Decrease In A1c Research Articles

Glycaemic Control with Insulin Glargine 300U/mL in Individuals with Type2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis.

IntroductionManagement of type 2 diabetes mellitus (T2DM) in patients with chronic kidney disease is complex. Using the REALI European pooled database, we determined the impact of baseline renal function on the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) initiated in adults with inadequately controlled T2DM.MethodsData from 1712 patients with available estimated glomerular filtration rate (eGFR) at baseline were pooled from six 24-week prospective studies. Patients who received once-daily subcutaneous injections of Gla-300 were classified into four renal function subgroups, according to baseline eGFR: ≥ 90 (N = 599), 60–89 (N = 786), 45–59 (N = 219), and 15–44 mL/min/1.73 m2 (N = 108).ResultsCompared to those with baseline eGFR ≥ 60 mL/min/1.73 m2, patients with lower eGFR values tended to be older, had a longer T2DM duration, and were more likely to present diabetic complications. After 24 weeks of Gla-300 therapy, the least-squares mean (95% confidence interval) decrease in haemoglobin A1c (HbA1c) from baseline (− 1.14% [− 1.28 to − 1.00], − 1.21% [− 1.34 to − 1.08], − 1.19% [− 1.36 to − 1.01], and − 0.99% [− 1.22 to − 0.76]) and the proportion of patients achieving HbA1c < 7.5% (53.3%, 51.3%, 49.5%, and 51.5%) were comparable in the ≥ 90, 60–89, 45–59, and 15–44 mL/min/1.73 m2 subgroups, respectively. Although the incidence of hypoglycaemia was overall low, more patients in the eGFR 15–44 mL/min/1.73 m2 subgroup experienced hypoglycaemia at night or at any time of the day compared with higher eGFR subgroups. There were no notable differences between the renal function subgroups in the changes in Gla-300 daily dose and body weight from baseline to week 24.ConclusionAlthough an eGFR of 15–44 mL/min/1.73 m2 was associated with a slightly increased risk of hypoglycaemia among patients with inadequately controlled T2DM, Gla-300 provided glycaemic improvement with an overall favourable safety profile regardless of baseline eGFR.

Glycemic benefits with adherence to testosterone therapy in men with hypogonadism and type 2 diabetes mellitus.

While previous studies have demonstrated testosterone's beneficial effects on glycemic control in men with hypogonadism and Type 2 Diabetes, the extent to which these improvements are observed based on the degree of treatment adherence has been unclear. To evaluate the effects of long-term testosterone therapy in A1C levels in men with Type 2 Diabetes Mellitus and hypogonadism, controlling for BMI, pre-treatment A1C, and age among different testosterone therapy adherence groups. We performed a retrospective analysis of 1737 men with diabetes and hypogonadism on testosterone therapy for 5years of data from 2008-2018, isolating A1C, lipid panels, and BMI results for analysis. Subjects were categorized into adherence groups based on quartiles of the proportion of days covered (> 75% of days, 51-75% of days, 26-50% of days and 0-25% of days), with >75% of days covered considered adherent to therapy. Pre-treatment median A1C was 6.8%. Post-treatment median A1C was 7.1%. The adherent group, >75%, was the only group notable for a decrease in A1C, with a median decrease of -0.2 (p=0.0022). BMI improvement was associated with improved post-treatment A1C (p=0.007). When controlling for BMI, age, and pre-treatment A1C, the >75% adherence group was associated with improved post-treatment A1C (p<0.001). When controlling for all studied variables, testosterone adherence was associated with improved post-treatment A1C. The higher the initial A1C at the initiation of therapy, the higher the potential for lowering the patient's A1C with >75% adherence. Further, all groups showed some reduction in BMI, which may indicate that testosterone therapy may affect A1C independent of weight loss. Even when controlling for improved BMI, pre-treatment A1C, and age, testosterone positively impacted glycemic control in diabetes patients with hypogonadism, with the most benefit noted in those most adherent to therapy (>75%).

Continuous glucose monitoring shared medical appointments improve diabetes self‐efficacy and hemoglobin A1C

AbstractIntroductionDiabetes self‐management education and support and professional continuous glucose monitoring (CGM) were combined into shared medical appointments (SMA) to provide care for people with diabetes. Although the individual components have evidence of efficacy, this combination has never been studied.ObjectivesThe purpose of this study is to assess the impact of CGM SMA on diabetes self‐efficacy and hemoglobin A1C (A1C) in persons with diabetes.MethodsAdults who attended a two‐part CGM SMA at a large academic medical center were included in this retrospective, pre‐post study. The CGM SMA incorporated diabetes education, peer support, and seven days of professional CGM. The primary outcome was change in diabetes self‐efficacy through a validated eight‐item Likert Scale instrument. Secondary objectives were changes in A1C, changes in diabetes medications, and type of planned lifestyle changes. Paired t tests were used to analyze change in A1C and diabetes self‐efficacy scores.ResultsA total of 171 participants were included in this analysis. Diabetes self‐efficacy scores increased by a mean of 1.63 ± 2.09 points (P &lt; .001) out of 10 points maximum after participation in the two‐part CGM SMA. The A1C decreased by a mean of 0.80 ± 1.52% (P &lt; .001), with a mean follow‐up A1C of 7.8 ± 1.60%. Those with an A1C &gt; 8% (n = 101) experienced a decrease of 1.20%. Participants utilizing the unblinded device (n = 133) experienced a decrease in A1C by 0.75% compared with 1.0% in those that utilized a blinded device (n = 38). Most medication changes made in the CGM SMA were dosage adjustments and changes in administration time.ConclusionsThe CGM SMA is a novel practice model incorporating diabetes education, peer support, professional CGM, and interprofessional care that demonstrated improvements in diabetes self‐efficacy and A1C.

Low-carbohydrate dietary pattern on glycemic outcomes trial (ADEPT) among individuals with elevated hemoglobin A1c: study protocol for a randomized controlled trial

BackgroundType 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality globally. Strong evidence supports the importance of diet and other lifestyle factors in preventing T2DM. Among individuals with T2DM, low-carbohydrate diets lead to decreases in hemoglobin A1c (HbA1c). However, research on the effects of low-carbohydrate diets on glycemic outcomes among individuals not currently on glucose-lowering medications who have elevated HbA1c is limited.MethodsThe objective of this randomized controlled trial is to study the effect of a healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation compared with usual diet on HbA1c and other metabolic risk factors among individuals with HbA1c from 6.0 to 6.9% who are not on glucose-lowering medications. In this parallel trial, 150 participants will be randomized to the intervention or control group for 6 months. The healthy low-carbohydrate diet target is < 40 g of net carbohydrates during the first 3 months and < 40 to 60 net grams for months 3 to 6. This diet is characterized by abundant unsaturated fat and protein, high-fiber foods such as non-starchy vegetables and nuts, and minimal refined carbohydrates. The primary outcome is the difference in HbA1c change from baseline to 6 months in the intervention compared with usual diet group. Secondary outcomes include differences between groups in 6-month changes in fasting glucose, systolic blood pressure, total-to-high-density lipoprotein (HDL) cholesterol ratio, and body weight. Exploratory outcomes include differences in 6-month changes in fasting insulin, homeostasis model assessment of insulin resistance, diastolic blood pressure, waist circumference, and 10-year cardiovascular disease risk. An intention-to-treat analysis will be used.DiscussionWe expect that the results from this study will lead to new approaches for developing and implementing dietary approaches (other than the most commonly used reduced fat diet) that will substantially reduce risk of cardiometabolic disease among adults with or at high risk of T2DM. The study intervention involves behavioral counseling and promotes consumption of dietary components thought to reduce risk of cardiometabolic disease and has expected applicability in clinical practice.Trial registrationClinicalTrials.gov NCT03675360. Registered on September 18, 2018 (prior to enrolment of the first participant).

Factors Associated with the Remission of Type 1 Diastolic Dysfunction after Dapagliflozin Treatment in Patients with Type 2 Diabetes.

Patients with type 2 diabetes (T2DM) are at high risk of developing cardiovascular disease and heart failure (HF), both with preserved and reduced ejection fraction of the left ventricle. Previous research demonstrated that dapagliflozin treatment is associated with the remission of type 1 diastolic dysfunction (DD1) in patients with T2DM. The main aim of this study was to evaluate the possible baseline predictors associated with the remission of DD1 in patients with T2D after one year of dapagliflozin treatment. In this prospective and observational study, 45 patients with T2DM were evaluated before and after one year of treatment with 10 mg dapagliflozin daily added to their background therapy. In the studied group, 73.3% (33/45) of the patients had DD1 at baseline. The primary outcome of this research was DD1 remission. DD1 remission was associated with improvement of liver stiffness, an increase in estimated glomerular filtration rate (eGFR), and a decrease in hemoglobin A1c (HbA1c). Independent predictors for the remission of DD1 were a more than 0.4 kPa difference in the initial stiffness score and the 1-year assessment fibrosis score and a duration of diabetes ≤8 years. Age, body mass index (BMI), or patient weight after one year did not influence the DD1 outcome. Patients with a T2DM duration of less than eight years have the additional benefit of DD1 remission associated with dapagliflozin treatment beyond the conventional benefits such as improvements in glycemic control, cardiovascular, renal, and hepatic risk reductions. In patients with T2DM, the remission of DD1 was associated with decrease of liver stiffness.

Evaluation of a clinical pharmacist team-based telehealth intervention in a rural clinic setting: a pilot study of feasibility, organizational perceptions, and return on investment

BackgroundRemote, centralized clinical pharmacist services provided by board-certified clinical pharmacists have been shown to effectively assist in chronic disease management. We assess the feasibility of implementing a pharmacist-led, remote, centralized pharmacy service to improve A1c levels in patient with diabetes in a rural clinic setting.MethodsThis was a non-randomized pilot and feasibility study. Participants were enrolled in a pharmacist-led telehealth intervention service, with data prior to enrollment used as baseline data for control. To be included, patients needed to have A1c readings of greater than 7% to be considered uncontrolled. A1c changes were reported for two groups based on A1c ranges: between 7 and 10% and ≥ 10%. Clinical pharmacists and clinical pharmacy interns initiated contact with patients via telephone communication and managed the patients remotely. The following outcomes were evaluated: organization perceptions (patients, providers, and clinic staff), changes in A1c, medication discrepancies, impact of an internally operated Patient Assistance Program, and potential return on investment (ROI).ResultsFifty-two patients were initially identified and referred to the service with 43 patients consenting to participate in the intervention. Patient and provider survey responses were recorded. In the initial analysis occurring during the first 3 to 5 months of the program, there was considerable improvement in diabetes control as measured by A1c. For patients with uncontrolled diabetes with a baseline A1c > 7% but less than < 10% and ≥ 10%, the intervention resulted in an A1c decrease of 0.57% and 2.55%, respectively. Clinical pharmacists and clinical pharmacy interns identified at least one medication discrepancy in 44% of patients, with number of discrepancies ranging from 1 to 5 per patient. At the conclusion of the study window, 42 potentially billable encounters were documented, which would have generated a net profit of $1140 USD, had they been submitted for reimbursement. Given the potential revenue generation, the service theoretically yields a ROI of 1.4 to 1.ConclusionsInitial results suggest that a pharmacist-led telehealth intervention has potential to decrease A1c levels in patients with diabetes, assist in identification of medication discrepancies, provide a positive return on investment for rural clinics, and potentially increase reimbursement for providers and clinics tasked with managing patients with uncontrolled diabetes.

Effects of a ready-to-eat cereal formula powder on glucose metabolism, inflammation, and gut microbiota in diabetic db/db mice.

The cereal formula powder, Zhengda Jingshan (ZDJS), comprises dietary fiber, multivitamins, fine protein, and various cereal ingredients. The present study evaluated the effects of ZDJS on glucose metabolism and explored the corresponding mechanisms in terms of modulating gut microbiota and the fecal metabolome. Type 2 diabetic db/db mice were given ZDJS (1 g/kg) orally twice daily for 55 days, after which glucose metabolism, inflammation, gut microbiota, and fecal metabolomics were assayed. Repeated administration of ZDJS was associated with a trend toward decreasing fasting blood glucose and a 0.12% decrease in hemoglobin A1c (HbA1c), as well as statistically significant increases in the insulin sensitivity index and decreases in serum levels of tumor necrosis factor (TNF‐α) and ileum expression of mucin‐2. ZDJS also ameliorated the compensatory enlargement of islets and decreased the ratio of the α‐cell area to total islet area; however, this amelioration of impaired oral glucose tolerance became less pronounced as treatment continued. In addition, ZDJS remarkably decreased the abundance of phylum Proteobacteria and the phylum ratio of Firmicutes to Bacteroidetes, as well as altered the fecal metabolic profile. Taken together, our findings demonstrate that ZDJS improved glucose metabolism and reduced inflammation in type 2 diabetic db/db mice, which may be associated with a reshaping of the gut microbiome and fecal metabolome in db/db mice. Thus, our study suggests that ZDJS may represent a complementary therapy for patients with type 2 diabetes.

337-OR: Continuous Glucose Monitoring Shared Medical Appointments Improve A1C and Diabetes Self-Efficacy

Background: Personal continuous glucose monitoring (CGM) is patient owned and often inaccessible due to cost and insurance requirements. Professional CGM is clinic owned, worn for 3-14 days and is an affordable, underutilized option. The present study combined diabetes education and professional CGM into a shared medical appointment (SMA). The SMA allows providers to deliver diabetes education in the setting of medical management and peer support. It was hypothesized that the SMA method of delivering professional CGM would positively impact clinical outcomes (improvements in self-efficacy, A1c and medication doses). Methods: Adults with type 1 and type 2 diabetes who attended the two-part CGM SMA at a large academic medical center were included in this retrospective, single-center study. The CGM SMA included 4-6 patients, diabetes educator and pharmacist. Participants wore professional CGM for 7 days. The primary outcome was change in diabetes self-efficacy through a validated 8-item Likert scale. Secondary objectives were changes in A1c, and changes in diabetes medications (dosage adjustments, time of administration). Paired t-tests were used to analyze change in A1c and diabetes self-efficacy scores. Results: Diabetes self-efficacy scores increased by a mean of 1.63 ± 2.09 points (p&amp;lt;.001) out of 10 points. The A1c decreased by a mean of 0.80 ± 1.52% (p&amp;lt;.001) with a mean follow-up A1C of 7.80 ± 1.60%. Those with baseline A1c ≤8.0% (n=70) experienced a decrease in A1c of 0.24% compared to 1.20% in those with A1c &amp;gt; 8.0% (n=101). Participants utilizing the real time device (n=133) experienced a decrease in A1c by 0.75% compared to 1.0% in those with the blinded device (n=38). Most medication changes made in the CGM SMA were dosage adjustments and changes in administration time. Discussion: The CGM SMA is a novel practice model incorporating diabetes education, peer support, professional CGM, and inter-professional care that demonstrated improvements in diabetes self-efficacy and A1c. Disclosure D. Isaacs: Consultant; Self; Companion Medical, LifeScan, Inc. Speaker’s Bureau; Self; Dexcom, Inc., Novo Nordisk Inc., Xeris Pharmaceuticals, Inc. A. Simonyan: None. J.E. Blanchette: Other Relationship; Self; Tandem Diabetes Care. S. Lekic: None. D. Noe: Consultant; Self; Pyure Organic Stevia. N.R. Galloway: None.

1311-P: Number of Daily Meals and Snacks Impacts Glycemic Outcomes in Youth with T1D

Aim: Most youth with T1D meet neither nutrition guidelines nor glycemic goals. We assessed macronutrient content of meals/snacks and impact of daily number of meals/snacks on glycemic outcomes in youth with T1D over 1 year. Methods: Youth completed 3-day food records (2 week days/1 weekend day) and wore 3-day masked CGM (iPro™) every 3 months for 1 year. Diet data were reviewed by 2 RDs and analyzed using Nutrition Data System for Research (NDSR). Glycemic outcomes were A1c and CGM metrics (glucose % time in range [TIR] 70-180 mg/dL, % time [T] &amp;lt;70, %T&amp;gt;180, and glucose CV [SD/mean]). Longitudinal mixed models assessed effect of number of daily meals/snacks on glycemic outcomes. Results: Youth (N=136, ages 8-17, 48% male) were ages 12.8±2.5 years with T1D duration 5.9±3.1 years and daily insulin dose 0.9±0.3 U/kg; 73% used insulin pumps. Number of meals/snacks ranged from 1-9 with most youth (69%) reporting 3-4 meals/snacks daily. Macronutrient intake varied by meal/snack (Figure). An increase of 1 meal/snack per day led to a 0.1% decrease in A1c (p=.001), 2.4% (35 minutes/day) more TIR (p=.0006), and 3.1% (45 minutes/day) less T&amp;gt;180 (p=.0001); T&amp;lt;70 and CV were unchanged. Conclusions: In youth with T1D, eating frequent meals/snacks may lead to lower A1c, more TIR, and less hyperglycemia. These findings may be due to dividing energy intake across the day with more frequent bolus dosing, given predominance of carbohydrates in meals/snacks. Disclosure R.O. La Banca: None. L.K. Volkening: None. E. Dassau: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; Roche Diabetes Care. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. S.N. Mehta: None. L.M. Laffel: Advisory Panel; Self; Roche Diabetes Care. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Insulogic LLC, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi US. Funding National Institutes of Health (P30DK036836, K12DK094721)

Treatment of Hepatitis C Virus and Long-Term Effect on Glycemic Control.

Chronic hepatitis C virus (HCV) infection has been linked to worsening glycemic control in patients with diabetes due to insulin resistance. Studies have shown that treating HCV improves glycemic control in this patient population. Most studies assess glycemic control until the patient's sustained viral response at 12 weeks (SVR12). To (a) assess the sustainability of glycemic control after the SVR12 date and (b) determine the change in diabetic medication use over time. This was a retrospective chart review of patients treated at an academic medical center's hepatology clinic from 2014 through 2017. Patients were eligible for review if they were treated for hepatitis C and had type 2 diabetes mellitus (DM) or pre-DM, defined by a hemoglobin A1c (A1c) > 5.7%, at baseline. Data were collected from the EPIC database available to Temple University Hospital. Results were analyzed using a linear mixed model and descriptive statistics. Of the 1,073 patients screened, 310 met the eligibility criteria. Most patients achieved SVR12 (87.8%). A statistically significant decrease in A1c from baseline to treatment completion with direct-acting antivirals (DAAs) and until current reading was seen (P < 0.05). Overall, A1c was reduced in patients treated for HCV with DAA by -0.27% (95% CI = -0.479% to -0.055%, P = 0.014) from baseline to current reading. No statistically significant difference existed in A1c at time of SVR12 to current reading (difference in A1c = 0.07%, 95% CI = -0.26% to 0.4%, P = 0.67), indicating that the reduction in A1c achieved by treating HCV can be sustained over time. Insulin dose also decreased from baseline to current values. Overall, patients with diabetes successfully treated for the hepatitis C virus may be able to maintain improved glycemic control past SVR12. This could lead to less antidiabetic medication use and decreased insulin requirements for this patient population. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The authors report no conflicts of interest.

790-P: Multicomponent Integrated Care Program Benefits on Diabetes-Related Grief and Stage of Change and Glycemic Control Association

Self-care behavior is the cornerstone in diabetes care. Strategies to promote behavior change and overcome grief process to improve diabetes outcomes have been poorly studied. We examined a quality initiative Multicomponent Integrated Care (MIC) program on Grief Stage (GS) and Stage of Change (SOC) allocation and its association with A1c in persons with type 2 diabetes (PwT2D) in a public primary care T2D clinic. DIABEMPIC is a 5-months empowerment-based program including: interdisciplinary case management team, diabetes self-management education, individual/group sessions, shared medical appointments, audit and feedback, and guaranteed supply of medications. We evaluated the effect of the intervention using a ’before and after’ design. Advanced stages were defined by higher than “anger” and higher than “contemplation” for GS and SOC, respectively. Total PwT2D were 451, the mean (SD) age was 54.6 (11) years, 66% were female, diabetes duration was 12 (8) years and baseline A1c was 9.5% (2.1). Baseline GS: denial 43.6%, anger 25.1%, bargaining 22.8%, depression 8.2% and acceptance 0.3%. Baseline SOC: precontemplation 55.4%, contemplation 40.6%, determination 2.5%, action 2.5% and maintenance 0%. GS and SOC improved after the intervention (83% and 68.7% presented advanced stages, respectively), p&amp;lt;0.001. A1c decreased 2.7% (2.2), p-value &amp;lt;0.001. Advanced GS and SOC were associated with an A1c ≦ 8% (OR 0.29, 95% CI, 0.16-0.52 and OR 0.21, 95% CI, 0.12-0.38, respectively). Also, these advanced stages had higher decrease of A1c (-0.8, -0.7%, respectively) than those who persist in earlier stages (p&amp;lt;0.001). We report a high prevalence of initial GS and SOC in PwT2D and poor glycemic control. MIC program participation was associated with improving GS and SOC. Advanced stages of GS and SOC at the end of the program were associated with better glycemic control. MIC strategies must be considered to promote behavior change and overcome grief process in PwT2D. Disclosure R. Silva-Tinoco: Speaker’s Bureau; Self; Novo Nordisk Inc. O. Salas-Martínez: None. V. delaTorre-Saldaña: None. E.B. Guzman: None. E.C. Cuatecontzi: None. D. Cabrera-Gerardo: None. L. Castillo-Martinez: None. H. Gallardo-Rincón: None. J. Serna: None. A. Gonzalez-Cantu: None. M. Romero-Ibarguengoitia: None.

P1037EFFECT OF VITAMIN D SUPPLEMENTATION ON PROTEINURIA, LIPID STATUS, GLICOREGULATION, C-REACTIVE PROTEIN, VEGF-A, TGF-BETA1 AND NEPHRIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

Abstract Background and Aims: Vitamin D insufficiency/deficiency is often present in patients with Type-2 diabetes mellitus and could present a risk factor for rapid progression of diabetic nephropathy and higher incidence of cardiovascular events. The aim of this study was to examine the influence of vitamin D supplementation on glucoregulation, inflammation, cholesterol, triglycerides, albuminuria and biomarkers of renal injury – nephrin, VEGF-A and TGF- β1 in patients with Type-2 diabetes mellitus and vitamin D insufficiency/deficiency. Method: We included 90 patients with Type-2 diabetes mellitus and vitamin D insufficiency/deficiency in this prospective, cohort study. Patients are divided in 3 equal groups: 30 patients with normal albuminuria, 30 with microalbuminuria and 30 with macroalbuminuria. Therapy included 6 months of supplementation with cholecalciferol drops: first 2 months with 20000 IU twice weekly, than if vitamin D level remained below normal range, we procedeed with same dose next 4 months. If the level of vitamin D normalized, we proceeded with 5000 IU twice weekly. At the beginning and at the end of the study we measured levels of albumin, hemoglobin, serum iron, urea, creatinine, fasting blood glucose, hemoglobin A1c, calcium, phosphorus, total cholesterol, triglycerides, C-reactive protein, intact parathyroid hormone, and urine analysis: 24-hour urine protein, albumin/creatinine ratio and creatinine clearance. Biomarkers are measured in serum and urine. Levels of calcium, phosphorus and vitamin D are also checked 2 months after beginning of therapy due to possible correction of cholecalciferol dose. Results are analysed according to the vitamin D level at the beginning and at the end of the study. Results: The lowest level of vitamin D, before therapy, is found in patients with macroalbuminuria, while at the end of the study we found significantly higher level of vitamin D in all three groups. After 6 months of therapy we found significant decrease of 24-hour urine protein, total cholesterol, triglycerides, hemoglobin A1c and VEGF-A in urine, in all three groups, and C-reactive protein in patients with normal albuminuria and microalbuminuria, nephrin in urine in patients with microalbuminuria and TGF- β1 in urine in patients with macroalbuminuria. Conclusion: vitamin D supplementation with high-dose cholecalciferol in patients with Type-2 diabetes mellitus (with or without albuminuria) decreases C-reactive protein, hemoglobin A1c, total cholesterol, triglycerides in serum, and albumin/creatinine ratio, 24-hour urine protein, VEGF-A, TGF- β1 and nephrin in urine.

2247-PUB: Shared Education Visits for Adolescents with Type 1 Diabetes

Introduction: Deterioration in glycemic control often occurs during adolescence in children with type 1 diabetes (T1D). Shared appointments have been shown to improve quality of life scores and treatment adherence in children with chronic illnesses. Objective: To examine the impact of combined individual visits and shared education appointments in adolescents with T1D on diabetes control, self-management, and diabetes related distress. Methods: Adolescents ages 11-19y with T1D for over 1y and poor control/adherence defined by HbA1C &amp;gt; 9%, 2 or more DKA episodes in the past year or 2 missed appointments were enrolled in a 6 month DKA prevention program consisting of monthly individual visits followed by an hour long shared education visit. HbA1C levels were obtained every 3 mo. Participants completed a diabetes distress score (DDS) and diabetes self-management questionnaire (DMSQ) prior to participation and at the 6th visit. Participants were followed for an additional 6 months after completion of the program. Those who attended 2 or more session were included in the analysis. Results: Ten adolescents (8 female, average age 13.9 y, diabetes duration from 1-11 y, average A1C 10.6% SD 2.0) were enrolled. None of the 10 participants had DKA during the program. There was no statistically significant change in A1C. No changes were noted in the DDS; however there was improvement in dietary control on DMSQ from 4.0 to 5.7 (p value 0.058). Six attended 5 or more of the sessions. Those 6 participants had a decrease in average A1C by 0.3% over 6 mo with no DKA episodes within 6 mo of completion. The 4 participants who attended 2-4 sessions had an increase in average A1C of 0.85% over the same period and 3 had DKA episodes within 6 mo after completion. Conclusions: Shared education visits may be a valuable approach to the care of adolescents with diabetes. No episodes of DKA and no significant changes in glycemic control were noted in 6 mo; however larger long-term studies are needed to explore whether continued shared visits can improve glycemic control. Disclosure M. Wilkes: None. T. Murphy: None. A. Aluf: None. D. Sperber: None. A. Sherry: None. S. Sethuram: None. L. Choleva: None. R. Rapaport: None.

Impact of Monthly A1C Values Obtained at Home on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

The purpose of this randomized controlled clinical trial was to determine whether an A1C value obtained at home by participants followed by a phone discussion of the result with a clinician would lead to 1) a more rapid and significant decrease in A1C, 2) more effective advancement of diabetes treatment, and 3) improvement in diabetes self-care behaviors. The study included 307 participants with type 2 diabetes, most of whom were of Latino origin. All study participants experienced a statistically significant reduction in mean A1C (control subjects -0.3%, P = 0.04; intervention subjects -0.5%, P = 0.0002), but there was a statistically significant difference in the number of people who achieved a reduction of ≥0.5% by 6 months, favoring the intervention (33.6 vs. 46.7%, P = 0.05).

SUN-678 Telediabetes Improves A1C and Patient Satisfaction: A Pilot Study in a VA Institution

Introduction: Rural Americans experience significant health disparities and have poorer health outcomes compared to their urban counterparts. Access to health care services in rural areas remains an ongoing challenge. Telehealth services can efficiently and effectively improve access to healthcare for people living in rural and remote areas. However, it is unclear if telemedicine services would be effective in the veteran population. Therefore, we have initiated a pilot studyto verify the effectiveness and satisfaction of diabetes care delivered through telehealth (Telediabetes) in a Phoenix VA community-based outpatient clinic (CBOC). Methods: The Southeast CBOC is a remote VA clinic in Phoenix with the largest volume of patients with diabetes. Inclusion criteria were patients with type 2 diabetes that have been seen at least one time in the endocrinology clinic at the Phoenix VA and were willing toparticipate in telemedicine. Of the 36 patients that qualified for the study, 20 (55%) were scheduled, 11 (31%) were unreached, and only 5 (14 %) declined. Interventions included optimizing use of newer diabetes medications such as GLP-1 agonists and SGLT2 inhibitors andefforts to improve adherence to treatment regimens. Methods to improve adherence included offering home self-monitoring of blood glucose, increased frequency of visits, including home video conferencing and recommending referrals to nutrition and clinical pharmacists for amultidisciplinary approach. Patient satisfaction was assessed through a validated 5-question survey using a Likert scale 1-5 immediately after each visit. The primary outcomes were change in A1c and patient satisfaction. Results: 95% (17/18) of the participants were males, the mean age was 62.5±.14.0 years-old, and the mean BMI was 34.4±6.8 kg/m2. Median follow-up time was 189 days (range: 89-417). During follow-up, A1c decreased by 0.8% (baseline: 9.5±2.2 vs. post-visit: 8.7±2.0%, p=0.017).Overall, all patients were fully satisfied (Likert score of 5) with the telediabetes visits and 94% of the patients would choose telehealth over face-to-face appointments. Up to now 37% of patients have had at least a second visit with telediabetes. Conclusion: Telediabetes is an effective alternative to face-to-face visits for rural veterans, as demonstrated in other communities. The high patient satisfaction and decrease in A1c in this study showed that the program can be expanded to increase access to diabetes care in remoteareas.

Pharmacist impact on health outcomes in a homeless population

ObjectiveThe aim of this study was to analyze the effect of clinical pharmacy services on health outcomes and medication adherence concerning hypertension and diabetes in the homeless population. MethodsThis was a retrospective quasi-experimental study conducted between January 1, 2015, and December 31, 2016. The primary outcomes included median blood pressure and median glycosylated hemoglobin (A1C) change from baseline. The secondary end points included adherence to hypertension and diabetes medication, in addition to the differences in the number of admissions to urgent care clinics, emergency departments, or hospitals pre- and postpharmacist clinic visit. ResultsOne-hundred ninety-eight homeless patients were seen by a pharmacist over the study time frame, and 116 of these patients were included. There was a decrease in systolic and diastolic blood pressure in the 6-months postpharmacist visit (139 mm Hg vs. 135 mm Hg, P = 0.413, and 85 mm Hg vs. 82 mm Hg, P = 0.197, respectively). The percentage of patients who met the blood pressure goals increased from 55% to 66% (P = 0.093). A statistically significant decrease in A1C was found (7.7% vs 7.2%, P = 0.038). The number of patients who met the A1C goal increased from 20% to 41% (P = 0.267) after pharmacist intervention. No medication class was associated with a median proportion of days covered of 80% or greater. However, differences were seen with biguanides (34% vs. 43%, P = 0.004), calcium channel blockers (44% vs. 59%, P < 0.001), and thiazides (28% vs. 39%, P = 0.039) pre- and postintervention. There was no difference in the number of visits to emergency departments or urgent care clinics, or hospitalizations. ConclusionHomeless patients with hypertension and type 2 diabetes who had at least 1 visit with a pharmacist showed some improved health outcomes. Statistically significant benefits were seen in diabetes management, but not for blood pressure control.

Outcomes of SGLT2 Inhibitors Use in Diabetic Renal Transplant Patients

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly introduced hypoglycemic drugs that work by inhibiting glucose reabsorption at proximal renal tubules. The use of SGLT2 inhibitors in nontransplant diabetic patients with or without cardiovascular disease has well-established efficacy and safety. The risks of renal graft dysfunction and urinary tract infections might be the limiting factors for their use in renal transplant patients. Data regarding the safety and long-term efficacy of SGLT2 inhibitors use in diabetic renal transplant patients is scanty. The aim of the study is to report our experience with use of SGLT2 inhibitors in 8 diabetic renal transplant patients supported by literature review. Eight diabetic renal transplant patients were recruited from Tawam hospital during the period between June 2016 and January 2019. Demographic, clinical, and laboratory data were collected and analyzed. Adding SGLT2 resulted in significant decrease in hemoglobin A1c and body mass index after 12 months of treatment. There was significant negative correlation between the duration of treatment with SGLT2 and hemoglobin A1c. Diabetic renal transplant patients with stable kidney function had better glycemic control with use of SGLT2 inhibitors. There was no deterioration of kidney function and risk of recurrent urinary tract infection was low.

Evaluation of a Conservative Pharmacist-led U-500R Insulin Management Protocol in the Primary Care Setting.

ObjectiveThe objective of this quality assurance study is to evaluate the impact of a conservative, pharmacist-led, U-500R insulin management protocol on diabetes control (A1c) and total daily dosage requirements between August 2016 and August 2018.MethodsThis was a retrospective chart review of adult patients, aged 18 to 79, with type 2 diabetes and managed with insulin, at 2 federally qualified healthcare clinics in Denver, Colorado. To determine if our conservative pharmacist-led U-500R insulin management protocol impacted efficacy and total daily dosage requirements when converting patients from U-100 to U-500R insulin, we compared the most effective dose of U-500R (defined as the total daily dose (TDD) of U-500R insulin at A1c goal or the lowest tolerated A1c) to the baseline A1c and TDD of U-100 insulin at time of conversion.ResultsFollowing conversion of U-100 to U-500R insulin, patients required an average of 21 fewer units of insulin with U-500R than U-100 and achieved an average A1c of 7.2% which reflected a reduction of 3.5 points from baseline. Five patients (62.5%) achieved A1c goal per ADA guidelines, and all patients achieved at least a 1.7 point reduction in A1c, with 1 patient achieving a 6.7 point reduction. Two patients (25%) were still in the process of U-500R titration at the time of data collection, and 1 patient (12.5%) did not achieve goal A1c while under pharmacy management at these clinics. Four of the five patients who achieved A1c goal did so with an overall reduction in total daily insulin dose (average of 57.5 units less than original U-100 dose) resulting in an average A1c decrease of 3.6 points.

Persistence with Basal-Bolus Insulin Therapy in Patients with Type 2 Diabetes Mellitus and Effect on Clinical and Economic Outcomes: A Retrospective Claims Database Study.

Persistence with multiple daily insulin injections (MDI) may be challenging for patients with type 2 diabetes (T2DM). However, limited information is available regarding the effect of persistence with MDI on outcomes. To evaluate persistence with basal and bolus insulin therapy and assess its relationship with clinical and economic outcomes in a real-world setting. This retrospective matched cohort study used 2012-2015 data from multiple U.S. commercial health plans (IBM MarketScan). Patients with T2DM aged 18-64 years with ≥ 2 basal and ≥ 2 bolus insulin claims during a 12-month period were eligible for inclusion if they had 18 months of continuous health plan enrollment (6-month baseline and 12-month post-index). Persistence during 12 months post-index was defined using 2 methods: (a) method 1, ≤ 90-day gaps in both basal and bolus insulin claims and (b) method 2, ≥ 1 basal and ≥ 1 bolus insulin claim every quarter (every 90 days) for 4 consecutive quarters after index bolus claim. Propensity score matching was used to match persistent and nonpersistent method 2 cohorts. Mean per-patient all-cause and diabetes-related medical costs (2015 U.S. dollars, excluding outpatient drugs) and health care resource use (HCRU) were calculated. For patients with hemoglobin A1c (A1c) values during baseline and post-index months 10-12, treatment success was defined as (a) A1c decrease from baseline of ≥ 1% and/or (b) baseline A1c ≥ 7% with post-index A1c < 7%. Baseline characteristics of matched cohorts were compared using standardized mean differences (SMDs). Outcome variables were compared using t-tests, chi-square tests, and generalized linear models. Characteristics of 12,882 eligible patients and 12-month persistence rates were similar as defined by method 1 (22.4%) and method 2 (21.1%). After matching, the method 2 cohorts included 2,723 and 8,169 persistent and nonpersistent patients, respectively, with well-balanced baseline characteristics (mean age 53 years; 58% men; all SMDs < 0.1). All-cause annual medical costs were lower for the persistent cohort (mean $13,499 vs. $17,362; P < 0.0001), as were annual diabetes-related costs (mean $6,392 vs. $8,376; P < 0.0001). In persistent versus nonpersistent cohorts, 11% versus 15% of patients, respectively, experienced ≥ 1 hospitalization; 21% versus 24%, respectively, had ≥ 1 ED visit; 9% versus 12%, respectively, experienced ≥ 1 diabetes-related hospitalization; and 13% versus 15%, respectively, had ≥ 1 diabetes-related ED visit (P ≤ 0.005 for all). Mean baseline A1c was similar in persistent and nonpersistent cohorts (9.7% vs. 9.6%, respectively; P = 0.63). Persistence with MDI was associated with greater mean reduction in A1c (-1.3% vs. -0.8%, respectively; P = 0.006) and greater percentages of patients achieving treatment success (55% vs. 39%, respectively, for nonpersistent; P = 0.009). Poor persistence with basal-bolus insulin therapy over 12 months of follow-up was prevalent and was associated with greater medical costs, greater HCRU, and poorer glycemic control than for patients who were persistent. Interventions are needed to improve persistence with insulin therapy and aid patients with T2DM to achieve glycemic control. Funding for this study was provided by Becton, Dickinson and Company (BD). All authors except Edelman are employees and stockholders of BD. Edelman reports board membership at Senseonics and participation in advisory board/speakers bureau at Lilly USA, MannKind, Novo Nordisk, Sanofi-Aventis U.S., Merck, and AstraZeneca, all unrelated to this study. A poster for this study was presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2018; April 23-26, 2018; Boston MA.

A Randomized Trial of the Close Reading and Creative Writing Program: An Alternative Educational Method for Adult Group Care Intervention in Type 2 Diabetes Management

ObjectivesGroup care for individuals with diabetes is a recognized educational practice, but techniques from narrative medicine using of literary works have never been incorporated in these programs. We designed a new educational model (i.e. the Close Reading and Creative Writing program) of group care for individuals with diabetes incorporating close reading and creative writing in group education. A randomized trial was designed to evaluate this intervention. MethodsA total of 49 individuals with type 2 diabetes, aged <85 years and with >6 years of school education, were randomized to 2 different group care dynamics: (a) a “control group,” with a classical structured educational approach currently used at our institution; and (b) an “intervention group,” with introduction of literary texts, narrative skills, close reading and creative writing. Evaluation included anthropometric measures, glycated hemoglobin (A1C) and questionnaires for psychological evaluation. Individual A1C levels in the 6-year period before the trial were collected from clinical records. ResultsA significant reduction of A1C was observed in the intervention group, showing noninferiority in relation to the classical approach. A significant decrease in A1C was observed in relation to the 6 previous years. A significant increase in satisfaction with the therapist and group process was observed. ConclusionsThis is the first randomized trial designed to evaluate a group care intervention to manage type 2 diabetes using narrative techniques. The results suggest that this may be a useful model for more highly schooled individuals, and may represent an alternative for the educational process.