Diabetes Therapy最新文献

Introduction: The Sinocare iCan i3 Continuous Glucose Monitoring (CGM) system, manufactured by Sinocare, is available in China and certain European markets. This study aimed to evaluate the performance of this system in a free-living environment.

Methods: Thirty-six (36) participants, with a diagnosis of either type 1 or type 2 diabetes, wore one Sinocare iCan i3 CGM system on the abdomen for up to 15 days and performed up to eight capillary fingerstick blood glucose tests per day, over the wear period, in a home setting. The CGM sensor performance was compared to the blood glucose meter (BGM) reference and evaluated in terms of analytical and clinical accuracy, as well as sensor survival.

Results: For the study period, the mean absolute relative difference (MARD) was 17.2%. 69.5% of the results were within 20 mg/dL or 20% of the BGM reference, with 98.8% of the data falling within zones A and B of the consensus error grid. 77.1% of the sensors lasted up to the 15 days of sensor wear.

Conclusions: In this real-world study of the Sinocare iCan i3 CGM system, the accuracy and reliability of the sensors were assessed in comparison to a capillary fingerstick blood glucose reference. The MARD was 17.2% while 77.1% of the sensors lasted the 15-day wear duration.

Introduction: This study assessed whether early weight loss following tirzepatide treatment was associated with clinical characteristics and outcomes at 52 weeks in Japanese patients with type 2 diabetes (T2D).

Methods: Post hoc analyses used pooled data from the phase 3 SURPASS J-mono and J-combo studies, which examined tirzepatide 5, 10, and 15 mg as monotherapy or combination therapy in Japanese participants over 52 weeks. Subgroup analyses of clinical characteristics and metabolic outcomes at 52 weeks were conducted based on early weight loss achievement of < 5% or ≥ 5% after 8 weeks of tirzepatide (comprising 4 weeks each at 2.5 mg and 5 mg, per dose-escalation scheme). Selected safety outcomes were evaluated by weight-loss subgroups.

Results: The analysis included 893 participants (< 5% subgroup: n = 683 [76.5%]; ≥ 5% subgroup: n = 210 [23.5%]). Multivariate regression analysis showed that participant clinical characteristics, including lower baseline weight, concomitant alpha-glucosidase inhibitor use, and lack of concomitant sulfonylurea use, were independently predictive of achieving ≥ 5% weight loss at 8 weeks. Clinically significant reductions with tirzepatide were observed in body mass parameters over 52 weeks in both subgroups, with greater weight reductions observed at week 52 in the ≥ 5% subgroup versus the < 5% subgroup (5 mg: - 13.8% vs. - 4.1%; 10 mg: - 16.5% vs. - 8.8%; 15 mg: - 20.0% vs. - 11.5% [p < 0.001, all comparisons]). Blood pressure and lipid level improvements were also significantly greater in the ≥ 5% subgroup. Improvements in glycated hemoglobin were similar between subgroups; however, the ≥ 5% subgroup had a higher proportion of participants who achieved normoglycemia at week 52 with a shorter time to reach normoglycemia. Tirzepatide was generally well tolerated across the weight-loss subgroups.

Conclusions: These findings suggest early weight loss following tirzepatide may be predictive of metabolic outcomes at 52 weeks in Japanese patients with T2D. These data may inform clinical management of tirzepatide-treated patients.

Clinicaltrials: GOV: NCT03861052, NCT03861039.

The increasing prevalence of type 2 diabetes (T2D) can be considered a global healthcare emergency, with far-reaching burdens on the health and well-being of people with diabetes, their carers and families, and the mounting costs within each national healthcare economy. Although application of diabetes technologies, such as insulin pumps, continuous glucose monitoring (CGM) systems, and a range of connected devices, is starting to have an impact on the outcomes of care for people with type 1 diabetes (T1D), similar application for people with T2D is lagging behind. This is a purely cost-based decision, since evidence from numerous randomized controlled trials (RCTs) and real-world studies has shown the significant clinical impact of diabetes technologies for people with T2D, whether they are on insulin therapy or not. Amongst available technologies, it is the lack of widespread access to CGM devices for people with T2D that is most pressing, as these systems have the potential to bring a quantum change in the way people with T2D and their healthcare professionals (HCPs) are supported to manage the adverse impact both of hyperglycemia and hypoglycemia. Central to improving diabetes care for people with T2D is the demonstration in many studies that CGM can actively support healthy behavioral changes to meal planning and physical activity, with concomitant improvements in mental health and quality of life. In this expert opinion, we review the significant evidence base on which application of CGM in people with T2D is founded, and make the case for wider access for every person with diabetes as early as possible after diagnosis, in order to mitigate the global impact of T2D.

Introduction: My Dose Coach (MDC) is a digital smartphone application approved in multiple countries, including Saudi Arabia and Kuwait, to help people with type 2 diabetes (T2D) titrate their basal insulin as per their clinician-guided, individualized diabetes care plan.

Methods: A retrospective, observational cohort analysis was conducted on MDC user data collected from 1 January 2021 to 1 June 2023 in Saudi Arabia and Kuwait. Primary outcome was change in fasting blood glucose (FBG). Key secondary outcomes included time to achieve FBG and HbA_1c targets, and time to first hypoglycemia event. Outcomes were analyzed by FBG target status and frequency of MDC usage (high: > 3 days per week; moderate: > 1- ≤ 3 days per week; low: ≤ 1 day per week).

Results: Among all users (N = 494), mean ± SD FBG decrease was -44.4 ± 72.5 mg/dL. Mean ± SD time to achieve FBG target was 14.8 ± 20.9 days and 12.8 ± 18.8, 29.1 ± 28.0, and 43.5 ± 41.7 days for high-, moderate-, and low-frequency MDC users, respectively. Individualized FBG targets were achieved by 276 (55.9%) users, and high-frequency of MDC use was associated with better target achievement (p < 0.01). Mean ± SD time to achieve HbA_1c target was 48.0 ± 40.5 days. Reduction in HbA_1c was more in high-frequency MDC users (18.3%) than low-frequency MDC users (6.3%). Mean ± SD time to the first hypoglycemia event was 4.86 ± 4.8 days. Hypoglycemia events were reported in only seven (1.4%) participants and not significantly correlated with MDC use frequency (p = 0.1431).

Conclusions: Current findings show that using MDC is associated with improved glycemic control in people with T2D in Saudi Arabia and Kuwait, with greater benefits observed with higher frequency MDC usage.

Introduction: The study aimed to explore the association between type 2 diabetes (T2D) and heart failure (HF) using echocardiography and NT-proBNP. The study also derived an NT-proBNP cut-off for diagnosing HF by echo in Asian Indians with T2D.

Methods: A retrospective study was performed using data from individuals with T2D, aged ≥ 18 years, who visited diabetes clinics in India between March 2019 and December 2023. NT-proBNP levels were quantified by chemiluminescence, and left ventricular ejection fraction (LVEF) was assessed from echo using two-dimensional (2D) echocardiography. Heart failure was classified based on the European Society of Cardiology (ESC) guidelines. Receiver operating characteristic (ROC) curve was performed to determine the optimal NT-proBNP cut-off for diagnosing HF by echo.

Results: Among the 1189 study individuals included in the study (714 men and 475 women), 5.9% were identified as having HF with reduced ejection fraction (HFrEF), 5.5% had mildly reduced ejection fraction (HFmrEF), and 14.1% had HF with preserved ejection fraction (HFpEF) while the rest (74.5%) had LVEF > 50%. Elevated NT-proBNP levels were observed in those with reduced ejection fraction. ROC analysis identified an optimal NT-proBNP threshold of 398 pg/mL for diagnosing HF, with 87% sensitivity and 78% specificity. HF prevalence increased with age, peaking at 30.6% in individuals aged 61-70 years. Women with HF had higher NT-proBNP levels than men.

Conclusions: In this diabetes clinic population, 11.5% of individuals with T2D had moderate to reduced LVEF. Early identification of HF using echocardiography and NT-proBNP in a diabetes clinic could help improve prognosis.

Diabetic retinopathy (DR) is a preventable, frequent, and serious complication of diabetes, with a large impact on morbidity and disability. More than 125 million people worldwide suffer from DR. The pathogenesis of DR involves different pathways, many of them exacerbated by chronic hyperglycemia, but not necessarily a direct consequence of it. Fibrates are a well-known family of medications traditionally employed for the treatment of hypertriglyceridemia and low HDL cholesterol, which act through binding to the nuclear receptor peroxisome proliferator-activated receptors (PPAR)-alpha in several tissues. PPAR-alpha is expressed in the human retina. Animal and cellular models have demonstrated that PPAR activation by fibrates improves cellular phenomena involved in the genesis of DR, including chronic inflammation, oxidative damage, vascular hyperpermeability and microglial activation. Secondary analyses of fenofibrate trials originally designed to assess cardiovascular outcomes, systematically found an apparent benefit from fenofibrate treatment on diverse measures of DR appearance and severity. Finally, the LENS (Lowering Events in Non-Proliferative Retinopathy) study proved in a dedicated randomized trial that early fenofibrate use lowers the risk of DR progression in a statistically significant and clinically meaningful manner. These results have positioned fenofibrate as the first agent proven to specifically delay DR, without mediation by glycemic control. Future studies will test whether this effect extends to other microvascular diabetes complications.

Introduction: The appropriate use of glycated haemoglobin (HbA1c), the international standard for assessing overall glycaemic status in diabetes mellitus, is critical to ensuring optimal clinical outcome and minimise complications. We describe a clinical laboratory-led general practice service development to facilitate targeted follow-up in high-risk patients.

Methods: The service development comprised monthly reports identifying high-risk individuals (HbA1c ≥ 58 mmol/mol) overdue HbA1c testing, sent by the Clinical Biochemistry Laboratory to general practices in the 'Intervention' group (n = 60). A 'Non-intervention' group comprised 51 practices not sent the reports. Comparisons comprised: (i) intervention vs non-intervention groups during two time periods (pre-intervention: 2017-2020; 275,843 tests; 59,206 patients, and post-intervention: 2020-2023; 307,525 tests; 65,449 patients), (ii) pre- versus post-intervention in each group.

Results: The intervention group (vs non-intervention group) showed larger net change in proportion overdue a test (- 20.6% vs - 10.3%, p < 0.001), particularly in the > 75 mmol/mol category (7.8-fold larger improvement, p < 0.001). Improvements were also observed in median time overdue in the 58-75 mmol/mol group (- 14.3 vs - 4.3%; p = 0.027). Improvements were identified in median HbA1c (p = 0.012) and overall proportion with HbA1c ≥ 58 mmol/mol (p = 0.037), compared with the non-intervention group, despite performing more tests/patient/year (p < 0.001). All remained significant after adjustment for practice characteristics (age, sex, social deprivation, list size, diabetes prevalence) and pre-intervention levels.

Conclusions: Our findings indicate that clinical laboratories can support general practices facilitating targeting monitoring to high-risk patients. Providing succinct reports that identify patients overdue for testing can reduce the number of such patients, thereby improving diabetes control and increasing the achievement of target levels.

Introduction: Type 2 diabetes mellitus (T2DM) is a global health concern with significant mortality rate associated with comorbidities like diabetic kidney disease (DKD) and cardiovascular disease (CVD). Thus, treatment guidelines recommend first-line treatment with sodium-glucose cotransporter 2 inhibitors (SGLT2Is) and/or glucagon-like peptide 1 (GLP-1) agonists for T2DM with comorbidities. However, in patients when these treatments are not tolerated, contraindicated, or considered expensive, dipeptidyl peptidase 4 inhibitors (DPP4Is) serve as an add-on or alternative for glycemic control without hypoglycemia risk. This study aimed to understand patients' preferences in three South Asian countries between SGLT2I (medication A) and DPP4I (medication B) and the reasons influencing their preference for effective management of T2DM.

Methods: In this cross-sectional study (November 2021 to November 2022) across India, Taiwan, and the Philippines, patients with T2DM on both SGLT2I and DPP4I or neither completed the survey to identify their medication preferences. Differences in baseline characteristics and preferred medication (chi-squared/Fisher's exact tests) and potential attributes influencing preferences (logistic regression) were analyzed.

Results: Among 1224 participants, SGLT2I (64.5%) was significantly preferred over DPP4I (35.5%). Mean age of participants was 59.3 years and the majority were female patients/individuals (52.5%), overweight/obese (56.6%), with glycated hemoglobin levels ≥ 7% (57.6%). Common comorbidities included hypertension (62.7%) and dyslipidemia (75.5%); the majority were without history of CVD (83.7%) or CKD (84%). The most prescribed T2DM medication was biguanide (83.9%), followed by combination of SGLT2Is and DPP4Is (51.3%). The most influential attributes were blood sugar reduction (56.9%), reduced heart failure hospitalization (14.4%), and kidney disease risk reduction (12.1%). SGLT2I users showed a higher preference for heart failure hospitalization reduction (16.5%) or weight reduction (11.1%). Country of residence, thiazolidinedione use, and SGLT2I/DPP4I use were significant factors in logistic regression analyses.

Conclusion: Asian patients with T2DM preferred medication profile resembling SGLT2Is over DPP4Is. Understanding patient preferences may aid optimal glycemic control while reducing cardiovascular and renal risks.