Diabetes Therapy最新文献

Sequential addition of oral glucose-lowering therapies, insulin or incretin-based therapy is often required to attain optimal glycemic control and reduce the risk of diabetes-associated complications. Despite advances in treatment, a large proportion of people with type 2 diabetes fail to achieve optimal glycemic control. Recent guidelines emphasize the need to commence injectable options in individuals unable to attain glycemic targets, despite maximal oral therapy. In individuals already on basal insulin, an improvement in glycemic control requires stepwise addition of prandial insulin, full basal-bolus insulin regimen, or additional injectable incretin-based therapy. However, concerns around weight gain and hypoglycemia often limit addition or increase in insulin to improve glycemic control. Treatment simplification i.e. a decrease in treatment complexity, particularly insulin therapy, seeks to alleviate treatment burden without compromising therapeutic efficacy and safety. However, currently there is a lack of guidance on simplifying treatment, particularly for individuals unable to attain glycemic targets. We now provide evidence-based treatment simplification strategies for people with diabetes in the Gulf Cooperation Council region.

Introduction: Type 2 diabetes is a leading cause of chronic kidney disease (CKD). Individuals with both conditions have increased risk of poor cardiorenal outcomes and mortality. The rapidly evolving landscape for CKD-protective therapies in type 2 diabetes currently includes sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA), both of which demonstrate cardiorenal outcome benefits. As part of the FOUNTAIN platform (ClinicalTrials.gov ID: NCT05526157; EUPAS ID: EUPAS48148), this study aimed to better understand changes in patient characteristics and treatment patterns corresponding with updates to clinical guideline recommendations and drug labeling and the emergence of new CKD-protective therapies such as finerenone in the US in 2021-2022.

Methods: An observational real-world data study assessed patient characteristics and drug utilization in separate SGLT2i and GLP-1 RA new-user cohorts of adults with CKD and type 2 diabetes in an earlier (1 January 2012-30 June 2021) and a later (9 July 2021-30 September 2023) period using Optum's de-identified Clinformatics^® Data Mart Database (Optum^® CDM).

Results: Compared with the earlier period new users, later period new users in both cohorts were older, had more severe CKD, used less intensive type 2 diabetes medication, and had better metabolic control; SGLT2i new users more frequently had no type 2 diabetes therapy before the index date and greater congestive heart failure prevalence; and GLP-1 RA new users had increased SGLT2i use and decreased insulin use.

Conclusions: These findings inform and contextualize future studies assessing cardiorenal outcomes for these and additional treatments, including finerenone, for individuals with CKD and type 2 diabetes.

Introduction: β-Hydroxybutyrate (βHB), the most stable form of ketone bodies, has exhibited protective effects in metabolic and chronic diseases. This study aimed to assess the association between fasting serum βHB levels, measured at baseline in drug-naïve state, and the risk of proteinuria in patients with newly diagnosed type 2 diabetes.

Methods: In this longitudinal study involving 280 patients, baseline fasting serum βHB levels, urine protein parameters, and metabolic parameters were evaluated. To monitor the development of albuminuria (spot urine albumin-to-creatinine ratio ≥ 30.0 mg/gCr) or proteinuria (spot urine protein-to-creatinine ratio > 0.15 g/gCr), patients with normal baseline levels were followed for a mean of 2.40 ± 1.40 years.

Results: Patients were classified into the highest tertile of baseline serum βHB level group and two other lower tertiles. The highest tertile group (median fasting serum βHB: 0.30 mmol/l) had a significantly lower incidence of proteinuria (6.90% vs. 24.3%, p = 0.028) and nonalbumin proteinuria (6.67% vs. 22.9%, p = 0.031) compared to the lower two tertiles. Higher baseline βHB levels were associated with a reduced risk of proteinuria (hazard ratio 0.313, 95% confidence interval 0.110-0.891), adjusted for confounders.

Conclusion: Higher baseline fasting serum βHB levels are linked to a lower risk of proteinuria in newly diagnosed type 2 diabetes, suggesting its potential as a protective metabolic marker in early diabetic kidney disease.

Introduction: This study aimed to examine glucose metrics and insulin delivery patterns in children, adolescents, and adults with type 1 (T1D) or 2 (T2D) diabetes in France using the tubeless Omnipod DASH^® pump with and a continuous glucose monitoring (CGM) sensor connected to myDiabby Healthcare^® Data Management Platform (DMP).

Methods: Time-stamped CGM and insulin data were extracted from the DMP on December 6, 2023 for 17,344 users whose first data point from the tubeless pump occurred after January 1, 2020. The study population included users with sufficient pump and CGM data (≥ 90 days of use) and ≥ 15.5% of CGM use days reaching > 70% coverage. Analyses were performed by type of diabetes and age group.

Results: Among 14,757 users included in this analysis, most reported having T1D (93.7%), the median age was 33 years (Q1-Q3, 16-51), and the median duration of pump use was 545 days for people with T1D and 505 days for people with T2D (1.49 and 1.38 years, respectively). People with T1D spent a median of 52.5% (Q1-Q3, 43.4-62.5) of time in range (70-180 mg/dL, TIR) and a TIR ≥ 70% was attained by 12.6% of users. The median time below range (TBR, < 70 mg/dL) was 3.7% (Q1-Q3, 2.1-6.1). For users with T2D, median TIR was 66.9% (Q1-Q3, 54.0-77.8), with 42.8% of users achieving a TIR ≥ 70%. Over 90% of all users consumed less than 60 UI/day.

Conclusion: This robust and scalable analysis of a database of substantial quantity, density, and quality found that tubeless pump users achieved moderate glycemic outcomes overall with favorablesafety outcomes in particular, and used the pump consistently. Such databases could be useful for research and patient care, and further work will show how best to use them.

Introduction: In recent years, diabetes management by diabetes specialists has evolved owing to various factors such as the introduction of new glucose-lowering drugs. In Japan, many patients with diabetes mellitus are managed by general practitioners (GPs), with the quality of management provided by these GPs playing a crucial role in preventing diabetes-related complications. Despite this importance, trends in diabetes management by GPs remain unclear. This study aimed to assess changes in diabetes management by GPs, comparing data from two nationwide surveys conducted in 2006 and 2018.

Methods: We compared the characteristics and pharmacotherapy of patients with type 2 diabetes (T2DM) managed by GPs and diabetes specialists in 2006 (14,312 and 1038 patients, respectively) and 2018 (6525 and 1545, respectively). Data on age, sex, glycosylated hemoglobin (HbA1c), body mass index (BMI), treatment modalities, types and number of oral antidiabetic drugs (OADs), types of sulfonylureas (SUs), and dose of SUs were compared between the two surveys.

Results: In 2018, patients with T2DM managed by GPs were older and had higher BMI, while exhibiting improved HbA1c levels compared to those in 2006. Dipeptidyl peptidase 4 inhibitors and biguanides were the most and second most frequently prescribed OADs, respectively, with SUs being less prescribed at lower doses. Combination OAD therapy was also more prevalent in 2018 than in 2006.

Conclusion: The observed trends with GPs were consistent with those observed among diabetes specialists, suggesting that many Japanese GPs are adopting current treatments strategies and may be providing appropriate diabetes management.

Introduction: The aim of this study was to investigate the cost-utility of real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG) in people with insulin-treated type 2 diabetes (T2D) in Sweden.

Methods: The CORE Diabetes Model (CDM v10) was used for the analysis. Clinical effectiveness data were obtained from the Steno2Tech trial, an investigator-initiated, 12-month, single center randomized controlled trial based in Denmark. Adverse event rates were sourced from a large-scale observational study based in the USA. Costs were obtained from Swedish and European studies and inflated to 2023 Swedish Krona (SEK). The analysis adopted the perspective of the Swedish payer, and a remaining lifetime horizon was used in the base case. A discount rate of 3% was applied to future costs and outcomes on an annual basis. A commonly cited willingness-to-pay (WTP) threshold of SEK 500,000 was used.

Results: rt-CGM led to a gain in mean incremental survival by 0.082 years (11.529 life years for rt-CGM versus 11.447 life years for SMBG). Total mean incremental costs were SEK 138,448 higher with rt-CGM compared with SMBG (SEK 1,151,049 for rt-CGM versus SEK 1,012,601 for SMBG). However, rt-CGM incurred fewer overall diabetes-related complication costs than SMBG over the remaining lifetime horizon. Rt-CGM also yielded a gain in mean incremental quality-adjusted life years (QALYs) of 0.632 (8.608 QALYs for rt-CGM versus 7.976 QALYs for SMBG). The mean incremental cost-utility ratio (ICUR) for rt-CGM was SEK 219,063 per QALY gained, which showed rt-CGM to be cost-effective when compared with the WTP threshold of SEK 500,000. When various indirect cost estimates were incorporated, rt-CGM was consistently more cost-effective than in the base case analysis.

Conclusions: For individuals living in Sweden with T2D requiring insulin treatment, rt-CGM is a cost-effective management option relative to SMBG.

Background/objectives: The exact prevalence of and recent changes in diabetic polyneuropathy (DPN) and diabetic peripheral neuropathic pain (DPNP) in Japan are unclear. The oral gabapentinoid, mirogabalin besylate (mirogabalin), is effective with a good safety profile for DPNP with moderate-to-severe pain (numerical rating scale [NRS] scores ≥ 4). However, clinical evidence for mild pain (NRS scores ≤ 3) is unclear. The Dia-NeP study aims to examine: (1) the prevalences of DPN and DPNP and background factors in patients with type 2 diabetes mellitus (T2DM); and (2) the efficacy and safety of mirogabalin in patients with DPNP, including those with mild pain.

Methods: The Dia-NeP study is a multicenter, prospective study consisting of two parts, a baseline survey and an interventional study, to be conducted from March 2025 to August 2026 in patients with T2DM in Japan. The baseline survey is the observational study investigating the epidemiology of DPN and DPNP, and the interventional study is an exploratory, single-arm, open-label study of 12-week mirogabalin treatment. Of patients with T2DM enrolled in the baseline survey, those diagnosed with DPNP who have an NRS score for pain ≥ 1 will be included in the interventional study. The target sample size is 1000 to 3000 patients for the baseline survey and 100 for the interventional study.

Planned outcomes: The primary endpoint is the change from baseline in the NRS score at week 12 in the interventional study. The safety endpoint is adverse events. This study will not only show the latest prevalence of DPN and DPNP in Japan, but is also the first study to investigate the efficacy and safety of mirogabalin in patients with DPNP having mild pain, as well as moderate-to-severe pain, and is expected to provide useful evidence for future DPN and DPNP treatment.

Trial registration: Japan Registry of Clinical Trials (jRCTs031240623, registered 20/January/2025, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs031240623 ).