = .999), and severe stage 18.2% (n = 2/11) and 0% (n = 0/7) (P = .497), respectively. The T2D remission rate varied significantly between the stages as follows: mild versus moderate odds ratio (OR) 8.3 (95% CI, 2.8-24.0; P < .001), mild versus severe OR 52.2 (95% CI 9.0-302.3; P < .001), and moderate versus severe OR 6.3 (95% CI, 1.3-29.8; P = .020). In our study, remission rates of T2D were not statistically different after LSG and LRYGB among all patients and among patients with mild, moderate, and severe diabetes stratified by the IMS score. However, the study may be underpowered to detect differences due to small number of patients in each subgroup. IMS score seemed to be useful in predicting long-term T2D remission after bariatric surgery.

Late Diabetes Relapse After Sleeve Gastrectomy Compared with Long-Term Remission: Characteristics and Cardiometabolic Outcomes.

Background: Studies of the relapse of type 2 diabetes mellitus (T2D) after laparoscopic sleeve gastrectomy (LSG) are scarce. We assessed the rate of relapse 5 years after LSG, compared relapsed patients to their baseline and to those with remission, and explored the independent predictors of relapse. Methods: Retrospective analysis of 103 adults who underwent primary LSG at our institution between 2011 and 2015. Data retrieved comprised 23 pre-/postoperative demographic, anthropometric, biochemical, and clinical characteristics. Univariate and multivariate analyses assessed the predictors of relapse. Results: In total, 54% of our patients experienced relapse. Nevertheless, their anthropometric and metabolic profiles significantly improved compared to the values before surgery, reflecting better weight, glycemic, clinical, and biochemical control (P values ranged from 0.012 to <0.0001). These improvements were mirrored by significant increase in the proportion of relapsed patients meeting the American Diabetes Association treatment goals of hemoglobin A1c (HbA1c), blood pressure, high-density lipoprotein, and triglyceride at 5 years compared with the proportion before surgery (P = 0.027-0.008). In addition, the anthropometric and metabolic profiles of relapsed patients were not different compared to those of patients with long-term remission (P = 0.075-0.686), except for a significantly higher prevalence of dyslipidemia and number of diabetes medications among the relapsed group (P = 0.008 and <0.0001, respectively). Multivariate analysis showed that most of the predictors tested operated in the appropriate direction but fell short of statistical significance. Weight regain at 3 years did not predict relapse at 5 years. Conclusions: Relapse of T2D per se should not undervalue the overall long-term health benefits of LSG. Long-term monitoring of glycemic status after LSG is recommended.

Evaluation of Diabetes Mellitus Type 2 Control in Home-Based Primary Care Patients Managed by Clinical Pharmacy Specialists.

Purpose To evaluate the impact of pharmacist-led diabetes care in a Home-Based Primary Care (HBPC) setting. Methods This was a single-center, retrospective, cohort chart review in HBPC veterans with diabetes mellitus type 2 (DMII) at Columbia VA Health Care System. A sample size of 80 patients was calculated to meet power of 80% and a P-value of less than 0.05 was used to determine clinical significance. The primary outcome was mean hemoglobin A1C (HgbA1C) change after up to 18 months of Clinical Pharmacy Specialist (CPS) diabetes-led care stratified by baseline HgbA1C. Secondary outcomes included change in the number of diabetes medications and doses per day stratified by baseline HgbA1C. Results One hundred twelve patients were included in the final analysis based on inclusion and exclusion criteria. The mean absolute HgbA1C reduction was 0.51%, 95% CI -0.20 to -0.82 from 8.1% at baseline. For the subgroup analyses, patients with baseline HgbA1C less than 8.5%, had a nonsignificant increase in their HgbA1C, while patients with HgbA1C 8.5% or more showed significant reductions in HgbA1C (P < 0.05). Patients with baseline HgbA1C less than 6.5% had a significant decrease of 0.52, 95% CI -0.18 to -0.87 and patients with baseline HgbA1C 6.5% or more had a nonsignificant increase in the number of diabetes medications (P > 0.05). Patients with baseline HgbA1C of less than 7.5% and 9.5% or more had a decrease in the number of diabetes medication doses with results being significant for patients with HgbA1C less than 6.5%, 95% CI -0.58 to -1.89. Conclusion The results of this study suggest that HBPC CPSs are improving glycemic control in HBPC veterans while simplifying diabetic regimens with attention to hypoglycemic risk reduction.

Nasal and Parotid Blood Pool Activity Is Significantly Correlated with Metabolic Syndrome Components and Sleep Apnea.

Background: Patients with metabolic syndrome components were frequently noted to have increased nasal and parotid activity on clinically referred scintigraphic whole-body blood pool scans. This increase in activity was not observed in patients without metabolic syndrome. Increased nasal blood pool activity in patients with elevated body mass indices (BMIs) has implications for (1) sleep apnea, (2) risk of nasal infection, and (3) possible impaired nasal lymphatic drainage of brain waste proteins. Methods: To follow-up this clinical observation, a retrospective study was performed on 200 patients having whole-body blood pool scans referred over a 3-year period. The whole-body blood pool scans were evaluated for an association between nose and parotid region of interest (ROI) to heart ROI maximum (max) pixel ratios as correlated with clinical conditions, including obesity, diabetes, hypertension, and sleep apnea. Continuous variables of BMI, hemoglobin A1c (HbA1c), blood glucose, and blood lipids were also correlated with these ratios. Results: A direct association of nose to heart max ratio (NHMR) with diabetes, sleep apnea, and hypertension was found with an increase in the ratio of +0.10 (P = 0.002), +0.13 (P = 0.0002), +0.08 (P = 0.0123), respectively. Correlation of NHMR with continuous variables had moderate correlation with BMI (r = 0.36, P < 0.0001), glucose (r = 0.27, P = 0.0001), HbA1c (r = 0.25, P = 0.0008) and less association with the number of diabetes medications (r = 0.22, P = 0.0021). Similar associations were found for parotid to heart max ratios but were weaker than the NHMR. Conclusions: Patients with metabolic syndrome components have significantly increased nasal and parotid activity on blood pool scans. These associations have implications for the treatment of sleep apnea, for nasal infections involving such agents as Covid-19, and for the risk of dementias related to decreased clearance of brain waste proteins through nasal turbinate lymphatics in patients with metabolic syndrome. If further studies support these findings, the nasal turbinates and the increased parasympathetic activity controlling their dilation could become a new therapeutic target.

866-P: Efficacy of Dapagliflozin by Baseline Diabetes Medications: A Prespecified Analysis from the DAPA-CKD Study

Background: The sodium-glucose cotransporter 2 inhibitor dapagliflozin improved kidney and cardiovascular (CV) outcomes in persons with chronic kidney disease (CKD) with and without type 2 diabetes (T2D) in the DAPA-CKD study. In this prespecified analysis we investigate the effects of dapagliflozin on kidney, CV, and mortality outcomes according to baseline diabetes drug class or number of diabetes drugs. Methods: We enrolled participants with CKD with eGFR 25-75 ml/min/1.73m2 and UACR 200-5000 mg/g, and included those with T2D at baseline in this analysis. The primary endpoint was a composite of sustained decline in eGFR of ≥50%, end-stage kidney disease, or death from kidney or CV causes. Secondary outcomes included a kidney-specific composite (the same as the primary without CV death) , composite of hospitalizations for heart failure and CV mortality, and all-cause mortality. We determined the effect of dapagliflozin, compared with placebo, in subgroups by use or not of diabetes drug classes at baseline: metformin, sulfonylureas, DPP4 inhibitors, GLP-1 receptor agonists and insulin, and by the number of diabetes medications at baseline. Results: Of 43participants enrolled 29 (68%) had T2D, of which 1598 (55%) were on insulin, 1244 (43%) on metformin, 774 (27%) on sulfonylureas, 742 (26%) on DPP4 inhibitors, and 122 (4%) on GLP-1 receptor agonists. At baseline 327 (11%) were without diabetes treatment, 1442 (50%) were treated with one diabetes drug, 943 (32%) with two drugs and 194 (7%) with three or more. The effect of dapagliflozin on the primary composite outcome was consistent across comparisons of baseline drug class (all pint&amp;gt;0.19) , and according to number of drugs (pint=0.08) . Similarly, we found consistent benefit of dapagliflozin compared to placebo on the secondary endpoints regardless of background drug class or number of drugs. Conclusion: Dapagliflozin reduced kidney and CV events in T2D with CKD independent of baseline diabetes drug class or number. Disclosure F.Persson: Advisory Panel; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Research Support; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. R.D.Toto: Advisory Panel; Bayer AG, Boehringer Ingelheim International GmbH, Chinook Therapeutics Inc., Lilly, Consultant; Amgen Inc., AstraZeneca, Medscape, Vifor Pharma Management Ltd., Other Relationship; Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc., Reata Pharmaceuticals, Inc. A.Langkilde: Employee; AstraZeneca, Stock/Shareholder; AstraZeneca. D.C.Wheeler: Advisory Panel; Bayer AG, Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., GlaxoSmithKline plc., Janssen Global Services, LLC, Merck Sharp &amp; Dohme Corp., Mundipharma, Tricida, Inc., Vifor Pharma Management Ltd., Consultant; AstraZeneca, Speaker's Bureau; Amgen Inc., Astellas Pharma Inc. H.L.Heerspink: Consultant; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Chinook Therapeutics Inc., CSL Behring, Gilead Sciences, Inc., Goldfinch Bio, Inc., Janssen Research &amp; Development, LLC, Mitsubishi Tanabe Pharma Corporation, Mundipharma, Traveere Pharmaceuticals, Research Support; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. Dapa-ckd trial committees and investigators: n/a. P.Rossing: Consultant; Astellas Pharma Inc., AstraZeneca, Bayer AG, Gilead Sciences, Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi, Speaker's Bureau; Eli Lilly and Company. N.Jongs: None. G.M.Chertow: Other Relationship; AstraZeneca. F.Hou: Other Relationship; AstraZeneca. P.Vart: None. J.J.Mcmurray: Other Relationship; Abbott, Alkem Metabolics, Alnylam Pharmaceuticals, Inc., Amgen Inc., AstraZeneca, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Cardurion, Cytokinetics Inc., DalCor Pharmaceuticals, Eris Lifesciences Ltd., GlaxoSmithKline plc., Ionis Pharmaceuticals, KBP Bioscience, Lupin Pharmaceuticals, Inc., Medscape, Novartis AG, ProAdWise Communications, Radcliffe Group, Servier Laboratories, Sun Pharmaceutical Industries Ltd., The Corpus, Theracos, Inc. R.Correa-rotter: Advisory Panel; Boehringer Ingelheim International GmbH, Consultant; Bayer AG, Other Relationship; AstraZeneca, GlaxoSmithKline plc., Novo Nordisk, Speaker's Bureau; AbbVie Inc., Amgen Inc., Janssen Pharmaceuticals, Inc., Sanofi. B.Stefansson: Employee; AstraZeneca. Funding AstraZeneca

834-P: Two-Year Effects of Carbohydrate-Restricted Nutrition Therapy Delivered via Continuous Remote Care among Veterans with Type 2 Diabetes: A Nationwide, Real-World Study

Type 2 diabetes (T2D) affects about one in four Veterans, a rate nearly three times the general population, and diabetes medications and supplies constitute about one quarter of these Veterans’ pharmacy spend. The Veterans Health Administration partnered with Virta Health to provide carbohydrate restricted nutrition therapy via a continuous remote care model to Veterans in a pilot program. Five-month outcomes demonstrated significant reductions in HbA1c, BMI, diabetes medications and cost, and outpatient visits, but long term sustainability in this population is unknown. This retrospective, real-world, longitudinal analysis assessed the 1- and 2-year effects of the treatment on glycemia, diabetes medications, and body weight using medical record data. Veterans retained at least two years at time of analysis were included (n=254, 58.5% of 434 eligible enrolled, 60±8 years, 12% female) . With initiation of nutritional intervention, glycemia fell necessitating medication titration and elimination to prevent hypoglycemia. The number of diabetes medications prescribed to each person significantly decreased from 2.4±0.9 to 1.3±0.9 and 1.6±0.8 at one and two years, respectively (ps&amp;lt;0.0001) . Despite this significant reduction in pharmacologic therapy, HbA1c was significantly reduced at one year (-0.7±1.6%, p&amp;lt;0.0001) and two years (-0.6±1.7%, p&amp;lt;0.0001) compared to enrollment (8.1±1.5%) . Body weight also declined from 241.1±50.1 lb to 223.2±44.4 lb at one year and 222.1±46.8 lb at two years (ps&amp;lt;0.0001) , reflecting 6.8±7.6% and 7.0±9.4% weight loss per person at one and two years, respectively. These findings demonstrate that sustained improvement in glycemia concurrent with medication deprescription and clinically significant weight loss are achievable in the real world among Veterans who choose this therapy. Disclosure A.L.Mckenzie: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. M.Vantieghem: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. B.Fell: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. R.E.Ratner: Employee; Virta Health Corp.

102-LB: GP-OSMOTIC: An RCT to Determine the Effect of 3-Monthly Retrospective Continuous Glucose Monitoring (rCGM) on 12-Month HbA1c in Adults with Type 2 Diabetes (T2D) in Primary Care

Introduction: Reviewing rCGM patterns may prompt lifestyle or therapeutic changes to achieve glycaemic targets but evidence for rCGM use in primary care management of T2D is limited. Methods: Two-arm RCT. Participants: Adults with T2D, HbA1c ≥0.5% above target, prescribed ≥2 non-insulin glycemia medications or insulin. Intervention: 1-hour diabetes education and (at 0/3/6/9/12 months): HbA1c assessment + wearing FreeStyle Libre Pro (Abbott) for up to 14 days prior to being discussed at a clinic visit. Physicians were trained in interpreting ambulatory glucose profiles. Control: 3-monthly ‘usual care’ clinic visits + r-CGM device worn (blinded, research data) at 0 and 12 months. Primary outcome: difference in mean HbA1c at 12 months. Secondary outcomes: mean differences in time in range (TIR: 4-10 mmol/L) and diabetes-specific distress (PAID) at 12 months, and HbA1c at 6 months. ITT analysis. Results: In 25 primary care practices, participants were: 299 adults with T2D, aged (mean(SD)) 60(10) years, HbA1c: 8.9(1.2)%, diabetes duration (median(IQR)) of 12(8,20) years. At 12 months, the between-group difference in mean HbA1c was 0.2% (p=0.112). The estimated mean percentage TIR was 8.4% higher in the intervention than the control arm (p=0.004). Diabetes-specific distress did not differ between arms (0.5; p=0.71). At 6 months, HbA1c was significantly lower in the intervention arm (0.5%; p&amp;lt;0.001). We found little evidence of changes in the number of glycemic medications in either arm. Discussion: Use of 3-monthly rCGM in adults with T2D in primary care does not improve HbA1c at 12 months. We showed a statistically and clinically significant reduction in HbA1c at 6 months in the intervention group, as well as significant improvements in TIR at 12 months, with no change in diabetes distress. Our findings suggest the primary impact of r-CGM use on HbA1c in this setting is short term, and not associated with increase in the number of diabetes medications. Disclosure J. Furler: Research Support; Self; Abbott, Sanofi. D.N. O’Neal: None. J. Speight: Research Support; Self; AstraZeneca, Medtronic, Sanofi. Speaker’s Bureau; Self; Novo Nordisk A/S, Roche Diabetes Care. J.E. Manski-Nankervis: Research Support; Self; Australian National Health and Medical Research Council, Boehringer Ingelheim International GmbH, Diabetes Australia, Eli Lilly and Company. Speaker’s Bureau; Self; RACGP. S. Thuraisingam: None. E. Holmes-Truscott: Research Support; Self; Sanofi. Speaker’s Bureau; Self; Novo Nordisk Inc. K.R. De La Rue: None. L.E. Ginnivan: None. R.C. Doyle: None. K. Khunti: Advisory Panel; Self; Amgen Inc., AstraZeneca, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi. Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Servier, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis. Speaker’s Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Menarini Group, Merck Sharp &amp; Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Servier, Takeda Pharmaceutical Company Limited. M. Catchpool: None. K. Dalziel: None. J.I. Chiang: None. I. Blackberry: None. R. Audehm: Advisory Panel; Self; AstraZeneca, Novartis Pharmaceuticals Corporation. M. Kennedy: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc., Sanofi. M.J. Clark: None. A.J. Jenkins: Advisory Panel; Self; Abbott, Australian Diabetes Society, Medtronic. Research Support; Self; Abbott, GlySens Incorporated, Medtronic, Mylan. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk Inc. A.S. Januszewski: None. D. Liew: Advisory Panel; Self; AstraZeneca, Bayer AG. Research Support; Self; AbbVie Inc., AstraZeneca, Bristol-Myers Squibb Company, CSL Behring, Pfizer Inc. P.M. Clarke: None. J.D. Best: Consultant; Self; Abbott. Funding National Health and Medical Research Council of Australia (APP1104241); Sanofi Australia; Abbott Diabetes Care

Improving Sleep by Trazodone Improves Glucose Control

Background: 77% of people with diabetes have some form of insomnia. Sleep disturbance results in impaired glucose control in healthy individuals or worsens glucose control in people with diabetes. Short-term sleep studies (1-6 weeks) improved glucose control and insulin resistance in obese “healthy” individuals. We have shown before the superior benefit Trazodone has in treating neuropathy over gabapentin. We show, in this abstract, the impact of improving sleep may have on glucose control. Methods: we treated 200 type 2 patients with diabetic neuropathy with either trazodone (100), or Gabapentin(100), compared the change in neuropathy, sleep and glucose control. We quantified their neuropathy with our previously published neuropathy grading system (Sakkal’s Scale: level of vibration sensory loss by the 128 tuning fork) we quantified their sleep with shortening latency of sleep onset, and sleep duration extension. We measured their glucose control with AM insulin-to-glucose ratio, HgA1c, and in-target glucose when CGMS was available (20 patients). We excluded patients with OSA. All patients followed our standard diabetes treatment protocol for type 2. Results: At 12 months, Trazodone improved the scale of diabetic neuropathy in 80% of patients, sleep hygiene in 70%; Sleep increased by 40 minutes, and sleep onset latency decreased by 10 minutes. Insulin/glucose ratio was 21/142=0.147, HgA1c 7.2%, HgA1c&amp;lt;7 in 68%, and in-target glucose in 72% on CGMS(12 patients). Gabapentin improved the scale of diabetic neuropathy in 66%, sleep hygiene in 44%; with sleep increasing by 14 minutes, and sleep onset latency decreased by 4 minutes. Insulin -to-Glucose ratio was 33/166=0.19, HgA1c 7.8%,HgA1c,7 in 56%, and in-target-glucose in 58% on CGMS (8 patients.) analysis. A maximum number of diabetes medications used were 3 in both groups. Percentage needing basal insulin at the end was 12% in the Trazodone group, 21% in the Gabapentin group. Conclusion: Improved sleep and neuropathy with Trazodone improved glucose control. Disclosure S. Sakkal: None.

USE OF MEDICATIONS FOR TYPE 2 DIABETES MELLITUS IN THE BRAZIL S FAMILY HEALTH STRATEGY: GENDER DIFFERENCES

Introduction: The medications are the main therapeutic inputs in the treatment of type 2 diabetes mellitus. When properly used, they allow disease control and reduction of morbidity and mortality, resulting in improvements in quality of life. Thus, the purpose of this article is to characterize the use of medications for type 2 diabetes mellitus with emphasis on gender differences. Methods: A cross-sectional study performed in Family Health Units in Ribeirao Preto, Sao Paulo, Brazil, with 100 men and 100 women. Sociodemographic characteristics, clinical data, lifestyle and use of medications were the variables of interest. Results: Mean number of diabetes medications referred by study participants was 1.6 (SD = 0.7) for women and 1.5 (SD = 0.6) for men (p = 0.40). The use of metformin was mentioned by 70% of women and 65% of men, and adverse reactions were reported by 15% of women and 2% of men (p < 0.01). Medications were obtained mainly from public health system pharmacies in both genders. Conclusions: Gender differences in the use of diabetes medications were found in reported adverse reactions, with more cases among women. Keywords: Drug therapy; pharmacoepidemiology; pharmaceutical care; chronic disease; diabetes mellitus; family health strategy.

Effect of Gastrogastric Fistula Closure in Type 2 Diabetes.

Roux-en-Y gastric bypass (RYGB) has been shown to significantly improve glucose control in patients with type 2 diabetes (T2DM). The formation of a gastrogastric fistula (GGF) allows nutrients to pass through the native route, rather than bypassing the duodenum in typical RYGB configuration. We sought to evaluate the effect of revisional bariatric surgery for known GGF on control of diabetes. A retrospective chart review of a single academic institution was performed to identify patients who had T2DM at the time of corrective surgery for a GGF. Baseline characteristics, and postoperative outcomes including changes in body mass index (BMI), glycated hemoglobin, fasting blood glucose (FBG), and diabetes medications were assessed. Ten patients were identified with GGF who had T2DM at the time of corrective surgery. Patients had a male-to-female ratio of 2:3, a mean age of 59.2±10years, a mean baseline BMI of 38.1±17.6kg/m2, and a median duration of 9years (interquartile range 6-14) from initial RYGB to revision. At a mean follow-up of 14.9±8.5months, a mean reduction in BMI of 4.9±6kg/m2 was associated with a significant mean reduction in FBG (167.1±88.2 vs. 106.1±20.4mg/dL, p=0.04) and number of diabetes medications (1.4±0.8 vs. 0.7±0.7, p=0.04). In patients with diabetes and GGF, a corrective surgery for closure of fistula and restoration of bypass anatomy results in improvement of glucose control and status of diabetes medications. This finding can highlight the potential metabolic significance of duodenal exclusion.

Real world clinical outcomes and patient characteristics for canagliflozin treated patients in a specialty diabetes clinic

Objective: To examine characteristics and outcomes of type 2 diabetes (T2DM) patients prescribed canagliflozin (CANA) and managed in the real-world setting of a diabetes clinic. Primary outcome was change in A1c, and secondary outcomes were change in weight and blood pressure.Methods: Study was an electronic health record (EHR) review of CANA prescribed at the diabetes clinic from June 2013 to June 2015. Patients were included in the study if they were adults with T2DM, received routine follow-up diabetes care at the diabetes clinic, received an initial prescription for CANA from a diabetes clinic prescriber, and returned for at least one follow-up office visit (OV) after initial CANA prescribing. Paired t-tests were performed on the primary and secondary outcomes, and p < .05 was considered statistically significant. Descriptive statistics were used to characterize the population and other outcomes.Results: A total of 462 patients met study inclusion criteria. Mean baseline values were: age 55.32 years, BMI 38.23 kg/m2, A1c 8.84%, mean number of diabetes medications (including CANA) 3.58. Men comprised 60% of patients. At baseline, 54% of patients were prescribed insulin. A1c decreased by 1.06% and 1.09% (p < .0001), weight decreased by 2.01% and 1.83% (p < .001), systolic blood pressure (SBP) decreased by 3.2% and 2.4% (p < .0001), and diastolic blood pressure (DBP) decreased by 2.59% and 2.16% (p = .0002) from baseline to first and second follow-up OV, respectively. Study limitations included retrospective design, inability to control for confounding factors (e.g. changes in nutrition, exercise, medical care plan, medications), missing information in the EHR, potential lack of generalizability of results to those in a non-specialty diabetes clinic, inability to assess adherence, and inability to assess reliable adverse event data.Conclusions: ANA was associated with a statistically and clinically significant reduction in A1c, weight, and blood pressure when added to multiple diabetes medication regimens by prescribers in a diabetes clinic.

FGF 19 and Bile Acids Increase Following Roux-en-Y Gastric Bypass but Not After Medical Management in Patients with Type 2 Diabetes

This study aims to quantify changes in fibroblast growth factor 19 (FGF19) and bile acids (BAs) in patients with uncontrolled type 2 diabetes randomized to Roux-en-Y gastric bypass (RYGB) vs intensive medical management (IMM) and matched for similar reduction in HbA1c after 1 year of treatment. Blood samples were drawn from patients who underwent a test meal challenge before and 1 year after IMM (n = 15) or RYGB (n = 15). Mean HbA1c decreased from 9.7 to 6.4% after RYGB and from 9.1 to 6.1% in the IMM group. At 12 months, the number of diabetes medications used per subject in the RYGB group (2.5 ± 0.5) was less than in the IMM group (4.6 ± 0.3). After RYGB, FGF19 increased in the fasted (93 ± 15 to 152 ± 19 pg/ml; P = 0.008) and postprandial states (area under the curve (AUC), 10.8 ± 1.9 to 23.4 ± 4.1 pg × h/ml × 10(3); P = 0.006) but remained unchanged following IMM. BAs increased after RYGB (AUC ×10(3), 6.63 ± 1.3 to 15.16 ± 2.56 μM × h; P = 0.003) and decreased after IMM (AUC ×10(3), 8.22 ± 1.24 to 5.70 ± 0.70; P = 0.01). No changes were observed in the ratio of 12α-hydroxylated/non-12α-hyroxylated BAs. Following RYGB, FGF19 AUC correlated with BAs (r = 0.54, P = 0.04) and trended negatively with HbA1c (r = -0.44; P = 0.09); these associations were not observed after IMM. BA and FGF19 levels increased after RYGB but not after IMM in subjects who achieved similar improvement in glycemic control. Further studies are necessary to determine whether these hormonal changes facilitate improved glucose homeostasis.

Short-Term Changes after a Weight Reduction Intervention in Advanced Diabetic Nephropathy

Obesity precedes and is strongly linked to the development of type 2 diabetic nephropathy in most patients, yet little is known about the effects of weight reduction on this disease. This study aimed to establish proof of concept for the hypothesis that weight reduction ameliorates diabetic nephropathy. Six obese individuals with advanced diabetic nephropathy (estimated GFR <40 ml/min per 1.73 m(2), urine albumin excretion >30 mg/d) currently taking a renin-aldosterone axis inhibitor underwent a 12-week very low calorie ketogenic weight reduction diet with encouragement of exercise between March and September 2012. Albuminuria and other parameters of kidney health were the main outcome measures. There was a 12% reduction in weight (median 118.5 versus 104.3 kg, P=0.03). The intervention was associated with a 36% reduction in albuminuria that did not reach statistical significance (2124 versus 1366 mg/24 h, P=0.08) and significant reductions in the filtration markers serum creatinine (3.54 versus 3.13 mg/dl, P<0.05) and cystatin C (2.79 versus 2.46 mg/l, P<0.05). Improvements were also noted for the diabetes markers fasting glucose (166 versus 131 mg/dl, P<0.05), fasting insulin (26.9 versus 10.4 μU/ml, P<0.05), and insulin resistance (9.6 versus 4.2, P=0.03). Physical function, general health, and the number of diabetes medications also showed statistically significant signs of improvement. After a short-term intensive weight reduction intervention in patients with advanced diabetic nephropathy, improvements were observed in markers of glomerular filtration, diabetes status, and risk factors for kidney disease progression, as well as other general indicators of health and well-being.

Factors affecting self-care activities, postprandial plasma glucose and HbA1c in patients with type 2 diabetes

Abstract Focal points

Impact of untreated obstructive sleep apnea on glucose control in type 2 diabetes.

Obstructive sleep apnea (OSA), a treatable sleep disorder that is associated with alterations in glucose metabolism in individuals without diabetes, is a highly prevalent comorbidity of type 2 diabetes. However, it is not known whether the severity of OSA is a predictor of glycemic control in patients with diabetes. To determine the impact of OSA on hemoglobin A1c (HbA1c), the major clinical indicator of glycemic control, in patients with type 2 diabetes. We performed polysomnography studies and measured HbA1c in 60 consecutive patients with diabetes recruited from outpatient clinics between February 2007 and August 2009. A total of 77% of patients with diabetes had OSA (apnea-hypopnea index [AHI] > or =5). Increasing OSA severity was associated with poorer glucose control, after controlling for age, sex, race, body mass index, number of diabetes medications, level of exercise, years of diabetes and total sleep time. Compared with patients without OSA, the adjusted mean HbA1c was increased by 1.49% (P = 0.0028) in patients with mild OSA, 1.93% (P = 0.0033) in patients with moderate OSA, and 3.69% (P < 0.0001) in patients with severe OSA (P < 0.0001 for linear trend). Measures of OSA severity, including total AHI (P = 0.004), rapid eye movement AHI (P = 0.005), and the oxygen desaturation index during total and rapid eye movement sleep (P = 0.005 and P = 0.008, respectively) were positively correlated with increasing HbA1c levels. In patients with type 2 diabetes, increasing severity of OSA is associated with poorer glucose control, independent of adiposity and other confounders, with effect sizes comparable to those of widely used hypoglycemic drugs.

Association between diabetes patients' knowledge about medications and their blood glucose control

Background Diabetes mellitus is a common chronic disorder frequently resulting in hyperglycemia and numerous long-term complications. Research has shown that improved glycemic control reduces the rate and number of diabetes-related complications. Evidence suggests that patients who are more knowledgeable about diabetes self-care may be more likely to achieve better glycemic control. Objective The purpose of this study is to determine the relationship between patients' knowledge about their diabetes medications and their blood glucose control. Methods Patients receiving oral pharmacologic treatment for type 2 diabetes mellitus were asked to answer a short questionnaire assessing their knowledge about their medications. Patients were part of an ambulatory care practice in Baltimore, Maryland, that provides primary care medical services to an inner-city, predominantly African American population. A medication knowledge score (number of correct responses to 8 components) was tabulated and correlated to the most recent glycosylated hemoglobin (A1c) (drawn within the previous 90 days). Multivariate models were constructed, with A1c as the outcome and patients' medication knowledge as the independent variable. Potential confounders included in the models were age, sex, education level, number of diabetes medications, and insurance status. Results Fifty patients were screened for the study; 44 agreed to participate and met inclusion criteria. Patients' diabetes medication knowledge scores ranged between 1 and 7, with a median score of 5. Older patients (65 years and older) and male patients scored lower than their counterparts. There was a strong inverse association between knowledge score and A1c ( r = −0.61; P < .001). Glycosylated hemoglobin was one-half unit lower with each one-unit increase in knowledge score among men; among women A1c was 1.6 units lower for each one-unit increase in knowledge score. Conclusion Patients with greater understanding and knowledge of their diabetes medications demonstrated better glycemic control. This cross-sectional association of medication knowledge and A1c was more pronounced in women than in men.