Tag Archives: HbA1c

Automatic Hybrid Insulin Delivery Systems Help Manage T1D

Diabetes News


Advanced hybrid closed-loop (AHCL) systems improve glycemic control in patients with type 1 diabetes, according to a prospective evaluation by 16 diabetes specialists in Spain. The current hybrid closed-loop systems have gone one step further by mimicking the body’s natural insulin delivery systems. 

The objective of this evaluation was to analyze the results of two AHCLs currently on the market (MM780G with SmartGuard and Tandem t:slimX2 with Control-IQ) and to determine their real-life benefits, based on the information provided by the patients.

“The evaluation involved 150 patients from 14 centers, 75 for each system, and lasted for 3 months. An initial evaluation was carried out, and another was done at the end of the 3 months to determine diabetes control and user satisfaction. Glycosylated hemoglobin (HbA1c), time in different glycemic ranges, and patient-reported outcomes were assessed. To take quality of life into consideration, a 146-point questionnaire was completed to assess all aspects of the condition at a later stage,” Pilar Beato, MD, specialist in endocrinology and nutrition at Badajoz University Hospital in Spain, told Univadis Spain.

The study enrolled adolescent and adult men and women with type 1 diabetes who had not previously been treated with AHCL. After analysis of the results, the specialists concluded that the two AHCLs provide a significant improvement in glucose control. Neither AHCL was superior. Interestingly, the improvement in diabetes-related anxiety was the greatest in Control-IQ users. But there were no differences in improvement in sleep quality.

Beato, the lead study author, said that “there have been other previous analyses, but none with a prospective joint assessment with the same design. Our results demonstrate that both systems are highly effective, reduce glycosylated hemoglobin, and improve all quality-of -life parameters evaluated. The results are comparable as different health centers took part. All experts taking part belong to the Spanish Diabetes Society’s applied technology in diabetes task force. The choice of which AHCL to use will depend on the specialists and availability at each site. User preferences should also be considered as the devices may have individual features making one or the other more convenient for a given individual. But based on our data, there is no clinical indication to choose one over the other.” 

The concept of the two systems analyzed is the same: They both have a glucose sensor that is constantly taking measurements, and both send the information in real time to the system algorithms that decide how much insulin should be supplied, thereby controlling glucose highs and lows. They differ in the design of the system components and in the engineering of the algorithms. But the important thing is that the information for managing an individual’s diabetes and the amount of insulin they need is obtained from the patient himself or herself. Making the systems automated addresses and corrects glucose variability itself even within a single day, as multiple factors such as food, nerves, or sports can affect glucose levels.

“Initial training and support are needed in the event of an incident or problem, but it does not necessarily require more consultation time as they are automated systems and are capable of automatically resolving glucose spikes that may occur in an individual. This may even involve less consultation time. Naturally, patients must continue to be monitored by endocrinology with some regularity,” said Beato. 

These technologies are endorsed by international scientific societies that are seeing more and more advantages of such devices. The societies therefore recommend that closed-loop hybrid systems be the standard of care in people with type 1 diabetes as they are more effective than conventional multidose insulin therapy. They have been recommended by the American Diabetes Association since 2022 and the National Institute for Health and Care Excellence guidelines since January 2023, among others.

Beato regrets that the use of these devices is not widespread in Spain. “We don’t have data about the percentage of people using them, but we get the impression that this number is low and not enough. We need a boost and to break down some barriers such as cost. The devices will ultimately reduce the cost of diabetes control as they are designed to provide better glucose control. They will reduce admissions for complications such as diabetic retinopathy or hypoglycaemia. They will also reduce absence from school and work. In the future, I’m sure the systems will be smaller, which will suit users better.”

This article was translated from Univadis Spain, which is part of the Medscape Professional Network.



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Analysis of remission and relapse rate of type 2 diabetes mellitus in Japan

Diabetes News


The phenomenon of improvement of glucose to levels in a normal range and cessation of the need for medication can occur in some patients diagnosed with type 2 diabetes who are provided with lifestyle therapy, temporary pharmacotherapy, bariatric surgery, or combinations of these treatments.

However, this phenomenon is not yet fully understood in routine care settings, and many factors remain to be clarified. Moreover, since there are differences in insulin secretion and resistance between East Asian and Western populations, the natural history of diabetes seems to differ widely between Western populations and East Asians.

Therefore, these concerns lead Dr. Kazuya Fujihara and colleagues to investigate the incidence/one year relapse from remission and associated factors in patients with type 2 diabetes. In the Diabetes, Obesity and Metabolism paper, the authors addressed these research questions using a database of specialists’ clinics.

They analyzed the data of Japan Diabetes Clinical Data Management Study Group (JDDM) which is one of the largest cohorts of Japanese people with type 2 diabetes. They tracked the information on 48,320 people with diabetes in Japan. In one arm of the study, they calculated remission rates per 1000 person-years. The authors reported that the median follow-up was 5.3 years. During the study period, 3,677 remissions occurred.

The overall incidence of remissions per 1,000 person-years was 10.5 that was similar to 9.7 in the United Kingdom. In addition, those with HbA1c levels of 48 to 53 mmol/mol (6.5% to 6.9%), those taking no glucose-lowering drugs at baseline, and those with a ≥10% body mass index (BMI) reduction in 1 year, it was 27.8, 21.7 and 48.2, respectively.

Male sex, shorter duration, lower baseline HbA1c, higher baseline BMI, higher BMI reduction at 1 year, and no glucose-lowering drugs at baseline were significantly associated with remission. Similar results were obtained with maintenance of remission over 1 year as an outcome. In another arm of the study, the investigators revealed the factors that predicted relapse from remission in 1 year.

Among 3,677 individuals who entered remission, two-thirds (2,490) relapsed from remission within 1 year. Longer duration of diabetes, lower BMI at baseline, and lower BMI reduction at 1 year were significantly associated with relapse. Commenting on the significance of their findings.

Compared to Westerners, Asians have higher insulin sensitivity and a lower acute insulin response. In addition, Asians have a much lower obesity level than Westerners, and the pathogenesis of diabetes mellitus is very different between the two. Therefore, the relationships of baseline BMI and BMI reduction with remission and relapse may be greater in East Asian than in Western populations, implying ethnic differences in returning from overt hyperglycemia to nearly normal glucose levels.”


Hirohito Sone, Niigata University

While the findings of these analytical study are impressive and provide new insight on remission in patients with type 2 diabetes should be, the authors noted that “present study is an observational study and does not show a cause and effect relationship, and that future intervention studies with lifestyle and/or medication will be needed to confirm how many people actually achieve remission and how long the state of remission lasts in real world setting”.

Source:

Journal reference:

Fujihara, K., et al. (2023) Incidence and predictors of remission and relapse of type 2 diabetes mellitus in Japan: Analysis of a nationwide patient registry (JDDM73). Diabetes, Obesity and Metabolism. doi.org/10.1111/dom.15100.



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Study suggests COVID-19 can cause diabetes

Diabetes News
Study: New-Onset Diabetes and COVID-19: Evidence from a Global Clinical Registry. Image Credit: ADragan / Shutterstock


The authors of a new study under review at Nature Portfolio and currently posted to the Research Square preprint* server showed the clinical possibility that the coronavirus disease 2019 (COVID-19) heightens the risk of developing diabetes mellitus (DM), supporting diabetes screening in those infected by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 

Study: New-Onset Diabetes and COVID-19: Evidence from a Global Clinical Registry. Image Credit: ADragan / ShutterstockStudy: New-Onset Diabetes and COVID-19: Evidence from a Global Clinical Registry. Image Credit: ADragan / Shutterstock

Background

An increasing body of evidence suggests that COVID-19 is associated with new diabetes diagnoses. However, it is unclear whether COVID-19 detects pre-existing diabetes or induces new-onset diabetes.

Although previous research reported high blood-sugar levels and metabolic consequences resulting from pre-existing diabetes following COVID-19 hospitalization, studies correlating the disease to new-onset DM are scarce.

COVID-19 has been shown to exacerbate pre-existing diabetes. This likely occurs because COVID-19 is associated with low-grade inflammation, which may initiate or worsen insulin resistance. In addition, numerous studies have also demonstrated that SARS-CoV-2 can infest and multiply within insulin-producing pancreatic beta-cells, thus impairing insulin synthesis and secretion. 

However, whether SARS-CoV-2 can cause clinically meaningful changes in glucose metabolism remains unclear. Nevertheless, it may be possible to find an answer by characterizing the clinical symptoms of COVID-19-related diabetes and by determining the period between the onset of hyperglycemia and that of the infection.

It is imperative to establish a causal relationship between COVID-19 and diabetes since both diseases are prevalent throughout the world. Furthermore, establishing a causal relationship will have significant implications for diagnosis, management, public health, and scientific research. Despite this, it remains unclear whether the association between COVID-19 and diabetes results from indirect health consequences of the former, such as – a higher rate of detection of pre-existing diseases, or whether the causative virus (SARS-CoV-2) directly precipitates hyperglycemia. 

Owing to the higher rate of pre-existing disease detection in the COVID era, newly diagnosed diabetes may be explained both during and after an episode of infectious exposure.

The study

This study investigated the possibility that COVID-19 may trigger new-onset diabetes and its associated symptoms by examining average blood-glucose levels at the time of diabetes presentation against a global clinical registry.

A global COVID-19-related diabetes (CoviDIAB) registry was established to determine whether COVID-19 can acutely induce diabetes and its clinical symptoms. The CoviDIAB registry collects information regarding “newly diagnosed diabetes” and “severe metabolic complications associated with pre-existing diabetes” resulting from COVID-19. 

Individuals with a fasting blood glucose of 126 mg/dL or above or non-fasting blood glucose of 200 mg/dL or above, with no prior diabetes history, and those who had never been on glucose-lowering medications, and with their glycated hemoglobin (HbA1c) levels below the diabetic range (< 6.5%) at presentation were categorized as new-onset diabetes. Here, the researchers examined cases of newly diagnosed diabetes that occurred within four weeks of COVID-19 confirmation. In addition, the HbA1c data were evaluated at the time of diabetes detection to rule out pre-existing hyperglycemia and to confirm the association with SARS-CoV-2 infection.

The findings

Data on 537 eligible newly diagnosed diabetes cases was entered from 61 hospitals in 25 countries between 2020-2022. COVID-19 patients with newly diagnosed diabetes at presentation had HbA1c levels above the diagnostic range, suggesting pre-existing hyperglycemia.

In cases with new-onset hyperglycemia after the SARS-CoV-2 infection, individuals displayed glycemic levels above the diagnostic thresholds, although their HbA1c levels remained within the non-diabetic range. The results showed that 22% of newly diagnosed patients with documented HbA1c levels had recently acquired diabetes.

The most common diabetes subtype among adults was type 2 DM (59%), and the “not yet known” subtype (41%). Two newly diagnosed cases of type 1 DM were recorded among children. After COVID-19 resolution, hyperglycemia persisted in 39 of 89 patients (45%) with newly diagnosed diabetes.

For 28 of these individuals, follow-up data beyond three months was collected, demonstrating that five of them were in remission from diabetes, while 23 (82%) remained diabetic. 

The findings suggested that COVID-19 causes clinically significant changes in glucose metabolism. Although this study does not prove that SARS-CoV-2 causes diabetes, it strongly suggests that the virus may impose a diabetogenic aftermath. 

Further, type 2 DM was the predominant subtype among COVID-19 participants with newly diagnosed diabetes. Thus, type 2 DM likely accounts for most newly diagnosed diabetes cases associated with the post-acute phase of the SARS-CoV-2 infection.

This study confirms this phenomenon across diverse geographical locations and ethnicities by incorporating clinical observations from 25 countries. 

Numerous areas for improvement have been identified in this study, including inherent heterogeneity in clinical practice and the judgment of contributing physicians. 

Conclusion

The results of this study suggest that COVID-19 likely has a diabetogenic effect. Thus, individuals exposed to SARS-CoV-2 infection must be screened for diabetes. Further research is necessary to confirm the mechanisms through which the virus interferes with glucose metabolism.

*Important notice

Research Square publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.



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