Diabetes Therapy

The effectiveness of basal insulin (BI) or glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in providing glycemic control in patients with type 2 diabetes (T2D) in Japanese routine practice is not well known. This real-world observational study evaluated the probability of achieving glycemic control in Japanese patients with T2D uncontrolled by oral antidiabetic drugs (OADs) who initiated BI or GLP-1 RA therapy. Patients with T2D aged ≥ 18 years initiating BI or GLP-1 RA therapy following treatment with OADs were selected from real-world data (RWD) retrieved from a large electronic medical record database in Japan, using data from 01 January 2010 to 30 June 2019. Patients were required to have glycated hemoglobin (HbA1c) ≥ 7% within 90 days prior to the first prescription of BI or GLP-1 RA. The probability of reaching first HbA1c < 7% was assessed over a 24-month period in cohorts of patients who initiated BI (n = 3477) or GLP-1 RA (n = 780) and in subcohorts by number of OADs at baseline (1, 2, or ≥ 3), HbA1c at baseline (≥ 7 to < 8%, ≥ 8 to < 9%, or ≥ 9%), and age (< 65 or ≥ 65 years). Mean (standard deviation) baseline HbA1c was 9.4% (1.8%) and 8.8% (1.4%) in patients initiating BI or GLP-1 RA therapy, respectively. The cumulative probability of achieving glycemic control was 50.1% with BI and 60.3% with GLP-1 RA therapy, respectively, at 12 months, and 60.8% and 66.6%, respectively, at 24 months. Quarterly (3-month intervals) conditional probabilities of achieving glycemic control decreased over time and were < 10% after 12 months. Patients with more OADs or higher HbA1c at baseline had a lower probability of achieving glycemic control. Among Japanese patients with T2D who initiated BI or GLP-1 RA therapy after treatment with OADs, the probability of reaching first glycemic control diminished over time. Further therapy intensification is warranted in patients who do not achieve glycemic control within 6–12 months with BI or GLP-1 RA, particularly those with high HbA1c or taking multiple OADs. Patients with type 2 diabetes (T2D) who are taking oral antidiabetic drugs (OADs) but still have high blood glucose often require injectable drugs, such as basal insulin (BI) or glucagon-like peptide-1 receptor agonists (GLP-1 RAs). While BI and GLP-1 RAs have been shown to be effective in controlled clinical trials, it is unclear how well they improve blood glucose in real-world routine practice. Here, we report the results of an observational study that used data retrieved from a large electronic medical records database in Japan to explore how well BI and GLP-1 RAs allow patients to achieve glycemic control [glycated hemoglobin (HbA1c) < 7%]. In Japanese patients with T2D receiving treatment with OADs and initiating BI or GLP-1 RA therapy, the probability of achieving glycemic control in the first quarter (3 months) after initiation was 20.3% with BI and 38.6% with GLP-1 RA. Among those patients who had not previously reached glycemic control, the probability of achieving first glycemic control declined over time, as evidenced in each quarterly assessment, and it was < 10% after the first year. Patients who had higher HbA1c levels or were taking multiple OADs were less likely to achieve glycemic control compared with those with lower HbA1c or taking fewer OADs. Our findings suggest that patients who have not achieved their glycemic goals within the first 6–12 months after starting BI or GLP-1 RA therapy have a low likelihood of achieving their target by maintaining the same therapy. For such patients, intensification with additional medication (e.g., combined BI and GLP-1 RA therapy) should be considered early in treatment.

Insulin degludec is a new, ultra-long-acting basal insulin. The aim of this study was to analyze the changes of basal insulin dose and blood glucose profile in basal–bolus therapy of type 1 diabetes mellitus (T1DM) at the switching of basal insulin from insulin glargine or detemir to insulin degludec. Sixteen patients with T1DM were enrolled. The patients underwent continuous glucose monitoring before and after the switching of insulin glargine or detemir to degludec. Ten patients treated with insulin glargine or detemir twice daily, were switched to insulin degludec with 80–90% of the prior insulin dose. The remaining six patients treated with insulin glargine once daily, were switched to insulin degludec without down titration. The changes of daily insulin dose and glycated hemoglobin (HbA1c) were also examined for 12 weeks after switching to insulin degludec. In the patients switched from twice-daily basal insulin, no significant difference was found between before and after switching in the blood glucose profile. In the once-daily group, blood glucose levels showed a tendency to decrease after switching to the degludec treatment. During the study period, total daily insulin dose (TDD) and total daily basal insulin dose (TBD) decreased significantly in the twice-daily group, and TDD and TBD showed a tendency to decrease after switching to degludec in the once-daily group. In both groups, the changes of HbA1c were not significantly different. It is possible to achieve similar glycemic control with once-daily injection and lower doses of insulin degludec in patients with T1DM who have been treated with insulin glargine or detemir.

The original version of this article unfortunately contained a mistake.

The prospective, non-interventional OCEAN study examined the use of intravitreal ranibizumab injections for the treatment of diabetic macular oedema (DME) in a real-world setting in Germany. Adults with DME receiving ≥ 1 ranibizumab (0.5 mg) injections were recruited by 250 ophthalmologists. Best-corrected visual acuity (VA) testing, imaging and treatments were performed according to the investigators’ routine practice and documented over 24 months. The full analysis set included 1226 participants. Mean baseline VA was 60.6 [95% CI: 59.7; 61.5] Early Treatment Diabetic Retinopathy Study letters. VA improved by ≥ 15 letters in 21.5% and 23.5% of the participants at 12 months and 24 months, respectively. They received a mean number of 4.42 [95% CI: 4.30; 4.54] injections in the first year and 5.52 [95% CI: 5.32; 5.73] injections over 24 months, which was markedly lower than in clinical trials. Only 33.4% of the participants received an upload with four initial monthly injections as recommended by the German ophthalmologic societies. Time-to-event analyses that account for missing data inherent to a non-interventional study design demonstrated that participants receiving ≥ 7 injections in the first year had a faster response, but the duration of the response was shorter compared to the subgroups receiving 1–3 and 4–6 injections. Serious adverse events were reported for 143/1250 (11.4%) participants in the safety population. Under-treatment is a major problem of DME anti- vascular endothelial growth factor therapy under real life conditions. Despite fewer injections given compared to randomised controlled trials with a consequently reduced overall mean visual gain, a profound functional improvement (≥ 15 letters) was achieved over 2 years in 23.5% of eyes with DME. NCT02194803, ClinicalTrials.gov. Novartis Pharma GmbH, Nuremberg, Germany.

The impact of telehealth use on healthcare utilization is limited, especially among Medicaid beneficiaries with type 2 diabetes. Considering the rapid adoption of telehealth during the COVID-19 pandemic, this study examined associations between telehealth use and healthcare utilization among Medicaid beneficiaries with type 2 diabetes. Using Louisiana Medicaid claims data from March 2019 to August 2021, the associations were examined using a difference-in-difference model with propensity score weighting. Demographic characteristics, baseline comorbidities and healthcare utilization, and zip code level environmental factors were included in the analysis. The monthly frequency of healthcare services, including in-person outpatient visits, inpatient visits, emergency department (ED) visits and hemoglobin A1C (HbA1C) tests, were measured as outcomes. Several sensitivity analyses were conducted across different subgroups. We included 48,992 beneficiaries with type 2 diabetes in the study of 27,340 beneficiaries in the telehealth group and 21,652 beneficiaries in the non-telehealth group. Of 1000 beneficiaries per month, the telehealth group had significantly more utilization compared to the non-telehealth group, with an increase of 195.049 in-person outpatient visits (95% CI: 166.169 to 223.929, p < 0.001), 3.816 inpatient visits (95% CI: 2.539 to 5.093, p < 0.001), 10.499 ED visits (95% CI: 7.287 to 13.712, p < 0.001) and 14.153 HbA1c tests (95% CI: 11.431 to 16.875, p < 0.001, respectively. Excluding beneficiaries who had ED or inpatient visits in the 30 days prior to receiving telehealth visits, overall ED visits significantly decreased for the telehealth group versus the non-telehealth group over time, by 9.456 visits (95% CI: – 12.356 to – 6.557, p < 0.001) per 1000 beneficiaries per month on average. The study found that telehealth was associated with a significant increase in healthcare utilization in general but has the potential to decrease ED and inpatient utilization for some groups among low-income populations with diabetes.

Foot disease is a devastating complication of diabetes. For almost 3 decades, the mission of the International Working Group on the Diabetic Foot (IWGDF) is to produce evidence-based guidelines to inform health care providers worldwide on strategies for the prevention and management of diabetes-related foot disease. In this publication, we aim to better inform the reader about ‘the story behind’ the IWGDF Guidelines and thus facilitate improved uptake of the recommendations described in the guidelines. The first IWGDF Guidelines were published in 1999, and these have been successfully updated every 4 years since. With each update, IWGDF has improved the methodological rigour and extended the topics covered. This has been possible thanks to the involvement of > 100 experts from > 60 countries, all voluntarily dedicating their time. We estimate that the 2023 update of the IWGDF Guidelines required a total 10 years of full-time work, which would have cost 2 million euros if the voluntary work had been financially compensated. The IWGDF Guidelines are not only published in English but also translated to support local implementation. Currently available translations serve 2.9 billion people globally in their native language. As an independent and multidisciplinary organisation, IWGDF hopes that the 2023 update will continue to stimulate clinicians from all different disciplines to deliver the best care possible for these patients, will motivate researchers to undertake the high-quality trials needed to deliver the new evidence to advance the field further, and collectively will support people with diabetes-related foot disease to minimize their disease burdens.