Hba1C Control And Cost-Effectiveness in Patients With Type 2 Diabetes Mellitus Initiated On Canagliflozin or A Glucagon-Like Peptide 1 Receptor Agonist in A Real-World Setting

Objective: To compare glycated hemoglobin (HbA1c) control and medication costs between patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin 300 mg (CANA) or a glucagon-like peptide 1 receptor agonist (GLP-1 RA) in a real-world setting.Methods: Adults with T2DM newly initiated on CANA or a GLP-1 RA (index date) were identified from IQVIA™ Real-World Data Electronic Medical Records U.S. database (March 29, 2012–April 30, 2016). Inverse probability of treatment weighting accounted for differences in baseline characteristics. HbA1c levels at 3-month intervals were compared using generalized estimating equations. Medication costs used wholesale acquisition costs.Results: For both cohorts (CANA: n = 11,435; GLP-1 RA: n = 11,582), HbA1c levels decreased at 3 months postindex and remained lower through 30 months. Absolute changes in mean HbA1c from index to 3 months postindex for CANA and GLP-1 RA were -1.16% and -1.21% (patients with baseline HbA1c ≥7% [53 mmol/mol]); -1.54% and -1.51% (patients with baseline HbA1c ≥8% [64 mmol/mol]); and -2.13% and -1.99% (patients with baseline HbA1c ≥9% [75 mmol/mol]), respectively. Postindex, CANA patients with baseline HbA1c ≥7% had similar HbA1c levels at each interval versus GLP-1 RA patients, except 9 months (mean HbA1c, 7.75% [61 mmol/mol] vs. 7.86% [62 mmol/mol]; P = .0305). CANA patients with baseline HbA1c ≥8% and ≥9% had consistently lower HbA1c numerically versus GLP-1 RA patients and statistically lower HbA1c at 9 (baseline HbA1c ≥8% or ≥9%), 27, and 30 months (baseline HbA1c ≥9%). Continuous 12-month medication cost $3,326 less for CANA versus GLP-1 RA.Conclusion: This retrospective study demonstrated a similar evolution of HbA1c levels among CANA and GLP-1 RA patients in a real-world setting. Lower medication costs suggest CANA is economically dominant over GLP-1 RA (similar effectiveness, lower cost).Abbreviations:AHA = antihyperglycemic agentBMI = body mass indexCANA = canagliflozin 300 mgDCSI = diabetes complications severity indexeGFR = estimated glomerular filtration rateEMR = electronic medical recordGLP-1 RA = glucagon-like peptide 1 receptor agonistHbA1c = glycated hemoglobinICD-9-CM = International Classification of Diseases–Ninth Revision–Clinical ModificationICD-10-CM = International Classification of Diseases–Tenth Revision–Clinical ModificationIPTW = inverse probability of treatment weightingITT = intent-to-treatMPR = medication possession ratioPDC = proportion of days coveredPS = propensity scorePSM = propensity score matchingQuan-CCI = Quan-Charlson comorbidity indexSGLT2 = sodium-glucose cotransporter 2T2DM = type 2 diabetes mellitusWAC = wholesale acquisition cost     

SGLT-2 Inhibitor Therapy Added to GLP-1 Agonist Therapy in the Management of T2DM

Objective: To assess the real-world efficacy and safety of canagliflozin therapy added to type 2 diabetes mellitus (T2DM) patients who have received a minimum 1 year of glucagon-like peptide-1 (GLP-1) agonist therapy.Methods: This pre-post observational study assessed the efficacy and safety of canagliflozin in a group of T2DM patients from a community endocrinology practice who received GLP-1 agonist therapy for a minimum of 12 months. The primary study outcome was change in mean glycated hemoglobin (HbA1c) level from baseline. Secondary endpoints included changes in average weight, and comparison of the percentage of patients obtaining an HbA1c <7%.Results: A total of 75 patients met all the study criteria. Baseline patient characteristics were as follows: average age, 58 ± 9 years; mean duration of T2DM, 14 ± 6 years; 56% male; 92% Caucasian; baseline body mass index (BMI), 39.4 ± 9.4 kg/m²; and mean baseline HbA1c, 7.94 ± 0.69%. HbA1c and weight were significantly reduced by 0.39% and 4.6 kg, respectively. Adverse effects were reported by 13 (17.3%) patients, including 4 (5.3%) who discontinued canagliflozin because of adverse reactions.Conclusion: Canagliflozin was generally well tolerated and significantly further reduced mean HbA1c levels and body weight in patients with T2DM when added to GLP-1 regimen.Abbreviations:BP = blood pressureBUN = blood urea nitrogenCANTATA = Canagliflozin Treatment and Trial AnalysisDBP = diastolic blood pressureDKA = diabetic ketoacidosisDPP-4 = dipeptidyl peptidase-4EMR = electronic medical recordFDA = Food and Drug AdministrationGFR = glomerular filtration rateGLP-1 = glucagon-like peptide-1HbA1c = glycated hemoglobinHDL-C = high-density lipoprotein cholesterolLDL-C = low-density lipoprotein cholesterolSCr = serum creatinineSGLT-2 = sodium glucose cotransporter 2T2DM = type 2 diabetes mellitusTZD = thiazolidinedioneUTI = urinary tract infection     

Treatment Intensification with Insulin Degludec/Insulin Aspart Twice Daily: Randomized Study to Compare Simple and Step-Wise Titration Algorithms

Objective: This 26-week, multicenter, randomized, open-label, parallel-group, treat-to-target trial in adults with type 2 diabetes compared the efficacy and safety of treatment intensification algorithms with twice-daily (BID) insulin degludec/insulin aspart (IDegAsp).Methods: Patients randomized 1:1 to IDegAsp BID used either a ‘Simple’ algorithm (twice-weekly dose adjustments based on a single prebreakfast and pre-evening meal self-monitored plasma glucose [SMPG] measurement; IDegAsp[BID_Simple], n = 136) or a ‘Stepwise’ algorithm (once-weekly dose adjustments based on the lowest of 3 pre-breakfast and 3 pre-evening meal SMPG values; IDegAsp[BID_Step-wise], n = 136).Results: After 26 weeks, mean change from baseline in glycated hemoglobin (HbA1c) with IDegAsp[BID_Simple] was noninferior to IDegAsp[BID_Step-wise] (-15 mmol/mol versus -14 mmol/mol; 95% confidence interval [CI] upper limit, <4 mmol/mol) (baseline HbA1c: 66.3 mmol/mol IDegAsp[BID_Simple] and 66.6 mmol/mol IDegAsp[BID_Step-wise]). The proportion of patients who achieved HbA1c <7.0% (<53 mmol/mol) at the end of the trial was 66.9% with IDegAsp[BID_Simple] and 62.5% with IDegAsp[BID_Step-wise]. Fasting plasma glucose levels were reduced with each titration algorithm (-1.51 mmol/L IDegAsp[BID_Simple] versus -1.95 mmol/L IDegAsp[BID_Step-wise]). Weight gain was 3.8 kg IDegAsp[BID_Simple] versus 2.6 kg IDegAsp[BID_Step-wise], and rates of overall confirmed hypoglycemia (5.16 episodes per patient-year of exposure [PYE] versus 8.93 PYE) and nocturnal confirmed hypoglycemia (0.78 PYE versus 1.33 PYE) were significantly lower with IDegAsp[BID_Step-wise] versus IDegAsp[BID_Simple]. There were no significant differences in insulin dose increments between groups.Conclusion: Treatment intensification with IDegAsp[BID_Simple] was noninferior to IDegAsp[BID_Step-wise]. Both titration algorithms were well tolerated; however, the more conservative step-wise algorithm led to less weight gain and fewer hypoglycemic episodes. Clinicaltrials.gov: NCT01680341Abbreviations:AEs = adverse eventsANOVA = analysis of varianceBID = twice-dailyBID_Simple = ‘Simple’ algorithm twice-weekly dose adjustments based on a single pre-breakfast and pre–evening meal self-monitored plasma glucose measurementBID_Step-wise = ‘Step-wise’ algorithm once-weekly dose adjustments based on the lowest of 3 prebreakfast and 3 pre–evening meal self-monitored plasma glucose valuesCI = confidence intervalETD = estimated mean treatment differenceFPG = fasting plasma glucoseHbA1c = glycated hemoglobinIAsp = insulin aspartIDeg = insulin degludecIDegAsp = insulin degludec/insulin aspartIGlar = insulin glargineOAD = oral antidiabetic drugPYE = patient-year of exposureSMPG = self-monitored plasma glucoseSU = sulfonylureaT2D = type 2 diabetes     

The Efficacy and Safety of Co-Administration of Sitagliptin With Metformin in Patients With Type 2 Diabetes at Hospital Discharge

Objective: Few randomized controlled trials have focused on the optimal management of patients with type 2 diabetes (T2D) during the transition from the inpatient to outpatient setting. This multicenter open-label study explored a discharge strategy based on admission hemoglobin A1c (HbA1c) to guide therapy in general medicine and surgery patients with T2D.Methods: Patients with HbA1c ≤7% (53 mmol/mol) were discharged on sitagliptin and metformin; patients with HbA1c between 7 and 9% (53–75 mmol/mol) and those >9% (75 mmol/mol) were discharged on sitagliptinmetformin with glargine U-100 at 50% or 80% of the hospital daily dose. The primary outcome was change in HbA1c at 3 and 6 months after discharge.Results: Mean HbA1c on admission for the entire cohort (N = 253) was 8.70 ± 2.3% and decreased to 7.30 ± 1.5% and 7.30 ± 1.7% at 3 and 6 months (P<.001). Patients with HbA1c <7% went from 6.3 ± 0.5% to 6.3 ± 0.80% and 6.2 ± 1.0% at 3 and 6 months. Patients with HbA1c between 7 and 9% had a reduction from 8.0 ± 0.6% to 7.3 ± 1.1% and 7.3 ± 1.3%, and those with HbA1c >9% from 11.3 ± 1.7% to 8.0 ± 1.8% and 8.0 ± 2.0% at 3 and 6 months after discharge (both P<.001). Clinically significant hypoglycemia (<54 mg/dL) was observed in 4%, 4%, and 7% among patients with a HbA1c <7%, 7 to 9%, and >9%, while a glucose <40 mg/dL was reported in <1% in all groups.Conclusion: The proposed HbA1c-based hospital discharge algorithm using a combination of sitagliptin-metformin was safe and significantly improved glycemic control after hospital discharge in general medicine and surgery patients with T2D.Abbreviations: BG = blood glucose; DPP-4 = dipeptidyl peptidase-4; eGFR = estimated glomerular filtration rate; HbA1c = hemoglobin A1c; T2D = type 2 diabetes     

Partial Hospitalization: An Intervention for Youth with Poorly Controlled Diabetes Mellitus

Objective: To examine the efficacy of an integrated medical/psychiatric partial hospitalization program (PHP) to improve glycemic control in youth with both diabetes mellitus and mental health disorders.Methods: This retrospective chart review is of patients admitted to a PHP between 2005–2015 with concerns about diabetes mellitus care. Clinical characteristics, laboratory data, diabetic ketoacidosis hospitalizations, and outpatient clinic visit frequency were collected from the year prior to the year after PHP admission.Results: A total of 43 individuals met inclusion criteria: 22 (51%) were female, 40 (93%) had type 1 diabetes, the mean age was 15.2 ± 2.3 years, and the mean diabetes mellitus duration was 4.6 ± 3.6 years. Of those individuals, 35 of these patients had hemoglobin A1c (HbA1c) data available at baseline, 6 months, and 1 year after PHP. The average HbA1c before PHP admission was 11.3 ± 2.3% (100.5 ± 25 mmol/mol), and decreased to 9.2 ± 1.3% (76.7 ± 14.8 mmol/mol) within 6 months of PHP admission (P<.001). The average HbA1c 1 year after PHP was 10.7 ± 1.7 % (93.3 ± 19.1 mmol/mol). Overall, 24 patients (68%) had lower HbA1c, and 75% of those with improvement maintained an HbA1c reduction of ≥1% (≥10 mmol/mol) at 1 year compared to before PHP.Conclusion: Most patients demonstrated improved glycemic control within 6 months of PHP admission, and many of those maintained a ≥1% (≥10 mmol/mol) reduction in HbA1c at 1 year following PHP admission. This program may represent a promising intervention that could serve as a model for intensive outpatient management of youth with poorly controlled diabetes mellitus.Abbreviations: ADA = American Diabetes Association; DKA = diabetic ketoacidosis; EMR = electronic medical record; HbA1c = hemoglobin A1c; ICD-9 = International Classification of Diseases, 9^th revision; PHP = partial hospitalization program     

The Impact of GLP-1 Receptor Agonists on Patients with Diabetes on Insulin Therapy

Objective: The clinical benefit of adding a glucagon-like peptide-1 receptor agonist (GLP-1RA) to basal-bolus or very high dose insulin regimens is unclear. This study investigated the impact of adding a GLP-1RA to a spectrum of insulin regimens (basal, basal-bolus, and U-500) to determine the impact on hemoglobin A1c (HbA1c), weight loss, and total daily insulin dose (TDD) over the course of 12 months.Methods: A retrospective chart review was conducted on 113 participants with type 2 diabetes mellitus using insulin therapy. Each participant's HbA1c, body weight, and TDD were recorded prior to initiation of GLP-1RA therapy and at the 3, 6, and 12-month time points while on combination therapy.Results: Across all participants, the HbA1c values decreased significantly from a baseline of 8.9 (74 mmol/mol) ± 0.14% to 8.2 (66 mmol/mol) ± 0.14% (P<.01) in the first 3 months, 8.0 (64 mmol/mol) ± 0.12% (P<.01) at 6 months, to 8.3 (67 mmol/mol) ± 0.14% (P<.01) at 12 months. There was no significant decrease in weight or TDD with the addition of a GLP-1RA overall or in different insulin groups. However, there was a clinically significant decrease in weight over the study duration.Conclusion: The results of this study suggest that adding a GLP-1RA to various insulin regimens may help to achieve glycemic goals while avoiding the less desirable side effects of weight gain and increasing insulin regimens. However, the expected weight loss and decrease in TDD may not be as sizable in the clinical setting.Abbreviations: DCOE = Diabetes Center of Excellence; DM = diabetes mellitus; GLP-1RA = glucagon-like peptide-1 receptor agonist; HbA1c = hemoglobin A1c; RCT = randomized controlled trial; TDD = total daily dose     

Efficacy and Safety of Dulaglutide in Hispanic/Latino Patients with Type 2 Diabetes in the Award Clinical Program

Objective: The aim of this post hoc analysis was to assess the efficacy and safety of once-weekly dulaglutide in Hispanic/Latino patients with type 2 diabetes (T2D) in phase 3 AWARD trials 1 to 6.Methods: Hispanic/Latino data at Week 26 were pooled across studies for each dulaglutide dose to analyze the change from baseline in glycosylated hemoglobin (HbA1c), percent to HbA1c goal, and adverse events (AEs). Change from baseline in HbA1c, change from baseline in weight and hypoglycemia were analyzed by Hispanic/Latino and non-Hispanic/Latino subgroups for each study.Results: Of the 3,136 patients randomized to dulaglutide 1.5 or 0.75 mg, 949 were reported as having Hispanic/Latino ethnicity. Baseline characteristics were similar for Hispanic/Latino and overall populations, except there were slightly more Hispanic/Latino females and weight was slightly lower for Hispanic/Latino patients. Hispanic/Latino patients receiving dulaglutide 1.5 mg had a reduction in HbA1c of 1.25% (95% confidence interval [CI]: -1.35, -1.15); dulaglutide 0.75 mg had a reduction of 1.07% (95% CI: -1.18, -0.96). Reductions in HbA1c and percent to goal HbA1c <7% and ≤6.5% were similar between Hispanic/Latino patients and the overall population. Weight change and hypoglycemia were similar between Hispanic/Latino and non-Hispanic/Latino subgroups for all studies. Treatment-emergent AEs were consistent with the overall population.Conclusion: Dulaglutide improved glycemic control with the potential for weight loss in Hispanic/Latino patients with T2D. Dulaglutide was well tolerated and had a low risk of hypoglycemia when used without insulin secretagogues or insulin. In the Hispanic/Latino population, dulaglutide efficacy and safety was consistent with that of the overall population.Abbreviations:AE = adverse eventAWARD = Assessment of Weekly AdministRation of dulaglutide in DiabetesBID = twice dailyCARMELA = The Cardiovascular Risk Factor Multiple Evaluation of Latin AmericaCI = confidence intervalGLP-1 RA = glucagon-like peptide-1 receptor agonistHbA1c = glycosylated hemoglobinT2D = type 2 diabetes     

Open Access to Diabetes Center from the Emergency Department Reduces Hospitalizations in the Susequent Year

Objective: Patients who present to the emergency department (ED) for diabetes without hyperglycemic crisis are at risk of unnecessary hospitalizations and poor outcomes. To address this, the ED Diabetes Rapid-referral Program (EDRP) was designed to provide ED staff with direct booking into the diabetes center. The objective of this study was to determine the effects of the EDRP on hospitalization rate, ED utilization rate, glycemic control, and expenditures.Methods: We conducted a single-center analysis of the EDRP cohort (n = 420) and compared 1-year outcomes to historic controls (n = 791). We also compared EDRP patients who arrived (ARR) to those who did not show (NS). The primary outcome was hospitalization rate over 1 year. Secondary outcomes included ED recidivism rate, hemoglobin A1c (HbA1c), and healthcare expenditures.Results: Compared with controls, the EDRP cohort was less likely to be hospitalized (27.1% vs. 41.5%, P<.001) or return to the ED (52.2% vs. 62.3%, P = .001) at the end of 1 year. Total hospitalizations were also lower in the EDRP (157 ± 19 vs. 267 ± 18 per 1,000 persons per year, P<.001). The EDRP cohort had a greater reduction in HbA1c (-2.66 vs. -2.01%, P<.001), which was more pronounced when ARR patients were compared with NS (-2.71% vs. -1.37%, P<.05). The mean per patient institutional healthcare expenditures were lower by $5,461 compared with controls.Conclusion: Eliminating barriers to scheduling diabetes-focused ambulatory care for ED patients was associated with significant reductions in hospitalization rate, ED recidivism rate, HbA1c, and healthcare expenditures in the subsequent year.Abbreviations:ARR = arrivedED = emergency departmentEDRP = emergency department diabetes rapid-referral ProgramHbA1c = hemoglobin A1cNS = no show     

An Individualized Inpatient Diabetes Education and Hospital Transition Program for Poorly Controlled Hospitalized Patients with Diabetes

ObjectiveTo evaluate predictors of outcomes associated with an inpatient diabetes education and discharge support program for hospitalized patients with poorly controlled diabetes (glycated hemoglobin [HbA1c]>9%).MethodsPatients participated in individualized diabetes education conducted by a certified diabetes educator (CDE) that included an exploration of barriers and goal setting during hospitalization with telephone follow-up and communication with primary providers at discharge. Predictors of HbA1c reduction, successful follow-up, and readmission were analyzed.ResultsThere were 82 subjects, and 48% were insulin naïve. Patients with type 2 diabetes (T2D, n = 58) had a significant decrease in HbAlc at follow-up (-2.8%, P < .0001), while those with type 1 diabetes (T1D, n = 19) did not (+ 0.02%, P = .96). However, after adjustment for other factors, only increasing age, higher baseline HbA1c, earlier education, and initiation of basal insulin were significant predictors of reduction in HbA1c. Higher area level income and empowerment and earlier education were significant predictors of outpatient follow-up within 30 days. While 28% were admitted for severe hyperglycemia, only 1 patient was readmitted with severe hyperglycemia. Successful phone contact was 77% and 57% with and without the support of non-CDE assistants respectively, but all outcomes were similar.ConclusionThe study suggests that an individualized inpatient diabetes education and transition program is associated with a significant reduction in HbA1c that is dependent on baseline HbA1c, older age, initiation of insulin, and earlier enrollment. Additional interventions are needed to ensure better continuity of care. (Endocr Pract. 2014;20:1265-1273)     

HbA1c and Blood Pressure Measurements: Relation with Gender,Body Mass Index,Study Field,and Lifestyle in Lebanese Students

Objective: The purpose of this study is to determine the prevalence of prediabetes/diabetes in Lebanese university students and to examine the relationship between both hemoglobin A1c (HbA1c) and blood pressure (BP) and gender, body mass index (BMI), study field, and lifestyle factors.Methods: This cross-sectional study was carried out at the Saint-Joseph University of Beirut. A total of 603 students aged 18 to 25 years were recruited from both the medical science campus (MSC) and the social science campus (SSC) between January, 2016, and May, 2018. Waist circumference (WC), BMI, and BP were determined for each student and HbA1c was measured using the Siemens vintage DCA device. Participants completed a self-administered questionnaire about their eating habits and level of physical activity.Results: The mean age of the population was 20.31 ± 1.76 years. The percentage of participants recruited from the MSC was 59.2%. The prevalence of prediabetes was 2.5%. Lower BMI, WC, and HbA1c values, and higher diastolic BP (DBP) were found in MSC students compared to SSC ones. HbA1c, systolic BP (SBP), and DBP were correlated with BMI (P = .02, P<.0001, and P = .017, respectively). HbA1c was not associated with eating habits or physical activity. DBP was inversely associated with physical activity (P = .002), while SBP was positively associated with fast food consumption (P = .003).Conclusion: The present study shows a low prevalence of prediabetes in Lebanese students. BMI and the study field are the main factors predicting HbA1c and BP. Further studies are needed to extrapolate our results to the overall young Lebanese population.Abbreviations: ADA = American Diabetes Association; BMI = body mass index; BP = blood pressure; DBP = diastolic blood pressure; HbA1c = hemoglobin A1c; HTN = hypertension; MSC = medical science campus; SBP = systolic blood pressure; SSC = social science campus; T2D = type 2 diabetes; US = United States; USJ = Saint-Joseph University; WC = waist circumference     

Integrated Insulin Pump and Continuous Glucose Monitoring Technology in Diabetes Care Today: A Perspective of Real-Life Experience With the Minimed™ 670G Hybrid Closed-Loop System

Objective: Intensive glucose management with insulin pump and continuous glucose monitoring therapy in insulin-treated patients with diabetes poses many challenges in all aspects of daily life. Automated insulin delivery (AID) is the ultimate goal of insulin replacement therapy to reduce the burden of managing this condition. Many systems are being tested in the clinical research setting, and one hybrid closed-loop (HCL) system has received Food and Drug Administration (FDA) approval for use in type 1 diabetes patients above the age of 14 years.Methods: Literature review and clinical practice experience from the Diabetes and Technology Program at an academic medical center.Results: This review outlines recent advances in AID systems, focusing on the FDA-approved MiniMed™ 670G HCL system and the real-life experience 1-year post-release in an academic medical center with over 60 patients on this system. The unique challenges of adapting to this new system outside the clinical trial setting are highlighted, and a training protocol designed specifically for the onboarding of first-time users is described.Conclusion: HCL insulin therapy offers several advantages, at the same time posing unique challenges to the user. Systematic training of patients with diabetes transitioning to this system is essential for retention and success of use.Abbreviations: AID = automated insulin delivery; CGM = continuous glucose monitoring; FDA = Food and Drug Administration; HbA1c = glycated hemoglobin; HCL = hybrid closed-loop; ICR = insulin to carbohydrate ratio; SAP = sensor augmented pump; T1DM = type 1 diabetes     

Opportunistic Screening For Diabetes And Prediabetes Using Hemoglobin A1C In An Urban Primary Care Setting

Objective: In 2010, the American Diabetes Association (ADA) endorsed hemoglobin A1c (HbA1c) as 1 of 3 tests for diabetes and prediabetes screening. We describe the use of HbA1c testing for screening during routine visits in primary care clinics of an urban health care system in the U.S.Methods: In 2013 to 2014, retrospective analyses of deidentified electronic health records over a 2-year period, January 2010 to December 2011, for academic private practices (clinic group 1) and federally-qualified Community Health Centers (clinic group 2) identified 11,885 adults without prior diabetes or recent HbA1c testing. We estimated the proportion of patients eligible for screening according to ADA and U.S. Preventative Services Task Force (USPSTF) guidelines and calculated the potential yield of previously undiagnosed diabetes or prediabetes among those who received at least 1 HbA1c test.Results: Overall, 3,316 and 5,613 patients of clinic groups 1 and 2 (75.2% of each) were eligible for screening by ADA guidelines, while only 1,764 (39.9%) of clinic group 1 and 3,799 (50.9%) of clinic group 2 were eligible by USPSTF guidelines. In those eligible by either guideline, 731 (21.4%) patients of clinic group 1 and 1,293 (21.5%) of clinic group 2 received HbA1c testing; among these, in 71 (9.7%) and 121 (9.4%) patients from clinic groups 1 and 2, respectively, HbA1c results were in the diabetes range, and in 330 (45.2%) and 733 (56.7%), results were in the prediabetes range.Conclusion: In urban primary care settings, appropriate HbA1c testing could result in the detection of a substantial number of previously undiagnosed diabetes and prediabetes cases needing treatment.Abbreviations:ADA = American Diabetes AssociationBMI = body mass indexCI = confidence intervalEHR = electronic health recordHbA1c = hemoglobin A1cHTN = hypertensionICD = International Classification of DiseasesIFCC = International Federation of Clinical ChemistryOGTT = oral glucose tolerance testUSPSTF = U.S. Preventative Services Task Force     

Differences in Achieving Hba1C Goals Among Patients Seen by Endocrinologists and Primary Care Providers

Objective: This study evaluated whether there is a difference in the proportion of patients with type 2 diabetes who achieve a hemoglobin A1c (HbA1c) <7% within one year following treatment by an endocrinologist or primary care physician (PCP).Methods: We conducted a retrospective, propensity-matched study of patients with type 2 diabetes that were not optimally controlled and seen within our health system from 2007–2016. We assessed differences in short term health outcomes for patients following an endocrinologist visit compared to a PCP visit.Results: Patients seen by endocrinologists obtained HbA1c control at a faster rate (hazard ratio = 1.226; 95% confidence interval = 1.01 to 1.488) than those seen by a PCP. Furthermore, 34.5% and 29.5% of those treated by endocrinologists and PCPs, respectively, obtained HbA1c control by one year. Endocrinologists were more likely to prescribe a new medication class within 90 days than PCPs (14.1% versus 10.3%, respectively, P = .043). There was no difference in the risk of hospitalization between groups; 24.4% and 24.1% of those treated by endocrinologists and PCPs, respectively, were hospitalized within one year.Conclusion: Patients treated by endocrinology specialists were more likely to achieve a target HbA1c of <7% (53 mmol/mol) than those treated by PCPs in our health-care system. The performance difference may be partially explained by a higher rate of adding new classes of diabetes medications to the patient's pharmacologic regimens within 90 days by endocrinologists compared with PCPs. The long-term impact of these differences is unknown but has the potential to have an unfavorable impact on the health of the population.Abbreviations: ACP = American College of Physicians; CI = confidence interval; DUHS = Duke University Health System; HbA1c = hemoglobin A1c; HR = hazard ratio; PCP = primary care physician; SMD = standard mean difference     

Regulation of Free Fatty Acid by Sitagliptin Monotherapy in DRUG-NAÏVE Subjects with Type 2 Diabetes

Objective: The aim of this study was to investigate the effects of sitagliptin on the regulation of free fatty acid (FFA) and other metabolic parameters in drug-naïve subjects with type 2 diabetes mellitus (T2DM).Methods: This was a prospective, nonrandomized, observational study. Drug-naïve subjects with T2DM received 25 to 50 mg/day sitagliptin monotherapy (n = 64). At 3 months, FFA and other metabolic parameters were compared with those at baseline. FFA was measured by colorimetry with enzymatic reactions. As a comparator, 12.5 to 25 mg/day alogliptin monotherapy was given to drug-naïve subjects with T2DM (n = 55).Results: Significant reductions in FFA (-13.2%, P<0.01) levels were observed with sitagliptin but not alogliptin. Both drugs showed similar glycemic efficacies. Significant correlations were observed between the changes (Δ) of FFA and Δglycated hemoglobin A1c (HbA1c), Dtotal cholesterol (TC), Δnon-high-density lipoprotein cholesterol (HDL-C), or Δlow-density lipoprotein cholesterol (LDL-C), and significant negative correlations were seen between ΔFFA and Δhomeostasis model assessment-B (HOMA-B), ΔC-peptide immunoreactivity (CPR)-index or Δbody mass index (BMI) in the sitagliptin group. The subjects in the sitagliptin group were further divided into 2 subgroups (n = 32 each) according to the changes of FFA (group B [above the median] ΔFFA = 23.1 %, P<.0005; group A [below the median] ΔFFA = -37.3 %, P<.00001). At baseline, FFA levels were significantly higher in group A versus group B (P<.001). Higher degrees of reductions of FBG (-14.6% vs. -9.3%, P<0.05) or HbA1c (-20.6% vs. -16.9%, P<.05), and increases of HOMA-B (52.7% vs. 38.3%, P<.03) or CPR-index (37.5% vs. 18.8%, P<.02) were observed in group A versus group B. Significant reductions of TC (-5.8%, P<.002), non-HDL-C (-7.8%, P<.001) or LDL-C (-6.3%, P<.02), and significant increases of C-peptide (11.3%, P<.05) were seen only in group A.Conclusion: Sitagliptin could downregulate high FFA levels. Subjects with reductions of FFA levels had better glycemic efficacies and higher degrees of enhancement of beta-cell function than others. Reductions of atherogenic cholesterols were seen in these populations.Abbreviations: CPR = C-peptide immunoreactivity; DPP-4 = dipeptidyl peptidase 4; FBG = fasting blood glucose; FFA = free fatty acid; HbA1c = glycated hemoglobin A1c; HDL-C = high-density lipoprotein cholesterol; HOMA-R = homeostasis model assessment-R; HOMA-B = homeostasis model assessment-B; non-HDL-C = non-HDL-cholesterol; LDL-C = low-density lipoprotein cholesterol; TC = total cholesterol; T2DM = type 2 diabetes; TG = triglyceride; UA = uric acid     

Impact of Switching Youth With Diabetes to Insulin Degludec in Clinical Practice

Objective: Many youth with diabetes struggle to meet glycemic targets. The new ultralong duration of action of insulin degludec (iDeg) holds potential to ameliorate missed doses of basal insulin and improve glycemic control in youth with diabetes.Methods: A retrospective chart review was undertaken of youth age 13 to <24 years in our practice with type 1 diabetes (T1D) or type 2 diabetes (T2D) who had been switched from glargine or detemir to iDeg to evaluate the impact of this transition on glycemic control.Results: Glycated hemoglobin A1c (HbA1c) in youth with T1D (n = 82) remained stable during 6 months of treatment with iDeg (10.1 ± 2.11% &lsqb;87 ± 23 mmol/mol] at start of iDeg compared to 10.1 ± 2.12% &lsqb;87 ± 23 mmol/mol] at 6 months of treatment), whereas in youth with T2D (n = 16), HbA1c significantly declined from 10.6 ± 2.3% (92 ± 25 mmol/mol) to 8.3 ± 2.2% (67 ± 24 mmol/mol) (P = .0024).Conclusion: In youth switched to iDeg, which in our practice is commonly due to ineffectiveness of the patient's current regimen, the outcome differences we saw may be due to preserved beta-cell function in youth with T2D. It remains to be seen whether there are benefits of transition to iDeg in youth with T1D beyond glycemic outcomes, such as reduction in ketosis and episodes of diabetic ketoacidosis.Abbreviations: DKA = diabetic ketoacidosis; DPV = Diabetes-Patienten-Verlaufsdokumentation (German/Austrian Prospective Diabetes Follow-Up Registry); HbA1c = glycated hemoglobin A1c; iDeg = insulin degludec; T1D = type 1 diabetes; T2D = type 2 diabetes     

Utility of Psychological Screening of Young Adults with Type 1 Diabetes Transitioning to Adult Providers

Objective: Screening for depression, diabetes distress, and disordered eating in youth with type 1 diabetes (T1D) is recommended, as these comorbidities contribute to poor glycemic control. No consensus exists on which measures are optimal, and most previous studies have used nondisease-specific measures. We examined the utility of screening for these disorders using two disease-specific and one general measure at the time of transition from pediatric to adult care.Methods: Forty-three young adults from a T1D transition clinic completed the Patient Health Questionnaire, the Diabetes Distress Scale, and the Diabetes Eating Problem Survey–Revised. Chart review determined if clinicians noted similar symptoms during the year prior to transition. Metabolic data were also recorded.Results: Chart review identified 5 patients with depressive symptoms and 8 patients with diabetes distress. Screening identified 2 additional patients with depressive symptoms and 1 additional patient with diabetes distress. Of those noted to have symptomatic depression or diabetes distress on chart review, several subsequently screened negative on transition. Disordered eating was not detected by chart review, but 23.5% screened positive on transition. While depression, diabetes distress, and disordered eating positively correlated with glycated hemoglobin (HbA1c) (r = 0.31, P = .05; r = 0.40, P = .009; r = 0.63, P<.001, respectively), disordered eating accounted for the majority of observed variance (df = 1; F = 18.6; P<.001). Even though HbA1c was higher in patients with versus without disordered eating (P<.001), body mass index did not differ between the 2 groups (P = .51).Conclusion: In young adults with T1D, formal screening provides an opportunity to detect psychological problems, which, when treated, may help optimize metabolic control during the transition process.Abbreviations:T1D = type 1 diabetesHbA1C = hemoglobin A1cYCDP = Yale Children's Diabetes ProgramPHQ-8 = Patient Health Questionnaire–8DDS = Diabetes Distress ScaleDEPS-R = Diabetes Eating Problem Survey–Revised     

Effect of Gluten-FREE Diet on Metabolic Control and Anthropometric Parameters in Type 1 Diabetes with Subclinical Celiac Disease: A Randomized Controlled Trial

Objective: It is unclear whether the institution of gluten-free diet (GFD) is beneficial in patients with type 1 diabetes (T1DM) and subclinical celiac disease (CD). Our primary objective was to evaluate the effect of GFD on the frequency of hypoglycemia, in patients with T1DM and subclinical CD. Our secondary objective was to investigate the effect of GFD on height, weight, glycosylated hemoglobin (HbA1c), insulin dose requirement, and bone mineral homeostasis.Methods: We carried out a prospective open label randomized controlled trial (RCT). Patients with T1DM and subclinical CD were randomized to receive GFD or a normal diet for 1 year. The primary outcome was the frequency of hypoglycemic episodes (blood glucose <70 mg/dL) measured by self-monitoring of blood glucose (SMBG) at the sixth month of the study in the 2 groups.Results: Screening for CD was carried out in 320 T1DM patients. Thirty eligible patients were randomized to receive GFD (n = 15) or a normal diet (n = 15). The mean number of hypoglycemic episodes/month recorded by SMBG and the mean time spent in hypoglycemia measured by CGM (minutes) in the GFD group versus the non-GFD group at six months was 2.3 minutes versus 3.4 minutes (P = .5) and 124.1 minutes versus 356.9 minutes (P = .1), respectively. The mean number of hypoglycemic episodes/month significantly declined in the GFD group (3.5 episodes at baseline versus 2.3 episodes at the sixth month; P = .03). The mean HbA1c declined by 0.73% in the GFD group and rose by 0.99% in non-GFD group at study completion.Conclusion: This is the first RCT to assess the effect of GFD in T1DM and subclinical CD. A trend towards a decrease in hypoglycemic episodes and better glycemic control was seen in patients receiving GFD.Abbreviations: BMC = bone mineral content; BMI = body mass index; CD = celiac disease; CGM = continuous glucose monitoring; GFD = gluten-free diet; Hb = hemoglobin; HbA1c = glycosylated hemoglobin; iPTH = intact parathyroid hormone; RCT = randomized controlled trial; SMBG = self-monitoring of blood glucose; T1DM = type 1 diabetes mellitus; tTG-IgA = tissue transglutaminase immunoglobulin A     

Cheiroarthropathy: A Common Disorder in Patients in the T1D Exchange

Objective: Diabetic cheiroarthropathy is a long-term complication of diabetes that causes significant morbidity and can impair functional abilities. It has not been well studied in individuals with type 1 diabetes (T1D). The T1D Exchange registry provided an opportunity to assess the frequency of cheiroarthropathy and related characteristics.Methods: An internet-based survey was sent to 6,199 registry participants ≥18 years old, with 1,911 (31%) responding (62% female, 90% non-Hispanic White, mean age 40 years, median diabetes duration 20 years, mean glycated hemoglobin &lsqb;HbA1c] 7.7% &lsqb;61 mmol/mol]).Results: A total of 586 (31%) adults reported a diagnosis of ≥1 upper extremity disorder: 293 (15%) reported frozen shoulder, 293 (15%) trigger finger, 261 (14%) carpal tunnel, and 92 (5%) Dupuytren contracture, with 281 (15%) reporting ≥2 disorders. Those with upper extremity joint disorders were more likely older (P<.001) and had longer duration of diabetes (P<.001) than those without. HbA1c levels at the time of survey completion were 7.6% in participants with cheiroarthropathy versus 7.8% (62 mmol/mol) in participants without cheiroarthropathy.Conclusion: Cheiroarthropathy is common in adults with T1D. Additional research is needed to understand the pathogenesis and risk factors for this disorder. Standards of care for early recognition and treatment of diabetic cheiroarthropathy are also needed, particularly for adults with long-term diabetes. Improved awareness of cheiroarthropathy signs and symptoms of is needed so that patients can be identified and seek treatment before the condition causes disability.Abbreviations: BMI = body mass index; CGM = continuous glucose monitor; DCCT/EDIC = Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications; HbA1C = glycated hemoglobin; T1D = type 1 diabetes; T2D = type 2 diabetes     

Serum Levels of Carcinoembryonic Antigen in Patients with Type 2 Diabetes

Objective: To investigate whether serum carcinoembryonic antigen (CEA) levels are associated with type 2 diabetes mellitus (T2DM) and glycated hemoglobin (HbA1c).Methods: A comparative, cross-sectional, observational study was conducted at Jordan University Hospital, Amman, Jordan, on 282 adult subjects from March 2012 to June 2015. Subjects were classified into 2 groups: T2DM subjects (n = 168) and a healthy comparison group (n = 114). Subjects with any condition known to be associated with elevated CEA levels were excluded. HbA1c and serum CEA levels were measured, and body mass index (BMI) was determined.Results: Subjects with T2DM had significantly higher mean serum CEA than controls (2.4 ± 1.5 vs. 1.5 ± 1.2 ng/mL, P<.0001). Sex did not correlate with CEA levels, while age (Spearman's rho [ρ] = 0.18, P =.002) and HbA1c (ρ = 0.56, P<.0001) did; however, age no longer correlated after correcting for diabetic status. HbA1c was the only variable shown to correlate with CEA in a stepwise linear regression (r = 0.37, P<.001).Conclusion: We observed a statistically significant association between elevated CEA and T2DM, despite average CEA values for both groups being within the reference range. In addition, serum CEA levels correlated positively with HbA1c values.Abbreviations:ADA = American Diabetes AssociationBMI = body mass indexCA 19-9 = carbohydrate antigen 19-9CEA = carcinoembryonic antigenCRP = C-reactive proteinDM = diabetes mellitusHbA1c = glycated hemoglobinJUH = Jordan University HospitalT2DM = type 2 diabetes mellitusρ = Spearman's correlation coefficient     

Increased Bone Turnover in Type 2 Diabetes Patients Randomized to Bariatric Surgery Versus Medical Therapy at 5 Years

Objective: The aim of our study was to determine the 5-year outcomes of bariatric surgery versus intensive medical therapy on bone turnover in patients with type 2 diabetes mellitus (T2DM) from the STAMPEDE trial.Methods: This was an ancillary investigation of a 5-year randomized control trial at a single tertiary care center involving 95 patients aged 48.5 ± 8 years with obesity (body mass index &lsqb;BMI], 36.5 ± 3.6 kg/m²) and uncontrolled T2DM (glycated hemoglobin 9.3 ± 1.6% &lsqb;78 mmol/mol]). Patients were randomized to intensive medical therapy (IMT; n = 25), Roux-en-Y gastric bypass (RYGB; n = 37), or sleeve gastrectomy (SG; n = 33) for diabetes treatment. Bone formation marker osteocalcin (OC), bone resorption marker serum C-telopeptide of type 1 collagen (CTX), and intact parathyroid hormone (PTH) were assessed at baseline and 5 years postintervention. Analysis with key clinical parameters and outcomes (i.e., age, menopausal status, gender, weight loss) was performed.Results: Percent change in CTX at 5 years increased in both surgical groups, by 137 ± 108% in RYGB (P<.001) and 61.1 ± 90% in SG (P<.001) compared to 29.8 ± 93% in IMT (P = .12). OC also increased from baseline in the surgical cohorts, by 138 ± 19% in RYGB (P<.001) and 71 ± 69% in SG (P<.001) compared to 43.8 ± 121.1% in IMT (P = .83). Increases in both CTX and OC correlated linearly with increases in PTH levels in RYGB patients (P<.001). Increase in CTX correlated with decreased BMI in SG patients (P = .039).Conclusion: In patients with T2DM, bone turnover remains chronically elevated at 5 years following RYGB, and to a lesser extent in SG patients.Abbreviations: BMI = body mass index; BTM = bone turnover marker; CTX = C-telopeptide of type 1 collagen; HbA1c = glycated hemoglobin; IMT = intensive medical therapy; OC = osteocalcin; PPI = proton-pump inhibitor; PTH = parathyroid hormone; RYGB = Roux-en-Y gastric bypass; SG = sleeve gastrectomy; T2DM = type 2 diabetes mellitus; TZD = thiazolidinedione