Insufficient Glycemic Control Research Articles

Converging Pathways between Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Diabetes in Children.

In the past thirty years, childhood obesity rates have risen significantly worldwide, affecting over 340 million children in affluent nations. This surge is intricately tied to metabolic disorders, notably insulin resistance, type 2 diabetes mellitus (T2DM), and the continually evolving spectrum of metabolic-associated (dysfunction) steatotic liver disease (MASLD). This review underscores the alarming escalation of childhood obesity and delves comprehensively into the evolving and dynamic changes of nomenclature surrounding diverse conditions of hepatic steatosis, from the initial recognition of non-alcoholic fatty liver disease (NAFLD) to the progressive evolution into MASLD. Moreover, it emphasizes the crucial role of pediatric endocrinologists in thoroughly and accurately investigating MASLD onset in children with T2DM, where each condition influences and exacerbates the progression of the other. This review critically highlights the inadequacies of current screening strategies and diagnosis, stressing the need for a paradigm shift. A proposed solution involves the integration of hepatic magnetic resonance imaging assessment into the diagnostic arsenal for children showing insufficient glycemic control and weight loss post-T2DM diagnosis, thereby complementing conventional liver enzyme testing. This holistic approach aims to significantly enhance diagnostic precision, fostering improved outcomes in this vulnerable high-risk pediatric population.

Diabetes treatment satisfaction among a multi-ethnic Aotearoa New Zealand population with uncontrolled type 2 diabetes mellitus.

To assess whether diabetes treatment satisfaction differs by ethnicity among participants with insufficient glycaemic control of type 2 diabetes mellitus in a clinical trial involving additional oral diabetes medications. Patient satisfaction is used as an indicator of healthcare quality. However, data on patients' diabetes treatment satisfaction in the context of insufficient glycaemic control is limited. Individuals with type 2 diabetes and an HbA1c of 58-110mmol/mol (7.5-12.5%) were recruited across Aotearoa New Zealand to participate in an 8-month randomised crossover study of vildagliptin and pioglitazone as add-on therapy to metformin and/or sulfonylurea. Participants completed the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline pre-randomisation. Treatment satisfaction scores were compared between ethnic groups and other characteristics using the analysis of variance and linear regression. Perceived hyper- and hypoglycaemia were summarised separately. Between February 2019 and March 2020, 346 participants (41% women, 32% Pacific peoples, 23% Māori, 26% European) completed the DTSQ. Mean (SD) age was 57.5 (10.9) years, diabetes duration was 9 (6.3) years and HbA1c was 75 (12)mmol/mol (9.0[3.2]%). At study entry, 40% were receiving monotherapy for diabetes. Treatment satisfaction was rated highly, with a score of 29(6) (interquartile range 25-33). Pacific peoples and older people reported greater treatment satisfaction than other groups (p<0.001). Diabetes treatment satisfaction was high, particularly among Pacific peoples, despite suboptimal glycaemic control and insufficient glucose-lowering therapy.

Relationship Between Glycated Hemoglobin (HbA1c) and Vitamin D Levels in Type 2 Diabetes Patients: A Retrospective Cross-Sectional Study.

Significant links between low serum levels of vitamin D3 and insufficient glycemic control in patients with type 2 diabetes mellitus (T2DM) have been reported previously in the literature. However, there is no exciting evidence on the association between glycated hemoglobin (HbA1c) and vitamin D levels in T2DM individuals in our nation (Yemen). This study aimed to investigate the relationship between HbA1c and vitamin D levels in T2DM patients in a resource-limited setting. A retrospective cross-sectional study was conducted at the Al-Raffa Center, Ibb, Yemen between June 2018 and September 2023 including 396 patients diagnosed with T2DM. The patient characteristics, comorbidities, HbA1c, and vitamin D levels were gathered from patients' medical profiles. Linear regression analysis was used to find the factors associated with vitamin D deficiency (serum 25(OH)D levels < 20 ng/mL) among T2DM patients. Subsequently, the correlation between HbA1c and vitamin D levels was examined using receiver operating characteristic (ROC) curve analysis. The mean age was 44.6 ±14.6 years and most of them (n= 227, 57.3%) were female and from a rural area (n= 229, 57.8%). Comorbidities were hypertension, dyslipidemia disease, and cardiovascular disease in 176 (44.4%), 63 (15.9%), and 88 (22.2%) cases, respectively. The mean HbA1c was 8.1 ±2.5%. The mean vitamin D level was 26.9 ±16.5 ng/mL and low vitamin D was present in 260 (65.7%) (vitamin D deficiency in 160 (40.4%) and vitamin D insufficiency in 100 (25.3%) cases). In regression analysis, obesity (>30 kg/m2) (odds ratio (OR): 299.49; 95% confidence interval (CI):72.66 - 1234.42, p <0.0001), higher HbA1c levels (OR: 1.61; 95% CI:1.26 - 2.05, p =0.0001), and urban residence (OR: 23.98; 95% CI:5.62 - 102.42, p <0.0001) were associated with vitamin D deficiency. There was a negative correlation between the vitamin D level and HbA1c which was statistically significant (correlation coefficient r: -0.5452; 95% CI: -0.6109 to -0.4720, p <0.0001). Using the ROC analysis, the serum vitamin D value of ≤18.42 ng/ml was the best cut-off point to predict hyperglycemia (area under the curve: 0.633, 95% CI: 0.672 to 0.770, sensitivity: 52%, specificity: 84.71 %, Yoden's index: 0.3671, p <0.001). Based on this cut-off, 39.4% of individuals (37.5% in the normoglycemic group and 90.9% in the hyperglycemic group) were vitamin D deficient. In this study, low vitamin D was common among T2DM patients, especially those with poor glycemic control. We observed a link between HbA1c levels, urban residency, and BMI with vitamin D deficiency in T2DM patients. The association was distinguished by low vitamin D levels and elevated HbA1c. Additionally, we found that the serum vitamin D value of ≤18.42 ng/ml was the best cut-off point to predict hyperglycemia in T2DM patients with moderate agreement. To manage their disease, patients with T2DM should take their medications as prescribed and live a healthy lifestyle. This will increase their overall health, especially their vitamin D levels.

Association of glycemic control with hypertension in patients with diabetes: a population-based longitudinal study

BackgroundDiabetes increases the risk of hypertension morbidity, but whether this association is varied with glycemic control remains unknown. We aimed to examine the association of glycemic control with hypertension among individuals with diabetes.MethodsData was from the China Health and Retirement Longitudinal Study (CHARLS) between 2011 and 2018. Participants were categorized as having adequate glycemic control (HbA1c < 7%) and inadequate glycemic uncontrol (HbA1c ≥ 7%) by combining blood glucose tests and physician’s diagnoses in 2011. Incident hypertension was ascertained through self-reported physician diagnoses from 2011 to 2018. Cox proportional hazards regression models were used to examine the effect of glycemic control on hypertension.ResultsAmong 436 participants with diabetes in this study, 102 met the glycemic control standard, and 334 were insufficient glycemic control. During 7 years of follow-up, 141 individuals developed hypertension. Compared with adequate glycemic control, the hazard ratio of inadequate glycemic control on hypertension was 1.54 (95% CI, 1.07–2.21) in the multivariate model. Additionally, the influence of glycemic control on hypertension varied based on educational attainment and the presence of depressive symptoms (P for interaction < 0.05).ConclusionsInsufficient glycemic control was associated with a higher risk of hypertension among individuals with diabetes. Notably, the effect of glycemic control on hypertension was more pronounced among those with lower educational attainment and those exhibiting depressive symptoms. These findings underscore the significance of vigilant glycemic monitoring, educational background considerations, and mental health assessments in managing diabetic individuals.

34-LB: Effectiveness of Combination Use of a Lifestyle Improvement Support App and a Wearable Device on Glycemic Control in Japanese People with T2DM—STEP-DM

Despite the availability of various therapeutic agents for T2DM, about half of patients do not achieve their glycemic control targets in Japan. In recent years, apps and wearable devices supporting diabetes treatment have rapidly spread. However, evidence of their impact, especially in combination, is limited. This is the first study to explore the effectiveness of combination use of a lifestyle improvement support app (TOMOCOTM Mitsubishi Tanabe Pharma Co.) and a wearable device (Fitbit) in Japanese people with T2DM under insufficient glycemic control (jRCT1070220007). Of 61 patients enrolled, 59 completed (HbA1c: 7.57 ± 0.42%, Body weight: 69.12 ± 13.36 kg; at baseline). The participants used TOMOCOTM and Fitbit in addition to conventional diet/exercise and antidiabetic drug therapy for 12 weeks, and were provided feedback/advice based on TOMOCOTM and Fitbit records from health care providers (Fig). At the end of the observation period, HbA1c was significantly decreased (-0.41 ± 0.41%; range -1.9 to 0.7, p&amp;lt;0.001) and body weight was also reduced (-0.88 ± 1.58 kg; range -5.7 to 2.1, p&amp;lt;0.001), and the trend was consistent across the pre-specified patient background. In conclusion, combination use of a lifestyle improvement support app and a wearable device with conventional therapy may be effective for glycemic control in people with T2DM. Disclosure A. Takahashi: Employee; Mitsubishi Tanabe Pharma Corporation. M. Ishii: Employee; Mitsubishi Tanabe Pharma Corporation. Y. Kino: Employee; Mitsubishi Tanabe Pharma Corporation. K. Sasaki: Employee; Mitsubishi Tanabe Pharma Corporation. T. Hashimoto: Employee; Mitsubishi Tanabe Pharma Corporation. T. Matsui: Employee; Mitsubishi Tanabe Pharma Corporation. K. Arakawa: Employee; Mitsubishi Tanabe Pharma Corporation. M. Kunisaki: Research Support; Mitsubishi Tanabe Pharma Corporation, Novo Nordisk.

Impact of Second-Line Combination Treatment for Type 2 Diabetes Mellitus on Disease Control: A Population-Based Cohort Study.

Type 2 diabetes mellitus is a chronic disease affecting millions of people worldwide. Achieving and maintaining glycemic control is essential to prevent or delay complications and different strategies are available as second-line treatment options for patients with type 2 diabetes who do not achieve glycemic control with metformin monotherapy. The aim of this work is to describe the impact of initiating a combination treatment to reduce glycated hemoglobin in patients with type 2 diabetes with insufficient glycemic control. We included patients with a type 2 diabetes diagnosis between 2015 and 2020 at the Information System for Research in Primary Care (SIDIAP) database in Catalonia, Spain. The primary outcome was the time to glycated hemoglobin control (≤ 7%) during the first 720 days, expressed as the restricted mean survival time. Adjusted differences of the restricted mean survival time were compared to analyze the performance of each treatment versus the combination with a sulfonylurea. Adherence was calculated as the medication possession ratio using an algorithm to model treatment exposure. A total of 28,425 patients were analyzed. The most frequent combinations were those with sulfonylureas and dipeptidyl peptidase-4 inhibitors. All treatments reduced glycated hemoglobin and the restricted mean survival time for the sulfonylurea treatment was 455 (451-459) days although combinations with glucagon-like peptide-1 and insulin reached glycemic control earlier, - 126 days (- 152 to - 100, p < 0.001) and - 69 days (- 88 to - 50, p < 0.001), respectively. Adherence was high in all groups apart from the insulin combination and had a significant effect in reducing glycated hemoglobin except in sodium-glucose cotransporter type 2 inhibitors and insulin. Glucagon-like peptide-1 and sodium-glucose cotransporter type 2 inhibitors showed significant reductions in weight. Patients achieved the glycated hemoglobin goal with second-line treatments. Glucagon-like peptide-1 and insulin combinations achieved the goal earlier than sulfonylurea combinations. Adherence significantly reduced the time to glycated hemoglobin control except for the combination withsodium-glucose cotransporter type 2 inhibitors.

Open-Angle Glaucoma with Diabetes Mellitus and Insufficient Glycaemic Control: Spectral-Domain Oct Characteristics

Open-Angle Glaucoma with Diabetes Mellitus and Insufficient Glycaemic Control: Spectral-Domain Oct Characteristics

Comparison of three insulin bolus calculators to increase time in range of glycemia in a group of poorly controlled adults Type 1 diabetes in a Brazilian public health service

BackgroundA main factor contributing to insufficient glycemic control, during basal/bolus insulin therapy, is poor self-management bolus. Insulin bolus administration frequency is strongly associated with glycated hemoglobin (A1c) in Type 1 Diabetes (T1D). In the present study, we analyzed the performance of two-bolus calculator’s software that could be accessible to T1D patients from a Public Health Service to improve glycemic time in range (TIR) and A1c.MethodsThis prospective, controlled, randomized, parallel intervention clinical trial was carried out with 111 T1D participants on basal/bolus therapy [multiple daily insulin injections (MDI) or subcutaneous infusion pump (CSII)] with basal A1c ≥ 8.5% for 24 weeks. Patients were divided into 3 groups: 2 interventions: COMBO® (bolus calculator) and GLIC (mobile application) and 1 control (CSII group). Anthropometrics and metabolic variables were assessed on basal, 3 and 6 months of follow-up.ResultsTIR was increased in 9.42% in COMBO group (29 ± 12% to 38.9 ± 12.7%; p < 0.001) in 8.39% in the GLIC® group (28 ± 15% to 36.6 ± 15.1%; p < 0.001) while remained stable in CSII group (40 ± 11% to 39.3 ± 10.3%). A1c decrease in 1.08% (p < 0.001), 0.64% (p < 0.001) and 0.38% (p = 0.01) at 6 months in relation to basal in the COMBO, GLIC and CSII respectively. Daily basal insulin dose was reduced by 8.8% (p = 0.01) in the COMBO group.ConclusionThe COMBO and a mobile applicative (GLIC) bolus calculator had a similar and a good performance to optimize the intensive insulin treatment of T1D in the public health system with increase in the TIR and reduction in A1C without increase hypoglycemia prevalence.

Circulatory and ventilatory power markers in patients with diabetes mellitus – influence of glycemic control

Introduction and aim. Cardiorespiratory function has been shown to be impaired in individuals with type 2 diabetes mellitus (T2DM). Some deficiencies in cardiopulmonary exercise test (CPET)-derived variables are known, however, the influence of glycemic control on cardiovascular integrity indices as circulatory power (CP) and ventilatory power (VP), deserve to be instigated. The aim was to investigate the influence of glycemic control on CP and VP indices in T2DM. Material and methods. T2DM individuals of both sexes aged between 40 and 64 years were allocated into two groups: Good glycemic control (GGC, n=11; HbA1c≤7%) and insufficient glycemic control (IGC, n=26; HbA1c&gt;7%). All participants underwent a CPET on a treadmill using a gas analyzer and a laboratory blood test. CP values were obtained by the product of peak of oxygen uptake and systolic blood pressure (SBP) and VP by dividing SBP by the ventilatory efficiency (VE/VCO2 slope). The level of significance was set at p&lt;0.05. Results. No baseline differences were found between the groups, except for the expected fasting glucose and glycated hemoglobin. No differences were found between GGC and IGC groups for CP (4756.05±1061.67 and 4434.15±1247.83 mmHg.ml.kg-1min-1, p=0.460) and VP (5.85±1.08 and 5.86±1.31 mmHg, p=0.978), respectively. Conclusion. CP and VP were similar in individuals with T2DM regardless of glycemic control. Predictive ability of these variables in health outcomes deserves to be further investigated in T2DM.

제2형 당뇨병 환자의 혈당조절 영향요인 분석: 제7기 국민건강영양조사자료(2016∼2018) 이용

Purpose: This study examined factors influencing glycemic control among type 2 diabetes mellitus (T2DM) patients using data from the seventh Korea National Health and Nutrition Examination Survey. Methods: The subjects were 1,459 patients aged 30 years and older who with T2DM. The subjects were divided into three groups according to glycated hemoglobin A (HbA1c) values: good glycemic control group (good GCG, HbA1c<7%), insufficient GCG (7≤HbA1c< 8%), and poor GCG (8%≥HbA1c). Univariate multiple multinomial logistic regression was used. Results: The patients were distributed as follows: 52.7%, good GCG; 28.4%, insufficient GCG; and 18.9%, poor GCG. In the insufficient GCG, DM duration was a significant factor influencing glycemic control in T2DM. In the poor GCG, age, DM duration, hypertriglyceridemia, waist circumference and muscular exercise were significant factors influencing glycemic control in T2DM. Conclusion: Strategies for insufficient glycemic control should include intensive glucose control interventions for patients with a DM duration over 5 years. Strategies for poor glycemic control should include intensive glucose control interventions for younger age groups, those with a DM duration >1 year, and those with hypertriglyceridemia. In addition, nursing interventions for weight loss and muscular exercise are needed.

Risk of death with sodium-glucose co-transporter-2 inhibitors across the hallmark cardiovascular and renal outcome trials: an updated meta-analysis

Abstract Background Patients with type 2 diabetes mellitus (T2DM) experience a 15% increase in the risk for death compared to the general population, with age less than 55 years, insufficient glycemic control and albuminuria representing the major risk factors for all-cause and cardiovascular mortality. Despite progression in diagnosis and treatment, mortality remains elevated among affected individuals. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors are considered as the optimal treatment option for patients with T2DM and concomitant cardiovascular or renal disease, while these regimens demonstrated a clear benefit in all-cause and cardiovascular mortality compared to placebo. Purpose As we recently welcomed the publication of large-scale randomized controlled trials (RCTs) with SGLT-2 inhibitors addressing surrogate, hard endpoints, we sought to perform an updated meta-analysis, investigating the effect of SGLT-2 inhibitors on all-cause, cardiovascular and renal death among the high- or very-high risk patients enrolled in those trials. Methods We pooled data from the relevant, recent hallmark RCTs; 10 trials were included in our analysis encompassing a total of 71,533 enrolled participants, assigned either to SGLT-2 inhibitor treatment or placebo. We set cardiovascular death as the primary efficacy outcome, while we assessed all-cause death and renal death as secondary efficacy outcomes. Results Treatment with SGLT-2 inhibitors resulted in a significant decrease in the risk of cardiovascular death, equal to 14% (RR = 0.86, 95% CI; 0.80 to 0.93, I2=22%). Only canagliflozin produced a significant result, while dapagliflozin led to a marginally non-significant reduction in cardiovascular mortality (Figure 1). Notably, SGLT-2 inhibitors led to a significant decrease in the risk for all-cause death, equal to 14% (RR=0.86, 95% CI; 0.81 to 0.92, I2=34%) the result was significant only for canagliflozin and dapagliflozin, while none of the rest SGLT-2 inhibitors resulted in a significant decrease in the risk for all-cause death (Figure 1). SGLT-2 inhibitors also produced a non-significant decrease in the risk for renal death (RR=0.36, 95% CI; 0.12 to 1.14, I2=0%). Neither canagliflozin nor dapagliflozin had a significant impact on risk reduction for renal death, while no cases of renal death were reported in VERTIS CV trial. No subgroup differences were identified for any of the three comparisons (Figure 2). Conclusions Antidiabetic treatment with SGLT-2 inhibitors provides a clear benefit in terms of cardiovascular and all-cause mortality for the very high-risk patients enrolled in the cardiovascular and renal outcome trials. Canagliflozin seems to be associated with the greatest impact on risk reduction for all-cause and cardiovascular death, followed by dapagliflozin. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

Analysis of the Adherence and Safety of Second Oral Glucose-Lowering Therapy in Routine Practice From the Mediterranean Area: A Retrospective Cohort Study.

The aims of our study was compare adherence measured by the medical possession ratio (MPR), time until discontinuation and describe adverse events after adding a DPP-4i, SGLT-2i, or sulfonylureas (SU) to metformin in a primary care population with insufficient glycemic control. We used routinely-collected health data from the SIDIAP database. The included subjects were matched by propensity score. The follow-up period was up to 24 months or premature discontinuation. The primary outcomes were the percentage of subjects with good adherence, treatment discontinuation and adverse events among treatment groups. The proportion of patients with good adherence (MPR> 0.8) after the addition of DPP-4i, SGLT-2i or SU was 53.6%, 68.7%, and 43.0%, respectively. SGLT-2i users were 1.7 times more likely to achieve good adherence compared with DPP-4i users (odds ratio [OR]:1.72, 98% confidence interval [CI]:1.51, 1.96), and 2.8 times more likely compared with SU users (OR: 0.35, 98% CI: 0.07, 0.29). The discontinuation hazard ratios were 1.43 (98%CI: 1.26; 1.62) and 1.60 (98%CI: 1.42; 1.81) times higher among SGLT-2i and SU users than DPP-4i users during the follow-up period. No differences were observed for adverse events among the treatment groups. In conclusion, in our real-world setting, the combination of SGLT-2i with metformin was associated with better adherence. The mean time until discontinuation was longer in the SGLT-2i group in comparison with the DPP-4i or SU groups.

Risky sexual behaviors in adolescents and young adult women with type 1 diabetes: An overlooked problem.

The presence of unprotected sex activity in women living with type 1 diabetes (T1D) who have insufficient glycemic control should be considered as a specific risky behavior. To evaluate risky behaviors, including unprotected sexual activity, sources of information and knowledge related to reproductive health in adolescents and young adult women with T1D (PwT1D) compared to a group of adolescents and young adult women without diabetes (Comparison group). PwT1D and the Comparison group completed a questionnaire with validated measures that assessed reproductive health. PwT1D (n=115, age=17.7 ± 3.2 years) and Comparison group (n=386, age=18.3 ± 2.9) were recruited. The proportion of women reporting having sex without any contraceptive was similar in both groups (57.1% and 50%, in PwT1D and Comparison group, respectively). The use of non-effective contraceptive was reported in 63.2% and 63.6% of the PwT1D and Comparison group, respectively. Among PwT1D, parents, formal sex education, and friends were the primary source of information on reproductive health. Low levels of knowledge about diabetes and pregnancy were observed in PwT1D. HbA1c level was associated with having at least one sexual activity without any contraception (OR=1.63, p=0.039). PwT1D have similar rates of risky behaviors compared to a Comparison group. Sexual risky behaviors should be especially considered in PwT1D with glycemic control above the optimal level. Parents are an important source of reproductive health information for PwT1D. Use of effective contraception should be reinforced in sexually active PwT1D.

Beyond the barriers of the use of continuous subcutaneous insulin therapy in type 1 diabetes: a new opportunity from catheter-less insulin pumps

Although it represents a valid alternative for patients with type 1 diabetes (T1DM) with insufficient glycemic control and/or with recurrent hypoglycemia, insulin pump therapy (Continuous Subcutaneous Insulin Infusion, CSII) in Italy is nowadays still relatively uncommon. The following review aims to investigate the barriers that limit the transition to CSII and the reasons behind the widespread cases of drop-out, particularly evident in younger patients. Among the interventions that could contribute to the solution of the problem, catheter-less insulin pumps (or patch-pumps) will be described: a tool potentially able to reduce, if not eliminate, some of the main obstacles encountered by patients. In particular, a new opportunity has become available today thanks to the evolution of the generation of catheter-less insulin pumps represented by Accu-Chek® Solo (Roche Diabetes Care GmbH), therefore three clinical cases of patients with T1DM undergoing therapy with the Accu-Chek® Solo insulin pump will be presented and discussed herein.

Patient-Tailored Decision Support System Improves Short- and Long-Term Glycemic Control in Type 2 Diabetes.

The increasing prevalence of type 2 diabetes mellitus (T2D) and specialist shortage has caused a healthcare gap that can be bridged by a decision support system (DSS). We investigated whether a diabetes DSS can improve long- and/or short-term glycemic control. This is a retrospective observational cohort study of the Diabetiva program, which offered a patient-tailored DSS using Karlsburger Diabetes-Management System (KADIS) once a year. Glycemic control was analyzed at baseline and after 12 months in 452 individuals with T2D. Time in range (TIR; glucose 3.9-10 mmol/L) and Q-Score, a composite metric developed for analysis of continuous glucose profiles, were short-term and HbA1c long-term measures of glycemic control. Glucose variability (GV) was also measured. At baseline, one-third of patients had good short- and long-term glycemic control. Q-Score identified insufficient short-term glycemic control in 17.9% of patients with HbA1c <6.5%, mainly due to hypoglycemia. GV and hyperglycemia were responsible in patients with HbA1c >7.5% and >8%, respectively. Application of DSS at baseline improved short- and long-term glycemic control, as shown by the reduced Q-Score, GV, and HbA1c after 12 months. Multiple regression demonstrated that the total effect on GV resulted from the single effects of all influential parameters. DSS can improve short- and long-term glycemic control in individuals with T2D without increasing hypoglycemia. The Q-Score allows identification of individuals with insufficient glycemic control. An effective strategy for therapy optimization could be the selection of individuals with T2D most at need using the Q-Score, followed by offering patient-tailored DSS.

Efficacy and safety of chiglitazar, a novel peroxisome proliferator-activated receptor pan-agonist, in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 3 trial (CMAP)

Chiglitazar (Carfloglitazar) is a novel non-thiazolidinedione (TZD) structured peroxisome proliferator-activated receptor (PPAR) pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes in previous clinical studies. This randomized phase 3 trial aimed to compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes with insufficient glycemic control by strict diet and exercise alone. Eligible patients were randomly assigned to receive chiglitazar 32 mg (n = 167), chiglitazar 48 mg (n = 166), or placebo (n = 202) once daily. The primary endpoint was the change in glycosylated hemoglobin A1c (HbA1c) at week 24 with superiority of chiglitazar over placebo. The results showed that both chiglitazar 32 and 48 mg resulted in significant and clinically meaningful reductions in HbA1c, and placebo-adjusted estimated treatment differences at week 24 for chiglitazar 32 and 48 mg were −0.87% (95% confidential interval (CI): −1.10 to −0.65; P < 0.0001) and −1.05% (95% CI: −1.29 to −0.81; P < 0.0001), respectively. Secondary efficacy parameters including glycemic control, insulin sensitivity and triglyceride reduction were also significantly improved in the chiglitazar groups. The overall frequency of adverse events and study discontinuation attributable to adverse events were similar among the groups. Low incidences of mild edema and body weight gain were reported in the chiglitazar dose groups. The results from this phase 3 trial demonstrated that the PPAR pan-agonist chiglitazar possesses an overall good efficacy and safety profile in patients with type 2 diabetes inadequately controlled with lifestyle interventions, thereby providing adequate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes.

Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS)

Chiglitazar (Carfloglitazar) is a novel peroxisome proliferator-activated receptor (PPAR) pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes. In this randomized phase 3 trial, we compared the efficacy and safety of chiglitazar with sitagliptin in patients with type 2 diabetes who had insufficient glycemic control despite a strict diet and exercise regimen. Eligible patients were randomized (1:1:1) to receive chiglitazar 32 mg (n = 245), chiglitazar 48 mg (n = 246), or sitagliptin 100 mg (n = 248) once daily for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin A1C (HbA1c) from baseline at week 24 with the non-inferiority of chiglitazar over sitagliptin. Both chiglitazar and sitagliptin significantly reduced HbA1c at week 24 with values of −1.40%, −1.47%, and −1.39% for chiglitazar 32 mg, chiglitazar 48 mg, and sitagliptin 100 mg, respectively. Chiglitazar 32 and 48 mg were both non-inferior to sitagliptin 100 mg, with mean differences of −0.04% (95% confidential interval (CI) −0.22 to 0.15) and −0.08% (95% CI −0.27 to 0.10), respectively. Compared with sitagliptin, greater reduction in fasting and 2-h postprandial plasma glucose and fasting insulin was observed with chiglitazar. Overall adverse event rates were similar between the groups. A small increase in mild edema in the chiglitazar 48 mg group and slight weight gain in both chiglitazar groups were reported. The overall results demonstrated that chiglitazar possesses good efficacy and safety profile in patients with type 2 diabetes inadequately controlled with lifestyle interventions, thereby providing adequate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes.

PP164 Prescribed Medication Use, Complications, And Cost of Type 2 Diabetes Mellitus In The Real World

IntroductionType 2 diabetes mellitus (T2DM) is one of the major diseases threatening the health of Chinese residents. Insufficient glycemic control results in inevitable and sometimes irreversible complications. The condition can be more complicated for patients with comorbidities. To maintain appropriate glycemic control, patients may need to add or switch to different classes of drugs as the disease progresses. The complicated drug treatment for diabetes poses a high risk for drug-drug interactions and challenges patient compliance, which is the most important factor affecting the ability to achieve glycemic control. In addition, T2DM is a life-long disease that is associated with a heavy economic burden for patients’ families and for society. Therefore, this paper aims to characterize the complexity of prescribed medications used to treat T2DM and to assess the trends in the number of complications, medications used, and costs incurred among these patients.MethodsData were retrieved from two tertiary hospitals. The population consisted of patients receiving at least one diagnosis of diabetes (International Classification of Diseases-10 codes: E11, E12, E13, and E14) between October 2007 and May 2017. Three measures were assessed, including the number of patients with different complications, concomitant drug use, and costs. Patients with a short disease duration (&lt; 5 years) were compared with patients who had a longer disease duration (≥ 5 years).ResultsOf 31,071 patients, about half of those with a longer disease duration had at least five concomitant diseases, compared with nine percent of patients with a shorter disease duration. The maximum number of concomitant diseases was nine for both disease duration groups. Patients with longer disease duration were more likely to use multiple classes of drugs, compared with patients in the short disease duration group. The average annual medical costs for patients without concomitant disease was CNY 1,894 (USD 265).ConclusionsOverall, the results demonstrated that T2DM is a relatively complex disease. Firstly, patients have up to nine concomitant diseases and use twenty-two classes of drugs. Secondly, patients with more complications tended to use more medications. Thirdly, patients with a longer disease duration tend to have a higher number of concomitant diseases, use more classes of drugs, and have higher medical costs than patients with a shorter disease duration.

Glycemic control before admission is an important determinant of prognosis in patients with coronavirus disease 2019.

Aims/IntroductionThis study aimed to explore the association between glycemic control before admission with severity and mortality of coronavirus disease 2019, and tried to reveal the mechanism.Materials and MethodsA total of 77 inpatients were grouped into sufficient control group (glycated hemoglobin [HbA1c] <6.5%, n = 49) and insufficient control group (HbA1c ≥6.5%, n = 28). Regression models were used to analyze the clinical data.ResultsCompared with patients with HbA1c <6.5, patients with HbA1c ≥6.5 showed higher heart rate (101 vs 89 b.p.m., P = 0.012), lower percutaneous oxygen saturation (93 vs 97%, P = 0.001), higher levels of multiple indicators of inflammation, such as white blood cell count (7.9 vs 5.9 × 109/L, P = 0.019), neutrophil count (6.5 vs 4.1 × 109/L, P = 0.001), high‐sensitivity C‐reactive protein (52 vs 30 mg/L, P = 0.025) and serum ferritin (1,287 vs 716 μg/L, P = 0.023), as well as lower levels of lymphocyte count (0.7 vs 0.8 × 109/L, P = 0.049) at hospital admission. Thus, patients with HbA1c ≥6.5 were more likely to develop secondary respiratory infections (25 [89%] vs 33 [67%], P = 0.032) and acute respiratory distress syndrome (17 [61%] vs 14 [29%], P = 0.006) than patients with HbA1c <6.5, resulting in a higher proportion of critically ill patients (19 [68%] vs 18 [37%], P = 0.009) and non‐survivors (13 [46%] vs 11 [22%], P = 0.029). After adjustment for potential risk factors, HbA1c was independently associated with in‐hospital death.ConclusionHbA1c was an independent risk factor for poor outcomes in coronavirus disease 2019 patients. Severe pulmonary infection and consequent acute respiratory distress syndrome might be the primary causes of death in insufficient glycemic control patients.

Diabetes complications - diabetes and the nervous system

Diabetes mellitus is a chronic metabolic disease associated with multiple long-term complications. Besides macro- and microvascular complications, patient's well-being can be severely impaired by complications affecting the nervous system. About 50 % of patients with diabetes suffer from polyneuropathy. Moreover, the risk of developing cognitive impairment and dementia is also increased in older people with diabetes. Insufficient glycemic control, young age at diagnosis of diabetes are discussed as risk factors for developing diabetes complications. The early identification and prevention of factors predicting diabetes complications that affect the nervous system are still challenging and in need for further research.