Change In Hemoglobin A1c Research Articles

Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study.

BackgroundV-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. The primary objective was to compare change in mean hemoglobin A1c (HbA1c) from baseline to the end of V-Go use.MethodsThis prospective, open-label, multicenter study recruited patients with type 2 diabetes (T2D) and suboptimal glycemic control (HbA1c ≥ 7%) across 28 centers. Efficacy analyses were conducted for all patients with a post-baseline HbA1c and results stratified based on prior antihyperglycemic medication therapies. Insulin dosing was at the discretion of the health care provider and the protocol did not mandate glycemic targets. Treatment satisfaction surveys were utilized to gain patient feedback on the use of V-Go.ResultsOne hundred eighty-eight patients were enrolled in the study, among whom 140 patients had a valid post-baseline HbA1c and were included in the primary efficacy analysis. Use of V-Go resulted in a change of − 0.64%; (P = 0.003) in HbA1c from baseline, and in those prescribed insulin, the total daily dose of insulin was decreased by 12 units/day (P < 0.0001). Twenty-two patients (12%) reported hypoglycemic events (≤ 70 mg/dL), with an event rate of 1.51 events/patient/year.ConclusionIn a T2D population with suboptimal HbA1c, initiating V-Go therapy in a real-world setting significantly improved glycemic control and led to significant insulin dose reductions.ClinicalTrial.gov registry identifier: NCT01326598.

Efficacy and safety of gemigliptin as add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study).

The objective of this study was to evaluate the efficacy and safety of gemigliptin added to a stable dose of insulin alone or of insulin in combination with metformin in patients with type 2 diabetes mellitus. After a two-week run-in period, patients were randomized 2:1 to receive gemigliptin 50 mg or placebo once daily as add-on to background therapy with insulin or insulin plus metformin for 24 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) from baseline at Week 24. Baseline characteristics were similar between the gemigliptin (n = 188) and placebo (n = 95) groups in terms of HbA1c (8.1%). At Week 24, the gemigliptin group showed a statistically significant reduction in mean HbA1c from baseline as compared with placebo (between-group mean difference, -0.7% [95% CI, -0.9% to -0.4%]; P-value < 0.0001). The incidence of overall adverse events and the number of hypoglycaemic adverse events were similar between the study groups. Gemigliptin added to insulin alone or to insulin in combination with metformin resulted in superior glycaemic control compared to that in the placebo group and was well tolerated for 24 weeks in patients with type 2 diabetes mellitus, without causing weight gain or increasing the incidence of hypoglycaemia.

A Pilot Study Embedding Clinical Pharmacists Within an Interprofessional Nephrology Clinic for the Initiation and Monitoring of Empagliflozin in Diabetic Kidney Disease

Background: The American Diabetes Association (ADA) recommends sodium-glucose cotransporter-2 (SGLT2) inhibitors as the second medication to be started, after metformin, for patients with chronic kidney disease (CKD). Sodium-glucose cotransporter-2 inhibitors may cause volume, blood pressure, and electrolyte disturbances; consequently, frequent monitoring and adjustments to other diabetes, blood pressure, and/or diuretic medications may be necessary. Objective: To evaluate the safety and efficacy of an interprofessional clinic model partnering nephrologists and pharmacists for the initiation and monitoring of SGLT2 inhibitors. Methods: A clinical pharmacist was embedded within the nephrology clinic to provide patient education, telephone follow-up, and to work collaboratively with the nephrologists. Diabetes, hypertension, and diuretic regimens were adjusted as needed after empagliflozin initiation. Diabetes regimens were adjusted to adhere to the 2019 ADA guidelines that promote agents with CKD and atherosclerotic cardiovascular disease benefit. Results: Fourteen patients were initiated on empagliflozin during the study period. Urine albumin-to-creatinine ratio (UACR) improved (mean % change −12% ± 61%); the mean percentage change was greater in patients with a higher baseline UACR. The mean change in hemoglobin A1c was 0.3% ± 0.6%. Common adverse reactions were observed and improved over time; no serious adverse drug reactions occurred. Finally, empagliflozin initiation necessitated adjustments to diabetes, hypertension, and diuretic regimens in almost all patients (n = 13, 93%). Conclusion: The implementation of an innovative, interprofessional care model within a nephrology clinic for the initiation and monitoring of empagliflozin in patients with DKD demonstrated clinical benefit with minimal safety concerns.

Social network interventions for health behaviours and outcomes: A systematic review and meta-analysis.

BackgroundThere has been a growing interest in understanding the effects of social networks on health-related behaviour, with a particular backdrop being the emerging prominence of complexity or systems science in public health. Social network interventions specifically use or alter the characteristics of social networks to generate, accelerate, or maintain health behaviours. We conducted a systematic review and meta-analysis to investigate health behaviour outcomes of social network interventions.Methods and findingsWe searched eight databases and two trial registries from 1990 to May 28, 2019, for English-language reports of randomised controlled trials (RCTs) and before-and-after studies investigating social network interventions for health behaviours and outcomes. Trials that did not specifically use social networks or that did not include a comparator group were excluded. We screened studies and extracted data from published reports independently. The primary outcome of health behaviours or outcomes at ≤6 months was assessed by random-effects meta-analysis. Secondary outcomes included those measures at >6–12 months and >12 months. This study is registered with the International Prospective Register of Systematic Reviews, PROSPERO: CRD42015023541. We identified 26,503 reports; after exclusion, 37 studies, conducted between 1996 and 2018 from 11 countries, were eligible for analysis, with a total of 53,891 participants (mean age 32.4 years [SD 12.7]; 45.5% females). A range of study designs were included: 27 used RCT/cluster RCT designs, and 10 used other study designs. Eligible studies addressed a variety of health outcomes, in particular sexual health and substance use. Social network interventions showed a significant intervention effect compared with comparator groups for sexual health outcomes. The pooled odds ratio (OR) was 1.46 (95% confidence interval [CI] 1.01–2.11; I2 = 76%) for sexual health outcomes at ≤6 months and OR 1.51 (95% CI 1.27–1.81; I2 = 40%) for sexual health outcomes at >6–12 months. Intervention effects for drug risk outcomes at each time point were not significant. There were also significant intervention effects for some other health outcomes including alcohol misuse, well-being, change in haemoglobin A1c (HbA1c), and smoking cessation. Because of clinical and measurement heterogeneity, it was not appropriate to pool data on these other behaviours in a meta-analysis. For sexual health outcomes, prespecified subgroup analyses were significant for intervention approach (p < 0.001), mean age of participants (p = 0.002), and intervention length (p = 0.05). Overall, 22 of the 37 studies demonstrated a high risk of bias, as measured by the Cochrane Risk of Bias tool. The main study limitations identified were the inclusion of studies of variable quality; difficulty in isolating the effects of specific social network intervention components on health outcomes, as interventions included other active components; and reliance on self-reported outcomes, which have inherent recall and desirability biases.ConclusionsOur findings suggest that social network interventions can be effective in the short term (<6 months) and longer term (>6 months) for sexual health outcomes. Intervention effects for drug risk outcomes at each time point were not significant. There were also significant intervention effects for some other health outcomes including alcohol misuse, well-being, change in HbA1c, and smoking cessation.

Feasibility of using a transition diabetes team to commence injectable therapies postdischarge from a tertiary hospital: a pilot, randomised controlled trial

ObjectivesThis study aimed to investigate if the use of a transition team was feasible for patients with diabetes being discharged from hospital on injectable diabetes therapies.DesignPilot, randomised controlled trial.SettingThe trial...

Sustained Improvement in Type 2 Diabetes Mellitus is Common After Treatment of Hepatitis C Virus With Direct-acting Antiviral Therapy.

To determine whether diabetic patients with hepatitis C virus (HCV) treated with direct-acting antiviral agents have improved diabetes, accounting for change in both hemoglobin A1c (HbA1c) and diabetes medications, and whether any improvement was sustained. HCV infection is associated with an increased risk of diabetes, with improvement in glycemic control after eradication. There remains uncertainty about the durability and magnitude of this effect. HbA1c and diabetes medications were recorded at 6-month intervals for 1.5 years pretreatment and posttreatment for 122 patients. Subjects were classified as having improved diabetes if there was a decrease in HbA1c≥0.5% with no increase in diabetes medications or a decrease in diabetes medications with a stable HbA1c. HbA1c at the nearest time point before treatment was 8.4%±1.9%, compared with 7.8%±1.7% after treatment, a mean difference of 0.6% [95% CI (0.2, 0.9), P<0.01]. A linear mixed effects model incorporating each subject's repeated measurements over time also demonstrated a reduction after treatment of 0.5% [95% CI, (0.3, 0.8), P<0.001]. Accounting for both HbA1c and diabetes medications, 42 of 122 (34%) had an improvement in diabetes after HCV treatment, and 20 of 28 (71%) of these subjects sustained improvement at 1.5 years follow-up. Prescription of insulin was associated with improved diabetes. Treatment of HCV with direct-acting antiviral agents was associated with improved diabetes in a significant portion of patients with an average reduction in HbA1c of clinically significant magnitude. Among responders, this effect was sustained over 1.5 years of follow-up.

Long-term hemoglobin A1c changes with apremilast in patients with psoriasis and psoriatic arthritis: Pooled analysis of phase 3 ESTEEM and PALACE trials and phase 3b LIBERATE trial

Long-term hemoglobin A1c changes with apremilast in patients with psoriasis and psoriatic arthritis: Pooled analysis of phase 3 ESTEEM and PALACE trials and phase 3b LIBERATE trial

Effect of Continuing Olanzapine vs Placebo on Relapse Among Patients With Psychotic Depression in Remission

Psychotic depression is a severely disabling and potentially lethal disorder. Little is known about the efficacy and tolerability of continuing antipsychotic medication for patients with psychotic depression in remission. To determine the clinical effects of continuing antipsychotic medication once an episode of psychotic depression has responded to combination treatment with an antidepressant and antipsychotic agent. Thirty-six week randomized clinical trial conducted at 4 academic medical centers. Patients aged 18 years or older had an episode of psychotic depression acutely treated with sertraline plus olanzapine for up to 12 weeks and met criteria for remission of psychosis and remission or near-remission of depressive symptoms for 8 weeks before entering the clinical trial. The study was conducted from November 2011 to June 2017, and the final date of follow-up was June 13, 2017. Participants were randomized either to continue olanzapine (n = 64) or switch from olanzapine to placebo (n = 62). All participants continued sertraline. The primary outcome was risk of relapse. Main secondary outcomes were change in weight, waist circumference, lipids, serum glucose, and hemoglobin A1c (HbA1c). Among 126 participants who were randomized (mean [SD] age, 55.3 years [14.9 years]; 78 women [61.9%]), 114 (90.5%) completed the trial. At the time of randomization, the median dosage of sertraline was 150 mg/d (interquartile range [IQR], 150-200 mg/d) and the median dosage of olanzapine was 15 mg/d (IQR, 10-20 mg/d). Thirteen participants (20.3%) randomized to olanzapine and 34 (54.8%) to placebo experienced a relapse (hazard ratio, 0.25; 95% CI, 0.13 to 0.48; P < .001). The effect of olanzapine on the daily rate of anthropometric and metabolic measures significantly differed from placebo for weight (0.13 lb; 95% CI, 0.11 to 0.15), waist circumference (0.009 inches; 95% CI, 0.004 to 0.014), and total cholesterol (0.29 mg/dL; 95% CI, 0.13 to 0.45) but was not significantly different for low-density lipoprotein cholesterol (0.04 mg/dL; 95% CI, -0.01 to 0.10), high-density lipoprotein cholesterol (-0.01 mg/dL; 95% CI, -0.03 to 0.01), triglyceride (-0.153 mg/dL; 95% CI, -0.306 to 0.004), glucose (-0.02 mg/dL; 95% CI, -0.12 to 0.08), or HbA1c levels (-0.0002 mg/dL; 95% CI, -0.0021 to 0.0016). Among patients with psychotic depression in remission, continuing sertraline plus olanzapine compared with sertraline plus placebo reduced the risk of relapse over 36 weeks. This benefit needs to be balanced against potential adverse effects of olanzapine, including weight gain. ClinicalTrials.gov Identifier: NCT01427608.

Development of malignancies and changes in time-dependent hemoglobin A1c among a nondiabetic population: longitudinal analysis.

The fluctuation of hemoglobin A1c (HbA1c) and changes in health habits over time was not considered in previous studies. The aim of this study was to evaluate the time-sequenced association between malignancy incidence and HbA1c with a longitudinal study design using repeated measurements of HbA1c. A retrospective longitudinal study was conducted at a large teaching hospital in Tokyo, Japan, from 2005 to 2016. All participants who underwent voluntary health check-ups at the hospital were included. Our outcomes were the development of malignancy. We compared these outcomes using HbA1c categories. Longitudinal analyses were conducted with a mixed effects model in which time-dependent HbA1c measurements were applied to consider fluctuations in HbA1c levels, adjusted for covariates. A total of 77,385 nondiabetic participants were included in the study; the mean age was 44.7 and 49.4% of participants were male. During a median follow-up of 1588 (interquartile range 730-2946) days, 4506 (5.8%) participants developed malignancies. The relationship between future malignancies and HbA1c was U-shaped; both the lower HbA1c groups (OR 1.31, 95% CI 1.17-1.46 for < 5.0%) and the higher HbA1c group (OR 1.87, 95% CI 1.03-3.39 for ≥ 7.5%) had significantly higher odds ratios compared to the 5.5-5.9%. The lowest HbA1c was associated with higher odds of breast cancer (OR 1.5, 95% CI 1.21-1.86) and female genital cancer (OR 1.57, 95% CI 1.04-2.37). Our study found a U-shaped association between HbA1c and future malignancies among nondiabetic people but did not find additional risk at the prediabetic level. Low HbA1c may be associated with the incidence of breast cancer and female genital cancer.

Clinical parameters affecting the therapeutic efficacy of empagliflozin in patients with type 2 diabetes.

We aimed to investigate the clinical factors affecting the therapeutic effectiveness of the sodium–glucose cotransporter-2 inhibitor empagliflozin in patients with type 2 diabetes mellitus (T2DM). We reviewed the medical records of 374 T2DM patients aged between 20 and 75 years who were prescribed empagliflozin 10 mg or 25 mg as add-on therapy for more than 90 consecutive days. Changes in hemoglobin A1c (HbA1c) from baseline levels and the reduction in body weights of the study participants were assessed. We found that younger patients (≤ 50 years), patients with the highest levels of HbA1c (>9%) at baseline, patients with an estimated glomerular filtration rate (eGFR) of >90 mL/min/1.73 m2, and patients with a shorter duration of T2DM (< 10 years) were more likely to exhibit a better glycemic response. Multivariate linear regression analysis revealed that a shorter duration of T2DM, higher baseline levels of HbA1c, and higher eGFR were positively associated with HbA1c reduction. Higher BMI and lower HbA1c levels were predictors of a more significant reduction in body weight among patients taking empagliflozin. The glucose-lowering effect of empagliflozin was more evident in T2DM patients with higher baseline HbA1c levels, better renal function, and shorter duration of T2DM.

Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study

PurposeThe aim of this study was to evaluate the blood pressure–lowering and cholesterol-lowering effects of a fixed-dose combination therapy using candesartan (CND)/rosuvastatin (RSV) compared with CND or RSV monotherapy in patients with hypertension and hypercholesterolemia. MethodsThis study was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 394 patients were screened. After a 4-week run-in period, 219 of these patients with hypertension and primary hypercholesterolemia were randomized. Patients received 1 of 3 regimens for 8 weeks: (1) CND 32 mg/RSV 20 mg, (2) RSV 20 mg, or (3) CND 32 mg. The primary outcome variables were changes in the systolic blood pressure (SBP) and diastolic blood pressure (DBP) and the percentage changes in LDL-C from baseline to the drug treatment at 8 weeks. The secondary outcome variables were percentage changes of total cholesterol, triglycerides, HDL-C, non–HDL-C, apolipoprotein B, apolipoprotein A-I, high-sensitivity C-reactive protein, and glucose metabolic indices, including percentage changes of the homeostasis model assessment of insulin resistance (HOMA-IR), adiponectin, and hemoglobin A1c. Tolerability of combination therapy was compared with other monotherapy groups. FindingsThe percentage changes of LDL-C were −48.6% (from 157.2 to 80.1 mg/dL) in the RSV group and −49.8% (from 160.2 to 78.9 mg/dL) in the CND/RSV group from baseline to the end of 8 weeks of treatment. Mean SBP and DBP were significantly decreased in the CND/RSV and CND groups after 8 weeks (P < 0.001 for all); however, no significant differences were found between the 2 groups. Total cholesterol levels, triglycerides, non–HDL-C, and apolipoprotein B were significantly reduced in the CND/RSV and RSV groups, with no significant differences between the groups compared with the CND group (P < 0.001 for all). The percentage changes of HOMA-IR, adiponectin, and hemoglobin A1c had no significant differences between the combination groups and monotherapy groups. However, in a 2-sample t test, HOMA-IR was significantly decreased in the CND/RSV group compared with the RSV group in nondiabetic patients (mean [SD] percentage change of HOMA-IR, −8.7% [37.6%] vs 17.1% [53.1%]; P = 0.048). There were no significant differences in metabolic indices between the diabetic groups. Adverse events in the CND/RSV group were similar to those in the monotherapy group. ImplicationsOnce-daily fixed-dose combination therapy with CND/RSV is an effective, tolerable, convenient treatment option for patients with essential hypertension and hypercholesteremia. ClinicalTrials.gov identifier: NCT02770261.

Randomized Evaluation of Anagliptin vs Sitagliptin On low-density lipoproteiN cholesterol in diabetes (REASON) Trial: A 52-week, open-label, randomized clinical trial

Additional reductions in low-density lipoprotein-cholesterol (LDL-C) via antidiabetic therapies should be considered in statin-using patients with sub-optimal LDL-C levels. We compared the efficacy of anagliptin and sitagliptin, two antidiabetic therapies, in reducing LDL-C in type 2 diabetic patients. A randomized, open-label, parallel-group trial was conducted at 17 centres in Japan between April 2015 and January 2018. Adults (age ≥20 years) with type 2 diabetes, any atherosclerotic vascular lesions, and statin prescriptions were included. Anagliptin or sitagliptin were administered for 52 weeks. Primary and secondary endpoints were changes in LDL-C and haemoglobin A1C (HbA1c) levels, respectively. We assessed the superiority (primary endpoint) and non-inferiority (secondary endpoint) of anagliptin over sitagliptin. This study was registered at Clinicaltrials.gov (NCT02330406). Of 380 participants, 353 were eligible and randomized. Mean participant age was 68 years, and 61% were males. Baseline median LDL-C and HbA1c were 108 mg/dL and 6.9%, respectively. Changes in LDL-C were −3.7 mg/dL with anagliptin and +2.1 mg/dL with sitagliptin at 52 weeks, and the estimated treatment difference was a significant −4.5 mg/dL (P = 0.01 for superiority). Changes in HbA1c were +0.02% with anagliptin and +0.12% with sitagliptin (P < 0.0001 for non-inferiority). Overall, anagliptin was superior to sitagliptin in lowering LDL-C without deteriorating HbA1c.

180-LB: Impact of a Multidisciplinary Diabetes Care Team in Primary Care Settings on Glycemic Control

Purpose: A multidisciplinary team approach to diabetes management involves various healthcare members to optimize patient outcomes. However, there are limited studies that look at the effect of a multidisciplinary team on diabetes outcomes outside of endocrinology services. This study aimed to evaluate the impact of a primary care multidisciplinary team on glycemic control and additional risk reduction during a 12-week diabetes program. Methods: Retrospective review of medical records for patients who completed the 12-week diabetes program at three primary care clinics from January to August of 2018 occurred. The primary outcome was mean change in hemoglobin A1c (HbA1c). Secondary outcomes included 24-week HbA1c, mean change in blood pressure, weight, Diabetes Distress Scale (DDS) score, and Patient Health Questionnaire (PHQ9) score. Other secondary objectives included the number of patients on statin therapy and ACE inhibitor or angiotensin receptor blocker therapy as indicated. Patients enrolled in the diabetes program were seen by a provider, pharmacist, dietician, and behavioral health specialist at an initial visit and a 12-week follow-up visit. Follow-up occurred either telephonically or face-to-face in the interim for lifestyle counseling and medication adjustments. Results: In total, 85 patients were included in the final analysis. At 3 month follow-up, the mean A1c was significantly decreased (2.1+/-2.3, p &amp;lt; 0.001), 54.1% of patients met their A1c goal (p &amp;lt; 0.001), 80.5% were on statin therapy (p &amp;lt; 0.001), and the mean change in weight (kg) was -1.96+/- 3.9 (p = 0.001) from baseline. Conclusion: This study demonstrates that a multidisciplinary approach to diabetes management can reduce HbA1c and other risk factors. A multidisciplinary model can be replicated in primary care offices to allow for comprehensive care and improvement in health outcomes for a broader patient population who may not have access to specialty services. Disclosure N.E. Handlow: None. B. Nolton: None. S.E. Winter: None. C.M. Wessel: None. J. Pennock: None. Funding R.K. Mellon Foundation

Safety and Effectiveness of Bexagliflozin in Patients With Type 2 Diabetes Mellitus and Stage 3a/3b CKD

Hyperglycemia exacerbates the progression of chronic kidney disease (CKD), but most glucose-lowering therapies donot address morbidities associated with CKD.Sodium/glucose cotransporter 2 (SGLT2) inhibitors offer potential benefits to patients with diabetes and CKD, but their effectiveness may be diminished with decreased kidney function. We aimed to evaluate the safety and effectiveness of bexagliflozin, a novel SGLT2 inhibitor, in patients with type 2 diabetes and CKD. Phase 3, double-blind, placebo-controlled, multicenter, multinational, randomized trial. 54 sites across 4 countries. Patients with CKD stage 3a or 3b, type 2 diabetes mellitus, and hemoglobin A1c level of 7.0% to 10.5% and estimated glomerular filtration rate (eGFR) of 30 to 59mL/min/1.73m2 who were taking oral hypoglycemic agents for 8 weeks. Bexagliflozin, 20mg, daily versus placebo for 24 weeks. Primary outcome was change in percent hemoglobin A1c from baseline to week 24. Secondary end points included changes in body weight, systolic blood pressure, albuminuria, and hemoglobin A1c level stratified by CKD stage. 312 patients across 54 sites were analyzed. Bexagliflozin lowered hemoglobin A1c levels by 0.37% (95% CI, 0.20%-0.54%); P<0.001 compared to placebo. Patients with CKD stages 3a (eGFR, 45-<60mL/min/1.73m2) and 3b (eGFR, 30-<45mL/min/1.73m2) experienced reductions in hemoglobin A1c levels of 0.31% (P=0.007) and 0.43% (P=0.002), respectively. Bexagliflozin decreased body weight(1.61kg; P<0.001), systolic blood pressure (3.8mm Hg; P=0.02), fasting plasma glucose level (0.76mmol/L; P=0.003), and albuminuria (geometric mean ratio reduction of 20.1%; P=0.03). Urinary tract infection and genital mycotic infections were more common in thebexagliflozin group; otherwise, frequencies of adverse events were comparable between groups. Not designed to evaluate the impact of treatment on long-term kidney disease and cardiovascular outcomes. Bexagliflozin reduces hemoglobin A1c levels in patients with diabetes and stage 3a/3b CKD and appears to be well tolerated. Additional observed benefits included reductions in body weight, systolic blood pressure, and albuminuria. Trial was sponsored by Theracos Sub, LLC.

Integrating a brief mental health intervention into primary care services for patients with HIV and diabetes in South Africa: study protocol for a trial-based economic evaluation

IntroductionDepression and alcohol use disorders are international public health priorities for which there is a substantial treatment gap. Brief mental health interventions delivered by lay health workers in primary care...

Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes.

African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics. This randomized controlled trial (n= 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18months, respectively, between arms. At 6months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p= 0.03). However, by 12 and 18months, the difference was no longer significant (12months - 0.63 intervention vs - 0.45 control, p= 0.52). There was a decrease in A1c over 18months in both the intervention (β= - 0.026, p= 0.003) and the comparison arm (β= - 0.018, p= 0.048) but no difference in trend (p= 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p= 0.002) and diet quality (4.0 vs - 0.5 point change, p= 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p< 0.05) at 12months. The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6months but the difference between groups was no longer significant at 12 and 18months. NCT01901952.

Coaching and Education for Diabetes Distress (CEDD): Protocol for a Randomized Controlled Trial.

BackgroundDiabetes distress (DD), a type of psychological distress specific to people with diabetes, is strongly associated with difficulties in performing self-care and inability to meet glycemic targets. Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD, but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD.ObjectiveThe aim of this study is to describe the rationale and design of an ongoing clinical trial, Coaching and Education for Diabetes Distress trial, that seeks to assess whether HC effectively reduces DD among primary care patients with diabetes and whether HC is more effective than an educational program targeting DD.MethodsThe 2-arm randomized controlled trial is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive 8 HC sessions over a 5-month period. The primary outcome measure is reduction in DD over a 6-month period. Additional outcome measures include changes in hemoglobin A1c and self-care practices (medication-taking, dietary, and physical activity behaviors).ResultsAs of March 2019, screening and recruitment are ongoing, and the results are expected by July 2020.ConclusionsHC is feasible in primary care and has been successfully applied to improving chronic disease self-management and outcomes. This study will provide evidence as to whether it has significant value in addressing important unmet psychological and behavioral needs of patients with diabetes.Trial RegistrationClinicalTrials.gov NCT03617146; https://clinicaltrials.gov/ct2/show/NCT03617146 (Archived by WebCite at http://www.webcitation.org/76Va37dbO)International Registered Report Identifier (IRRID)DERR1-10.2196/12166

A Pragmatic Clinical Trial to Compare the Real-World Effectiveness of V-Go versus Standard Delivery of Insulin in Patients with Advanced Type 2 Diabetes.

BackgroundMany patients with type 2 diabetes mellitus (T2DM) do not have adequate glycemic control, leading to poor patient outcomes and high healthcare costs.ObjectiveThis prospective pragmatic clinical trial evaluated V-Go, a wearable insulin delivery device, compared with standard treatment optimization (STO) among insulin-treated patients with T2DM in a real-world, community-based practice setting.MethodsStudy sites, rather than individual patients, were randomized to V-Go or STO via cluster randomization. Patients were treated according to routine clinical practice and followed up to 4 months. T2DM medications and supplies were purchased utilizing usual insurance and co-pay systems. The primary analysis was an unadjusted treatment group comparison of glycosylated hemoglobinA1c (HbA1c) change from baseline to end of study (EOS). A cost of therapy analysis was completed on patients who had received comparable baseline T2DM treatment with multiple daily basal-bolus insulin injections (MDI).ResultsAnalysis included 415 patients (169 V-Go, 246 STO) enrolled from 52 US sites. Mean baseline HbA1c (9.6%) was higher in V-Go (9.9%, range 8.0% – 14.2%) than STO (9.3%, range 7.9% – 13.9%, p <.001). HbA1c decreased from baseline to EOS in both V-Go (−1.0%, p<.001) and STO (−0.5%, p<.001); V-Go had significantly larger decrease (p=.002). V-Go had a significant reduction (p<.001) in mean insulin total daily dose (TDD; 0.76 U/kg baseline, 0.57 U/kg EOS), not seen in STO (0.72 U/kg baseline and EOS). The MDI group included 95 (56.2%) V-Go and 113 STO (45.9%) patients. Mean baseline HbA1c was significantly higher in V-Go (9.9%) than STO (9.4%). V-Go also experienced larger decrease in HbA1c from baseline (−1.0%) than STO (−0.36%) (p=.006) with a decrease in TDD, while STO TDD remained unchanged. EOS mean per patient per day cost of diabetes treatment was lower for V-Go ($30.59) vs STO ($32.20) (p=.006). V-Go was more cost effective than STO ($24.02 per 1% drop in HbA1c vs $58.86, respectively).ConclusionsThis pragmatic clinical trial demonstrated improved HbA1c levels, lower cost, and decreased insulin dose in patients with T2DM initiating V-Go vs STO in a real-world community-based practice setting. Observed baseline HbAlc indicated use of V-Go in more difficult to manage diabetes patients.

Impact of body mass index on the efficacy and safety of ipragliflozin in Japanese patients with type2 diabetes mellitus: A subgroup analysis of 3-month interim results from the Specified Drug Use Results Survey of Ipragliflozin Treatment in Type2 Diabetic Patients: Long-term Use study.

Aims/IntroductionSpecified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use is an ongoing postmarketing study of ipragliflozin for long‐term use in Japanese patients with type 2 diabetes mellitus. A subgroup analysis of data from the study was carried out to investigate the impact of obesity on the efficacy and safety of ipragliflozin in this population.Materials and MethodsPatients were divided into the following subgroups according to their body mass index (BMI): <22.0, 22.0 to <25.0, 25.0 to <30.0 and ≥30.0 kg/m2. Changes in bodyweight and glycemic parameters up to 3 months were evaluated, as well as adverse drug reactions (ADRs) that occurred during ipragliflozin treatment.ResultsIn the efficacy analysis set (8,633 patients), glycemic control and bodyweight statistically significantly improved from baseline to 3 months in all BMI subgroups (all P < 0.05). No strong correlations were identified between changes in bodyweight and changes in hemoglobin A1c, waist circumference or BMI in any of the subgroups. The incidence of adverse drug reactions was 6.29, 8.44, 11.18 and 11.74% in the <22.0, 22.0 to <25.0, 25.0 to <30.0 and ≥30.0 kg/m2 groups, respectively (P = 0.001), in the safety analysis set (n = 11,053 patients).ConclusionsIn Japanese patients with type 2 diabetes mellitus, ipragliflozin improved glycemic control and reduced bodyweight, regardless of BMI. Adverse drug reactions were more common in patients with higher BMI than in those with lower BMI.

Impact of professional continuous glucose monitoring by clinical pharmacists in an ambulatory care setting

IntroductionUse of continuous glucose monitoring (CGM) in the management of diabetes continues to grow. Despite professional‐use CGM serving as an opportunity for clinical pharmacists to improve care and generate revenue for managing patients with diabetes, there is limited literature describing their involvement with this technology.ObjectivesThe primary objective was to determine if professional CGM improves measures of glycemic control including percentage of time in target glycemic range, change in estimated average interstitial glucose, and change in hemoglobin A1c (HbA1c) from baseline to postintervention. Secondary objectives were to evaluate revenue generation measured by reimbursement rates for Current Procedural Terminology (CPT) codes 95250 and 95251 and utilization of clinical pharmacist services related to professional CGM.MethodsThis was a quasi‐experimental, retrospective, pre‐post intervention analysis. Patients that had a professional CGM placed and more than 24 hours of data interpreted by a clinical pharmacist were included for analysis. All clinical data were extracted from patients' electronic medical records, while reimbursement data were provided by the organization's billing department.ResultsTwenty‐nine patients that received professional CGM were included for analysis. Patients' mean baseline and post‐intervention HbA1c were 9.0% and 8.3%, respectively (P = 0.156). There was no difference in the mean percentage of time in target glycemic range (P = 0.966) or mean estimated average interstitial glucose (P = 0.779) from baseline to post‐intervention. Patients met with clinical pharmacists for a total of 68 follow‐up visits during their individual 14‐day wear periods, 14 of which were unanticipated visits. The mean payment amount for CPT code 95250 was $126.87, while $39.17 was received for 95251.ConclusionsClinical pharmacist‐led professional CGM did not demonstrate a statistically significant difference in measures of glycemic control; however, the 14‐day device wear period provided opportunities for optimization of antihyperglycemic therapy that resulted in a clinically significant reduction in HbA1c and reimbursement for clinical pharmacy services.