Greater Decrease In HbA1c Research Articles

Real-World Evidence of Off-Label Use of Commercially Automated Insulin Delivery Systems Compared to Multiple Daily Insulin Injections in Pregnancies Complicated by Type 1 Diabetes.

Aims: To compare glycemic control and maternal-fetal outcomes of women with type 1 diabetes (T1D) using hybrid closed loop (HCL) versus multiple daily insulin injections (MDI) plus continuous glucose monitoring. Methods: Multicenter prospective cohort study of pregnant women with T1D in Spain. We evaluated HbA1c and time spent within (TIR), below (TBR), and above (TAR) the pregnancy-specific glucose range of 3.5-7.8 mmol/L. Adjusted models were performed for adverse pregnancy outcomes, including baseline maternal characteristics and center. Results: One hundred twelve women were included (HCL n = 59). Women in the HCL group had a longer duration of diabetes and higher rates of prepregnancy care. There was no between-group difference in HbA1c in any trimester. However, in the second trimester, MDI users had a greater decrease in HbA1c (-6.12 ± 9.06 vs. -2.16 ± 7.42 mmol/mol, P = 0.031). No difference in TIR (3.5-7.8 mmol/L) and TAR was observed between HCL and MDI users, but with a higher total insulin dose in the second trimester [+0.13 IU/kg·day)]. HCL therapy was associated with increased maternal weight gain during pregnancy (βadjusted = 3.20 kg, 95% confidence interval [CI] 0.90-5.50). Regarding neonatal outcomes, newborns of HCL users were more likely to have higher birthweight (βadjusted = 279.0 g, 95% CI 39.5-518.5) and macrosomia (ORadjusted = 3.18, 95% CI 1.05-9.67) compared to MDI users. These associations disappeared when maternal weight gain or third trimester HbA1c was included in the models. Conclusions: In a real-world setting, HCL users gained more weight during pregnancy and had larger newborns than MDI users, while achieving similar glycemic control in terms of HbA1c and TIR.

Neighborhood built and food environment in relation to glycemic control in people with type 2 diabetes in the moving to health study

ObjectiveTo examine whether built environment and food metrics are associated with glycemic control in people with type 2 diabetes.Research Design and Methods: We included 14,985 patients with type 2 diabetes using electronic health records from Kaiser Permanente Washington. Patient addresses were geocoded with ArcGIS using King County and Esri reference data. Built environment exposures estimated from geocoded locations included residential unit density, transit threshold residential unit density, park access, and having supermarkets and fast food restaurants within 1600-m Euclidean buffers. Linear mixed effects models compared mean changes of HbA1c from baseline at 1, 3 (primary) and 5 years by each built environment variable. ResultsPatients (mean age = 59.4 SD = 13.2, 49.5% female, 16.6% Asian, 9.8% Black, 5.5% Latino/Hispanic, 57.1% White, 20% insulin dependent, mean BMI = 32.7±7.7) had an average of 6 HbA1c measures available. Participants in the 1st tertile of residential density (lowest) had a greater decline in HbA1c (−0.42, −0.43, and −0.44 in years 1, 3, and 5 respectively) than those in the 3rd tertile (HbA1c = −0.37 at 1- and 3-years and −0.36 at 5-years; all p-values <0.05). Having any supermarkets within 1600 m of home was associated with a greater decrease in HbA1c at 1-year and 3-years compared to having none (all p-values <0.05). ConclusionsLower residential density and better proximity to supermarkets may benefit HbA1c control in people with people with type 2 diabetes. However, effects were small and indicate limited clinical significance.

SAT094 Closed-Loop Insulin Delivery Versus Standard Care In Type 1 Diabetic Adult Patients: A Meta-analysis Of Randomized Controlled Trials

Abstract Disclosure: A. Godoi: None. I.R. Marques: None. A. Mahesh: None. C. Oommen: None. E.M. Padrao: None. V.C. Moreira: None. A.C. Silva: None. L.C. Hespanhol: None. C.H. Silva: None. I.A. Souza: None. C. Gomes: None. I.A. Miyawaki: None. J.E. Loyola Júnior: None. J. De Sa: None. Background: Optimal glycemic control of Type 1 Diabetes Mellitus (T1DM) remains a clinical challenge instigated by hypoglycemic episodes and the burden of insulin self-management. Remarkable advancements have been made with the development of automated insulin devices, particularly closed-loop systems (CL). Yet, previous meta-analyses have not focused on the long-term use and effects of CL systems, and their potential to improve glycemic outcomes in this population remain controversial. Purpose: To compare the therapeutic efficacy of long-term use of CL insulin delivery systems to standard care (SC) in adult patients with T1DM. Methods: PubMed, Cochrane and EMBASE were systematically searched in October 2022 to include randomized controlled studies (RCTs) comparing CL systems (automated pancreas, hybrid CL and advanced hybrid CL) versus SC (daily insulin injections, sensor augmented pump and continuous glucose monitoring) with at least 12 weeks of duration. Outcomes assessed were percentage time in range (% TIR) 70-180mg/dL and change in HbA1c. Statistical analysis was performed with RevMan 5.4.1 and R software. Heterogeneity was assessed with I² statistics. The protocol was registered in PROSPERO (ID: CRD42022366710). Results: A total of 13 randomized studies with 1082 patients with T1DM were included, of whom 586 (54.2%) used automated devices and 496 (45.8%) continued their usual care. The %TIR was higher in the CL systems when compared to SC (MD 11.91%; 95% CI 8.66 to 15.17; p &amp;lt; 0.001; I² = 81%). The HbA1c significantly higher in the CL systems when compared to SC (MD -0.42; 95% CI -0.70 to -0.14; p = 0.003; I² = 78%). The %TIR was significantly higher in patients using CL (MD 9.25; 95% CI 6.79–11.72; p &amp;lt; 0.0001; I² = 34%), hybrid CL (MD 8.20; 95% CI 3.32–13.09; p=0.001; I² = 66%) and advanced hybrid CL (MD 25.38; 95% CI 21.30–29.46; p &amp;lt; 0.0001; I² = 0%). A greater decrease in HbA1c was also found with the use of CL (MD -0.24; 95% CI -0.47 to -0.010.14; p = 0.04; I² = 0%), hybrid CL (MD -0.26; 95% CI -0.43 to -0.10; p=0.002; I² = 3%) and advanced hybrid CL (MD -0.90; 95% CI -1.86 to -0.06; p = 0.07; I² = 83%). Conclusion: In this meta-analysis of randomized trials, the use of CL insulin delivery systems was associated with a higher proportion of time in the optimal glucose range and greater decrease of HbA1c relative to standard care in the adult diabetic population. Presentation: Saturday, June 17, 2023

Effectiveness of synchronous teleconsultation for patients with type 2 diabetes mellitus: a systematic review and meta-analysis

The popularity of teleconsultation during the COVID-19 pandemic enabled increased accessibility for individuals with type 2 diabetes mellitus (T2DM). However, previous studies did not distinguish between synchronous and asynchronous teleconsultation....

Changes in Glycemic Control Following Use of a Spanish-Language, Culturally Adapted Diabetes Program: Retrospective Study

Several barriers to diabetes treatment and care exist, particularly in underserved medical communities. This study aimed to evaluate a novel, culturally adapted, Spanish-language mHealth diabetes program for glycemic control. Professional Spanish translators, linguists, and providers localized the entirety of the Vida Health Diabetes Management Program into a culturally relevant Spanish-language version. The Spanish-language Vida Health Diabetes Management Program was used by 182 (n=119 women) Spanish-speaking adults with diabetes. This app-based program provided access to culturally adapted educational content on diabetes self-management, one-on-one remote counseling and coaching sessions, and on-demand in-app messaging with bilingual (Spanish and English) certified health coaches, registered dietitian nutritionists, and certified diabetes care and education specialists. Hemoglobin A1c (HbA1c) was the primary outcome measure, and a 2-tailed, paired t test was used to evaluate changes in HbA1c before and after program use. To determine the relationship between program engagement and changes in glycemic control, a cluster-robust multiple regression analysis was employed. We observed a significant decrease in HbA1c of -1.23 points between baseline (mean 9.65%, SD 1.56%) and follow-up (mean 8.42%, SD 1.44%; P<.001). Additionally, we observed a greater decrease in HbA1c among participants with high program engagement (high engagement: -1.59%, SD 1.97%; low engagement: -0.84%, SD 1.64%; P<.001). This work highlights improvements in glycemic control that were clinically as well as statistically significant among Spanish-preferring adults enrolled in the Vida Health Spanish Diabetes Management Program. Greater improvements in glycemic control were observed among participants with higher program engagement. These results provide needed support for the use of digital health interventions to promote meaningful improvements in glycemic control in a medically underserved community.

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program.

Culinary medicine is an evidence-based approach that blends the art of cooking with the science of medicine to inculcate a healthy dietary pattern. Food prescription programs are gaining popularity in the Unites States, as a means to improve access to healthy foods among patient populations. The purpose of this paper is to describe the implementation and preliminary impact of A Prescription for Healthy Living (APHL) culinary medicine curriculum on biometric and diet-related behavioral and psychosocial outcomes among patients with diabetes participating in a clinic-led food prescription (food Rx) program. We used a quasi-experimental design to assess APHL program impact on patient biometric outcome data obtained from electronic health records, including glycosylated hemoglobin (HbA1c), body mass index (BMI), and blood pressure (n = 33 patients in the APHL group, n = 75 patients in the food Rx-only group). Pre-post surveys were administered among those in the APHL group to monitor program impact on psychosocial and behavioral outcomes. Results of the outcome analysis showed significant pre-to-post reduction in HbA1c levels among participants within the APHL group (estimated mean difference = −0.96% (−1.82, −0.10), p = 0.028). Between-group changes showed a greater decrease in HbA1c among those participating in APHL as compared to food Rx-only, albeit these differences were not statistically significant. Participation in APHL demonstrated significant increases in the consumption of fruits and vegetables, fewer participants reported that cooking healthy food is difficult, increased frequency of cooking from scratch, and increased self-efficacy in meal planning and cooking (p < 0.01). In conclusion, the results of our pilot study suggest the potential positive impact of a virtually-implemented culinary medicine approach in improving health outcomes among low-income patients with type 2 diabetes, albeit studies with a larger sample size and a rigorous study design are needed.

Efficacy of Dulaglutide in Chinese Patients with Type 2 Diabetes and Different Glycemic Patterns: a Post-hoc Analysis of the Phase 3 AWARD-CHN2 Trial.

IntroductionWe evaluated the effect of dulaglutide on the relative contributions of fasting glucose (FG) and postprandial glucose (PPG) to overall hyperglycemia in patients with type 2 diabetes (T2D), and assessed responses to dulaglutide versus insulin glargine (glargine) in patients with different baseline glycemic patterns.MethodsThis post-hoc analysis of the phase 3 AWARD-CHN2 trial included data from 560 Chinese patients with uncontrolled T2D who received once-weekly dulaglutide (1.5 or 0.75 mg) or once-daily glargine for 26 weeks. The relative contributions of FG and PPG to overall hyperglycemia across different glycated hemoglobin (HbA1c) categories were calculated using the area under the curve of 7-point self-monitored blood glucose profiles. Patients were also categorized into four subgroups according to median baseline FG (cutoff 8.9 mmol/L) and PPG (cutoff 12.5 mmol/L): low FG/low PPG, low FG/high PPG, high FG/low PPG and high FG/high PPG. Changes in glycemic parameters and body weight were calculated for patients in each subgroup.ResultsAmong patients receiving dulaglutide, higher HbA1c was associated with higher relative contributions of FG and lower relative contributions of PPG to overall hyperglycemia at baseline and week 26 of dulaglutide treatment. After 26 weeks, dulaglutide 1.5 mg led to statistically greater decreases in HbA1c from baseline versus glargine in most subgroups, including the high FG subgroups, and a numerically greater decrease in HbA1c was observed in the low FG/high PPG subgroup. Across all subgroups, higher proportions of patients achieved HbA1c ≤ 6.5% with dulaglutide 1.5 mg than with glargine (all P < 0.05). Dulaglutide 1.5 mg showed better control of body weight than glargine in all subgroups (all P < 0.05).ConclusionsDulaglutide reduced HbA1c through reductions in both FG and PPG across HbA1c categories in T2D patients with uncontrolled hyperglycemia. Furthermore, treatment with dulaglutide provided a greater reduction in HbA1c than glargine, regardless of baseline FG and PPG levels.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01182-z.

Improved Glycemic Control With a Digital Health Intervention in Adults With Type 2 Diabetes: Retrospective Study

BackgroundTraditional lifestyle interventions have shown limited success in improving diabetes-related outcomes. Digital interventions with continuously available support and personalized educational content may offer unique advantages for self-management and glycemic control.ObjectiveIn this study, we evaluated changes in glycemic control among participants with type 2 diabetes who enrolled in a digital diabetes management program.MethodsThe study employed a single-arm, retrospective design. A total of 950 participants with a hemoglobin A1c (HbA1c) baseline value of at least 7.0% enrolled in the Vida Health Diabetes Management Program. The intervention included one-to-one remote sessions with a Vida provider and structured lessons and tools related to diabetes management. HbA1c was the primary outcome measure. Of the 950 participants, 258 (27.2%) had a follow-up HbA1c completed at least 90 days from program start. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up. Additionally, a cluster-robust multiple regression analysis was employed to evaluate the relationship between high and low program usage and HbA1c change. A repeated measures analysis of variance was used to evaluate the difference in HbA1c as a function of the measurement period (ie, pre-Vida enrollment, baseline, and postenrollment follow-up).ResultsWe observed a significant reduction in HbA1c of –0.81 points between baseline (mean 8.68, SD 1.7) and follow-up (mean 7.88, SD 1.46; t257=7.71; P<.001). Among participants considered high risk (baseline HbA1c≥8), there was an average reduction of –1.44 points between baseline (mean 9.73, SD 1.68) and follow-up (mean 8.29, SD 1.64; t139=9.14; P<.001). Additionally, average follow-up HbA1c (mean 7.82, SD 1.41) was significantly lower than pre-enrollment HbA1c (mean 8.12, SD 1.46; F2, 210=22.90; P<.001) There was also significant effect of program usage on HbA1c change (β=–.60; P<.001) such that high usage was associated with a greater decrease in HbA1c (mean –1.02, SD 1.60) compared to low usage (mean –.61, SD 1.72).ConclusionsThe present study revealed clinically meaningful improvements in glycemic control among participants enrolled in a digital diabetes management intervention. Higher program usage was associated with greater improvements in HbA1c. The findings of the present study suggest that a digital health intervention may represent an accessible, scalable, and effective solution to diabetes management and improved HbA1c. The study was limited by a nonrandomized, observational design and limited postenrollment follow-up data.

689-P: Association of Preoperative Glycemic Response to GLP-1 Receptor Agonists (GLP-1RA) and Outcomes of Bariatric Surgery

Background: GLP1RAs are an increasingly common treatment in the setting of type 2 diabetes mellitus (T2DM). One hypothesized mechanism by which bariatric surgery contributes to T2DM remission is by increasing intestinal GLP-1 secretion. We aimed to evaluate the association of the response to GLP1RA pre-operatively on hemoglobin A1c (HbA1c) level and weight loss after bariatric surgery. Methods: The NorthShore bariatric surgery database was retrospectively queried for patients with T2DM who had taken a GLP1RA prior to Roux-en-Y gastric bypass (N=38) or gastric sleeve surgery (N=9). GLP1RA response was measured by change in HbA1c from initiation of therapy to 6mo. Outcomes included HbA1c level and percent total body weight loss (TBWL) at 6mo, 1 and 2yr post-op. The association between GLP1RA response and post-operative outcomes was evaluated with partial correlation coefficients adjusted for baseline HbA1c with/without baseline weight. Results: The average HbA1c at initiation of therapy was 8.3±1.4% and decreased by 1.1±1.5% on GLP1RA treatment with liraglutide being most commonly prescribed (44.7%). A greater decrease in HbA1c from GLP1RA was correlated with a lower HbA1c at 6mo (r=0.38, p=0.02), and 2yr (r=0.43, p=0.03), but not 1yr (r=0.35, p=0.06) or TBWL. After adjustment for baseline weight, the association remained at 6mo (r=0.37, p=0.02). Stratification by procedure noted a strong association between GLP1RA response and reduced post-operative HbA1c at 6mo (r=0.99, p&amp;lt;0.01) and TBWL at 1yr (r=0.82, p=0.02) and 2yrs (r=0.99, p=0.01) for patients who had undergone gastric sleeve, but not gastric bypass. Conclusion: To our knowledge, this is the first study examining the association of GLP1RA response on glycemic and weight outcomes post-bariatric surgery in people with T2DM. Despite a number of limitations, results from this small cohort suggest the need for further evaluation of this relationship as a potentially useful predictor of surgical outcomes. Disclosure D. Amusin: None. K. Kuchta: None. T. Ewing: None. L. Tucker: None. M. Campbell: None. M. Ujiki: Advisory Panel; Self; Boston Scientific Corporation, Consultant; Self; Cook Medical, Speaker’s Bureau; Self; Medtronic. L. K. Billings: Advisory Panel; Self; Bayer Inc., Lilly Diabetes, Novo Nordisk, Sanofi.

Impact of tumor necrosis factor inhibitors and methotrexate on diabetes mellitus among patients with inflammatory arthritis

BackgroundTo determine whether initiation of a tumor necrosis factor inhibitor (TNFi) or methotrexate improves hemoglobin A1c in patients with psoriatic arthritis (PsA), rheumatoid arthritis (RA), or ankylosing spondylitis (AS) who also have diabetes mellitus (DM).MethodsA retrospective cohort study was conducted in Optum’s de-identified Clinformatics® Data Mart Database, an administrative claims database, using data from 2000 to 2014. Patients with PsA, RA, or AS, with DM (defined by ICD-9-CM codes) and/or HbA1c ≥7%, who newly initiated either a TNFi, MTX, or metformin (positive control) were identified. The change in HbA1c after drug initiation was calculated. Statistical differences in the change in HbA1c between drugs were assessed using the Wilcoxon rank sum test and linear regression models adjusting for potential confounders.ResultsAmong 10,389 drug initiations in 9541 patients with PsA, RA, or AS, and available HbA1c values, HbA1c was ≥7 at baseline in 254 (35%) TNFi initiations, 361(37%) MTX initiations, and 2144 (50%) metformin initiations. Median HbA1c change was − 0.35 (IQR -1.10, 0.30) after TNFi initiation, − 0.40 (IQR -1.20, 0.30) after MTX initiation, and − 0.80 (IQR -1.60, − 0.10) after metformin initiation. In adjusted analyses, TNFi initiators had less of a decrease in HbA1c compared to MTX initiators (β 0.22, 95% CI: 0.004, 0.43), p = 0.046. Metformin initiators had a significantly greater decrease in HbA1c than MTX, β − 0.38 (95% CI: − 0.52, − 0.23), p < 0.001. Glucocorticoid use was not accounted for in the models.ConclusionHbA1c decreased with TNFi initiation or MTX initiation. Reductions in HbA1c after initiation of a TNFi or MTX are about half (~ 0.4 units) the decrease observed after initiation of metformin.

2190-PUB: A Pragmatic Study of Basal and Mid-Mixture Insulins as Insulin Starters in Chinese Patients with T2DM

This study aimed to compare the effectiveness and safety of basal insulin (BI) and mid-mixture insulin (MMI) in a real-world setting. Chinese patients with T2DM uncontrolled on oral antihyperglycemic medications (OAMs) were randomized 1:1 to receive add-on BI (QD) or MMI (BID) for 48 weeks (wks). Insulin titration and OAM dose adjustment were based on clinical practice. Compared to BI, MMI led to numerically greater decrease in HbA1c from baseline to wk 24 and statistically greater decrease in HbA1c at wk 48. Fasting blood glucose (FBG) in both groups further decreased from wk 24 to wk 48, and BI caused greater decrease at wk 48 compared to MMI. Both groups had similar decreases in postprandial glucose. Also, significant intergroup difference in OAM use change was detected (p &amp;lt;0.0001) with more patients increasing OAM use in BI group and decreasing OAM use in MMI group. Noticeably, both groups had very limited insulin titration. Body weight increased subtly in both groups. Total hypoglycemia incidence was higher in MMI group through 48 wks, but both groups had low and similar nocturnal hypoglycemia incidence and no severe hypoglycemia. Both BI and MMI could significantly improve glycemic control in Chinese T2DM patients with OAM adjustment and limited insulin titration without major safety issues. Compared to BI, MMI showed larger improvement on glycemic control in relatively long period of treatment. Disclosure L. Chen: Consultant; Self; AstraZeneca, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S. H. Chen: Employee; Self; Eli Lilly and Company. L. Du: Employee; Self; Eli Lilly and Company. Y. Lou: Employee; Self; Eli Lilly and Company. L. Ji: None.

The Effects of Wheat Germ Supplementation on Anthropometric, Biochemical, and Stool Measures in Overweight Adults

Abstract Objectives This study investigated the effects of a 4-week wheat germ supplementation on anthropometric, biochemical, and stool measures in overweight adults. Methods Forty overweight (body mass index = 25.0–30 kg/m2) adults (18–45 years old) were recruited to participate in this randomized controlled study. After initial screening, participants were asked to consume energy balls containing either cornmeal (control) or 30 g of wheat germ (WG) daily for 4 weeks. The energy balls were isocaloric and provided an additional 225 kcal/day. Participants were asked to otherwise maintain their normal diet and physical activity. Anthropometric and metabolic parameters, as well as dietary (3-day food record), medical history, physical activity (Yale Physical Activity Survey) and stool measures (Bristol Stool Chart and the Cleveland Clinic Constipation Scoring System) were assessed at baseline and at the end of the 4-week supplementation period. Results Thirty-nine participants completed the 4-week supplementation (n = 20 and 19 for the WG and control group, respectively). There were no significant differences in anthropometrics, metabolic parameters (i.e., lipid panel, glucose, and HbA1c) or stool measures between the control and WG groups at baseline or at the end of supplementation. However, when comparing change from baseline, significant differences in % body fat, HbA1c, and constipation score were observed between the two groups. Individuals who received the WG supplement exhibited a greater increase in % body fat (0.68 ± 0.28% vs. 0.40 ± 0.36%, P = 0.02) and a greater decrease in HbA1c (−0.095 ± 0.05% vs. −0.039 ± 0.04%, P = 0.04). On the other hand, the control group (−1.00 ± 0.57) perceived a more significant improvement (P = 0.01) in their constipation score compared to WG (−0.85 ± 0.42). Conclusions Similar to our findings in animals, this study demonstrates that daily supplementation with 30 g of WG may be beneficial in glucose homeostasis as indicated by improvement in HbA1C, despite increasing % body fat. Whether the effects of WG on HbA1C will be observed at longer supplementation duration or in other populations such as obese individuals or pre-diabetics needs to be investigated in future studies. Funding Sources United States Department of Agriculture.

GLP1 Receptor Agonist and SGLT2 Inhibitor Combination: An Effective Approach in Real-world Clinical Practice

PurposeThe aim of this study was to evaluate the effectiveness and safety of combination therapy with a sodium-glucose cotransporter-2 (SGLT2) inhibitor and a glucagon-like peptide-1 receptor agonist (GLP1RA) in patients with inadequately controlled type 2 diabetes. MethodsA retrospective search of electronic prescriptions of patients undergoing GLP1RA and SGLT2 inhibitor combination therapy was conducted. Once the patients had been identified, demographic data, blood and urine analyses (glycosylated hemoglobin [HbA1c], glucose, renal function, albuminuria, lipid profile, liver enzymes, and uric acid), physical examination (weight, body mass index, and blood pressure), and adverse effects were obtained from their electronic clinical records according to each of the following 3 periods: before the initiation of the combination, the first visit after initiation, and the last available visit. The influence of the duration of diabetes and the drug combination sequence on the effectiveness of the treatment was also analyzed. Statistical analysis was performed with SPSS version 21.0 (IBM SPSS Statistics, IBM Corporation, Armonk, New York). Quantitative variables are presented as mean and SD and were compared by using the Student t test, one-way ANOVA, or repeated measures ANOVA with Bonferroni correction. Categorical variables are expressed as percentages and were compared by using the χ2 test. ResultsA total of 212 patients were included, with women accounting for 52.4%. The mean age (SD) of the population was 61.5 (9.6) years. A significant reduction in HbA1c (−12 mmol/mol [–1.1%]) was observed with combined therapy (P < 0.001). The target of HbA1c <53 mmol/mol (<7%) was achieved in 42% of the participants. Mean weight loss was −3.5 kg, and almost 40% of the patients attained the weight loss goal of ≥5% (P < 0.001 in all analyses). Transaminase levels and renal parameters also improved. These benefits persisted over time and bore no relation to the evolution of diabetes. Simultaneous initiation of a combination of a GLP1RA and SGLT2 inhibitor led to faster weight loss and a greater decrease in HbA1c than when they are used sequentially; however, the long-term benefits in terms of metabolic control were similar. Adverse events were rare, and a tendency for a reduced insulin dose was observed. ImplicationsThe findings of this study reveal the combined benefits of a GLP1RA and SGLT2 inhibitor in real-world clinical practice. In general, the combined treatment was well tolerated, and few adverse events were detected.

Insulin Glargine 300U/mL and Insulin Glulisine Treatment in Patients with Type2 Diabetes: A Non-Interventional Study of Effectiveness in Routine Clinical Practice.

IntroductionThe EDITION development program confirmed that insulin glargine 300 U/mL (Gla-300) provides comparable glycemic control to insulin glargine 100 U/mL (Gla-100) but with lower hypoglycemia risk. Our study aimed to evaluate the effectiveness of Gla-300 in everyday practice.MethodsThis one-arm, non-interventional study included patients with type 2 diabetes who were switched to Gla-300-based basal-bolus therapy (BBT) and followed for 6 months. Indications for switching included inadequate glycemic control and/or hypoglycemic events with the previous regimen.ResultsOverall 229 patients were included, with mean age of 60.9 years. All glycemic variables improved between baseline and 6 months significantly (mean ± standard deviation [SD] hemoglobin A1c [HbA1c] from 8.9 ± 1.5% to 7.5 ± 1.1%, fasting blood glucose from 9.5 ± 3.1 mmol/L to 7.0 ± 2.1 mmol/L, postprandial blood glucose from 12.0 ± 3.8 mmol/L to 8.9 ± 2.5 mmol/L). Gla-300 doses were increased and mealtime insulin doses were unchanged. Rates of both non-severe and severe hypoglycemic events decreased significantly compared to pre-study and 6-month follow-up periods. Patients switched because of elevated HbA1c had higher baseline HbA1c and greater decrease in HbA1c paralleled with increase in insulin doses compared to those switched because of hypoglycemia.ConclusionsIn day-to-day practice, switching from human insulin to Gla-300-based BBT resulted in significant improvement in glycemic control and decrease in hypoglycemia risk.

A comparison study on efficacy, insulin sensitivity and safety of Glimepiride/Metformin fixed dose combination versus glimepiride single therapy on type 2 diabetes mellitus patients with basal insulin therapy

AimThe aim of this study was to analyze the efficacy, insulin sensitivity and safety in the event of administering sulfonylurea-based drugs and metformin in combination with basal insulin. MethodsA randomized, open-label, parallel, 16-week trial was conducted across four study centers. The 97 type 2 diabetic patients were selected and randomized into two groups, the insulin glargine plus fixed-dose combination glimepiride 1 mg and metformin 500 mg twice daily group (the G/M group) and the insulin glargine plus glimepiride 4 mg once daily group (the G group). The primary endpoint evaluated was change in HbA1c. The secondary endpoints evaluated were changes in fasting blood glucose (FPG), 2-h post prandial glucose (PPG 2 h), insulin, and C-peptide levels. ResultsThe G/M group was found to have experienced a significantly greater decrease in HbA1c, as well as PPG 2 h compared to the G group. While no significant intergroup difference was found regarding FPG in the ITT, the G/M group in the PP set experienced a significantly greater decrease in FPG. ConclusionComparison of combined therapy consisting of either the G/M group or the G group indicated that both forms of therapy are relatively safe but that the former more effectively decreases blood glucose levels.

Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial

Glucagon-like peptide-1 (GLP-1) receptor agonists are effective treatments for type 2 diabetes, lowering glycated haemoglobin (HbA1c) and weight, but are currently only approved for use as subcutaneous injections. Oral semaglutide, a novel GLP-1 agonist, was compared with subcutaneous liraglutide and placebo in patients with type 2 diabetes. In this randomised, double-blind, double-dummy, phase 3a trial, we recruited patients with type 2 diabetes from 100 sites in 12 countries. Eligible patients were aged 18 years or older, with HbA1c of 7·0-9·5% (53-80·3 mmol/mol), on a stable dose of metformin (≥1500 mg or maximum tolerated) with or without a sodium-glucose co-transporter-2 inhibitor. Participants were randomly assigned (2:2:1) with an interactive web-response system and stratified by background glucose-lowering medication and country of origin, to once-daily oral semaglutide (dose escalated to 14 mg), once-daily subcutaneous liraglutide (dose escalated to 1·8 mg), or placebo for 52 weeks. Two estimands were defined: treatment policy (regardless of study drug discontinuation or rescue medication) and trial product (assumed all participants were on study drug without rescue medication) in all participants who were randomly assigned. The treatment policy estimand was the primary estimand. The primary endpoint was change from baseline to week 26 in HbA1c (oral semaglutide superiority vs placebo and non-inferiority [margin: 0·4%] and superiority vs subcutaneous liraglutide) and the confirmatory secondary endpoint was change from baseline to week 26 in bodyweight (oral semaglutide superiority vs placebo and liraglutide). Safety was assessed in all participants who received at least one dose of study drug. This trial is registered on Clinicaltrials.gov, number NCT02863419, and the European Clinical Trials registry, number EudraCT 2015-005210-30. Between Aug 10, 2016, and Feb 7, 2017, 950 patients were screened, of whom 711 were eligible and randomly assigned to oral semaglutide (n=285), subcutaneous liraglutide (n=284), or placebo (n=142). 341 (48%) of 711 participants were female and the mean age was 56 years (SD 10). All participants were given at least one dose of study drug, and 277 (97%) participants in the oral semaglutide group, 274 (96%) in the liraglutide group, and 134 (94%) in the placebo group completed the 52-week trial period. Mean change from baseline in HbA1c at week 26 was -1·2% (SE 0·1) with oral semaglutide, -1·1% (SE 0·1) with subcutaneous liraglutide, and -0·2% (SE 0·1) with placebo. Oral semaglutide was non-inferior to subcutaneous liraglutide in decreasing HbA1c (estimated treatment difference [ETD] -0·1%, 95% CI -0·3 to 0·0; p<0·0001) and superior to placebo (ETD -1·1%, -1·2 to -0·9; p<0·0001) by use of the treatment policy estimand. By use of the trial product estimand, oral semaglutide had significantly greater decreases in HbA1c than both subcutaneous liraglutide (ETD -0·2%, 95% CI -0·3 to -0·1; p=0·0056) and placebo (ETD -1·2%, -1·4 to -1·0; p<0·0001) at week 26. Oral semaglutide resulted in superior weight loss (-4·4 kg [SE 0·2]) compared with liraglutide (-3·1 kg [SE 0·2]; ETD -1·2 kg, 95% CI -1·9 to -0·6; p=0·0003) and placebo (-0·5 kg [SE 0·3]; ETD -3·8 kg, -4·7 to -3·0; p<0·0001) at week 26 (treatment policy). By use of the trial product estimand, weight loss at week 26 was significantly greater with oral semaglutide than with subcutaneous liraglutide (-1·5 kg, 95% CI -2·2 to -0·9; p<0·0001) and placebo (ETD -4·0 kg, -4·8 to -3·2; p<0·0001). Adverse events were more frequent with oral semaglutide (n=229 [80%]) and subcutaneous liraglutide (n=211 [74%]) than with placebo (n=95 [67%]). Oral semaglutide was non-inferior to subcutaneous liraglutide and superior to placebo in decreasing HbA1c, and superior in decreasing bodyweight compared with both liraglutide and placebo at week 26. Safety and tolerability of oral semaglutide were similar to subcutaneous liraglutide. Use of oral semaglutide could potentially lead to earlier initiation of GLP-1 receptor agonist therapy in the diabetes treatment continuum of care. Novo Nordisk A/S.

Pumps or Multiple Daily Injections in Pregnancy Involving Type 1 Diabetes: A Prespecified Analysis of the CONCEPTT Randomized Trial.

To compare glycemic control, quality of life, and pregnancy outcomes of women using insulin pumps and multiple daily injection therapy (MDI) during the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT). This was a prespecified analysis of CONCEPTT involving 248 pregnant women from 31 centers. Randomization was stratified for pump versus MDI and HbA1c. The primary outcome was change in HbA1c from randomization to 34 weeks' gestation. Key secondary outcomes were continuous glucose monitoring (CGM) measures, maternal-infant health, and patient-reported outcomes. At baseline, pump users were more often in stable relationships (P = 0.003), more likely to take preconception vitamins (P = 0.03), and less likely to smoke (P = 0.02). Pump and MDI users had comparable first-trimester glycemia: HbA1c 6.84 ± 0.71 vs. 6.95 ± 0.58% (51 ± 7.8 vs. 52 ± 6.3 mmol/mol) (P = 0.31) and CGM time in target (51 ± 14 vs. 50 ± 13%) (P = 0.40). At 34 weeks, MDI users had a greater decrease in HbA1c (-0.55 ± 0.59 vs. -0.32 ± 0.65%, P = 0.001). At 24 and 34 weeks, MDI users were more likely to achieve target HbA1c (P = 0.009 and P = 0.001, respectively). Pump users had more hypertensive disorders (P = 0.011), mainly driven by increased gestational hypertension (14.4 vs. 5.2%; P = 0.025), and more neonatal hypoglycemia (31.8 vs. 19.1%, P = 0.05) and neonatal intensive care unit (NICU) admissions >24 h (44.5 vs. 29.6%; P = 0.02). Pump users had a larger reduction in hypoglycemia-related anxiety (P = 0.05) but greater decline in health/well-being (P = 0.02). In CONCEPTT, MDI users were more likely to have better glycemic outcomes and less likely to have gestational hypertension, neonatal hypoglycemia, and NICU admissions than pump users. These data suggest that implementation of insulin pump therapy is potentially suboptimal during pregnancy.

Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults.

This study evaluated the effectiveness of a community health worker (CHW) diabetes self-management education (DSME) program, followed by two different approaches to maintain improvements in HbA1c and other clinical and patient-centered outcomes over 18 months. The study randomized 222 Latino adults with type 2 diabetes and poor glycemic control from a federally qualified health center to 1) a CHW-led, 6-month DSME program or 2) enhanced usual care (EUC). After the 6-month program, participants randomized to the CHW-led DSME were further randomized to 1) 12 months of CHW-delivered monthly telephone outreach (CHW-only) or 2) 12 months of weekly group sessions delivered by peer leaders (PLs) with telephone outreach to those unable to attend (CHW+PL). The primary outcome was HbA1c. Secondary outcomes were blood pressure, lipid levels, diabetes distress, depressive symptoms, understanding of diabetes self-management, and diabetes social support. Assessments were conducted at baseline and at 6, 12, and 18 months. Participants in the CHW intervention at the 6-month follow-up had greater decreases in HbA1c (-0.45% [95% CI -0.87, -0.03]; P < 0.05) and in diabetes distress (-0.3 points [95% CI -0.6, -0.03]; P < 0.05) compared with EUC. CHW+PL participants maintained HbA1c improvements at 12 and 18 months, and CHW-only participants maintained improvements in diabetes distress at 12 and 18 months. CHW+PL participants also had significantly fewer depressive symptoms at 18 months compared with EUC (-2.2 points [95% CI -4.1, -0.3]; P < 0.05). Participants in CHW-led DSME had significant improvements in diabetes social support and in understanding of diabetes self-management at 6 months relative to EUC, but these intervention effects were not sustained at 18 months. This study demonstrates the effectiveness of a 6-month CHW intervention on key diabetes outcomes and of a volunteer PL program in sustaining key achieved gains. These are scalable models for health care centers in low-resource settings for achieving and maintaining improvements in key diabetes outcomes.

Change in Glycemic Control With Use of a Digital Therapeutic in Adults With Type 2 Diabetes: Cohort Study.

BackgroundIntensive lifestyle change can treat and even reverse type 2 diabetes. Digital therapeutics have the potential to deliver lifestyle as medicine for diabetes at scale.ObjectiveThis 12-week study investigates the effects of a novel digital therapeutic, FareWell, on hemoglobin A1c (HbA1c) and diabetes medication use.MethodsAdults with type 2 diabetes and a mobile phone were recruited throughout the United States using Facebook advertisements. The intervention aim was to effect a sustainable shift to a plant-based dietary pattern and regular exercise by advancing culinary literacy and lifestyle skill acquisition. The intervention was delivered by an app paired with specialized human support, also delivered digitally. Health coaching was provided every 2 weeks by telephone, and a clinical team was available for participants requiring additional support. Participants self-reported current medications and HbA1c at the beginning and end of the 12-week program. Self-efficacy related to managing diabetes and maintaining dietary changes was assessed via survey. Engagement was recorded automatically through the app.ResultsWe enrolled 118 participants with a baseline HbA1c >6.5%. Participants were 81.4% female (96/118) and resided in 38 US states with a mean age of 50.7 (SD 9.4) years, baseline body mass index of 38.1 (SD 8.8) kg/m2, and baseline HbA1c of 8.1% (SD 1.6). At 12 weeks, 86.2% (94/109) of participants were still using the app. Mean change in HbA1c was –0.8% (97/101, SD 1.3, P<.001) for those reporting end-study data. For participants with a baseline HbA1c >7.0% who did not change medications midstudy, HbA1c change was –1.1% (67/69, SD 1.4, P<.001). The proportion of participants with an end-study HbA1c <6.5% was 28% (22/97). After completion of the intervention, 17% (16/97) of participants reported a decrease in diabetic medication while 8% (8/97) reported an increase. A total of 57% (55/97) of participants achieved a composite outcome of reducing HbA1c, reducing diabetic medication use, or both; 92% (90/98) reported greater confidence in their ability to manage their diabetes compared to before the program, and 91% (89/98) reported greater confidence in their ability to maintain a healthy dietary pattern. Participants engaged with the app an average of 4.3 times per day. We observed a significantly greater decrease in HbA1c among participants in the highest tertile of app engagement compared to those in the lowest tertile of app engagement (P=.03).ConclusionsClinically meaningful reductions in HbA1c were observed with use of the FareWell digital therapeutic. Greater glycemic control was observed with increasing app engagement. Engagement and retention were both high in this widely distributed sample.

Dose effect of patient–care team communication via secure portal messaging on glucose and blood pressure control

Organizational strategies for implementing eHealth tools influence patient and provider use of portal technology. This study examines whether the intensity of bidirectional secure portal messaging is associated with improved clinical outcomes. This is a retrospective cohort analysis of 101 019 patients with diabetes or hypertension (11 138 active portal users) who received primary care within the Ochsner Health System between 2012 and 2014. Propensity score-adjusted multivariable fixed effects regression panel analysis was used to examine associations between intensity of "medical advice" portal messaging and glucose/blood pressure control. Most portal users rarely used medical advice messaging. A higher proportion of patients who were age 50 years and older, female, white non-Hispanic, and with co-morbid diabetes and hypertension had higher frequency and intensity of medical advice messaging. Study findings revealed a dose-response effect of the intensity of messaging on glucose control, whereby, compared to nonportal users, each level of messaging among portal users was associated with greater decreases in HbA1c (β estimate [95% CI]: none -0.28 (-0.34 to -0.22); low -0.28 (-0.32 to -0.24); medium -0.41 (-0.52 to -0.31); high -0.43 (-0.60 to -0.27), all P ≤ .001). There was no observed effect on blood pressure. The digital divide exists not only between portal users and nonusers but also among portal users. Research exploring the relationship between intensity of bidirectional secure messaging and health outcomes for a broader scope of chronic conditions is needed. Future implementation research must also elucidate best practices that enhance not only the use of portals by patients and providers, but how they use portals.