Difference In HbA1c Reduction Research Articles

The effect of personalized intelligent digital systems for self-care training on type II diabetes: a systematic review and meta-analysis of clinical trials.

Type 2 diabetes (T2D) is rising worldwide. Self-care prevents diabetic complications. Lack of knowledge is one reason patients fail at self-care. Intelligent digital health (IDH) solutions have a promising role in training self-care behaviors based on patients' needs. This study reviews the effects of RCTs offering individualized self-care training systems for T2D patients. PubMed, Web of Science, Scopus, Cochrane Library, and Science Direct databases were searched. The included RCTs provided data-driven, individualized self-care training advice for T2D patients. Due to the repeated studies measurements, an all-time-points meta-analysis was conducted to analyze the trends over time. The revised Cochrane risk-of-bias tool (RoB 2.0) was used for quality assessment. In total, 22 trials met the inclusion criteria, and 19 studies with 3071 participants were included in the meta-analysis. IDH interventions led to a significant reduction of HbA1c level in the intervention group at short-term (in the third month: SMD = - 0.224 with 95% CI - 0.319 to - 0.129, p value < 0.0; in the sixth month: SMD = - 0.548 with 95% CI - 0.860 to - 0.237, p value < 0.05). The difference in HbA1c reduction between groups varied based on patients' age and technological forms of IDH services delivery. The descriptive results confirmed the impact of M-Health technologies in improving HbA1c levels. IDH systems had significant and small effects on HbA1c reduction in T2D patients. IDH interventions' impact needs long-term RCTs. This review will help diabetic clinicians, self-care training system developers, and researchers interested in using IDH solutions to empower T2D patients.

Glycaemic control, risk of hypoglycaemia and all-cause mortality in new users of second-generation basal insulin with type 2 diabetes and chronic kidney disease: a nationwide register-based cohort study.

The aim of this study was to compare the performance of the second-generation basal insulins, insulin degludec 100 U/ml (Deg-100) and insulin glargine 300 U/ml (Gla-300), in terms of change in HbA1c, hospitalisation for hypoglycaemia and all-cause mortality among individuals with type 2 diabetes and concurrent chronic kidney disease. This register-based cohort study, based on the entire Danish diabetes population, included 6519 new users of Deg-100 and Gla-300 with type 2 diabetes and moderate to end-stage chronic kidney disease. HbA1c trajectories, from initiation of either Deg-100 (2013) or Gla-300 (2015) to end of follow-up (2020), were modelled with mixed-effect models while rates of hospitalisation for hypoglycaemia and all-cause mortality were modelled in separate models using Poisson likelihood. Of the 6519 (44% women) individuals included in the study, 3747 were exposed to Deg-100 and 2772 to Gla-300. Both mean (SD) type 2 diabetes duration (14.4 [6.6] years vs 15.2 [6.7] years) and median (IQR) chronic kidney disease duration (2.3 [1.3, 3.9] years vs 2.8 [1.6, 4.6] years) were significantly shorter in the Gla-300 group. The median (IQR) follow-up time was similar between groups: 1.0 (0.5-1.6) year for Gla-300 and 1.0 (0.3-1.5) year for Deg-100. In both groups mean HbA1c levels were reduced by 13-14 mmol/mol (1.2-1.3%) from initiation to end of follow-up, with the largest reduction (of 8-9 mmol/mol [0.7-0.8%]) occurring during the first year. There was no significant difference in HbA1c reduction between Deg-100 and Gla-300. Both the rate of hospitalisation for hypoglycaemia (rate ratio 1.02 [95% CI 0.70, 1.49], Deg-100 vs Gla-300) and the rate of all-cause mortality (rate ratio 0.98 [95% CI 0.84, 1.15], Deg-100 vs Gla-300) were similar between the groups. We found no difference in HbA1c reduction, hospitalisation for hypoglycaemia or all-cause mortality between Gla-300 and Deg-100 in a real-world population of new users with type 2 diabetes and moderate to end-stage chronic kidney disease. Therefore, we conclude that these two treatment options are equally effective and safe in this vulnerable population.

Rapid Reduction of HbA1c and Early Worsening of Diabetic Retinopathy: A Real-world Population-Based Study in Subjects With Type 2 Diabetes.

Early worsening of diabetic retinopathy (EWDR) due to the rapid decrease of blood glucose levels is a concern in diabetes treatment. The aim of the current study is to evaluate whether this is an important issue in subjects with type 2 diabetes with mild or moderate nonproliferative DR (NPDR), who represent the vast majority of subjects with DR attended in primary care. This is a retrospective nested case-control study of subjects with type 2 diabetes and previous mild or moderate NPDR. Using the SIDIAP ("Sistema d'informació pel Desenvolupament de la Recerca a Atenció Primària") database, we selected 1,150 individuals with EWDR and 1,150 matched control subjects (DR without EWDR). The main variable analyzed was the magnitude of the reduction of HbA1c in the previous 12 months. The reduction of HbA1c was categorized as rapid (>1.5% reduction in <12 months) or very rapid (>2% in <6 months). We did not find any significant difference in HbA1c reduction between case and control subjects (0.13 ± 1.21 vs. 0.21 ± 1.18; P = 0.12). HbA1c reduction did not show significant association with worsening of DR, neither in the unadjusted analyses nor in adjusted statistical models that included the main confounding variables: duration of diabetes, baseline HbA1c, presence of hypertension, and antidiabetic drugs. In addition, when stratification by baseline HbA1c was performed, we did not find that those patients with higher levels of HbA1c presented a higher risk to EWDR. Our results suggest that the rapid reduction of HbA1c is not associated with progression of mild or moderate NPDR.

818-P: Glycemic Control in Naïve Users of Second-Generation Basal Insulins with T2D and CKD—A Nationwide Register-Based Cohort Study

Objective: We aimed to compare the effectiveness and safety of second-generation basal insulins, insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (Deg-100), in terms of change in HbA1c, hospitalization for hypoglycemia and all-cause mortality. Methods: In this register-based cohort study, using real-word data on the entire Danish diabetes population in the period 2013-2020, we included 6519 naïve users of Gla-300 or Deg-100 with T2D and chronic kidney disease (CKD). Change in HbA1c, from initiation of either study drugs to end of follow-up, was modeled with mixed-effect models while rates of hospitalization for hypoglycemia and all-cause mortality were modeled in separate Poisson models. Results: Mean HbA1c levels were reduced by 13-14 mmol/mol over a four-year period in both groups with no significant difference (Figure). The rate of hospitalization for hypoglycemia was slightly but not significantly higher in the Deg-100 group (rate-ratio 1.03 (CI 95%: 0.71, 1.49) while the all-cause mortality rate was slightly but not significantly lower in the Deg-100 group (0.97 (0.83, 1.14)). Conclusion: We found no difference in HbA1c reduction, hospitalization for hypoglycemia or all-cause mortality between Gla-300 and Deg-100, in a real-world population of naïve users with T2D and CKD. Disclosure V.Kosjerina: Research Support; Sanofi-Aventis Deutschland GmbH. B.Carstensen: Stock/Shareholder; Novo Nordisk. H.Amadid: Employee; Novo Nordisk A/S. D.Vistisen: Research Support; Bayer Inc., Sanofi, Boehringer-Ingelheim, Stock/Shareholder; Novo Nordisk A/S. Funding Sanofi-Aventis Deutschland GmbH

Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials.

Digital health interventions have shown promising results for the management of type 2 diabetes, but a comparison of the effectiveness and implementation of the different modes is not currently available. Therefore, this study aimed to compare the effectiveness of SMS, smartphone application, and website-based interventions on improving glycaemia in adults with type 2 diabetes and report on their reach, uptake, and feasibility. In this systematic review and meta-analysis, we searched CINAHL, Cochrane Central, Embase, MEDLINE, and PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) that examined the effectiveness of digital health interventions in reducing glycated haemoglobin A1c (HbA1c) in adults with type 2 diabetes, published in English from Jan 1, 2009. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint assessed was the change in the mean (and 95% CI) plasma concentration of HbA1c at 3 months or more. Cochrane risk of bias 2 was used to assess risk of bias. Data on reach, uptake, and feasibility were summarised narratively and data on HbA1c reduction were synthesised in a meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation criteria was used to evaluate the level of evidence. The study was registered with PROSPERO, CRD42021247845. Of the 3236 records identified, 56 RCTs from 24 regions (n=11 486 participants), were included in the narrative synthesis, and 26 studies (n=4546 participants) in the meta-analysis. 20 studies used SMS as the primary mode of delivery of the digital health intervention, 25 used smartphone applications, and 11 implemented interventions via websites. Smartphone application interventions reported higher reach compared with SMS and website-based interventions, but website-based interventions reported higher uptake compared with SMS and smartphone application interventions. Effective interventions, in general, included people with greater severity of their condition at baseline (ie, higher HbA1c) and administration of a higher dose intensity of the intervention, such as more frequent use of smartphone applications. Overall, digital health intervention group participants had a -0·30 (95% CI -0·42 to -0·19) percentage point greater reduction in HbA1c, compared with control group participants. The difference in HbA1c reduction between groups was statistically significant when interventions were delivered through smartphone applications (-0·42% [-0·63 to -0·20]) and via SMS (-0·37% [-0·57 to -0·17]), but not when delivered via websites (-0·09% [-0·64 to 0·46]). Due to the considerable heterogeneity between included studies, the level of evidence was moderate overall. Smartphone application and SMS interventions, but not website-based interventions, were associated with better glycaemic control. However, the studies' heterogeneity should be recognised. Considering that both smartphone application and SMS interventions are effective for diabetes management, clinicians should consider factors such as reach, uptake, patient preference, and context of the intervention when deciding on the mode of delivery of the intervention. Nine in ten people worldwide own a feature phone and can receive SMS and four in five people have access to a smartphone, with numerous smartphone applications being available for diabetes management. Clinicians should familiarise themselves with this modality of programme delivery and encourage people with type 2 diabetes to use evidence-based applications for improving their self-management of diabetes. Future research needs to describe in detail the mediators and moderators of the effectiveness and implementation of SMS and smartphone application interventions, such as the optimal dose, frequency, timing, user interface, and communication mode to both further improve their effectiveness and to increase their reach, uptake, and feasibility. EU's Horizon 2020 Research and Innovation Programme.

ODP620 A Cross-over Trial Using Insulin Glargine And Neutral Protamine Hagedorn Insulin For The Poorly Controlled Patients With Type 2 Diabetes Who Refused Multiple Daily Insulin Injections

Abstract A Cross-Over Trial Using Insulin Glargine and Neutral Protamine Hagedorn insulin for the Poorly Controlled Patients with Type 2 Diabetes Who Refused Multiple Daily Insulin Injections Background: Data in the literature describing the comparison between Neutral Protamine Insulin of Hagedorn (NPH) and glargine insulins are conflicting. While some studies revealed the superiority of Glargine, others had shown comparable results and even NPH superiority figures. We have many patients on NPH basal therapy in our clinical practice and another good number on Glargine. We did observe adverse effects in both groups, but local data and real numbers comparing both regimens are lacking. Objective To compare basal insulin regimen using NPH or Glargine in efficacy, hypoglycaemic events, and weight gain. Design and setting: A prospective interventional crossover study was conducted in Faiha Specialized Diabetes, Endocrine and Metabolism Center from 2018 through 2021, involving patients less than 65 years old with uncontrolled Type 2 Diabetes Mellitus whose HbA1c &amp;gt;10% on oral antidiabetic drugs (OAD); randomized into two groups (G1 &amp; G2), 70 patients in each group had completed the study, one group received NPH and the other received Glargine in addition to their OAD for one year, then they were crossed over for another one year after a period of washout. Results The mean age was 48.9±5.5 and 45.9±4.1 years for G1 and G2, respectively. 36(51.4%) in G1 were women versus 27(38.6%) in G2. In the first phase of the study, HbA1c reduction was 5.5±1.1% for the NPH group and 5.3±1.1% for the Glargine group (p=0.418), there was 1.7±2.7 versus 1.1±2.9 Kg weight gain (p=0.209), 27(39.7%) hypoglycemic event versus 26(37.7%) (p=0.883) and 5 patients(7.4%) achieved HbA1c &amp;lt;7% versus 8(11.6%) (p=0.397) for the patients in NPH and Glargine groups respectively. While in the crossover phase, the data comparing Glargine and NPH groups are as following: 0.6±0.8 versus 0.5±0.9% reduction in HbA1c (p=0.413), 1.7±3.1 versus 0.6±2.2 Kg weight loss (p=0. 035) although the final weight was not much different 77.3±12. 0 versus 77.7±11.5 (p=0.841), 16(27.1%) versus 23(36.5%) hypoglycemic events (p=0.493) and 17(29.8%) versus 11(17.7%) achieved HbA1c&amp;lt;7% (p=0.121) respectively. Conclusion In our study, there was no significant difference in HbA1c reduction, Hypoglycemic events, and weight gain between patients using NPH or Glargine basal insulin regimen. Keywords: Diabetes; Glargine; NPH. Presentation: No date and time listed

Noninferiority of Telemedicine Delivered Compared With In-person Diabetes Self-Management Education and Support (DSMES) During Covid-19 Pandemic in Thailand.

This study aimed to compare the clinical outcomes and program satisfaction of diabetes self-management education and support (DSMES) for type 2 diabetes patients delivered by telehealth during COVID-19 pandemic to in-person delivery during pre-COVID-19. A retrospective case-controlled study was conducted (95 telehealth and 95 on-site). Differences in hemoglobin A1c (HbA1c) reductions between groups were analyzed by linear mixed-effects models, and satisfaction was collected. Compared with baseline, at the three-month follow-up, the HbA1c reductions of the telehealth and on-site DSMES were 1.20 ± 0.15% and 1.21 ± 0.15%, respectively (P < .001), whereas these were 1.28 ± 0.16% and 1.18 ± 0.15% at six-month follow-up, respectively (P < .001). There were no significant differences in HbA1c reduction between the two groups (P = .967 and .674 at three- and six-month follow-up). Majority of participants in both groups had high program satisfaction (telehealth 98.7% vs on-site 95.1%, P = .269). In conclusion, DSMES delivered via telehealth is as effective in lowering HbA1c as that delivered in-person, with a high satisfaction rate.

Discordance in the reduction rate between glycated albumin and glycated hemoglobin levels in type 2 diabetes patients receiving SGLT2 inhibitors

AimsAlthough the difference in HbA1c reduction between sodium-glucose cotransporter 2 (SGLT2) inhibitors and other oral glucose-lowering agents is relatively small, SGLT2 inhibitors exhibit beneficial cardiorenal protection. This study was based on the hypothesis that changes of HbA1c in patients treated with SGLT2 inhibitors may not accurately reflect an improved glycemic profile. MethodsTwo studies were conducted: 1) a retrospective cohort study of 3039 patients administered with either an SGLT2 or a dipeptidyl peptidase-4 (DPP4) inhibitor for 12 months comparing the changes in glycated albumin (GA) and HbA1c levels and 2) a pilot study of 10 patients whose glycemic dynamics were evaluated using flash glucose monitoring at baseline and 2 months after treatment with an SGLT2 inhibitor. ResultsSGLT2 inhibitors reduced GA more markedly than HbA1c in both studies. DPP4 inhibitors decreased both GA and HbA1c to a comparable degree. The mean glucose levels and glycemic standard deviation were significantly reduced after treatment with an SGLT2 inhibitor, in concordance with GA decline, although the lowering of HbA1c was marginal. ConclusionsChanges in HbA1c levels underestimated the glucose-lowering effect and the diminished glycemic fluctuation induced by SGLT2 inhibitors. Thus, the distinct biomarker roles of GA and HbA1c should be reevaluated.

Prescribing Patterns and Response to Antihyperglycemic Agents Among Novel Clusters of Type 2 Diabetes in Asian Indians.

Aim: To assess the prescribing patterns and response to different classes of antihyperglycemic agents in novel clusters of type 2 diabetes (T2D) described in India. Materials and Methods: We attempted to replicate the earlier described clusters of T2D, in 32,867 individuals with new-onset T2D (within 2 years of diagnosis) registered between October 2013 and December 2020 at 15 diabetes clinics located across India, by means of k-means clustering utilizing 6 clinically relevant variables. Individuals who had follow-up glycated hemoglobin (HbA1c) up to 2 years were included for the drug response analysis (n = 13,247). Results: Among the 32,867 participants included in the study, 20,779 (63.2%) were males. The average age at diagnosis was 45 years and mean HbA1c at baseline was 8.9%. The same four clusters described in India earlier were replicated. Forty percent of the study participants belonged to the mild age-related diabetes cluster, followed by insulin-resistant obese diabetes (27%), severe insulin-deficient diabetes (21%), and combined insulin-resistant and insulin-deficient diabetes (12%) clusters. The most frequently used antihyperglycemic agents were sulfonylureas, metformin, and dipeptidyl peptidase-4 inhibitors apart from insulin. While there were significant differences in HbA1c reduction between drugs across clusters, these were largely driven by differences in the baseline (pretreatment) HbA1c. Conclusions: In this new cohort, we were able to reliably replicate the four subtypes of T2D earlier described in Asian Indians. Prescribing patterns show limited usage of newer antihyperglycemic agents across all clusters. Randomized clinical trials are required to establish differential drug responses between clusters.

Role of Bariatric Surgery in Managing Metabolic Syndrome

Background: Lifestyle modifications provide a limited control of diabetes mellitus type 2 (DM2), especially in patients with morbid obesity and uncontrolled DM. Compared with non-surgical treatment, bariatric surgery achieved more sustained weight loss and higher remission rates of DM2. Roux-en-Y gastric bypass (RYGB) has been the most common procedure in the past but sleeve gastrectomy (SG) with duodenal switch (DS) is gaining more popularity now. Objective: To compare the significant differences in the outcomes of these procedures; such as the reduction in hemoglobin A1c (HbA1c), weight, basic metabolic index (BMI) and atherosclerotic cardiovascular disease (ASCVD) risk score of the patients at our community hospital. Methods: This was a retrospective observational study consisting of a chart review of 151 patients during 2016 to 2019. Patients included were >18 years old, and underwent one of the three types of bariatric surgeries, including RYGB, SG and sleeve with DS. Comparison between different continuous variables was made using analysis of variance. Chi square analysis was used to determine associations between different outcomes and various categorical variables. Results: Among all, 33.1% had SG, 33.8% had RYGB and 33.1% had DS. The median age was 66 years and 71.5% were females. Median height was 63 inches. 84.8% were white, 14.6% were African American and 0.7% were Asian. The associated comorbidities were asthma, hypertension, dyslipidemia, DM, smoking and coronary artery disease. Median weight prior to surgery was 280 pounds (lb) and reduced to a median weight of 240 lb. Median BMI before surgery was 44 kg/m2 and reduced to 39 kg/m2. Median blood pressure (BP) was 128/74 mmHg and reduced to 120/68 mmHg. Patients with elevated BP reduced from 70% to 20% in SG, 66.7% to 49% in RYGB and 82% to 54% in DS. Fasting blood sugar reduced from a median of 98 mg/dl to 87 mg/dl. HbA1c reduced from a median of 6 to 5.4. ASCVD risk score reduced from 4 to 2. Mean difference in HbA1c reduction was 0.81 for SG, 1.44 for RYGB and 2.19 for DS. Prior to surgery, 43% patients had DM, 16.6% had prediabetes and 40.4% were nondiabetic. Three months later, patients with DM2 reduced to 14.8% and prediabetes reduced to 10.7%. Patients with DM in SG group reduced from 14% to 12.2% and prediabetics reduced from 12 to 6%. In RYGB group, DM reduced from 56.9% to 16% and prediabetics increased from 13.7% to 24%. In DS group, DM reduced from 58% to 16% and prediabetics reduced from 24% to 2%. Insulin users reduced from 4% to 2 % in SG, 21.6% to 3.9% in RYGB and 22% to 6% in DS. Median number of DM2 medications reduced from 1 to 0. Conclusion: Our study demonstrates the differences in the reduction of HbA1c, weight, BMI and ASCVD risk score among various bariatric surgery procedures. It suggests that DS leads to a greater reduction in the HbA1c and ASCVD risk scores as compared to RYGB, although the risks of malabsorption complications are considerable.

Self-monitoring of blood glucose in association with glycemic control in newly diagnosed non-insulin-treated diabetes patients: a retrospective cohort study

The benefits of self-monitoring of blood glucose (SMBG) on glycemic control among type 2 diabetes (T2DM) patients not receiving insulin remains controversial. This study aimed to examine the association between SMBG and glycemic control in these patients. This retrospective longitudinal study enrolled 4987 eligible patients from a medical center in Taiwan. Data were collected from electronic medical records at 0 (baseline), 3, 6, 9, and 12 (end-point) months after enrollment. Patients were assigned to the early SMBG group or to the non-user group depending on whether they performed SMBG at baseline. Differences in glycated hemoglobin (HbA1c) reduction between groups at each time-point were assessed using SMBG group-by-time interaction in generalized estimating equations models, which were established using backward elimination method for multivariate regression analysis. Subgroup analyses for patients using non-insulin and insulin secretagogues were performed additionally. The estimated maximal difference in HbA1c reduction between groups (early SMBG users vs. non-users) was 0.55% at 3 months. Subgroup analyses showed maximal differences of 0.61% and 0.52% at 3 months in the non-insulin and insulin secretagogues groups, respectively. SMBG group-by-time interaction was statistically significant at 3 months and lasted for 12 months. The finding suggests that performing SMBG at disease onset was positively associated with better glycemic control in newly diagnosed non-insulin-treated T2DM patients, regardless whether non-insulin secretagogues or insulin secretagogues were used.

A 52-week randomized controlled trial of ipragliflozin or sitagliptin in type 2 diabetes combined with metformin: The N-ISM study.

AimTo compare the long‐term efficacy of sodium‐glucose co‐transporter‐2 inhibitors and dipeptidyl peptidase‐4 inhibitors as second‐line drugs after metformin for patients not at high risk of atherosclerotic cardiovascular disease (ASCVD).Materials and methodsIn a 52‐week randomized open‐label trial, we compared ipragliflozin and sitagliptin in Japanese patients diagnosed with type 2 diabetes, without prior ASCVD and treated with metformin. The primary endpoint was a glycated haemoglobin (HbA1c) reduction of ≥0.5% (5.5 mmol/mol) without weight gain at 52 weeks.ResultsOf a total of 111 patients (mean age 59.2 years, mean body mass index [BMI] 26.6 kg/m2, 61.3% men), 54 patients received ipragliflozin and 57 received sitagliptin. After 52 weeks, achievement of the primary endpoint was not significantly different (37.0% and 40.3%; P = 0.72). HbA1c reduction rate at 24 weeks was greater for sitagliptin (56.1%) than for ipragliflozin (31.5%; P = 0.01). From 24 to 52 weeks, the HbA1c reduction with sitagliptin was attenuated, with no significant difference in HbA1c reduction after 52 weeks between sitagliptin (54.4%) and ipragliflozin (38.9%; P = 0.10). Improvements in BMI, C‐peptide and high‐density lipoprotein cholesterol were greater with ipragliflozin than with sitagliptin. Adverse events occurred in 17 patients with ipragliflozin and in 10 patients with sitagliptin (P = 0.11).ConclusionThe HbA1c‐lowering effect at 24 weeks was greater with sitagliptin than with ipragliflozin, but with no difference in efficacy related to HbA1c and body weight at 52 weeks. However, some ASCVD risk factors improved with ipragliflozin.

Insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with premix or addition of meal-time insulin to basal insulin in people with type 2 diabetes: A systematic review and Bayesian network meta-analysis.

To assess the efficacy and safety of iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide, relative to premix insulin and other insulin options through network meta-analysis. A systematic literature search identified randomized controlled trials (RCTs) comparing iGlarLixi, premix insulin or basal insulin (BI) in combination with meal-time insulin, in people inadequately controlled with BI. Eligible RCTs were compared using Bayesian network meta-analysis. Eight RCTs, some open-label, involving 3538 participants, with a study duration of 24-30 weeks were included. The estimated difference in HbA1c reduction with iGlarLixi compared with premix insulin was -0.50%-units (95% credible interval: -0.93 to -0.06) with 98% probability of iGlarLixi being superior to premix. Estimates for iGlarLixi versus meal-time + BI (thrice-daily meal-time insulin + basal) and basal-plus (once-daily meal-time insulin + BI) were -0.35 (-0.89 to +0.13)%-units and -0.68 (-1.18 to -0.17)%-units with probabilities of real difference of 94% and 99%, respectively. Safety outcome analysis suggested that iGlarLixi had lower rates of both confirmed and documented symptomatic hypoglycaemia compared with premix insulin (probabilities of 85% and 93%, respectively) and lower weight gain (probability 98%). iGlarLixi showed similar or improved efficacy and safety versus other intensification choices from BI included in this study, providing a clinically relevant treatment option in people with type 2 diabetes not well controlled on BI.

Improvement in glycated hemoglobin A1C after laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy in an ethnically diverse population with diabetes.

Obesity is a well-known risk factor for the development of type 2 diabetes. The efficacy of bariatric surgery in reducing weight with resulting improvement in type 2 diabetes has been reliably demonstrated. We investigated and compared the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) on glycated hemoglobin (HbA1C) levels in a predominantly Hispanic and black population. Community Hospital in New York, New York, United States. This is a retrospective review of a 5-year data from a single center where patients with diabetes who underwent LRYGB or LSG were included. HbA1C levels and body mass index were analyzed preoperatively and then annually postoperatively for up to 5 years. Improvements in HbA1C were compared between the 2 groups after adjusting for age, sex, race, and hypertension with linear mixed-effects or logistic regression models. Of the 676 included patients, 84.8% were females and the mean age was 47 years. HbA1C levels decreased significantly (P < .05) in the entire group at 1 (21%), 2 (20%), 3 (20%), 4 (18%), and 5 (14%) years. Compared with LSG, LRYGB patients displayed greater improvement in HbA1C levels at 1 year (25% versus 17%, P = .001). The differences in the reduction of HbA1C between LRYGB and LSG for the other time intervals were not significant (P > .05), 24% versus 17% (2 yr), 22% versus 16% (3 yr), 22% versus 13% (4 yr), and 17% versus 10% (5 yr). Changes in body mass index were not correlated to changes in HbA1C at various study points. Both LRYGB and LSG resulted in significant decreases in HbA1C levels and are correlated with changes in body mass index. LRYGB had the greatest effect at 1 year postoperatively. There was no significant difference in HbA1C reduction for LRYGB and LSG after 1 year postoperatively in this predominantly Hispanic and black cohort.

Glycemic effect of post-meal walking compared to one prandial insulin injection in type 2 diabetic patients treated with basal insulin: A randomized controlled cross-over study.

Studies demonstrate that post-meal walking decreases postprandial hyperglycemia in type 2 diabetic patients but it has never been tested with the active treatment comparator. The objective of this study was to determine the effect of post-meal walking on glycemic control compared with one prandial insulin in type 2 diabetic patients who failed basal insulin. A randomized controlled cross-over study of post-meal walking or one prandial insulin was done in type 2 diabetic patients who were being treated with basal insulin between May 2017 and March 2018. In post-meal walking group, patients walked after meal for 15-20 minutes one meal a day every day for 6 weeks. In prandial insulin (basal plus) group, one prandial insulin was injected before breakfast or main meal with rapid-acting insulin. The primary outcome was a difference in HbA1c reduction in post-meal walking compared with basal plus groups. Fourteen patients completed the study. By intention-to-treat analysis, HbA1c was reduced by -0.05(range:-1.08 to 0.74) and -0.19(range:-0.8 to 0.56) % in post-meal walking and basal plus groups respectively. By per-protocol analysis, post-meal walking and basal plus groups decreased HbA1c by 0.13(range:-0.74 to 1.08) and 0.2(range:-0.56 to 0.8) %, respectively. There was were no significant differences in HbA1c reduction from baseline in each group and between groups in both intention-to-treat and per-protocol analysis. Fructosamine levels were decreased by 17.5(-59 to 43) and 10(-15 to 40) μmol/L, respectively at 3 and 6 weeks in post-meal walking group whereas the respective changes in basal plus group were 12.5(-17 to 64) and 17.5(-28 to 38) μmol/L and there were no significant differences in fructosamine reduction from baseline in each group and between groups. In conclusion, although post-meal walking might be as effective as one prandial insulin to improve glycemic control in type 2 diabetic patients who failed basal insulin but the magnitude of reduction was small. A longer-term study with a larger sample size or with a different walking protocol is required.

Effectiveness of Smartphone App-Based Interactive Management on Glycemic Control in Chinese Patients With Poorly Controlled Diabetes: Randomized Controlled Trial.

BackgroundIn recent years, the rapid development of mobile medical technology has provided multiple ways for the long-term management of chronic diseases, especially diabetes. As a new type of management model, smartphone apps are global, convenient, cheap, and interactive. Although apps were proved to be more effective at glycemic control, compared with traditional computer- and Web-based telemedicine technologies, how to gain a further and sustained improvement is still being explored.ObjectiveThe objective of this study was to investigate the effectiveness of an app-based interactive management model by a professional health care team on glycemic control in Chinese patients with poorly controlled diabetes.MethodsThis study was a 6-month long, single-center, prospective randomized controlled trial. A total of 276 type 1 or type 2 diabetes patients were enrolled and randomized to the control group (group A), app self-management group (group B), and app interactive management group (group C) in a 1:1:1 ratio. The primary outcome was the change in glycated hemoglobin (HbA1c) level. Missing data were handled by multiple imputation.ResultsAt months 3 and 6, all 3 groups showed significant decreases in HbA1c levels (all P<.05). Patients in the app interactive management group had a significantly lower HbA1clevel than those in the app self-management group at 6 months (P=.04). The average HbA1c reduction in the app interactive management group was larger than that in the app self-management and control groups at both months 3 and 6 (all P<.05). However, no differences in HbA1c reduction were observed between the app self-management and control groups at both months 3 and 6 (both P>.05). Multivariate line regression analyses also showed that the app interactive management group was associated with the larger reduction of HbA1c compared with groups A and B at both months 3 and 6 (all P>.05). In addition, the app interactive management group had better control of triglyceride and high-density lipoprotein cholesterol levels at both months 3 and 6 compared with baseline (both P<.05).ConclusionsIn Chinese patients with poorly controlled diabetes, it was difficult to achieve long-term effective glucose improvement by using app self-management alone, but combining it with interactive management can help achieve rapid and sustained glycemic control.Trial RegistrationClinicalTrials.gov NCT02589730; https://clinicaltrials.gov/ct2/show/NCT02589730.

131-LB: Differences in HbA1c Reduction between Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Adults ≥70 Years of Age with T2DM in the BRIGHT Trial

Diabetes prevalence in older people is increasing and older people have an increased risk of hypoglycemia. Results are shown here of subgroup analyses in adults aged ≥65 years (pre-planned) and ≥70 years (post hoc) of the BRIGHT study in insulin-naïve adults with T2DM. Between treatment groups, baseline characteristics were similar; expected differences were observed between age subgroups: diabetes duration was longer, renal function was worse and BMI slightly lower in the ≥65 and ≥70 years groups vs. the overall population (Table). HbA1c reductions from baseline to week 24 were similar between treatment groups in the overall and ≥65 years populations. Heterogeneity of treatment effect was seen across the &amp;lt;/≥70 years subgroups (p=0.0087); HbA1c reduction in both treatment arms was similar in those &amp;lt;70 years but greater with Gla-300 vs. IDeg-100 in those ≥70 years. Incidence and rates of hypoglycemia at week 24 were similar between treatment groups in all populations assessed. Insulin dose increase was slightly greater with Gla-300 vs. IDeg-100 in the overall and ≥65 years populations, but similar in both treatment groups in the ≥70 years subgroup. Gla-300 provided similar HbA1c reduction vs. IDeg-100 in older people with T2DM, and greater reductions vs. IDeg-100 in those aged ≥70 years with no increased hypoglycemia risk in this frail population. Disclosure B. Charbonnel: Consultant; Self; AstraZeneca, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi, Servier. Speaker’s Bureau; Self; AstraZeneca, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi, Takeda Pharmaceutical Company Limited. V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck &amp; Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research &amp; Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. J. Westerbacka: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. F. Lauand: Employee; Self; Sanofi. E. Boelle: Employee; Self; Sanofi Research &amp; Development. A.Y. Cheng: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics, Janssen Pharmaceuticals, Inc., Merck &amp; Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Boehringer Ingelheim International GmbH, Sanofi. Speaker’s Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., mdBriefCase Group Inc., Merck &amp; Co., Inc., Novo Nordisk A/S, Sanofi. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck &amp; Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. G.B. Bolli: Advisory Panel; Self; Sanofi. Research Support; Self; A. Menarini Diagnostics, Medtronic. Funding Sanofi (NCT02738151)

Lower rates of hypoglycaemia in older individuals with type 2 diabetes using insulin degludec versus insulin glargine U100: Results from SWITCH 2.

AimThis study aimed to investigate the safety of insulin degludec (degludec) in relation to age and risk of hypoglycaemia post hoc in individuals with type 2 diabetes (T2D) (SWITCH 2 trial).MethodsIn this crossover study, individuals with T2D who were at risk of hypoglycaemia were randomized to double‐blind treatment with degludec or insulin glargine 100 units/mL (glargine U100) ± oral antidiabetic drugs. After 32 weeks, patients crossed over to the other treatment. Primary endpoint was number of overall severe (positively adjudicated) or glucose‐confirmed (plasma glucose <56 mg/dL; 3.1 mmol/L) symptomatic hypoglycaemia events during the two 16‐week maintenance periods.ResultsFor individuals ≤65 (n = 450) and >65 (n = 270) years, baseline median (range) duration of diabetes was 12 (1–40) vs 15 (1–54) years, mean HbA1c was 7.7% vs 7.4% and mean estimated glomerular filtration rate was 87.0 vs 63.7 mL/min/1.73 m2, respectively. No significant differences in HbA1c reduction were seen in individuals ≤65 or >65 years. During both maintenance periods, treatment with degludec lowered rates of hypoglycaemia (overall/nocturnal symptomatic) vs those with glargine U100 in individuals ≤65 (31% vs 43%) and >65 (30% vs 41%) years. With degludec and glargine U100, respectively, six vs nine severe hypoglycaemic events occurred in individuals ≤65 years and four vs eight events occurred in those >65 years. Adverse event rates were 3.2 and 3.3 events/patient‐year for individuals ≤65 years and were 3.5 and 4.1 events/patient‐year for individuals >65 years with degludec and glargine U100, respectively.ConclusionTreatment with degludec was safe and effective, with a frequency of hypoglycaemia lower than that with glargine U100 in both younger and older individuals (>65 years) with T2D.

Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials.

IntroductionInsulin dosing based on carbohydrate counting is the gold standard for improving glycaemic control in type 1 diabetes (T1D). This post hoc analysis aimed to explore the efficacy and safety of fast-acting insulin aspart (faster aspart) according to bolus dose adjustment method in people with T1D.MethodsPost hoc analysis of two 26-week, treat-to-target, randomised trials investigating treatment with double-blind mealtime faster aspart, insulin aspart (IAsp), or open-label post-meal faster aspart (onset 1, n = 1143; onset 8, n = 1025). Participants with previous experience continued carbohydrate counting (onset 1, n = 669 [58.5%]; onset 8, n = 428 [41.8%]), while remaining participants used a bolus algorithm.ResultsIn onset 1, HbA1c reduction was statistically significantly in favour of mealtime faster aspart versus IAsp with carbohydrate counting (estimated treatment difference [ETD 95% CI] − 0.19% [− 0.30; − 0.09]; − 2.08 mmol/mol [− 3.23; − 0.93]). In onset 8, there was no statistically significant difference in HbA1c reduction with either dose adjustment method, although a trend towards improved HbA1c was observed for mealtime faster aspart with carbohydrate counting (ETD − 0.14% [− 0.28; 0.003]; − 1.53 mmol/mol [− 3.10; 0.04]). In both trials, bolus insulin doses and overall rates of severe or blood glucose-confirmed hypoglycaemia were similar between treatments across dose adjustment methods.ConclusionFor people with T1D using carbohydrate counting, mealtime faster aspart may offer improved glycaemic control versus IAsp, with similar insulin dose and weight gain and no increased risk of hypoglycaemia.Trial RegistrationClinicalTrials.gov: NCT01831765 (onset 1) and NCT02500706 (onset 8).FundingNovo Nordisk.Electronic supplementary materialThe online version of this article (10.1007/s13300-019-0608-4) contains supplementary material, which is available to authorized users.

The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial

AimsFlash sensor-based glucose monitoring (FSGM) provides people with diabetes considerably more information on their glycaemic control. We have developed and evaluated a structured education and treatment programme, termed FLASH, to assist FSGM users to understand and use the available glycaemic information for optimization of their diabetes treatment. MethodsWe report on a multi-centre, randomized, parallel trial with a six-month follow-up involving 216 eligible participants (16–75 years old) on intensive insulin therapy. The primary outcome was HbA1c change from baseline to six months. Secondary outcomes were measures of glucose control as assessed by FSGM, as well as changes in behavioural and psychosocial measures. ResultsAt six months, the between-group difference in HbA1c reduction was significant, favouring FLASH education compared to the control group receiving no FLASH education (−0.28%, 95% CI −0.16% to −0.40% vs.−0.11%, 95% CI 0.00% to −0.22%; with a between-group difference of −0.17%, 95% CI −0.01% to −0.33%; p = 0.033). Participation in FLASH education also resulted in significant improvements in time spent in the target glucose range, in diabetes-related distress scores and in satisfaction with the glucose monitoring method. FLASH education also resulted in significant improvements in the use of glycaemic information provided by FSGM and in reduced self-monitoring of blood glucose (SMBG) fingerstick testing. ConclusionFLASH is an effective programme to improve glycaemic control and lower diabetes-related distress in users of FSGM.The study was registered in ClinicalTrials: NCT03175315.