Change In Hemoglobin A1c Research Articles

P1050THE EFFICACY AND RENAL SAFETY OF SWITCHING FROM DAPAGLIFLOZIN TO EMPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES

Abstract Background and Aims Both dapagliflozin (DPG) and empagliflozin (EPG) are highly selective sodium-glucose cotransporter-2 (SGLT-2) inhibitors that inhibit glucose reabsorption and increase its excretion in urine. Previously, DPG was limited to patients with an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2, while EPG can be used for those with an eGFR ≥ 45 mL/min/1.73 m2. Therefore DPG was switched to EPG in many patients when eGFR decreased. However, the clinical efficacy and safety of these switches are not clear. In this study, we compared the efficacy and renal safety between patients switching from DPG to EPG and those continuing DPG in patients with type 2 diabetes mellitus (T2DM). Method This retrospective observational study included patients with T2DM who were treated with DPG for more than 6 months. This study included patients who switched to EPG and those who continued using DPG. All other hypoglycemic drugs were maintained at the same dosage before and after the study period. The primary outcome measure was the change in hemoglobin A1c (HbA1c) level after 6 months. The EPG group was evaluated for whether the hypoglycemic effect remain effective after drug switching. Patients with HbA1c levels at or lower than the baseline value after 6 months were defined as effective and patients with levels higher than the baseline were defined as invalid. Safety was evaluated by comparing the difference of eGFR between the baseline value and six months after treatment. Results This study included 169 patients. Among them, 72 patients continued DPG and 97 patients switched to EPG. HbA1c level decreased significantly only in EPG group. In EPG group, 59 patients belong to the effective group (60.8%) and 38 patients were invalid (39.2%). There was no significant change in eGFR after treatment in both groups. Ten patients in DPG group develop adverse reactions (three patients felt uncomfortable and seven patients had urinary tract symptoms), but all continued treatment. In EPG group, five patients lacked follow-up records during the study period and it was difficult to determine whether the patient’s willingness to continue treatment was affected by adverse reactions. Conclusion Our study showed that switching from DPG to EPG in patients with T2DM was effective for blood glucose maintenance and caused no significant changes in renal function. In addition, no severe drug-related adverse reactions were found.

Abstract C032: A hospital farm: Using urban agriculture to address nutrition, physical activity, and food insecurity in cancer survivors

Abstract Purpose: Lyndon B Johnson (LBJ) Hospital, a safety net hospital, serves the racially/ethnically diverse (60% Hispanic) and low-socioeconomic status urban population of Harris County, Texas. A number of chronic disease outcomes including cancer are worse than national statistics, of which a major determinant is modifiable behaviors related to energy balance – nutrition and physical activity. A lack of educational opportunities promoting healthy living and a high prevalence of food insecurity further exacerbate the problem. In response, we are building a farm on the campus of LBJ Hospital. We report the current status and future plan of this long-term project. Methods: The 1.5-acre farm broke ground in April 2018. In the context of cancer, the 2 objectives are: 1) to educate survivors about nutrition and gardening as physical activity, and 2) to reduce cancer incidence by engaging the community through educational activities and satellite gardens. We assembled a task force consisting of a medical oncologist, a nurse, dieticians, a farmer and population health experts to design a skill-based curriculum. Funding thus far comes from philanthropy and a competitive grant. Results: A full-time farmer was hired in March 2019 to oversee daily operations and to be the liaison with community groups. To date, 34 raised garden boxes have been built, 1/4-acre main plot is expected to yield 250kg of produce/week in fall/winter 2019, 32 fruit trees have been planted, and a nursery is planned. An evidence-based curriculum has been developed: 5 1-hour learning modules integrate nutrition (culinary techniques, culturally-sensitive recipes) with gardening (basic soil biology, seasonality). A 12-month pilot is to begin in fall/winter 2019. Outpatients with hypertension, diabetes or cancer will be eligible for the class. Participant questionnaires will be administered at baseline, completion and after to assess the primary endpoints of knowledge in nutrition (food groups, labeling, etc.), change in consumption of fruits and vegetables (amount, frequency), change in physical activity level (intensity, duration, frequency), and adoption of gardening as physical activity (duration, frequency). Secondary endpoints will be rate of adherence to medical appointments, change in weight, blood pressure control, change in hemoglobin A1c, and quality of life. Food insecurity will be identified using the Hager 2-item screen. We have solidified partnerships with city government officials and community organizations – local high school, churches, county public health department, local food bank and farms. Conclusion: The hospital-based farm is a multi-level intervention targeting energy balance as a root cause of chronic diseases including cancer and food insecurity as a social determinant of health on the patient and community levels. In the upcoming 12-month pilot, we hypothesize the integrated nutrition/gardening classes will increase consumption of fruits and vegetables and uptake of gardening as physical activity. Citation Format: Hilary Y Ma, Avni P Mody, Janelle Lustgarten, Lisa Ronning, Rebecca Verm, Thomas Garcia-Prats, Michelle Seitzinger. A hospital farm: Using urban agriculture to address nutrition, physical activity, and food insecurity in cancer survivors [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr C032.

4063 Glycemic control in a weight management-focused group medical visits (WM/GMV) intervention: examining the moderating effects of body mass index (BMI)

OBJECTIVES/GOALS: The impact of baseline BMI on glycemic response to group medical visits (GMV) and weight management (WM)-based interventions is unclear. Our objective is to determine how baseline BMI class impacts patient responses to GMV and interventions that combine WM/GMV. METHODS/STUDY POPULATION: We will perform a secondary analysis of Jump Start, a randomized, controlled trial that compared the effectiveness of a GMV-based low carbohydrate diet-focused WM program (WM/GMV) to traditional GMV-based medication management (GMV) on diabetes control. The primary and secondary outcomes will be change in hemoglobin A1c (HbA1c) and weight at 48 months, respectively. Study participants will be stratified into BMI categories defined by BMI 27-29.9kg/m2, 30.0-34.9kg/m2, 35.0-39.9kg/m2, and ≥40.0kg/m2. Hierarchical mixed models will be used to examine the differential impact of the WM/GMV intervention compared to GMV on changes in outcomes by BMI class category. RESULTS/ANTICIPATED RESULTS: Jump Start enrolled 263 overweight Veterans (BMI ≥ 27kg/m2) with type 2 diabetes. At baseline, mean BMI was 35.3 and mean HbA1c was 9.1. 14.5% were overweight (BMI 27–29.9) and 84.5% were obese (BMI ≥ 30). The proposed analyses are ongoing. We anticipate that patients in the higher BMI obesity classes will demonstrate greater reductions in HbA1c and weight with the WM/GMV intervention relative to traditional GMV. DISCUSSION/SIGNIFICANCE OF IMPACT: This work will advance the understanding of the relationship between BMI and glycemic response to targeted interventions, and may ultimately provide guidance for interventions for type 2 diabetes.

4265 Effect of individual characteristics, healthcare access, and built environment on care coordination outcomes related to cardiovascular disease risk factors

OBJECTIVES/GOALS: We examined how individual characteristics and characteristics of the socioeconomic and built environment were associated with care coordination’s effect on cardiovascular disease (CVD) risks to identify geographic areas that may benefit from supplementary clinic-community linkages. METHODS/STUDY POPULATION: We analyzed data with geocoded residential addresses and data from electronic health records for 9946 adults from a Centers for Medicare & Medicaid Services funded innovation project from 7/1/2013 to 3/30/2015. Variables included patient-level demographics, Elixhauser comorbidity index, total time with a nurse care manager, and neighborhood factors such as poverty indicators, walkability, and social capital index. Outcomes were change in CVD risk factors, hemoglobin A1C, blood pressure (BP), and low-density lipoprotein (LDL). Generalized linear models were used to assess the effect of nurse care management program on outcomes after controlling for confounding factors. RESULTS/ANTICIPATED RESULTS: We report preliminary models that include patient demographics (age, sex, race), health care utilization, nurse care manager contact time, Elixhauser comorbidity index, neighborhood education status, percent of population below 200% federal poverty level, median home value, walkability score of the residential address, and social capital index. After adjusting for all mentioned variables, in adults with HbA1C more than 7.5% at baseline, females had worsening HbA1C by 0.53% over the study period. Additionally, LDL values in females worsened over the study period by 4.8 mg/dL after adjusting for all variables. No clinically significant changes were noted for BP. DISCUSSION/SIGNIFICANCE OF IMPACT: Women’s HbA1C and LDL worsened despite nurse care management and may benefit from additional community-based interventions or interventionists. In future analyses, we anticipate that CVD risk will worsen for patients with higher fast food proximity and with greater geographic distance from their PCP.

Efficacy of Nutrition Counseling by a Dietitian in Improving Clinical Outcomes for People with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of RCTs

Abstract Objectives Nutrition therapy is crucial for the treatment of type 2 diabetes. Preliminary data indicate that nutrition therapy delivered by accredited dietitians achieves better clinical outcomes than when delivered by other healthcare professionals. We compared dietetic intervention provided by accredited dietitians with nutrition advice provided by other healthcare professionals. Methods Systematic literature review and meta-analysis of RCTs of type 2 diabetes management programmes (3 months or more) implementing medical nutrition therapy and reporting changes in haemoglobin A1c (HbA1c) and other clinical outcomes that have been published in CENTRAL, CINAHL, EMBASE, MEDLINE and PsychINFO between 2008 to 18th June 2019. Results Seven studies with a total of 950 participants were included in the meta-analysis. The mean changes [95% CI:] at six or twelve months follow-up in HbA1c, BMI, weight and low-density lipoprotein (LDL) were –0.37 [–0.56, –0.19], –0.56 [–1.14, 0.02], –2.40 [–3.59, –1.20] and –0.16 [–0.29, –0.02] respectively in favour of the intervention group. Conclusions Nutrition intervention provided by a dietitian results in better clinical outcomes of type 2 diabetes, compared with that delivered by other healthcare professionals. Further longitudinal randomised studies are warranted to elucidate long-term (more than one year) effects of the interventions. Funding Sources Nil funding.

Should Baseline Hemoglobin A1c or Dose of SGLT-2i Guide Treatment With SGLT-2i Versus DPP-4i in People With Type 2 Diabetes? A Meta-Analysis and Systematic Review.

Our aim was to explore whether the baseline hemoglobin A1c or the dose of sodium glucose cotransporter-2 inhibitor (SGLT-2i) chosen better predicted the efficacy of SGLT-2i versus dipeptidyl peptidase-4 inhibitor (DPP-4i) in type 2 diabetes. We searched for randomized trials that compared SGLT-2i with DPP-4i in type 2 diabetes and reported a change in hemoglobin A1c over time. We created 2 separate analyses (one based on baseline hemoglobin A1c and the other according to US Food and Drug Administration [FDA]-approved SGLT-2i dose). Thirteen trials were included. In the analysis according to baseline hemoglobin A1c , there was a significantly greater reduction in hemoglobin A1c when baseline hemoglobin A1c was ≥8.5%, favoring SGLT-2i over DPP-4i but not when baseline hemoglobin A1c was <8.5% (mean difference [95%CI], -0.36% [-0.53% to -0.18%] and 0.04% [-0.09% to 0.17%], respectively). On restricting the analysis to trials stratifying hemoglobin A1c to <8.0% or ≥8.0%, results did not change. In the analysis based on FDA-approved SGLT-2i doses, higher SGLT-2i doses caused a significantly greater hemoglobin A1c reduction at ≤26 and ≥52 weeks compared with the highest DPP-4i doses (mean difference [95%CI], -0.11% [-0.18% to -0.04%] and -0.24% [-0.34% to -0.15%], respectively). Lower SGLT-2i doses caused a significantly greater hemoglobin A1c reduction at ≥52 weeks but not at ≤26 weeks compared with the highest DPP-4i doses (mean difference [95%CI], -0.12% [-0.23% to -0.02%] and 0.01% [-0.05% to 0.07%], respectively). In people with type 2 diabetes and a baseline hemoglobin A1c ≥ 8.0%, SGLT-2i produced significantly greater reductions in hemoglobin A1c compared with DPP-4i and may be preferred. SGLT-2i dose titration to a higher FDA-approved dose is recommended in suitable patients.

Ketogenic, hypocaloric diet improves nonalcoholic steatohepatitis

Background and objectivesNonalcoholic steatohepatitis (NASH) is strongly associated with obesity. A weight loss of ≥10% is necessary to improve NASH severity, but this goal has rarely been achieved in published studies using different diet protocols. The effect of a ketogenic, hypocaloric, commercial diet (“Ideal Protein,” IP) on body weight, metabolic markers, and liver tests in a group of NASH patients is evaluated in this study. Daily calorie intake was tailored to achieve a weight loss of ≥10%.MethodsWe analyzed 38 patients with NASH who were placed on the IP diet between 2014 and 2018 and compared their outcomes with 6 control patients who declined the diet. All patients were evaluated by a trained health coach in weekly intervals throughout the study period. Clinical and laboratory data obtained before and at 6.5 months after intervention were compared using paired t-testing.ResultsThe patients on the IP diet experienced a significant weight reduction (217 ± 8 lb vs. 194 ± 7 lb; mean ± S.E.M.), corresponding to an average weight loss of 9.7% ± 1.6%. Significant changes in systolic blood pressure (133 ± 3 mmHg vs. 123 ± 3 mmHg), triglycerides (200 ± 21 mmol/L vs. 132 ± 11 mmol/L), hemoglobin A1c (6.71% ± 0.29% vs. 5.74% ± 0.19%), SGPT (97.3 ± 11.1 IU/L vs. 44.2 ± 5.9 IU/L), SGOT (82.4 ± 10.5 IU/L vs. 32.8 ± 5.2 IU/L), and Fib-4 scores (2.25 ± 0.23 vs. 1.40 ± 0.13) were also observed (P<0.05 in all cases). In the IP group, 50.5% of patients lost ≥10% body weight. In contrast, no significant changes were observed in the control group. The IP diet was well tolerated, and no safety signals were noticed.ConclusionsA ketogenic, hypocaloric resulted in striking weight loss and significant improvements in metabolic parameters and liver tests, suggesting that this approach carries promise for the dietary management of patients with NASH.

Effect of Pharmacist-Driven Professional Continuous Glucose Monitoring in Adults with Uncontrolled Diabetes.

Diabetes requires close monitoring to achieve optimal outcomes and avoid adverse effects. Continuous glucose monitoring (CGM) is one approach to measuring glycemia and has become more widespread with recent advances in technology; however, ideal implementation of CGM into clinical practice is unknown. CGM can be categorized as personal CGM, which can be for at-home use to replace self-monitoring of blood glucose, or professional CGM (proCGM), which is used intermittently under the direction of a health care professional. The expanding role of the clinical pharmacist allows pharmacists to be at the forefront of implementing proCGM technology, but literature on the effect of pharmacist-driven proCGM is lacking. Pharmacists and physicians within 1 physician-owned clinic used proCGM technology differently. Pharmacists conducted 1 or 2 office visits to interpret data and make interventions, while physicians interpreted data 1 time and relayed interventions via phone. To (a) compare the change in hemoglobin A1c from baseline to 6 months between the different methods of proCGM implementation, and (b) describe and compare the clinical interventions made as a result of the different methods of proCGM implementation. In this retrospective cohort study, adults identified in the electronic medical record via Current Procedural Terminology code 95250 or 95251 undergoing proCGM with CGM data interpreted and baseline A1c ≥ 7% were included. Patients with additional CGM use within the 6-month follow-up period were excluded. Data collection included demographics, A1c at baseline and during the 6-month follow-up period, and CGM-associated interventions. Patients were categorized as undergoing 1 pharmacist-driven encounter (RPh1), 2 pharmacist-driven encounters (RPh2), or 1 physician-driven encounter (MD1) for proCGM implementation. Combined RPh1 and RPh2 (cRPh) data were also used for analysis. The primary outcome was change in A1c from baseline to 6 months, which was evaluated by analysis of covariance. Of 378 patient charts reviewed, 315 instances of proCGM implementation met inclusion criteria (58 RPh1, 35 RPh2, 222 MD1), and 253 had post-implementation A1c data for analysis of the primary outcome (52 RPh1, 30 RPh2, 171 MD1). Baseline A1c was 8.4%, 8.8%, and 9.1% with mean reduction from baseline to 6 months of 1.0%, 1.3%, and 0.6%, respectively. cRPh patients experienced a greater mean reduction in A1c compared with MD1 (P = 0.002). RPh2 patients had a statistically significant reduction compared with MD1 (P = 0.005), but RPh1 patients did not (P = 0.054). The number of CGM-associated pharmacological interventions was 1.33 for RPh1 patients, 1.63 for RPh2 at the first encounter and 1.34 at the second, and 1.17 for MD1. Pharmacist-driven implementation of proCGM was associated with greater A1c reductions and more pharmacological interventions versus physician-driven implementation. This study demonstrated improved clinical outcomes with pharmacists providing direct patient care through implementation of new diabetes technology. No outside funding supported this study. The authors have nothing to disclose. Preliminary results of this work were presented at the American College of Clinical Pharmacy Virtual Poster Symposium, May 28-29, 2019. The abstract was not peer-reviewed because of enrollment in the Mentored Research Investigator Training (MeRIT) program. Final peer-reviewed results were presented at the American College of Clinical Pharmacy Annual Meeting; October 26-29, 2019; New York, NY.

Significant Dose-Response between Exercise Adherence and Hemoglobin A1c Change.

The Diabetes Aerobic and Resistance Exercise trial found that aerobic training and resistance training alone each reduced hemoglobin A1c (HbA1c) compared with nonexercising controls, and combined aerobic and resistance training caused greater HbA1c reduction than either training type alone. Our objective was to determine whether a dose-response relationship existed between frequency of exercise training and HbA1c change, and whether this varied by exercise modality or participant characteristics. Post hoc analysis of data from 185 Diabetes Aerobic and Resistance Exercise trial participants with type 2 diabetes randomized to aerobic, resistance or combined training thrice weekly. Dose-response relationships between adherence (percent of prescribed training sessions completed) and HbA1c change were assessed with linear regression. Median overall adherence was 84.9% (interquartile range, 74.4%-93.6%). Higher exercise adherence was associated with greater HbA1c reduction; a 20% increase in adherence (e.g., an additional two sessions per month) was associated with a 0.15% (2 mmol·mol) decrease in HbA1c (β = -0.0076, R = -0.170, P = 0.021). Significant dose-response relationships were identified for aerobic (β = -0.0142, R = -0.313, P = 0.016) and combined training (β = -0.0109, R = -0.259, P = 0.041), but not resistance training (β = 0.0068, R = 0.153, P = 0.233). Dose-response relationships in all training groups combined were significant in subgroups younger than 55 yr (β = -0.0113, R = -0.286, P = 0.005), males (β = -0.0123, R = -0.234, P = 0.010), and baseline HbA1c ≥7.5% (58 mmol·mol) (β = -0.013, R = -0.263, P = 0.011). There was a dose-response relationship between adherence to prescribed exercise and HbA1c reduction suggesting that glycemic control is improved more in individuals with type 2 diabetes with a higher training volume. Dose-response relationships existed for aerobic and combined training but not resistance training. These findings support aerobic and combined exercise prescriptions outlined in clinical practice guidelines.

Beneficial Effects of Ipragliflozin on the Renal Function and Serum Uric Acid Levels in Japanese Patients with Type 2 Diabetes: A Randomized, 12-week, Open-label, Active-controlled Trial.

Objective To examine the add-on effects, compared to the existing antidiabetes treatment, of the sodium-glucose cotransporter 2 inhibitor ipragliflozin on glycemic control and the risk factors of cardiovascular disease (CVD) and chronic kidney disease (CKD) in patients with inadequately controlled type 2 diabetes. Methods This 12-week, randomized, open-label, active-controlled trial included 30 patients with type 2 diabetes who were randomized 1:1 to ipragliflozin and control groups (n=15 each). The ipragliflozin group received 50 mg of ipragliflozin once daily in addition to conventional therapy. The primary outcome was the change in hemoglobin A1c (HbA1c) from the baseline. Secondary outcomes were changes from the baseline in indices of glycemic control, uric acid (UA), renal function, and arterial stiffness. Results The patients' diminished estimated glomerular filtration rate (eGFR) was alleviated in the ipragliflozin group compared to the control group [difference between groups (Δ)=4.6 (95% confidence interval (CI): 1.5-7.7) mL/min/1.73 m2, p=0.006] prior to significant improvements in HbA1c and other parameters, including anthropometric indices and arterial stiffness. Furthermore, ipragliflozin add-on therapy resulted in a greater reduction in serum UA levels than control therapy [Δ=-52.3 (95% CI: -85.5-19.1) μmol/L, p=0.003]. The changes in the eGFR with ipragliflozin treatment were associated with ipragliflozin-mediated changes in the UA, even after adjusting for the age, sex, baseline HbA1c, baseline UA, and baseline eGFR (standardized regression coefficient=-0.535, p=0.010). Conclusion Ipragliflozin add-on therapy was associated with beneficial renal effects in parallel with reducing serum UA levels.

A Retrospective Study of Glucagon-Like Peptide1 Receptor Agonists for the Management of Diabetes After Transplantation.

IntroductionManagement of post-transplant diabetes mellitus is challenging; there is a lack of prospective randomized controlled trials for safety and efficacy of antidiabetic medications in solid organ recipients. Glucagon-like peptide 1 receptor agonists (GLP-1RA) are a relatively new class of medications used to manage type 2 diabetes in the general population. They have several benefits besides glycemic control, including weight loss and improved cardiovascular risk. However, they have not been studied extensively in the post-transplant population for safety and efficacy.MethodsWe conducted a retrospective study of patients who had received kidney, liver, or heart transplant, had diabetes either pre- or post-transplant, and were treated with GLP-1RA. We identified seven kidney, seven liver, and five heart transplant recipients who had received GLP-1RA. We assessed changes in immunosuppressant levels, rejection episodes, changes in hemoglobin A1c (HbA1c), weight, and body mass index (BMI) while on the GLP-1RA. We also looked at changes in insulin dose, other diabetes medications, heart rate, blood pressure, and renal function.ResultsAfter a mean follow-up period of 12 months, there were no significant changes in tacrolimus (FK506) levels and renal function for the period of GLP-1RA use. At the end of 12 months, the mean drop in weight was 4.86 kg [95% CI − 7.79, − 1.93]. The BMI decreased by a mean of 1.63 kg/m2 at the end of 12 months [95% CI − 2.53, − 0.73]. HbA1c decreased from baseline by 1.08% [95% CI − 1.65, − 0.51], 0.96% [95% CI − 1.68, − 0.25], and 0.75% [95% CI − 1.55, 0.05] at 3, 6, and 12 months, respectively.ConclusionsOur data suggest that GLP-1RA do not affect tacrolimus levels or transplant outcomes in solid organ transplant (SOT) recipients in the short term. GLP-1RA also seem to be as effective in SOT recipients for glycemic control and weight loss as in the non-transplant population with diabetes.

Self-management of type 2 diabetes mellitus utilizing technology based mobile medical assisted blood glucose management: Study protocol for a prospective, multi-center, observational study

IntroductionDiabetes mellitus is a major health concern globally as well as in China. Currently, the blood glucose (BG) control and patient outcome of diabetes are less than optimal, due to the poor adherence to established evidence-based treatment guidelines and low utilization of preventive care services by both providers and patients. Evidence suggest the benefit of mobile technology-based applications in improving BG monitoring and management in type 2 diabetes mellitus (T2DM). This study is designed to evaluate the effectiveness, safety and timeliness of the mobile internet technology in improving outpatients blood glucose self-management of Chinese T2DM. Methodsand Analysis: This is a prospective, single-arm, multi-center, observational study involving 250 hospitals across China. Patients aged ≥18 and ≤ 80 years with a diagnosis of T2DM and poor glycemic control, who were willing to receive premixed insulin analogues and could use their own WeChat account independently, were included in the study. The primary outcome of the study is to assess the benefit of programme based on change in hemoglobin A1c (HbA1c) from baseline to 3 months. Secondary outcomes included proportion of patients achieving HbA1c<7% at 3 months, change in fasting and postprandial glucose levels from baseline, incidence of hypoglycemia, frequency of self-monitoring blood glucose (SMBG), the patient behavior of BG monitoring on platform and the association of BG control with health care professionals (HCP)-patient interaction. The mobile based technology intervention can improve the HbA1c and BG levels in the patients receiving premixed insulin analogues and that the adherence of SMBG was increased and the incidence of hypoglycemia was decreased. Additionally, early detection of treatment-related hypoglycemia or other complications will contribute to timely therapeutic adjustments and lifestyle modifications under HCP's recommendations through the seamless HCP-patients interaction based on the mobile application. Ethics and disseminationThe study protocol was approved by the ethics committees from each study site according to the International Conference on Harmonization guidelines for Good Clinical Practice and conformed to Declaration of Helsinki. The results of the analyses will be shared with all the participating hospitals and will be published in peer-reviewed journals. No personal information will be included in the findings. RegistrationThis study was registered at chictr.org.cn (ChiCTR 1900021191).

Favorable pleiotropic effects of sodium glucose cotransporter 2 inhibitors: head-to-head comparisons with dipeptidyl peptidase-4 inhibitors in type 2 diabetes patients

BackgroundSodium glucose cotransporter 2 (SGLT2) inhibitors have shown greater reductions of cardiovascular event risks than dipeptidyl peptidase-4 (DPP4) inhibitors, whereby possible mechanisms may involve the better pleiotropic effects of SGLT2 inhibitors. However, no published data are currently available to directly compare glycemic and pleiotropic effects in real-world type 2 diabetes patients initiating SGLT2 inhibitors or DPP4 inhibitors.MethodWe conducted a retrospective cohort study by analyzing the Chang Gung Research Database, the largest multi-institutional electronic medical records database in Taiwan. We included patients newly receiving SGLT2 inhibitor or DPP4 inhibitor intensification therapy for type 2 diabetes from 2016 to 2017. We matched SGLT2 inhibitor users to DPP4 inhibitor users (1:4) by propensity scores to ensure comparable characteristics between the groups. We primarily evaluated 1-year post-treatment changes of hemoglobin A1c (HbA1c) after SGLT2 inhibitor or DPP4 inhibitor initiation, using two-tailed independent t-test. We also evaluated post-treatment changes in body weight, systolic blood pressure (SBP), alanine aminotransferase (ALT) and estimated glomerular filtration rate (eGFR) values, associated with SGLT2 inhibitors and DPP4 inhibitors.ResultsWe identified a cohort of 2028 SGLT2 inhibitors and 8112 matched DPP4 inhibitors new users. SGLT2 inhibitors and DPP4 inhibitors showed similar HbA1c reductions (− 1.0 vs. − 1.1%; P = 0.076), but patients receiving SGLT2 inhibitors had greater improvements in body weight (− 1.5 vs. − 1.0 kg; P = 0.008), SBP (− 2.5 vs. − 0.7 mmHg; P < 0.001) and ALT values (− 4.1 vs. − 0.0 U/l; P < 0.001) and smaller declines in eGFR values (− 2.0 vs. − 3.5 ml/min/1.73 m2; P < 0.001) when compared to DPP4 inhibitors.ConclusionSGLT2 inhibitors had glucose-lowering effects comparable to those of DPP4 inhibitors but more favorable pleiotropic effects on body weight, ALT and eGFR changes, potentially improving type 2 diabetes patients’ cardio-metabolic disease risks.

Evaluation of Dipeptidyl Peptidase-4 Inhibitors versus Thiazolidinediones or Insulin in Patients with Type 2 Diabetes Uncontrolled with Metformin and a Sulfonylurea in a Real-World Setting.

Guidelines do not make clear recommendations for third add-on agents to metformin plus a sulfonylurea. This study compared the effectiveness and safety of dipeptidyl peptidase-4 inhibitors (DPP4is) to thiazolidinedione (TZD) or insulin as a third add-on agent to metformin plus a sulfonylurea in an integrated health care setting. This retrospective database cohort study included adults with type 2 diabetes not at goal hemoglobin A1C (HbA1C) who initiated DPP4i, TZD, or insulin as a third add-on agent to metformin plus a sulfonylurea from January 2006 to June 2016. Primary outcomes were the proportion of patients who achieved goal HbA1C after starting the third add-on agent and change in HbA1C. Subgroup analysis was performed for patients with baseline HbA1C greater than 9%. In this study, 2080 patients started on a DPP4i were matched to 8320 patients started on TZD and to 8320 patients taking insulin. A significantly higher percentage of patients taking TZD reached goal HbA1C (31.0% versus 23.6%; p < 0.05) and had a significantly larger HbA1C reduction (-0.94% ± 1.34% versus -0.79% ± 1.23%; p < 0.01) compared to patients taking a DPP4i. No difference in the percentage of patients meeting goal HbA1C nor in change in HbA1C was demonstrated between insulin versus DPP4i regimens. For patients with baseline HbA1C greater than 9%, insulin or TZD resulted in a significantly higher proportion of patients achieving goal HbA1C compared to DPP4i (17.3% and 19.0% versus 12.4%, respectively; p < 0.01). TZD was more effective than DPP4i but DPP4i was as effective as insulin as a third add-on agent in the overall study population. Insulin was more effective than DPP4i only in the subgroup analysis of patients with baseline HbA1C greater than 9%.

Evaluation of Dipeptidyl Peptidase-4 Inhibitors versus Thiazolidinediones or Insulin in Patients with Type 2 Diabetes Uncontrolled with Metformin and a Sulfonylurea in a Real-World Setting

BACKGROUND Guidelines do not make clear recommendations for third add-on agents to metformin plus a sulfonylurea. This study compared the effectiveness and safety of dipeptidyl peptidase-4 inhibitors (DPP4is) to thiazolidinedione (TZD) or insulin as a third add-on agent to metformin plus a sulfonylurea in an integrated health care setting. METHODS This retrospective database cohort study included adults with type 2 diabetes not at goal hemoglobin A1C (HbA1C) who initiated DPP4i, TZD, or insulin as a third add-on agent to metformin plus a sulfonylurea from January 2006 to June 2016. Primary outcomes were the proportion of patients who achieved goal HbA1C after starting the third add-on agent and change in HbA1C. Subgroup analysis was performed for patients with baseline HbA1C greater than 9%. RESULTS In this study, 2080 patients started on a DPP4i were matched to 8320 patients started on TZD and to 8320 patients taking insulin. A significantly higher percentage of patients taking TZD reached goal HbA1C (31.0% versus 23.6%; p < 0.05) and had a significantly larger HbA1C reduction (-0.94% ± 1.34% versus -0.79% ± 1.23%; p < 0.01) compared to patients taking a DPP4i. No difference in the percentage of patients meeting goal HbA1C nor in change in HbA1C was demonstrated between insulin versus DPP4i regimens. For patients with baseline HbA1C greater than 9%, insulin or TZD resulted in a significantly higher proportion of patients achieving goal HbA1C compared to DPP4i (17.3% and 19.0% versus 12.4%, respectively; p < 0.01). CONCLUSION TZD was more effective than DPP4i but DPP4i was as effective as insulin as a third add-on agent in the overall study population. Insulin was more effective than DPP4i only in the subgroup analysis of patients with baseline HbA1C greater than 9%.

Pharmacist Interventions in Improving Clinical Outcomes in Patients with Type 2 Diabetes Mellitus Among the Underrepresented Population: A Collaborative Ambulatory Care Pharmacy Practice (CAPP) Approach.

Objective:The objective of this study was to evaluate the impact of pharmacist's interventions through a collaborative ambulatory care pharmacy practice (CAPP) model in patients with type 2 diabetes mellitus (T2DM) among the underrepresented population.Methods:Eligible patients were 18 years and older with a diagnosis of T2DM with or without comorbid cardiovascular disease risk factors. Patients were enrolled through routine primary care provider referrals. During a one-on-one, face-to-face scheduled clinic visit, the pharmacist provided a comprehensive medication management by reviewing vital signs and laboratory values, provided medication reconciliation and management, followed by medication counseling through a CAPP approach in a primary care setting. The pharmacist worked in close collaboration with the primary care provider to intervene on medication therapy through recommendations to initiate, adjust, modify, or discontinue drug therapy and order laboratory tests and drug concentration levels as appropriate. Each visit was documented as a “PharmD Progress Note” in the patient's electronic medical record. Follow-up visits were scheduled until patients' targeted treatment goals were achieved. Primary and secondary outcome data were collected and then analyzed.Findings:A pharmacist saw 47 patients over 12 months. Sixty-four percent of the participating patients were able to achieve targeted treatment goals. A statistically significant decrease in the mean change in hemoglobin A1c, diastolic blood pressure, fasting blood glucose, and triglyceride levels was observed from the baseline which was −2.3%, −7.75 mmHg, −76.1 mg/dL, and −55.5 mg/dL, respectively. No significant changes in other clinical outcomes were observed.Conclusion:The CAPP model demonstrated a significant reduction in clinical endpoints in patients with T2DM among the high-risk underrepresented population.

Efficacy of non-surgical treatment accompanied by professional toothbrushing in the treatment of chronic periodontitis in patients with type 2 diabetes mellitus: a randomized controlled clinical trial.

PurposeThe present study aimed to evaluate the clinical benefit of additional toothbrushing accompanying non-surgical periodontal treatment on oral and general health in patients with type 2 diabetes mellitus (T2DM).MethodsWe conducted a doubled-blind randomized controlled trial in 60 T2DM patients between June 2013 and June 2014. The patients were randomly assigned to the scaling and root planing (SRP) group; the scaling and root planing with additional toothbrushing (SRPAT) group, in which additional toothbrushing was performed by toothpick methods; or the control group. Microbiological and oral examinations were performed for up to 12 weeks following treatment. Non-surgical treatment was conducted in the experimental groups. The SRP group received scaling and root planing and the SRPAT group received additional toothbrushing with the Watanabe method once a week from the first visit through the fifth visit. The primary outcomes were changes in haemoglobin A1c (or glycated haemoglobin; HbA1c) levels, serum endotoxin levels, and interleukin-1 beta levels. Periodontal health status was measured by periodontal pocket depth, the calculus index, and bleeding on probing (BOP).ResultsBoth the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group. Furthermore, only the SRPAT group showed a statistically significant decrease in serum endotoxin levels.ConclusionsNon-surgical periodontal treatment was effective in improving HbA1c and serum endotoxin levels in T2DM patients. Furthermore, non-surgical treatment with additional tooth brushing had a more favourable effect on gingival bleeding management.Trial RegistrationClinical Research Information Service Identifier: KCT000416

Patient activation and Type 2 diabetes mellitus self-management: a systematic review and meta-analysis.

Patient activation has been recognised as a reliable driver of self-management decision-making. This systematic review and meta-analysis examines existing evidence on whether embedding patient activation within Type 2 diabetes mellitus (T2DM) self-management programs can improve patient outcomes. This review has included 10 randomised controlled trials (RCTs) conducted between 2004 and 2019 retrieved from well-known databases such as MEDLINE, PubMed, CINAHL Plus, Scopus, ProQuest and ScienceDirect. The eligible RCTs were excluded if they scored low according to Cochrane Collaboration's 'risk of bias' criteria. Random-effects meta-analyses showed that there were no significance changes in haemoglobin A1C (HbA1c), body mass index (BMI) and patient activation measure (PAM) between intervention and control groups after the intervention; however, the systematic review findings indicated that an improved patient activation level led to significant improvements in T2DM self-management and clinical outcomes including HbA1c level. Studies with a longer follow-up period conducted in community settings and delivered by peer coaches were more likely to lead to significant improvement in both patient activation levels and T2DM self-management and clinical outcomes. This review concludes that patient activation can be used as a reliable tool for improving T2DM self-management and clinical outcomes.

Development and implementation of a collaboration between a patient-centered medical home and community pharmacy

ObjectivesThis study aimed to describe the development and implementation strategies used in the collaboration between a patient-centered medical home (PCMH) and a grocery pharmacy chain and to evaluate the effectiveness of a community pharmacist’s clinical integration in reducing hemoglobin A1c levels at clinic and patient levels. SettingThe Kroger Co and Catholic Health Initiative St. Vincent. Practice descriptionThe Kroger Co is a large grocery store that operates 27 pharmacies in the state of Arkansas, with 20 locations in the central Arkansas area. PCMH is part of a large health system in central Arkansas with 10 primary-care clinics in the area. Practice innovationWith the transition to value-based payment models, pharmacists are being utilized in settings outside of the pharmacy. This project demonstrates a partnership between a community pharmacy and PCMH. The community pharmacist spent 20 h/week in the PCMH providing medication therapy and disease state management services. Services were focused on patients with uncontrolled diabetes. EvaluationDescriptive statistics were used to describe the distribution of the pharmacists’ time. A patient-level pre–post analysis of the mean changes in hemoglobin A1c (HbA1c) was conducted for patients who interacted directly with the pharmacist. A clinic-level analysis was conducted to evaluate changes in HbA1c compared to that in a nonequivalent control group using a standard quality measure. ResultsIn total, 312 individual patients interacted with the pharmacist. Of those patients, 228 had diabetes. A total of 111 patients underwent pre–post HbA1c analysis. In those patients, there was a statistically significant reduction in mean HbA1c . There was no difference in clinic-level results between the intervention and control locations. ConclusionCollaboration between a community pharmacy and PCMH is feasible and may improve patient care. Future research should include pharmacy-based visits and development of a process for improved communication.

Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial.

To investigate the efficacy of adding the glucagon-like peptide-1 receptor agonist liraglutide to continuous subcutaneous insulin infusion (CSII) in overweight or obese persons with type 1 diabetes and non-optimal glycaemic control. A 26-week, randomized, double-blind, placebo-controlled trial including 44 overweight or obese adults with type 1 diabetes randomized 1:1 to liraglutide 1.8 mg once daily (QD) or placebo added to CSII treatment. The primary endpoint was change in haemoglobin A1c (HbA1c). Secondary endpoints included change in insulin dose, CSII settings, glycaemic variability, body weight and patient-reported outcome measures. Finally, adverse effects including hypoglycaemic events were registered. HbA1c was reduced by 5 mmol/mol (0.5%) from a baseline of 66 mmol/mol (8.2%) in patients treated with liraglutide compared with a non-significant change of +2.3 mmol/mol (0.2%) from a baseline of 66 mmol/mol (8.1%) in patients treated with placebo (between-group difference 7 mmol/mol [0.7%], P < 0.001). Liraglutide reduced total insulin dose by 8 units/day or 16% of total insulin dose (P = 0.008). Mean body weight was reduced by 6.3 kg (P < 0.001) compared with placebo. Concomitantly, time spent in glycaemic target range 4-10 mmol/L (71-180 mg/dL) increased while the risk of hypoglycaemia did not differ between groups at the end of treatment. Liraglutide treatment reduced HbA1c, total daily insulin dose and body weight without increasing the risk of hypoglycaemia in CSII-treated patients with type 1 diabetes and insufficient glycaemic control. Liraglutide may be considered a potential add-on therapy to insulin in this subgroup of patients.