Diabetes Therapy最新文献

Introduction: Weight and diabetes stigma among healthcare professionals (HCPs) may negatively impact treatment decisions, patient outcomes, and physician-patient interactions. We assessed the relationship between weight stigma, diabetes stigma, perceptions of healthcare quality, and avoidance of healthcare among adults with type 2 diabetes (T2D).

Methods: This observational, online survey-based study included 857 US adults with T2D. The survey included perceptions of patient-centered care with questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey, perceptions of provider communication with questions from the Diabetes Attitudes, Wishes, and Needs (DAWN) study, de novo questions assessing participants' interactions with HCPs, perceived weight stigma and discrimination, and healthcare quality/avoidance delay questions. Mean scores were reported for patient-reported outcome measures: Modified Weight Bias Internalization Scale, Weight Self-Stigma Questionnaire, and Type 2 Diabetes Stigma Assessment Scale. Additional analyses were based on CAHPS, DAWN, and healthcare quality/avoidance responses.

Results: High degrees of weight bias internalization (WBI) and diabetes stigma were observed among participants dissatisfied with their HCP's overall involvement in their care and those who perceived judgment from the HCP because of their weight. Participants with high degrees of WBI and diabetes stigma were more likely to avoid seeking care, felt uncomfortable with body examinations, and rarely underwent regular health checkups. Those who had suboptimal interactions with their HCPs reported greater stigma.

Conclusions: Increasing awareness among HCPs regarding weight and diabetes stigma and promoting compassionate communication in healthcare interactions may help diminish these forms of stigma, thereby potentially improving health outcomes for people with T2D.

Despite advances in cardiovascular risk reduction in type 2 diabetes (T2D), a persistent gap remains compared to individuals without diabetes. Glucagon-like peptide-1 receptor agonists (GLP-1RA) have provided consistent cardiovascular benefits. With more cardiovascular protective agents available for diabetes management, their incremental effect may be nearing a ceiling. The SURPASS-CVOT trial innovatively compared the dual GIP/GLP-1RA tirzepatide with the selective GLP-1RA dulaglutide, demonstrating noninferiority for major adverse cardiovascular events (MACE; HR 0.92; 95.3% CI 0.83-1.01; p = 0.086) and suggesting a potential 28% MACE risk reduction versus an imputed placebo. However, superiority over dulaglutide was narrowly missed. Despite greater improvements in glycemia (0.8% greater HbA1c reduction) and weight (7% greater weight loss), tirzepatide appeared to confer limited incremental cardiovascular benefit, raising questions about mechanism saturation or trial design constraints. Exploratory analyses showed promising benefits on mortality and renal function but require cautious interpretation. The trial's active comparator/imputed placebo design reflects an evolving ethical and therapeutic landscape in diabetes care. Whether dual incretin receptor agonism can meaningfully exceed current cardioprotective thresholds remains uncertain. By now, we may need new paradigms to overcome what may turn out to be a therapeutic ceiling for cardiovascular protection in the T2D population.

Introduction: This post hoc analysis of an A Toujeo^® Observational Study (ATOS) aims to evaluate the real-world effectiveness and safety of insulin glargine 300 U/ml (Gla-300) in high-risk subgroups of insulin-naïve people with type 2 diabetes (PwT2D) from multiple geographical regions (Asia, the Middle East, North Africa, Latin America, and Eastern Europe).

Methods: In these post hoc analyses of ATOS, a real-world, 12-month, prospective study included 4422 insulin-naïve adults (age ≥ 18 years) with type 2 diabetes (T2D) uncontrolled (HbA_1c > 7% and ≤ 11%) on one or more oral antidiabetic drugs (OADs) who initiated Gla-300 treatment as per routine practice. Primary and secondary endpoints were studied according to renal impairment (RI) status (without or with) and age group (

Results: At baseline, participants with a history of RI (N = 581, 13.1%) and older participants (aged ≥ 70 years, N = 514, 11.6%) had a longer duration of diabetes and were more likely to present diabetic complications compared to without RI and younger participants (aged < 70 years). At month 6, the individualized HbA_1c target (as determined by their treating physician) was achieved in 27.5% of participants with RI compared to 24.8% of participants without RI whereas 32.3% of older participants achieved their individualized HbA_1c target compared to 24.2% of younger participants. In this post hoc analysis, Gla-300 treatment improved glycemic control with meaningful reductions in HbA_1c, fasting plasma glucose (FPG) and fasting self-monitored blood glucose (SMBG) across all subgroups. The incidence of hypoglycemia was low and changes in body weight were minimal across all subgroups.

Conclusions: In a real-world setting, the initiation of Gla-300 in insulin-naïve PwT2D uncontrolled on OADs resulted in improved glycemic control with a low incidence of hypoglycemia and minimal weight change in participants with a history of RI and in older participants.

Trial registration: Clinicaltrials.gov number NCT03703869.

Introduction: Although many people with diabetes are treated with insulin in Japan, data on the incidence of hypoglycemia in this population are limited. This real-world, retrospective, cohort analysis assessed the incidence of hypoglycemia-related hospitalization, and the time to first hypoglycemia-related hospitalization, after insulin initiation in adults with type 2 diabetes (T2D) in Japan.

Methods: Adults with T2D who initiated basal, basal-bolus, or premix insulin between January 2016 and September 2022 were identified from the Medical Data Vision (MDV) database. Index date was defined as the date on which the first insulin prescription was issued. The 12 months preceding and the 24 months after this date comprised the baseline and follow-up periods, respectively. Inverse probability of treatment weighting was used to address potential confounding effects.

Results: Of 65,668 individuals in the weighted cohort (median [interquartile range] age, 66.00 [55.00, 73.00] years), 21,846 (33.27%) initiated basal insulin, 21,852 (33.28%) initiated basal-bolus insulin, and 21,969 (33.45%) initiated premix insulin. During the follow-up period, 150 individuals (0.23%) had a hypoglycemia-related hospitalization; incidence rate (95% confidence interval [CI]): 0.35 (0.29, 0.40) per 100 person-years. Of those 150 individuals, 89 (0.41%) in the basal-bolus group experienced hypoglycemia-related hospitalization compared with 29 (0.13%; p < 0.001) and 33 (0.15%; p < 0.001) in the basal and premix groups, respectively. There was a trend towards a higher risk of hypoglycemia-related hospitalization in the basal-bolus group than in either the basal (hazard ratio [HR] 0.32; 95% CI 0.15, 0.66; p = 0.002) or premix group (HR 0.36; 95% CI 0.13, 1.03; p = 0.056). The basal-bolus group had the shortest time to first hypoglycemia-related hospitalization compared with the basal and premix groups.

Conclusions: In adults with T2D in Japan, treatment with basal-bolus insulin was associated with a higher incidence of hypoglycemia-related hospitalization than with basal or premix insulin.

Introduction: Metabolic dysfunction-associated steatotic liver disease (MASLD) is closely associated with diabetes mellitus, representing a significant health concern owing to its potential progression to cirrhosis of the liver. We aim to determine the prevalence of MASLD using transient elastography (TE by FibroScan^R by Echosens, Paris) in individuals with type 2 diabetes (T2D).

Methods: The retrospective data (between 2020 and 2024) of 1070 individuals with T2D (who reported no alcohol intake) who underwent FibroScan assessment at two diabetes clinics were included for analysis. Steatosis was classified using controlled attenuation parameters (CAP) (dB/m) as: S0 (< 238 dB/m), S1 (238-260 dB/m), S2 (260-290 dB/m), and S3 (290-400 dB/m). Liver stiffness measurement (LSM)(kPa) was graded as: F0-F1 (no significant fibrosis, ≤ 8.1 kPa), F2 (≥ 8.2-9.6 kPa), F3 (≥ 9.7-13.5 kPa), and F4 (≥ 13.6 kPa). Fibrosis 4 score (FIB-4), nonalcoholic fatty liver disease (NAFLD) fibrosis score (NFS), and aspartate transaminase (AST)-to-platelet ratio index (APRI) were calculated for LSM.

Results: The mean age, duration of diabetes, and body mass index (BMI) were 55.1 ± 11.5 yrs, 11.8 ± 8.6 years, and 27.9 ± 4.8 kg/m², respectively. S0, S1, S2, and S3 steatosis were present in 24.4%, 16.0%, 20.1%, and 39.5%, respectively. Fibrosis was absent (F0-F1) in 71.4%, while F2 was present in 9.9%, F3 in 9.3%, and F4 in 9.4%. Any degree of steatosis and fibrosis were present in 75.6% and 28.6%, respectively, and were more frequently observed in women than in men. Among the risk scores, the sensitivity for detecting fibrosis was 67.2% for FIB-4, 84.1% for NFS, and 40.9% for APRI, although the latter had higher specificity (84.4%).

Conclusions: More than 75.6% of individuals with T2D have evidence of hepatic steatosis and 28.6% have fibrosis, as indicated by TE (FibroScan). FIB-4, NFS, and APRI have variable sensitivity and specificity for detecting hepatic fibrosis in Asian Indian individuals with T2D.

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.