Diabetes Therapy最新文献

Introduction: Young adulthood is well documented as being a particularly challenging area of type 1 diabetes (T1D) healthcare. Many young adults with T1D (YAT1D) are distracted from effective disease self-management; T1D healthcare service engagement can be problematic and inconsistent, and high rates of unplanned healthcare contacts prevail. Video conferencing use can facilitate services to be flexible and responsive. We aimed to evaluate clinical outcomes and satisfaction related to the use of videoconferencing for T1D healthcare in YAT1D.

Methods: A quantitative narrative review was undertaken, using a systematic process. PubMed, Scopus and CINAHL were searched (until August 2023) to identify relevant articles, using Medical Subject Headings and keywords. A total of 12 records (eight studies) from four countries were retrieved.

Results: Ten records considered clinical outcomes; eight of these records focused on the effectiveness of videoconferencing as part of routine care. Findings largely demonstrate benefits to glycaemic control, particularly when used during the COVID-19 pandemic; no data were available relating to the impact of videoconferencing use on blood pressure and lipid control in YAT1D. Four records considered satisfaction with use of videoconferencing, with data indicating YAT1D were satisfied with the use of videoconferencing technology.

Conclusions: There is a need to configure T1D healthcare services to incorporate and offer use of videoconferencing technology, where applicable, appropriate and acceptable for YAT1D, and feasible and workable for service providers. This will require some adjustments from healthcare systems and possible changes to funding mechanisms.

Introduction: The study objective was to describe characteristics and utilization patterns of tirzepatide users with type 2 diabetes (T2D) using the Healthcare Integrated Research Database in the USA.

Methods: Adults (≥18 years) included had T2D diagnosis; ≥1 tirzepatide claim (May 2022-January 2023; first claim date = index date); and continuous medical and pharmacy enrollment during the 6-month baseline and follow-up periods from the index date. Baseline demographics, clinical characteristics, and 6-month follow-up dosing and treatment patterns were summarized descriptively.

Results: The study included 15,665 patients with T2D initiating tirzepatide (mean age: 53.2 years; 58.5% women; 76.7% non-Hispanic white). During the 6-month baseline period, hypertension (69.2%), dyslipidemia (69.2%), overweight/obesity (58.4%), and obstructive sleep apnea (22.8%) were commonly reported comorbidities. Over half of the patients (51.2%) had used glucagon-like peptide-1 (GLP-1) receptor agonist (RA) before initiating tirzepatide. The mean glycated hemoglobin (HbA1c) was 7.6% (n = 5175), and 58.4% of these patients had HbA1c ≥7%. The mean body mass index (BMI) was 38.7 kg/m² (n = 3459), and 87.8% of these patients either had Class 1, 2, or 3 obesity. Among patients with a single prescription on each fill date (N = 14,986), 84.1% initiated tirzepatide at ≤5 mg dose. During sixth prescription refill (n = 7304), 56.5% were receiving tirzepatide doses of <10 mg. During the 6-month follow-up period, 69.6% of patients had ≥1 dose escalation and 17.2% had ≥1 dose de-escalation. The mean time to first dose escalation was 59.1 days and first dose de-escalation was 104.8 days. Tirzepatide adherence (proportion of days covered [PDC] ≥80%) was 57.5% and persistence (45-day gap) was 73.3% at 6 months. Of patients who discontinued tirzepatide (n = 4177; 26.7%), 29.1% re-initiated tirzepatide (45-day gap).

Conclusion: Patients with T2D initiating tirzepatide had multimorbidity; uncontrolled diabetes; and mean BMI was consistent with Class 2 obesity. Patients showed favorable tirzepatide adherence and persistence profiles, and the majority remained at <10 mg doses during the 6-month follow-up period.

Type 1 diabetes is associated with excess cardiovascular risk, even after accounting for traditional cardiovascular risk factors, including glycaemia. Hence, there is an urgent need to document the metabolic abnormalities that contribute to the cardiovascular mortality gap in type 1 diabetes, and to examine whether cardioprotective type 2 diabetes medications prevent premature morbidity and mortality in this population.

Type 2 diabetes (T2D) frequently coexists with cardiorenal complications. Therefore, a holistic approach to patient management is required, with specialists such as primary care physicians, cardiologists, endocrinologists, and nephrologists working together to provide patient care. Although glycemic control is important in the management of T2D, patients with T2D and acceptable glycemic control are still at risk from cardiovascular (CV) events such as stroke, heart attack, and heart failure (HF). Therefore, management of other risk factors, such as high blood pressure, high cholesterol, smoking cessation, and excess bodyweight, are imperative for reducing the risk of CV disease and HF in patients with T2D. In addition to pharmacological interventions, patient self-care, including beneficial dietary changes, regular exercise, and smoking cessation are critical for improving heart health and reducing the risk of CV events and progression of HF. In this podcast, a patient with lived experience of the heart-related challenges of T2D and a cardiologist discuss the link between T2D and heart-related complications, the pharmacological interventions and lifestyle modifications that can be used to reduce the risk of CV events and prevent HF, and the complexities of engaging with the healthcare system when managing multiple comorbidities. The discussion highlights the importance of patient education and empowerment for the management of heart-related challenges of T2D, and the central role of collaborative care between physicians of multiple specialties to reduce CV risk for patients with T2D.

Introduction: While people with diabetes (PWD)'s experiences with their insulin delivery systems (IDS) are frequently reported in clinical trials, few real-world data exist on the subject. This study aimed to assess the real-world experience and satisfaction with IDS in PWD.

Methods: This cross-sectional survey of PWD treated with tubed or tubeless insulin pumps, hybrid closed loop (HCL) systems, or multiple daily injections (MDI) for at least 3 months ran from 4 to 16 May 2023. The questionnaire containing bespoke questions and the Insulin Delivery System Rating Questionnaire (IDSRQ) satisfaction and interference subscales was answered by subscribers of the Aide aux Jeunes Diabétiques patient association and users of the MyDiabby Healthcare web platform.

Results: Of 896 analysable respondents (552 children [age 10.7 ± 3.8 years, 46.9% female, all type 1] and 344 adults [age 43.1 ± 19.3 years, 61.9% female, 87.2% type 1]), HCL and pump users reported greater satisfaction with their IDS on the IDSRQ satisfaction subscale (HCL, 70.9 ± 17.7 [n = 208]; tubeless, 66.6 ± 19.1 [n = 272]; tubed, 64.1 ± 21.6 [n = 215]) than MDI users (53.1 ± 23.0 [n = 201]; all p < 0.001). Regarding the interference subscale, tubeless pumps (31.1 ± 24.8) performed similarly to HCLs (37.0 ± 25.5; p = 0.07) and significantly better than tubed pumps (38.6 ± 26.0; p < 0.001) and MDI (42.2 ± 24.3; p < 0.001). Furthermore, 84.6% of tubeless pump users would retain their style of pump for their ideal HCL, almost twice as often as tubed pump users.

Conclusion: These results demonstrate a more positive person-reported experience with HCLs or tubeless pumps than with tubed pumps or MDI, primarily due to less interference with daily life, which most tubeless pump users would like to retain when transitioning to a HCL system. Overall, this pioneering study underscores the importance of patient preferences, providing valuable information for physicians prescribing IDS, and facilitating discussions about treatment options.

Introduction: This analysis aimed to evaluate the long-term cost-effectiveness of tirzepatide 5 mg versus dulaglutide 0.75 mg (both administered once weekly) in people not achieving glycemic control on metformin, based on the results of the head-to-head SURPASS J-mono trial from a Japanese healthcare payer perspective.

Methods: A cost-utility analysis was performed over a 50-year time horizon using an implementation of the UKPDS Outcomes Model 2 developed in Microsoft Excel. Baseline cohort characteristics, treatment effects and adverse event rates were sourced from the SURPASS J-mono trial. Simulated patients were assumed to receive either tirzepatide 5 mg or dulaglutide 0.75 mg until HbA1c exceeded 8.0%, at which point treatment was discontinued and basal insulin was initiated. Direct costs were derived from the Japan Medical Data Center claims database. Future costs and clinical benefits were discounted at 2% annually.

Results: In this cost-utility modeling analysis, tirzepatide 5 mg was associated with lower diabetes-related complication rates, improved life expectancy, improved quality-adjusted life expectancy and higher direct costs versus dulaglutide 0.75 mg. This resulted in an incremental cost-effectiveness ratio (ICER) of JPY (Japanese yen) 1,302,240 per quality-adjusted life year (QALY) gained for tirzepatide 5 mg versus dulaglutide 0.75 mg (JPY 140 = USD 1). Tirzepatide remained cost-effective versus dulaglutide over a range of sensitivity analyses.

Conclusions: In this analysis, tirzepatide 5 mg was associated with an ICER below the commonly quoted willingness-to-pay threshold of JPY 5,000,000 per QALY gained, suggesting that tirzepatide is a cost-effective treatment option for adult patients with type 2 diabetes mellitus, compared with dulaglutide 0.75 mg.

Introduction: The glucagon-like peptide-1 (GLP-1) analogue semaglutide is approved as an oral formulation for the treatment of type 2 diabetes. This study aimed to confirm bioequivalence between a new, second-generation (2G) oral semaglutide formulation (1.5, 4 and 9 mg) and the initially approved first-generation (1G) formulation (3, 7 and 14 mg).

Methods: This was a randomised, multicentre, open-label, full replicate crossover study to confirm bioequivalence between 2G and 1G oral semaglutide formulations at steady-state (SS) in healthy participants (NCT05227196). Participants were recruited to three groups. In each group, participants were randomised to one of two alternating sequences comparing once-daily oral semaglutide treatment of 9 and 14 mg (group 1), 4 and 7 mg (group 2) or 1.5 and 3 mg (group 3) at SS. Treatment duration was 20 weeks, comprising four 5-week steady-state periods on alternating formulations. Repeated 24-h blood sampling at the end of each steady-state period supported pharmacokinetic analysis. Co-primary endpoints were area under the semaglutide plasma concentration-time curve during a dosing interval at SS (AUC_0-24h,SS) and maximum semaglutide plasma concentration at SS (C_{max, 0-24h,SS}). Bioequivalence for co-primary endpoints was assessed using European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA) criteria. Safety was monitored.

Results: A total of 222, 201 and 123 participants were recruited into groups 1, 2 and 3, respectively. The prespecified EMA, FDA and PMDA bioequivalence criteria were met for 2G versus 1G oral semaglutide for all three dose levels (1.5 vs 3 mg, 4 vs 7 mg and 9 vs 14 mg). The safety profile of 2G oral semaglutide was consistent with 1G oral semaglutide.

Conclusions: The 2G oral semaglutide formulation was confirmed as bioequivalent to 1G oral semaglutide, with no new safety concerns identified.

Trial registration: ClinicalTrials.gov identifier, NCT05227196.

Introduction: We previously reported sex differences in the distribution of glycated haemoglobin (HbA1c) for men/women aged < 50 years vs older individuals, with implications for delayed diabetes diagnosis. Here, we explored whether this pattern was also seen in matched fasting plasma glucose (FPG) levels.

Methods: We extracted data on same-day, paired HbA1c and FPG levels from clinical biochemistry laboratory databases from Mersey and West Lancashire Teaching Hospitals NHS Trust (n = 10,153) and Cambridge University Hospitals NHS Foundation Trust (n = 10,022) between Jan 2019 and Dec 2023. Only cases with a single, general-practice HbA1c test were utilised to minimise the risk of including non-diagnostic tests and tests from specialist care (e.g. endocrinology, antenatal services; final dataset: n = 17,271). We examined the links of HbA1c and FPG levels to age and sex.

Results: Median HbA1c levels were 1 mmol/mol lower in women aged < 45 years compared to men aged < 45 years but not in those aged ≥ 45 years. This pattern was not seen with FPG, where median levels in women were 0.1-0.2 mmol/L lower across all ages. The HbA1c:FPG ratio was significantly higher in women than men in the 45-54 and ≥ 55 years age groups (p = 0.004, Z-score = 2.9 and p =  < 0.001, Z-score = 8.9, respectively) but not in the < 45 years age group (p = 0.649, Z-score = 0.5). We confirmed our previous finding that median HbA1c levels in women aged ≥ 55 years and 45-55 years were the same as those in men (39 and 37 mmol/mol, respectively) and that for women aged < 45 years, the median HbA1c (34 mmol/mol) was 1 mol/mol lower than for men (35 mmol/mol). This is reflected in the Z-scores, which showed the largest deviation from zero in the < 45 years age group (- 9.1) and the smallest in the older age group (- 2.9).

Conclusion: We showed differences in HbA1c and FPG patterns with age between men and women, with implications for the diabetes diagnostic threshold for HbA1c in pre-menopausal women, the underdiagnosis of type 2 diabetes in younger women, and missed opportunities for intervention. We propose that a suggested change to HbA1c reference ranges in this group warrants serious consideration and detailed evaluation.

Introduction: It is widely accepted that the higher the number of medications prescribed and taken by an individual, the higher the risk of poor health outcomes. We have investigated whether polypharmacy and comorbidities conveyed more risk of adverse health outcomes following COVID-19 infection (as a paradigm of serious viral infections in general) in people with type 1 diabetes (T1DM) or type 2 diabetes (T2DM).

Methods: The Greater Manchester Care Record (GMCR) is an integrated database of electronic health records containing data collected from 433 general practices in Greater Manchester. Baseline demographic information (age, body mass index [BMI], gender, ethnicity, smoking status, deprivation index), hospital admission or death within 28 days of infection were extracted for adults (18+) diagnosed with either T1DM or T2DM.

Results: The study cohort included individuals diagnosed as T1DM and T2DM separately. Across the Greater Manchester Region, a total of 145,907 individuals were diagnosed with T2DM and 9705 were diagnosed with T1DM. For the T2DM individuals, 45.2% were women and for the T1DM individuals, 42.7% were women. For T2DM, 16-20 medications (p = 0.005; odds ratio [OR] [95% confidence interval (CI) 2.375 [1.306-4.319]) and > 20 medications (p < 0.001; OR [95% CI] 3.141 [1.755-5.621]) were associated with increased risk of death following COVID-19 infection. Increased risk of hospital admissions in T2DM individuals was associated with 11 to 15 medications (p = 0.013; OR = 1.341 (95% CI) [1.063-1.692]). This was independent of comorbidities, metabolic and demographic factors. For T1DM, there was no association of polypharmacy with hospital admission. Additionally, respiratory, cardiovascular/cerebrovascular and gastrointestinal conditions were associated with increased risk of hospital admissions and deaths in T2DM (p < 0.001). Many comorbidities were common across both T1DM and T2DM.

Conclusions: We have shown in T2DM an independent association of multiple medications taken from 11 upwards with adverse health consequences following COVID-19 infection. We also found that individuals with diabetes develop comorbidities that were common across both T1DM and T2DM. This study has laid the foundation for future investigations into the way that complex pharmacological interactions may influence clinical outcomes in people with T2DM.