Good Glycemic Control In Patients Research Articles

Bihormonal fully closed-loop system for the treatment of type 1 diabetes: a real-world multicentre, prospective, single-arm trial in the Netherlands

Management of insulin administration for intake of carbohydrates and physical activity can be burdensome for people with type 1 diabetes on hybrid closed-loop systems. Bihormonal fully closed-loop (FCL) systems could help reduce this burden. In this trial, we assessed the long-term performance and safety of a bihormonal FCL system. The FCL system (Inreda AP; Inreda Diabetic, Goor, Netherlands) that uses two hormones (insulin and glucagon) was assessed in a 1 year, multicentre, prospective, single-arm intervention trial in adults with type 1 diabetes. Participants were recruited in eight outpatient clinics in the Netherlands. We included adults with type 1 diabetes aged 18-75 years who had been using flash glucose monitoring or continuous glucose monitors for at least 3 months. Study visits were integrated into standard care, usually every three months, to evaluate glycaemic control, adverse events, and person-reported outcomes. The primary endpoint was time in range (TIR; glucose concentration 3·9-10·0 mmol/L) after 1 year. The study is registered in the Dutch Trial Register, NL9578. Between June 1, 2021, and March 2, 2022, we screened 90 individuals and enrolled 82 participants; 78 were included in the analyses. 79 started the intervention and 71 were included in the 12 month analysis. Mean age was 47.7 (SD 12·4) years and 38 (49%) were female participants. The mean preintervention TIR of participants was 55·5% (SD 17·2). After 1 year of FCL treatment, mean TIR was 80·3% (SD 5·4) and median time below range was 1·36% (IQR 0·80-2·11). Questionnaire scores improved on Problem Areas in Diabetes (PAID) from 30·0 (IQR 18·8-41·3) preintervention to 10·0 (IQR 3·8-21·3; p<0·0001) at 12 months and on World Health Organization-Five Well-Being Index (WHO-5) from 60·0 (IQR 44·0-72·0) preintervention to 76·0 (IQR 60·0-80·0; p<0·0001) at 12 months. Five serious adverse events were reported (one cerebellar stroke, two severe hypoglycaemic, and two hyperglycaemic events). Real-world data obtained in this trial demonstrate that use of the bihormonal FCL system was associated with good glycaemic control in patients who completed 1 year of treatment, and could help relieve these individuals with type 1 diabetes from making treatment decisions and the burden of carbohydrate counting. Inreda Diabetic.

Coping and risk perception during the COVID-19 pandemic in type 2 diabetes: Does it influence metabolic control?

Diabetes and poor glycemic control are significant predictors of severity and death in the COVID-19 disease. The perception of this risk in individuals with type 2 diabetes (T2D) could modify coping styles, leading to behaviors associated with better self-care and metabolic control. Theoretically, active coping is associated with better glycemic control in patients with T2D. Nonetheless, information during extreme risk like the COVID-19 pandemic is still limited. Our objective was to evaluate the association between coping styles and risk perception in the COVID-19 pandemic and the change in metabolic parameters. This is a prospective study that included individuals with T2D treated in a tertiary care center during the COVID-19 outbreak who returned to follow-up one year later. We assessed coping styles and risk perception with the Extreme Risk Coping Scale and the risk perception questionnaire. Clinical characteristics and metabolic parameters were registered in both visits. Groups were compared using Kruskal Wallis tests, and changes in metabolic parameters were assessed with Wilcoxon rank sum tests. Our sample included 177 participants at baseline, and 118 concluded the study. Passive coping was more frequent in women. Low-risk perception was associated with higher age, lower psychiatric comorbidities, and lower frequency of psychiatric treatment compared with other risk perception groups. Patients with active coping plus high-risk perception did not have a change in metabolic parameters at follow-up, whereas patients with other coping styles and lower risk perception had an increase in total cholesterol, LDL-cholesterol, and triglycerides. There were no differences by coping group or by risk perception in glycemic control.

Effects of COVID-19 lockdown on metabolic control in patients with type 2 diabetes in Sri Lanka

Introduction: The COVID-19 pandemic has led to an island-wide lockdown in Sri Lanka, leading to restrictions in daily routines. The ensuing lifestyle changes have drastically influenced the prevalence and worsening of chronic diseases like diabetes with poor metabolic control of the disease.Objectives: To evaluate the immediate impact of the lockdown on the metabolic parameters associated with diabetes control in individuals with type-2 diabetes mellitus (T2DM).Methodology: A single center cross-sectional descriptive study was conducted on 157 T2DM patients attending a diabetes clinic in the private sector. Pre- and post-lockdown data on metabolic control of the study population was collected from patient records. Patients’ perceptions of diet/exercise and access to medication/medical care during the lockdown were collected through a telephone interview.Results: Pre- and post-lockdown data of 157 male (Females 88; mean age-58.68±SD 13.44 years) patients belonging to the age group 48-72 were evaluated. Of the patients who had a HbA1c of ≤ 7% pre-lockdown, 80% had shown to maintain their HbA1c. Of the patients with HbA1c &gt; 7% pre-lockdown, 27.9% showed a reduction of their HbA1c below 7%.The majority of the responders had no difference in their diet (69.2%) and exercise (65.4%) during the lockdown. Among those with improved HbA1c (n=101;63% of cohort), 16.9% and 13% had better diet and exercise respectively while none in worsened HbA1c group had improved diet or exercise.Conclusions: Lockdown in Sri Lanka has not been associated with worsening of glycaemic control in the studied cohort of patients with type 2 diabetes. Adherence to the recommended diet and exercise regime during lockdown is associated with better glycaemic control in patients with type 2 diabetes.

Adherence to mediterranean diet is associated with better glycaemic control in patients with prediabetes and diabetes type 2

Adherence to mediterranean diet is associated with better glycaemic control in patients with prediabetes and diabetes type 2

Recommendations on the use of prehabilitation, i.e. comprehensive preparation of the patient for surgery.

Prehabilitation is a comprehensive preparation of a patient for primarily surgical treatments. Its aim is to improve the patient&apos;sgeneral condition so as to reduce the risk of complications and ensure the fastest possible recovery to full health. Thebasic components of prehabilitation include: improvement of nutritional status, appropriate exercises to improve functioning,psychological support, and help in eliminating addictions. Other important aspects of prehabilitation are: increasinghemoglobin levels in patients with anemia, achieving good glycemic control in patients with diabetes, treatment or stabilizationof any concurrent disorders, or specialist treatment associated with a specific procedure (endoprostheses, ostomyprocedure). This article organizes and outlines the indications for prehabilitation, its scope, duration, and the method to conductit. Experts of various specialties related to prehabilitation agree that it should be an element of surgery preparationwhenever possible, especially in patients with co-existing medical conditions who have been qualified for major procedures.Prehabilitation should be carried out by interdisciplinary teams, including family physicians and various specialists in thetreatment of comorbidities. Prehabilitation requires urgent systemic and reimbursement solutions.

Impact of a Tripartite Collaboration between Oncologist, Pharmacist and Diabetologist in the Management of Patients with Diabetes Starting Chemotherapy: The ONCODIAB Trial.

Diabetes negatively impacts cancer prognosis. The objective of this work was to evaluate a tripartite oncologist-pharmacist-diabetologist collaboration in the management of patients with diabetes starting chemotherapy. The prospective ONCODIAB study (NCT04315857) included 102 adults with diabetes starting chemotherapy by whom a continuous glucose monitoring device was worn for fourteen days from the first day of the first and second chemotherapy cycles. The primary outcome was to assess pharmacist and diabetologist interventions. The secondary outcome was to evaluate the impact of the ONCODIAB follow-up on individualized patient glycemic targets at 6 months. A total of 191 (2 per patient) were made either by clinical pharmacists (n = 95) or diabetologists (n = 96) during the first two chemotherapy cycles. The anatomic therapeutic chemical drug classes most frequently involved in pharmacist interventions were cardiovascular system (23%), alimentary tract and metabolism (22%), and anti-infectives for systemic use (14%). Diabetologists modified the antidiabetic treatment in 58 (62%) of patients: dose reduction (34%), drug discontinuation (28%), drug addition (24%), and dose increase (15%). Glycated hemoglobin decreased from 7.6 ± 1.7% at baseline to 7.1 ± 1.1% at 6 months (p = 0.02). Compared to individualized targets, HbA1c was higher, in the interval, or lower in 29%, 44%, and 27% of patients at baseline vs. in 8%, 70%, and 22% of patients at 6 months, respectively (p < 10-3). In our study, a close collaboration between oncologists, pharmacists, and diabetologists helped by continuous glucose monitoring led to overall medication optimization and better glycemic control in patients with diabetes starting chemotherapy.

Healthy Lifestyle Score and Glycemic Control in Type 2 Diabetes Mellitus Patients: A City-Wide Survey in China.

Few studies have investigated the combined impact of healthy lifestyle factors on glycemic control. Our study aimed to examine the associations of a healthy lifestyle score (HLS) with glycemic control and to explore the interactive effects of lifestyle factors among patients with type 2 diabetes mellitus (T2DM) in China. This cross-sectional study was conducted among T2DM patients based on the health management of residents from Guangzhou, China. Good glycemic control was defined as fasting plasma glucose < 7.0 mmol/L. HbA1c < 7.0% was also defined as good glycemic control in sensitivity analysis. The HLS was defined as including physical activity, waist circumference, body mass index, dietary habit, smoking, and alcohol consumption. Logistic regression models were used to examine the associations and interactions between the lifestyle factors and glycemic control. Compared with participants with an HLS ≤ 2, the odds ratios (95% confidence intervals) for an HLS of 3, 4, 5, and 6 were 0.82 (0.77-0.87), 0.74 (0.70-0.79), 0.61 (0.57-0.65), and 0.56 (0.53-0.60), respectively. Significant interactions of healthy lifestyle factors in relation to glycemic control were shown (Pinteraction < 0.05). A healthier lifestyle was significantly associated with good glycemic control in patients with T2DM, and combined healthy lifestyle factors had a better effect than considering them individually.

Pre-treatment with IL-6 potentiates β-cell death induced by pro-inflammatory cytokines

BackgroundType I Diabetes mellitus (T1D) is characterized by a specific destruction of β-cells by the immune system. During this process pro-inflammatory cytokines are released in the pancreatic islets and contribute for β-cells demise. Cytokine-induced iNOS activation, via NF-κB, is implicated in induction of β-cells death, which includes ER stress activation. Physical exercise has been used as an adjunct for better glycemic control in patients with T1D, since it is able to increase glucose uptake independent of insulin. Recently, it was observed that the release of IL-6 by skeletal muscle, during physical exercise, could prevent β-cells death induced by pro-inflammatory cytokines. However, the molecular mechanisms involved in this beneficial effect on β-cells are not yet completely elucidated. Our aim was to evaluate the effect of IL-6 on β-cells exposed to pro-inflammatory cytokines.ResultsPre-treatment with IL-6 sensitized INS-1E cells to cytokine-induced cell death, increasing cytokine-induced iNOS and Caspase-3 expression. Under these conditions, however, there was a decrease in cytokines-induced p-eIF2-α but not p-IRE1expression, proteins related to ER stress. To address if this prevention of adequate UPR response is involved in the increase in β-cells death markers induced by IL-6 pre-treatment, we used a chemical chaperone (TUDCA), which improves ER folding capacity. Use of TUDCA increased cytokines-induced Caspase-3 expression and Bax/Bcl-2 ratio in the presence of IL-6 pre-treatment. However, there is no modulation of p-eIF2-α expression by TUDCA in this condition, with increase of CHOP expression.ConclusionTreatment with IL-6 alone is not beneficial for β-cells, leading to increased cell death markers and impaired UPR activation. In addition, TUDCA has not been able to restore ER homeostasis or improve β-cells viability under this condition, suggesting that other mechanisms may be involved.

Adherence to Oral Antidiabetic Drugs in Patients with Type 2 Diabetes: Systematic Review and Meta-Analysis.

Poor adherence to oral antidiabetic drugs (OADs) in patients with type 2 diabetes (T2D) can lead to therapy failure and risk of complications. The aim of this study was to produce an adherence proportion to OADs and estimate the association between good adherence and good glycemic control in patients with T2D. We searched in MEDLINE, Scopus, and CENTRAL databases to find observational studies on therapeutic adherence in OAD users. We calculated the proportion of adherent patients to the total number of participants for each study and pooled study-specific adherence proportions using random effect models with Freeman-Tukey transformation. We also calculated the odds ratio (OR) of having good glycemic control and good adherence and pooled study-specific OR with the generic inverse variance method. A total of 156 studies (10,041,928 patients) were included in the systematic review and meta-analysis. The pooled proportion of adherent patients was 54% (95% confidence interval, CI: 51-58%). We observed a significant association between good glycemic control and good adherence (OR: 1.33; 95% CI: 1.17-1.51). This study demonstrated that adherence to OADs in patients with T2D is sub-optimal. Improving therapeutic adherence through health-promoting programs and prescription of personalized therapies could be an effective strategy to reduce the risk of complications.

Effect of social app-assisted education and support on glucose control in patients with coronary heart disease and diabetes mellitus.

BackgroundSocial app-assisted education and support may facilitate diabetes self-management. We aim to evaluate the effect of WeChat, a popular social app, on glycemic control in patients with coronary heart disease (CHD) and diabetes mellitus (DM).MethodsWe conducted a parallel-group, open-label, randomized clinical trial that included 160 patients with both CHD and diabetes mellitus from a tertiary hospital in China. The intervention group (n = 80) received educational materials (information on glucose monitoring, drug usage, medication, and lifestyle) and reminders in response to individual blood glucose values via WeChat. The control group (n = 80) received usual care. The primary outcome was a change in glycated hemoglobin (HbA1C) levels over 3 months. Secondary outcomes included fasting blood glucose (FBG), systolic blood pressure, and low-density lipoprotein (LDL) cholesterol from baseline to 3 months. Analysis was conducted using a linear mixed model.ResultsThe intervention group had a greater reduction in HbA1C (−0.85 vs. 0.15%, between-group difference: −1.00%; 95% CI −1.31 to −0.69%; p < 0.001) compared with the control group. Change in fasting blood glucose was larger in the intervention group (−1.53 mmol/L; 95% CI −1.90 to −1.17; p < 0.001) and systolic blood pressure (−9.06 mmHg; 95% CI −12.38 to −5.73; p < 0.001), but not LDL (between-group difference, −0.08 mmol/L; 95% CI −0.22 to 0.05; p = 0.227).ConclusionThe combination of social app with education and support resulted in better glycemic control in patients with CHD and DM. These results suggest that education and support interaction via social app may benefit self-management in CHD and DM.

Pharmacists' Adherence Support System FollowNavi for Patients with Type 2 Diabetes.

In Japan, the Pharmaceutical and Medical Device Act was amended in December 2019 and now requires pharmacists to follow-up patients continuously during treatment to ensure proper use of medicines. According to some reports on patients with type 2 diabetes mellitus (T2DM), follow-up by doctors is effective for improving treatment. Enhanced face-to-face medication counseling by pharmacists leads to good glycemic control in patients with diabetes. However, the effects of information and communication technology (ICT)-based follow-up during the medication period are not well-understood. We determined the efficacy of pharmacists' follow-up using FollowNavi, a patient compliance instruction support system, and using our developed LINE tool for patients with T2DM. Through a before-after study, changes in glycemic control and medication adherence after 6 months of follow-up were investigated, and multiple regression analysis was performed to investigate the factors associated with changes in hemoglobin A1c (HbA1c) levels. Questionnaire surveys related to usability were completed by patients and pharmacists. In the 35 patients with T2DM, HbA1c levels decreased significantly after 6 months, although fasting blood glucose levels and medication adherence showed no significant differences. Changes in HbA1c levels were significantly associated with age (p = 0.044), baseline HbA1c levels (p < 0.001), and diabetes duration (p = 0.004). In the questionnaire, 81.8% of patients responded that they would prefer to continue using FollowNavi. These results suggest that follow-up using FollowNavi is useful for glycemic control in patients with T2DM.

Impact of Digital Health Education among Patients with Type 2 Diabetes Mellitus

Background: Effective delivery of health education is critical to achieving the goal of controlled diabetes. The objective was to assess the impact of health education among patients with Type 2 Diabetes mellitus.&#x0D; Materials and Methods: This study was quasi-experimental done with type 2 diabetes mellitus of tertiary care hospital.100 diabetes patients were included and randomized into two groups to receive health education material and standard care. The intervention consisted of health education intervention via text messages and images. The glycemic parameters were assessed before and at the end of 3 months of intervention. Paired t-tests were applied.&#x0D; Results: Mean (SD) of HbA1c before the start of the intervention among the patients with intervention and control arm were 10.1(±0.9) and10.6 (±0.3) respectively. There was a significant difference in FBS, PPBS and HbA1c- (198(±14) vs 112(±6), 277(±50) vs 151(±16) and 10.1(±0.9) vs 7.2(±0.9) in the intervention group before and after the intervention (p-value &lt;0.05).No significant difference was found in the control arm.&#x0D; Conclusion: There was a significant difference in the group that received health education intervention compared to the standard therapy group. Thus, well-designed health education delivery could maintain better glycemic control in patients with uncomplicated type 2 diabetes mellitus.

Remote monitoring of adolescents with type 1 diabetes mellitus using a mobile application

Background: The prevalence of type 1 diabetes mellitus (T1DM) in childhood is increasing every year. Adolescence is the most challenging age for achieving optimal metabolic control of T1DM. Telemedicine has already been shown to be ­effective in children with the condition, but there are not enough studies in adolescents. The use of mobile apps may be associated with better glycemic control in patients with type 1 diabetes.Aims: To assess the effectiveness and safety of a model of medical care for adolescents with type 1 diabetes using remote counseling and a mobile application.Materials and methods: Were included adolescents aged ≥14 and 18 years with a T1DM duration&gt; 3 months, a glycated hemoglobin level (HbA1c)&gt; 7%. The duration of the study was 26 weeks. There were 3 face-to-face and at least 4 remote visits using a mobile application. All patients underwent standard examination and anthropometry, study of HbA1c, registration and analysis of indicators, assessment and correction of the treatment. The quality of life of adolescents was assessed at baseline and at the end of the study. Adolescents and physicians were interviewed about program evaluation.Results: 56 patients were included, 7 adolescents withdrew. HbA1c significantly decreased by the 12th week of the study (–0.3%; p = 0.005), by the end of the study the change in HbA1c was –0.5% (p &lt;0.001). There was an increase in the percentage of glucose measurements in the target range (+5.3 pp; p = 0.016) and a decrease in blood glucose variability (-3.1 pp; p = 0.015). There was a significant improvement in both the total assessment of the quality of life by patients (+2.9 points; p = 0.008) and individual components of its indicators: attitude to diabetes (+3.0 points; p = 0.049), attitude to treatment (+4.6 points; p = 0.010) and communication with others (+4.5 points; p = 0.015). The majority of doctors and patients assessed their participation in the study positively. The incidence of adverse events did not change significantly during the study from baseline.Conclusion: Remote counseling using a mobile app is a safe and effective approach for adolescents with T1DM in terms of glycemic control and quality of life, and provides convenience and speed of interaction.

Smanjenje direktnih i indirektnih troškova lečenja pacijenata sa dijabetesom tip 2 usled dobre kontrole glikemije i smanjenja učestalosti komplikacija

Introduction: Patients with type 2 diabetes represent a large burden on healthcare systems primarily due to the multidisciplinary treatment of complications. Good glycemic control is associated with a reduced incidence of complications. Objective: The aim of this paper is to estimate the absolute amount of reduction in costs of type 2 diabetes treatment due to better glycemic control and reduction in the frequency of complications in an upper-middle income country, such as Serbia. Method: The research was designed as a study of costs emerging from complications of type 2 diabetes, and specifically the impact of lowering glycosylated hemoglobin on cost reduction due to changes in complication rates. Direct and indirect costs were taken into account from the perspective of the Republic Health Insurance Fund (RHIF) and private health insurance, i.e. patients themselves as direct payers of services. The time horizon is one year. All cost calculations were performed using a mathematical model, with simulation on a cohort of 1.000 virtual patients and data input in the form of inverse probability distributions. Results: The results of our study indicate that good glycemic control due to the optimal use of antidiabetic drugs leads to a significant reduction in the frequency of complications and treatment costs. Reduction of glycosylated hemoglobin by only 1% reduces direct treatment costs by about 8.300 RSD per year per patient with diabetes from the perspective of the RHIF, and by about 52.500 RSD from the perspective of the patient as a direct payer of services or that of private (supplementary) health insurance; if both perspectives are taken into account at the same time (60:40 payment ratio RHIF/private insurance), the annual saving is about 26.000 RSD per patient. Reduction of indirect costs due to reduction of glycosylated hemoglobin and reduced absenteeism per patient on an annual basis is about 24.000 RSD. Conclusion: Good glycemic control in patients with type 2 diabetes in the Republic of Serbia brings significant savings on an annual basis due to a reduced frequency of complications. These savings open up space to increase the availability of innovative antidiabetic drugs for a significantly wider range of patients with type 2 diabetes, without the restrictions that currently exist, primarily in terms of body weight.

In-Hospital Mortality and Glycemic Control in Patients with Hospital Hyperglycemia

BACKGROUNDStress-induced hyperglycemia is a phenomenon that occurs typically in patients hospitalized for acute disease and resolves spontaneously after regression of the acute illness. However, it can also occur in diabetes patients, a fact that is sometimes overlooked. It is thus important to make a proper diabetes diagnosis if hospitalized patients with episodes of hyperglycemia with and without diabetes are studied.AIMSTo estimate the extent of the association between stress-induced hyperglycemia and in-hospital mortality in patients with hospital hyperglycemia (HH), and to explore potential differences between patients diagnosed with diabetes (HH-DBT) and those with stress-induced hyperglycemia (SH), but not diagnosed with diabetes.METHODSA cohort of adults with hospital hyperglycemia admitted to a tertiary, university hospital in Buenos Aires, Argentina, was analyzed retrospectively.RESULTSIn the study, 2,955 patients were included and classified for analysis as 1,579 SH and 1,376 HH-DBT. Significant differences were observed in glycemic goal (35.53% SH versus 25.80% HH-DBT, p < 0.01), insulin use rate (26.66% SH versus 46.58% HH-DBT, p < 0.01), and severe hypoglycemia rate (1.32% SH versus 1.74% HH-DBT, p < 0.01). There were no differences in hypoglycemia rate (8.23% SH versus 10.53% HH-DBT) and hospital mortality. There was no increase in risk of mortality in the SH group adjusted for age, non-scheduled hospitalization, major surgical intervention, critical care, hypoglycemia, oncological disease, cardiovascular comorbidity, and prolonged hospitalization.CONCLUSIONSIn this study, we observed better glycemic control in patients with SH than in those with HH-DBT, and there was no difference in hospital mortality.

Implementation of Technology in the Follow-up of Patients with Diabetes: Is it Possible in a South American Country?

Despite better treatments and technology available in usual clinical practice, achieving a good glycemic control in patients with diabetes is challenging. In times of SARSCoV- 2/COVID-19 infection, chronic diseases like diabetes have been associated with adverse outcomes [1]. Regardless of the limited information, it is known that individuals with diabetes are at risk of respiratory infections [2]. This risk can be reduced by achieving good glycemic control and for this reason, the care of patients with diabetes is a main concern.

High adherence to recommended diabetes follow-up procedures by general practitioners is associated with lower estimated cardiovascular risk.

To explore whether the general practitioners' (GPs') performance of recommended processes of care was associated with estimated risk of cardiovascular disease (CVD) and poor glycaemic control in patients with type 2 diabetes. A cross-sectional study from Norwegian general practice including 6015 people with type 2 diabetes <75years old, without CVD and their 275 GPs. The GPs were split into quintiles based on each GP's average performance of six recommended processes of care. The quintiles were the exposure variable in multilevel regression models with 10-year risk of cardiovascular events estimated by NORRISK 2 (total and modifiable fraction) and poor glycaemic control (HbA1c >69mmol/mol (>8.5%)) as outcome variables. The mean total and modifiable estimated 10-year CVD risk was 12.3% and 3.3%, respectively. Compared with patients of GPs in the highest-performing quintile, patients treated by GPs in the lowest quintile had an adjusted total and modifiable CVD risk that was 1.88 (95% CI 1.17-2.60) and 1.78 (1.14-2.41) percent point higher. This represents a relative mean difference of 16.6% higher total and 74.8% higher modifiable risk among patients of GPs in the lowest compared with the highest quintile. For patients with GPs in the lowest-performing quintile, the adjusted odds of poor glycaemic control was 1.77 (1.27-2.46) times higher than that for patients with a GP in the highest quintile. We found a pattern of lower CVD risk and better glycaemic control in patients of GPs performing more recommended diabetes processes of care.

Smart spectrophotometric methods for the simultaneous determination of newly co-formulated hypoglycemic drugs in binary mixtures

Achieving good glycemic control in patients with type II diabetes mellitus is essential for preventing both microvascular and macrovascular complications. Combination therapy represents the principle strategy for successful long term control of type II diabetes mellitus with minimal complications. Two sensitive, precise and non-destructive spectroscopic methods were developed for the simultaneous estimation of two new co-formulated hypoglycemic drugs; canagliflozin/metformin (CAG/MEF) and empagliflozin/linagliptin (EMG/LIG) in tablets with no need of previous separation. The first method was amplitude modulation (a normalized spectra-based UV spectrophotometric method) for the analysis of (CAG/MEF) binary mixture. The amplitude of the constant at the plateau region at (264–310 nm) on the ratio spectrum was measured and used for the determination of CAG concentration in the mixture. On the other hand, MEF was estimated by subtracting the previously obtained amplitude from the total amplitude of CAG and MEF at the isosbestic point (λiso) at 250 nm. The second method was chemometric-assisted FTIR spectrophotometric method for the determination of (EMG/LIG) binary mixture. (EMG/LIG) mixture in chloroform was analyzed using FTIR in the region 4000–400 cm−1. The spectral region 3900–2900 cm−1 was selected for (EMG/LIG) determination using principal component regression and partial least squares chemometric methods. The methods were validated according to ICH guidelines. The studied drugs were successfully determined in tablets applying the developed methods. Validation parameters were in agreement with acceptance limits, ensuring methods accuracy and selectivity. Besides, no significant difference was obtained by statistically comparing the obtained results with the reported one.

Needle-free jet injection of insulin glargine improves glycemic control in patients with type 2 diabetes mellitus: a study based on the flash glucose monitoring system

ABSTRACT Background: To investigate the effects of insulin glargine injection given with a QS-P jet injector on the glucose profile using a professional mode flash glucose monitoring (FGM) system in patients with type 2 diabetes mellitus (T2DM). Research design and methods: In this randomized, controlled, cross-sectional study, 66 patients with T2DM who received insulin glargine (12–18 IU/day) injection were enrolled. The patients were randomly divided into group A (jet injector before insulin pen) and group B (insulin pen before jet injector). Each subject injected insulin daily before breakfast. We analyzed the changes in the glucose profile using a professional mode FGM system. Results: Treatment with a jet injector led to significantly lower 24-h mean glucose, maximum blood glucose, area under the curve (AUC) > 10.0 mmol/L, time above range and increased AUC < 3.9 mmol/L and time below range than those when using an insulin pen. There was no difference in glycemic variability between the two groups. We observed that patients using a jet injector had significantly lower mean glucose between 12:00 to 22:00. Conclusions: Needle-free jet injection of insulin glargine was more effective than use of an insulin pen for good glycemic control in patients with T2DM. Clinical trial registration: www.clinicaltrials.gov identifier is NCT04093284.

Combined exenatide and dapagliflozin has no additive effects on reduction of hepatocellular lipids despite better glycaemic control in patients with type 2 diabetes mellitus treated with metformin: EXENDA, a 24-week, prospective, randomized, placebo-controlled pilot trial.

AimsTo investigate the potential synergistic effects of combined exenatide (EXE) and dapagliflozin (DAPA) versus (PLAC) placebo and DAPA on hepatocellular lipid (HCL) reduction after 24 weeks of treatment.Materials and methodsThirty patients with type 2 diabetes were randomized to weekly EXE and daily DAPA (n = 16) or weekly PLAC and daily DAPA (n = 14). Inclusion criteria were glycated haemoglobin (HbA1c) 48 to 97 mmol/mol (6.5‐11%), age 18 to 75 years, body mass index (BMI) ≥25 kg/m2 and metformin ≥1000 mg. The primary endpoint, HCL levels, were measured at baseline and after 24 weeks of treatment using magnetic resonance spectroscopy. Between‐group effects were analysed using general linear models, adjusted for baseline outcome variables, age, sex and BMI. Within‐group differences were assessed using a paired t‐test.ResultsAfter 24 weeks, HCLs were reduced in both treatment groups (absolute change from baseline: EXE + DAPA −4.4%, 95% confidence interval [CI] −8.2, −0.7, P < 0.05; PLAC + DAPA −3.9%, 95% CI −6.0, −1.7, P < 0.01; relative change: EXE + DAPA −35.6%, PLAC + DAPA −32.3%) with no difference between groups. Similar findings were observed for subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT). HbA1c (EXE + DAPA −17.8 mmol/mol, [95% CI −24.8, −10.8], P <0.001; PLAC + DAPA −6.9 mmol/mol, [95% CI −10.5, −3.3], P = 0.001) and fasting glucose significantly decreased in both groups, although EXE + DAPA achieved better glycaemic control than PLAC + DAPA (adjusted difference: HbA1c −6.0 mmol/mol [95% CI −9.7, −2.2], P < 0.01). Body weight was reduced in both treatment groups (EXE + DAPA −7.3 kg, 95% CI −9.9, −4.8, P <0.001; PLAC + DAPA −4.6 kg, 95% CI −7.4, −1.8, P <0.01) with comparable results between groups. Changes in HCLs and weight, hip and waist circumference, VAT and SAT were positively associated.ConclusionAfter 24 weeks, HCLs were significantly but comparably reduced in the EXE + DAPA and PLAC + DAPA groups, despite significantly better glycaemic control in the combined group EXE + DAPA. Changes in HCLs were associated with weight loss and reduction of visceral adiposity, but not with glucose control. Further studies are necessary to evaluate possible additional long‐term effects of a combined treatment.