Diabetes Therapy最新文献

Introduction

In people with type 2 diabetes (PwT2D) who also have obesity, efforts targeting weight loss, including lifestyle, medication and surgical interventions, are recommended. The objective of this study was to explore the relationship between glycemic control and obesity among PwT2D in Europe and Australia using recent real-world data and applying consistent methodology across countries.

Methods

Retrospective study utilizing IQVIA electronic medical records (EMR) databases grouped into panels based on specialty of contributing physicians. General practitioner (GP) and endocrinologist/diabetologist (E/D) panels were used in Germany and France, while GP panels were used in Italy, UK and Australia. The Spanish database included all physician specialties. The sample included PwT2D with glycated hemoglobin A1c (HbA1c) and body mass index (BMI) values measured within 90 days of each other between January 2015 and December 2018 (second record termed the ‘index date’). PwT2D had a 1-year baseline period and a recorded HbA1c at the end of the 1-year post-index period.

Results

The final sample comprised 194,729 PwT2D. At baseline, across countries/panels, 36.8–58.0% were above HbA1c target (HbA1c ≥ 7%) and 39.4–56.7% had obesity (BMI ≥ 30.0 kg/m²). Mean HbA1c ranged from 6.9 to 7.6% and mean BMI ranged from 29.3–31.6 kg/m². At baseline, a higher proportion of PwT2D with obesity (40.8–64.2%) were above HbA1c target compared to their counterparts without obesity (32.2–52.4%). A higher proportion of patients with obesity at baseline (38.1–60.6%) had post-index HbA1c above target compared to their counterparts without obesity (30.9–56.0%). In logistic regression, patients with obesity had substantially lower odds of post-index HbA1c below target compared to those without obesity in all countries/panels except for France (E/D), Spain and Australia.

Conclusions

This study presents data on HbA1c and BMI among type 2 diabetes (T2D) populations in Europe and Australia. A notable proportion of PwT2D had obesity and were above HBA1c target. Higher BMI was associated with poorer glycemic control.

Introduction

The management of type 1 diabetes, a non-preventable chronic disease, leads to a high physical and psychological burden on the individual. Digital health technology can improve a person’s psychosocial self-efficacy and thereby contribute to improved diabetes self-care. The aim of this study was to explore associations between psychosocial self-efficacy and demographic-, disease specific-, well-being as well as digital health technology (DHT) related factors among adults with type 1 diabetes.

Methods

A primarily web-based cross sectional survey was conducted among adults with type 1 diabetes in Sweden (n = 301). Psychosocial self-efficacy was assessed using the Swedish version of the Diabetes Empowerment Scale, Swe-DES-23. The survey also contained questions related to demographic-, disease specific-, well-being as well as digital health technology related variables.

Results

Higher well-being scores and lower HbA1c levels were associated with higher psychosocial self-efficacy in multiple linear regression analysis. In multivariate analysis, gender, body mass index, well-being scores, and HbA1c levels showed association with psychosocial self-efficacy. None of the DHT factors were found associated with psychosocial self-efficacy.

Conclusions

In this study, higher well-being score and lower self-reported HbA1c levels were associated with higher psychosocial self-efficacy in both univariate- and multivariate analysis and accounted for 30% of the variation in psychosocial self-efficacy in the regression model. Thus, measures to improve psychosocial self-efficacy in adults with type 1 diabetes may help maintain their psychological well-being and blood glucose control.

Introduction

Short-term studies reported improved glycemic control and a decrease in eHbA1c (estimated hemoglobin A1c) in patients with type 1 diabetes during COVID-19 lockdown, but long-term changes are unknown. Therefore, the main objectives are to (1) analyze whether laboratory-measured HbA1c changed during and after two lockdowns and (2) investigate potential variables influencing HbA1c change.

Methods

In this cohort study, 291 adults with type 1 diabetes were followed over 3 years including the prepandemic phase and two lockdowns. The data from medical records and validated questionnaires assessing health literacy (HLS-EU-Q16), diabetes self-management (DSMQ-R27), general self-efficacy (GSE), and social support (F-SOZU-K14) were used to analyze associations with HbA1c levels (N = 2370) by performing multivariable linear regressions.

Results

The median age was 54 (38–63) years and 159 (54.6%) were male. All phases of the COVID-19 pandemic were associated with a significant increase in laboratory-measured HbA1c levels in percent (e.g., during first lockdown β = 0.23, 95% confidence interval (CI) 0.07–0.39, p = 0.005; during the second lockdown, β = 0.27, 95% CI 0.15–0.38, p < 0.001). HbA1c change during lockdowns was significantly affected by the number of checkups (β = −0.03, 95% CI −0.05 to −0.01, p = 0.010), the value of HbA1c at previous observation (β = 0.33, 95% CI 0.29–0.36, p < 0.001), educational level (secondary versus tertiary: β = 0.22, 95% CI 0.06–0.38, p = 0.008; primary versus tertiary: β = 0.31, 95% CI 0.10–0.52, p = 0.004), health literacy score (for each point: β = −0.03, 95% CI −0.05 to − 0.002, p = 0.034), and diabetes self-management score (for each point: β = −0.03, 95% CI −0.04 to −0.02, p < 0.001). The use of continuous glucose monitoring or insulin pump had no effect on HbA1c change.

Conclusions

Lockdowns can lead to worsening glycemic control in patients with type 1 diabetes. Particularly patients with few check-ups, poor blood glucose values, deficits in diabetes self-management, low health literacy, and a low level of education seem to be at greater risk of worsening glycemic control during lockdowns and, therefore, require special medical care, e.g., through telemedicine.

Trial Registration

ClinicalTrials.gov identifier, NCT04821921.

Introduction

Second-generation basal insulins like glargine 300 U/mL (Gla-300) have a longer duration of action and less daily fluctuation and interday variability than first-generation ones, such as glargine 100 U/mL (Gla-100). The EF-BI study, a nationwide observational, retrospective study, was designed to compare persistence, acute care complications, and healthcare costs associated with the initiation of such basal insulins (BI) in a real-life setting in France.

Methods

This study was conducted using the French healthcare claims database (SNDS). Adult patients living with type 1 or type 2 diabetes mellitus (T1DM or T2DM) initiating Gla-300 or Gla-100 ± other hypoglycemic medications between January 1, 2016 and December 31, 2020, and without any insulin therapy over the previous 6 months were included. Persistence was defined as remaining on the same insulin therapy until discontinuation defined by a 6 month period without insulin reimbursement. Hospitalized acute complications were identified using ICD-10 codes. Total collective costs were established for patients treated continuously with each basal insulin over 1–3 years. All comparisons were adjusted using a propensity score based on initial patient/treatment characteristics.

Results

A total of 235,894 patients with T2DM and 6672 patients with T1DM were included. Patients treated with Gla-300 were 83% (T1DM) and 44% (T2DM) less likely to discontinue their treatment than those treated with Gla-100 after 24 months (p < 0.0001). The annual incidence of acute hospitalized events in patients with T2DM treated with Gla-300 was 12% lower than with Gla-100 (p < 0.0001) but similar in patients with T1DM. Comparison of overall costs showed moderate but statistically significant differences in favor of Gla-300 versus Gla-100 for all patients over the first year, and in T2DM only over a 3-year follow-up.

Conclusion

Use of Gla-300 resulted in a better persistence, less acute hospitalized events at least in T2DM, and reduced healthcare expenditure. These real-life results confirmed the potential interest of using Gla-300 rather than Gla-100.

Introduction

Health2Sync (H2S) is a digital health technology platform that provides coaching and titration support to patients with diabetes. The Mallya cap converts a conventional insulin pen into a smart connected device that can automatically synchronize dose values and associated timestamps (upon injection) to the H2S platform. This single-arm real-world study evaluated the effectiveness of insulin glargine 300 U/mL (Gla-300) combined with H2S and Mallya cap (Gla-300 + Cap + App program) on clinical outcomes among users with type 2 diabetes (T2D) in Taiwan.

Methods

Adults (aged ≥ 20 years) with T2D who were registered H2S users and initiated Mallya cap for a new/existing Gla-300 regimen (identification period May 1, 2021–May 31, 2022) were included in this retrospective cohort study. Follow-up data from H2S were collected for 90 days. Glycated hemoglobin (HbA_1c) change (baseline to follow-up) and HbA_1c goal attainment were primary outcomes. Hypoglycemia incidence and usage metrics of Mallya cap were secondary outcomes.

Results

Of 83 participants, 38.6% were new Gla-300 users. HbA_1c was reduced in both new (− 2.4 [2.7] %, − 26.2 [29.5] mmol/mol) and previous Gla-300 users (− 0.5 [1.6] %, − 5.5 [17.5] mmol/mol). Reduction in HbA_1c was significant (p < 0.05) in both groups. At follow-up, 43.4% of users had a reduction of > 0.5%. Mean HbA_1c reductions increased numerically with higher baseline HbA_1c and with longer duration of Mallya cap usage.

Conclusions

Use of digital technology within a connected ecosystem such as Gla-300 + Cap + App program could help people with type 2 diabetes to improve their glycemic condition.

The rising prevalence of type 2 diabetes (T2D) is posing major challenges for the healthcare systems of many countries, particularly in the Asia–Pacific Region, in which T2D can present at younger ages and lower body mass index when compared with Western nations. There is an important role for insulin therapy in the management of T2D in these nations, but available evidence suggests that insulin is under-utilized and often delayed, to the detriment of patient prognosis. The authors of this article gathered as an advisory panel (representative of some of the larger Asia–Pacific nations) to identify their local barriers to insulin use in T2D, and to discuss ways in which to address these barriers, with their outputs summarized herein. Many of the key barriers identified are well-documented issues of global significance, including a lack of healthcare resources or of an integrated structure, insufficient patient education, and patient misconceptions about insulin therapy. Barriers identified as more innate to Asian countries included local inabilities of patients to afford or gain access to insulin therapy, a tendency for some patients to be more influenced by social media and local traditions than by the medical profession, and a willingness to switch care providers and seek alternative therapies. Strategies to address some of these barriers are provided, with hypothetical illustrative case histories.

Introduction

The prevalence of diabetes mellitus and its sequelae has been on the rise, and diabetic foot ulcer (DFU) is the leading cause of non-traumatic lower limb amputation globally. The rising occurrence and financial burden associated with DFU necessitate improved clinical assessment and treatment. Diabetes has been found to enhance the formation of neutrophil extracellular traps (NETs) by neutrophils, and excessive NETs have been implicated in tissue damage and impaired wound healing. However, there is as yet insufficient evidence to clarify the value of NETs in assessing and predicting outcomes of DFU.

Methods

We designed this prospective study with three cohorts formed from type 2 diabetes mellitus (T2DM) patients with DFU (n = 200), newly diagnosed T2DM patients (n = 42), and healthy donors (n = 38). Serum levels of NETs were detected for all groups, and the prognostic value for DFU-related amputation was analyzed.

Results

The results showed that serum NET levels of the DFU group were significantly higher than in the T2DM group (P < 0.05), which also had significantly elevated serum NET levels compared to healthy donors (P < 0.05). Multivariate Cox regression showed that serum NET levels, diabetic foot surgical history, and Wagner grade were the risk factors for amputation (P < 0.05), and these three variables also exhibited the highest coefficient values in additional Lasso Cox regression. For patients with DFU, Kaplan-Meier curves showed that high serum NET levels associated with higher amputation probability (HR = 0.19, P < 0.01) and ROC curve based on NET value showed good validity for amputation (AUC: 0.727, CI 0.651–0.803).

Conclusion

Elevated serum NET levels serve as an easily accessible serological prognostic marker for assessing the risk of DFU-related amputation, thereby offering evaluation metrics for healthcare providers. Further investigations are necessary to understand the mechanisms driving this relationship.

Introduction

Efficacy and safety of the fixed ratio combination of insulin degludec and liraglutide (IDegLira) has been largely documented. However, long-term data are limited. This study aimed at describing persistence in therapy and the effectiveness at 48 months of IDegLira.

Methods

We conducted an observational study based on retrospective chart review. All patients treated with IDegLira during 2018–2022 were included. Data on treatment approaches and clinical outcomes were collected at the first prescription of IDegLira (T0) and after 6, 12, 24, 36, and 48 months.

Results

Overall, 156 patients (mean age 68 years, 64.1% men) started IDegLira, of whom 88 (56.4%) were previously treated with basal-oral therapy (BOT) and 68 (43.6%) with basal-bolus schemes (BB). Before starting IDegLira, 23.8% were treated with ≥ 2 oral antihyperglycemic agents in association with insulin; at T0, the proportion decreased to 3.2%. Short-acting insulin was discontinued after the first week. After 48 months, levels of HbA1c were significantly reduced by 1.34% in the BOT group and 1.07% in the BB group (p < 0.0001 in both groups). In the BOT group, FBG levels decreased by about 50 mg/dl and body weight was unchanged. In the BB group, FBG levels decreased by about 40 mg/dl and body weight was significantly reduced by an average of 7.7 kg. Five patients (3.2%) interrupted therapy with IDegLira during 48 months, and no severe hypoglycemia occurred.

Conclusions

Our study emphasizes the important role of IDegLira in maintaining a good metabolic control while minimizing the risk of major hypoglycemia and weight gain in the long term. The substantial simplification of treatment schemes can increase adherence.

Introduction

Continuous glucose monitoring (CGM) introduces novel indicators of glycemic control.

Methods

This cross-sectional study, based on the Swedish National Diabetes Register, examines 27,980 adults with type 1 diabetes. It explores the relationships between HbA1c (glycated hemoglobin) and various CGM-derived metrics, including TIR (time in range, representing the percentage of time within the range of 4–10 mmol/l for 2 weeks), TAR (time above range), TBR (time below range), mean glucose, standard deviation (SD), and coefficient of variation (CV). Pearson correlation coefficients and linear regression models were utilized for estimation.

Results

The analysis included 46% women, 30% on insulin pump, 7% with previous coronary heart disease and 64% with retinopathy. Mean ± SD values were age 48 ± 18 years, diabetes duration 25 ± 16 years, HbA1c 58.8 ± 12.8 mmol/mol, TIR 58.8 ± 19.0%, TAR 36.3 ± 20.0%, TBR 4.7 ± 5.4%, mean sensor glucose 9.2 ± 2.0 mmol/l, SD 3.3 ± 1.0 mmol/l, and CV 36 ± 7%. The overall association between HbA1c and TIR was − 0.71 (Pearson’s r), with R² 0.51 in crude linear regression and 0.57 in an adjusted model. R² values between HbA1c and CGM mean glucose were 0.605 (unadjusted) 0.619 (adjusted) and TAR (unadjusted 0.554 and fully adjusted 0.568, respectively), while fully adjusted R² values were 0.458, 0.175 and 0.101 between HbA1c and CGM SD, CGM CV and TBR, respectively.

Conclusions

This descriptive study demonstrates that the degree of association between HbA1c and new and readily available CGM-derived metrics, i.e., time in range (TIR), time above range (TAR), and CGM mean glucose, is robust in assessing the management of individuals with type 1 diabetes in clinical settings. Metrics from CGM that pertain to variability and hypoglycemia exhibit only weak correlations with HbA1c.

Introduction

Aberrant brain functional connectivity network is thought to be related to cognitive impairment in patients with type 2 diabetes mellitus (T2DM). This study aims to investigate the triple-network effective connectivity patterns in patients with T2DM within and between the default mode network (DMN), salience network (SN), and executive control network (ECN) and their associations with cognitive declines.

Methods

In total, 92 patients with T2DM and 98 matched healthy controls (HCs) were recruited and underwent resting-state functional magnetic resonance imaging (rs-fMRI). Spectral dynamic causal modeling (spDCM) was used for effective connectivity analysis within the triple network. The posterior cingulate cortex (PCC), medial prefrontal cortex (mPFC), lateral prefrontal cortex (LPFC), supramarginal gyrus (SMG), and anterior insula (AINS) were selected as the regions of interest. Group comparisons were performed for effective connectivity calculated using the fully connected model, and the relationships between effective connectivity alterations and cognitive impairment as well as clinical parameters were detected.

Results

Compared to HCs, patients with T2DM exhibited increased or decreased effective connectivity patterns within the triple network. Furthermore, diabetes duration was significantly negatively correlated with increased effective connectivity from the r-LPFC to the mPFC, while body mass index (BMI) was significantly positively correlated with increased effective connectivity from the l-LPFC to the l-AINS (r = − 0.353, p = 0.001; r = 0.377, p = 0.004).

Conclusion

These results indicate abnormal effective connectivity patterns within the triple network model in patients with T2DM and provide new insight into the neurological mechanisms of T2DM and related cognitive dysfunction.