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13th March 2024
The UK’s first type 1 diabetes registry for children and adults at risk of the condition is to be launched by the University of Oxford after receiving a grant from the charity Diabetes UK.
The grant of £610,480 will support the creation of a database and website to form the foundation of the registry. Individuals who test positive for diabetes autoantibodies in clinical care will be added to the registry, along with those identified in screening studies.
The team will also work with clinical and research sites, and approach people who would be interested in joining.
The aims of the registry include providing guidance for doctors on how best to care for and support people who are at risk of type 1 diabetes (T1D) and identify whether being at risk causes people to attend their GP or A&E more regularly. This will allow healthcare teams to catch the onset of T1D as early as possible.
The registry will also collect data on how T1D develops and aid understanding of why people progress from being antibody positive and at risk of T1D to needing insulin.
Dr Rachel Besser, a paediatric diabetes consultant at Oxford University Hospitals NHS Foundation Trust and researcher at the University of Oxford’s Centre for Human Genetics, who is leading the project, said: ‘This registry is a first for the UK and brings together children and adults who are at risk of T1D.
‘It is an important step towards a better understanding of the care and support people at high risk of type 1 require, allowing us to offer them a “softer landing” into life with the condition.’
Indeed, the registry can also be used to inform people about treatments and research into T1D prevention, particularly immunotherapy that they could get involved in to help prevent or delay T1D onset.
People on the registry will also be easier to reach with resources to support people after diagnosis, and support people with the mental health burden of living with T1D.
Dr Loredana Marcovecchio, academic consultant in paediatric endocrinology and diabetes at the University of Cambridge and co-lead for the project, added: ‘We’re hoping that it will be easier to tell people about opportunities to take part in research to develop new treatments that might prevent or delay the onset of T1D.’
The Diabetes Trials Unit at Oxford University will host the registry, and Cambridge University will co-lead with the support of researchers from Birmingham, Bristol, Cardiff, Dundee, Edinburgh, Exeter, Imperial College and the British Heart Foundation.
Recruitment to the type 1 diabetes registry is expected to start later in 2024.
Around 400,000 people live with T1D in the UK, including over 29,000 children and young people, and it is becoming more prevalent.
In fact, the incidence of type 1 diabetes in children and adolescents significantly increased during the Covid-19 pandemic compared to pre-pandemic levels, according to a meta-analysis published in 2023. Causal mechanisms for this change are still unclear.
Previous research also suggested that the risk of T1D was significantly elevated in children and adolescents more than 30 days after an infection with Covid-19.
Risk registries are increasingly being developed to reveal more about how genetic variation affects diagnoses of conditions such as Lynch syndrome, which exposes people to greater risk of bowel and other cancers.
9th November 2023
NICE has recommended the use of ‘game changer’ wearable technology to help patients manage type 1 diabetes.
Hybrid closed loop systems allow insulin to be delivered automatically to the body, keeping blood glucose at a healthy level. This technology includes a continuous glucose monitor sensor which transmits data to an insulin pump, both of which are worn on the body.
The final draft guidance published by NICE said hybrid closed loop systems should be offered to people whose current device is not controlling their diabetes.
NICE and NHS England have agreed that this wearable technology will be rolled out over a five-year period in order to allow for trusts to employ the extra staff needed and for specialist training for both patients and staff to be completed.
The technology will be offered first to all children and young people, women who are pregnant or planning a pregnancy, and those who already have an insulin pump. It is also recommended more widely for adults with an average HbA1c reading of 7.5% or more.
The draft guidance on hybrid closed loop systems for managing blood glucose levels in type 1 diabetes, which is due to be published in its final format in December, evaluated clinical trial evidence showing that these systems are ‘more effective than standard care at maintaining blood glucose levels within a healthy range’.
The hybrid closed loop wearable technology allows patients to continue daily life without needing to regularly conduct finger prick testing or insulin injections.
There are around 270,000 people in England and 16,000 people in Wales living with type 1 diabetes, according to NHS data.
Patients will only be able to access this wearable technology with the support of a trained multidisciplinary team experienced in continuous subcutaneous insulin infusion.
Professor Jonathan Benger, chief medical officer at NICE, highlighted the importance of focusing on ensuring best value for money for diabetes technology since the disease takes up around 10% of the NHS budget.
He said: ‘Using hybrid closed loop systems will be a game changer for people with type 1 diabetes.
‘By ensuring their blood glucose levels are within the recommended range, people are less likely to have complications such as disabling hypoglycaemia, strokes and heart attacks, which lead to costly NHS care.
‘This technology will improve the health and wellbeing of patients, and save the NHS money in the long term.’
NHS England’s national specialty advisor for diabetes Professor Partha Kar said the NICE recommendation is ‘amazing news’ for people living with type 1 diabetes.
He said: ‘This tech might sound sci-fi like but it will have a dramatic impact on the quality of people’s lives, not to mention outcomes – it is as close to the holy grail of a fully automated system as science can provide at the moment, where people with type 1 diabetes can get on with their lives without worrying about glucose levels or medication.’
Colette Marshall, chief executive of the charity Diabetes UK, said: ‘We’re excited to welcome these recommendations which broaden access to the technology for key groups including children and young people, recognising our comments to the consultation earlier this year.
‘However, funding to roll out this technology to the people that need it is of paramount importance and we reiterate the campaign call we made last month for Government and the NHS to agree this.
‘We’ll also be working with the NHS to help ensure that everyone who could benefit from this technology has access to it as soon as possible in the phased rollout that has been agreed to achieve this.‘
A version of this article was originally published by our sister publication Pulse.
3rd July 2023
The incidence of type 1 diabetes in children and adolescents significantly increased during the Covid-19 pandemic compared to pre-pandemic levels, according to a recent meta-analysis.
Suggestions of an association between infection with Covid-19 and a new diagnosis of of type 1 and type 2 diabetes emerged early in the pandemic. However, the causal mechanisms responsible are unclear. Moreover, understanding the nature of any relationship between diabetes and infection with Covid-19 is complicated by several factors including the seasonality of diagnoses and evidence of an estimated 3.4% annual increase in the incidence of the condition.
In trying to untangle the potential association between the rise in cases of type 1 diabetes and infection with Covid-19, a team of Canadian researchers, writing in JAMA Network Open, compared the incidence rates of paediatric diabetes during and before the Covid-19 pandemic.
The team undertook a systematic review and meta-analysis of all medical databases, using subject headings and text terms related to Covid-19, diabetes and diabetic ketoacidosis (DKA). Studies were included in the analysis if these reported differences in incident diabetes cases during compared to before the pandemic, among individuals under 19 years of age.
Researchers set the primary outcome as the change in the incidence rate of paediatric diabetes from before and during the pandemic. The secondary outcome was the change in the incidence rate of DKA among youths with new-onset diabetes during the pandemic.
In total, 42 studies with 102,984 incident diabetes cases were included in the analysis.
The type 1 diabetes incidence rate was 14% higher during the first year of the pandemic compared with the pre-pandemic period (incidence rate ratio, IRR = 1.14 95% CI 1.08 – 1.21). Nevertheless, this rate increased further during months 13 to 24 of the pandemic compared to the pre-pandemic level (IRR = 1.27, 95% CI 1.18 – 1.37). There was also a higher incidence of DKA compared to before the pandemic (IRR = 1.26, 95% CI 1.17 – 1.36).
The underlying mechanisms responsible for this observed increase are unclear and require further investigation.
7th March 2023
A randomised, placebo-controlled trial found that among adolescents recently diagnosed with type 1 diabetes (T1D), use of verapamil tablets preserved beta cell function to a greater extent than placebo after 52 weeks.
Type 1 diabetes is an autoimmune disorder resulting in the destruction of insulin-producing beta cells in the pancreas. Among patients with T1D, measurement of connecting peptide (C-peptide) which is co-secreted with insulin from the islets of Langerhans cells, allows for an evaluation of the amount of remaining beta cell secretion of insulin. One recently identified therapeutic target is thioredoxin-interacting protein which is elevated in diabetes and over-expression of the protein leads to beta-cell apoptosis. Moreover, it has been found that verapamil can inhibit thioredoxin-interacting protein, thereby enhancing beta cell function and could serve as a means of preventing diabetes. In fact, a 2018 study with 26 T1D patients, observed that use of verapamil improved the area under the curve (AUC) for C-peptide after 3 and 12 months.
In the current study, researchers randomised adolescents recently diagnosed (within 24 days) with T1D, 1:1 to either 60 or 120 mg/day (depending on the participant’s weight) of verapamil or placebo as part of study in which subjects also received either intensive diabetes management or standard care. The primary outcome was set as the AUC values for C-peptide stimulated by a mixed-meal tolerance test, 52 weeks from their date of diabetes diagnosis.
Verapamil and changes in C-peptide area under the curve
A total of 88 participants with a mean age of 12.7 years (41% female) were randomised to either verapamil (47) or placebo.
The mean baseline C-peptide AUC for the verapamil group was 0.66 pmol/mL and 0.65 pmol/mL at 52 weeks. In contrast, in the placebo group C-peptide AUC reduced from 0.60 pmol/mL to 0.44 pmol/mL (adjusted between-group difference = 0.14, 95% CI 0.01 – 0.27, p = 0.04), which equated to a 30% higher C-peptide level at 12 months in the verapamil group.
The authors concluded that use of verapamil was able to partly preserve stimulated C-peptide secretion at 52 weeks and called for further longitudinal studies to confirm the durability of this response and the optimal length of treatment.
Citation
Forlenza GP et al. Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial. JAMA 2023
11th October 2022
A bionic pancreas can provide better control of glycated haemoglobin levels compared to standard care according to the findings of a randomised trial by a team of US researchers.
The term ‘diabetes’ refers to a group of diseases characterised by high blood glucose levels that occur due to a deficiency in the production or function of insulin or both. Type 1 diabetes is the main form diagnosed in childhood and characterised by increased blood glucose levels resulting from insulin deficiency. It is relatively common and in a 2020 study, it was estimated that globally, the incidence of type 1 diabetes was 15 per 100,000 and had a prevalence of 9.5%.
Multiple studies have confirmed that a higher glycated haemoglobin (HbA1c) level is an independent risk factor for diabetes complications. As a result, according to a consensus report in 2021 by the American Diabetes Association and the European Association for the Study of Diabetes, a HbA1c goal for most adults of <53 mmol/mol (<7.0%) without significant hypoglycaemia is appropriate. Nevertheless, in a US real-world study of 31,430 type 1 patients, only around 20% had a HbA1c of < 7%.
Currently, hybrid closed-loop insulin-delivery systems are able to partially automate insulin delivery and have shown improved glycaemic control in adults and youth with type 1 diabetes by reducing both hyperglycaemia and hypoglycaemia. Another innovation is a bionic pancreas, which represents an automated insulin delivery system initialised only with body weight and without any information about previous insulin dosing. A bionic pancreas works together with a continuous sugar monitoring (CGM) tool to autonomously deliver insulin and/or glucagon to control an individual’s blood glucose level in response to their real-time sensor glucose readings from the CGM.
In the present study, US researchers undertook a randomised trial to compare a bionic pancreas which provided either aspart or insulin lispro with standard care in terms of managing glycated haemoglobin levels. For the study, standard care was defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring. Individuals aged 6 years and older who were diagnosed with type 1 diabetes and using insulin for at least 12 months, were randomised 2:1 to the bionic pancreas (with insulin aspart or lispro) or standard care. The primary outcome was the glycated haemoglobin level at 13 weeks, whereas secondary outcomes included the percentage time that glucose levels were below 3 mmol/L and the percentage of time that glucose levels remained in the target range of 3.9 to 10 mmol/L.
Bionic pancreas and glycated haemoglobin
A total of 326 adults and children with a mean age of 28 years (49% female in the bionic group) were included in the analysis.
The mean glycated haemoglobin level was 7.3% (down from a baseline of 7.9%) in the bionic group but remained unchanged at 7.7% in the standard care group (mean adjusted difference = -0.5, 95% CI -0.60 to – 0.30, p < 0.001).
However, the percentage of time with glucose levels below 3 mmol/L was not significantly different. In contrast, both the mean glucose level and the percentage time spend in the target range of 3.9 to 10 mmol/L were both statistically significant, favouring the bionic pancreas. In fact, based on the percentage time within the target range, the researchers calculated that the difference of 11% equated to an increase of 2.6 hours/day for the bionic group.
The rate of severe hypoglycaemia was 17.7 events per 100 participant-years in the bionic group and 10.8 events for the standard care group which was non-significant (p = 0.39).
The authors concluded that the bionic pancreas was associated with a greater reduction in glycated haemoglobin compared to standard care.
Citation
Bionic Pancreas Research Group. Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes N Eng J Med 2022
30th September 2022
A study presented at the European Association for the Study of Diabetes (EASD) annual meeting by Norwegian researchers suggests that the risk of developing new-onset type 1 diabetes is significantly elevated among children and adolescents, more than 30 days after an infection with COVID-19.
Type 1 diabetes (TID) is a chronic, autoimmune disease that is influenced by both genetic and environmental factors and characterised by the destruction of insulin-producing cells. It also appears to be on the increase with a 2019 study finding that the pooled estimate across European centres continued to show a 3.4% increase per annum in incidence rate, suggesting a doubling in incidence rate within approximately 20 years in Europe.
There is some data to suggest that the onset of type 1 diabetes can be initiated after respiratory infections that give rise to the common cold, influenza-like illness, sinusitis, and laryngitis/tracheitis. Moreover, while some evidence suggests that COVID-19 can trigger severe diabetic keto-acidosis in those with new-onset diabetes, there is no hard evidence that the virus can induce T1D.
As a result, for the study presented at EASD, the Norwegian team undertook nationwide register-based study to test whether infection with COVID-19 was associated with an increased risk of developing TID in children and adolescents.
Using the Norwegian preparedness register that is updated daily with individual-level data on PCR-confirmed COVID-19 infections, vaccinations and disease diagnoses from primary and secondary health care, the team linked individual level data for children and adolescents. Individuals were then followed from the start of the pandemic (1 March 2020) until diagnosis of type 1 diabetes, age 18 years, death, until March 2022 (whichever came first).
The researchers used both a test-negative design and a full population cohort to examine the relationship between the first type 1 diabetes diagnosis within or after 30 days post-COVID-19 infection. The results were expressed as hazard ratios which were adjusted for age, sex, non-Nordic country of origin, geographical area and socio-economic factors.
Type 1 diabetes and COVID-19 infection
A total of 424,354 children with COVID-19 infection (of 1,202,174 children included at study start) and 990 incident cases of T1D were identified .
Using the test negative design, the adjusted HR for type 1 diabetes at least 31 days after COVID-19 infection was 1.63 (95% CI 1.08 – 2.47, p = 0.02). However, less than 30 days post-infection, the adjusted hazard ratio was not significant (HR = 1.25, 95% CI 0.72 – 2.17, p = 0.42).
For the whole population cohort, the adjusted hazard ratio was 1.57 (95% CI 1.06 – 2.33, p = 0.03) and again was not significant for less than 30 days post-infection.
Based on these findings, the authors concluded that COVID-19 infection is associated with increased risk of subsequent T1M.
Citation
Gulseth HL et al. SARS-CoV-2 infection and subsequent risk of type 1 diabetes in 1.2 million children
4th August 2022
Daily insulin use increases the risk of developing cancer in patients with type 1 diabetes, with a greater risk among those who use a higher daily dose, according to findings of a study by US and Greek researchers.
Although diabetes and cancer are two heterogeneous, multifactorial, and chronic diseases, there are some epidemiological data indicating a higher risk of several types of cancer (including pancreas, liver, breast, colorectal, urinary tract, and female reproductive organs) in diabetic patients. Moreover, in an analysis of diabetic registries that specifically focused on patients with type 1 diabetes, a higher cancer risk was also identified for several types of cancer.
However, whether this observed link is causal remains unclear. For example, in a 2016 meta-analysis of 16 observational studies in type 1 diabetics who used long-acting daily insulin, 13 studies reported no association between insulin glargine and detemir and any cancer and 4 studies reported an increased risk of breast cancer with insulin glargine. The authors concluded that observational studies examining the risk of cancer associated with long-acting insulin analogues have important methodological shortcomings that limit the conclusions that can be drawn.
Nevertheless, whilst it is possible that the presence of type 1 diabetes is linked to an increased risk of cancer, no studies have examined potential patient risk factors. Consequently, for the present study, researchers turned to data from the Diabetes Control and Complications trial (DCCT) and the Epidemiology of Diabetes Interventions and Complications study (EDIC) to gain a better understanding of which, if any, factors increased the risk of cancer.
The DCCT enrolled patients between 1983 and 1989 and when the trial was completed in 1993, 1375 survivors continued in the EDIC study and follow-up data was available for 28 years. Daily insulin dose was categorised as low (< 0.5 units/kg), medium (> 0.5 and < 0.8 units/kg) and high (> 0.8 units/kg). The researchers used multivariable models to assess the association between several different factors and cancer incidence.
Daily insulin and cancer
Among a total of 1303 patients who were followed-up for 33,813 person-years, 93 (7%) developed cancer, giving an incidence rate of 2.8 (95% CI 2.2 – 3.3) per 1000 person-years. The mean age of participants at their cancer diagnosis was 50 years and the mean duration of diabetes was 25 years.
Among the 93 who developed cancer, 61% were female. The majority of individuals (58%) developed their cancer after 21 and 28 years and the cancers affected the skin (27), breast (15) and digestive tract (6).
Factors associated with the development of cancer were age (hazard ratio, HR = 1.08, 95% CI 1.05 – 1.12) and female gender (HR = 1.74, 95% CI 1.15 – 2.64). Interestingly, participation moderate or strenuous exercise was associated with a reduced risk of cancer (HR = 0.31, 95% CI 0.16 – 0.59, p = 0.001).
In multivariable models, daily insulin use was associated with a 4-fold higher risk of cancer (HR = 4.13, 95% CI 1.13 – 15.17, p = 0.03). The cancer incidence was 2.11, 2.87 and 2.91 per 1000 person-years in the low, medium and high-dose daily insulin groups respectively.
Although the previous 2016 meta-analysis described earlier did not derive a clear association between type 1 diabetes and cancer, the authors of the current study suggested that this was because in the cohorts examined the doses of insulin used were low (< 0.3 units/kg) and many had discontinued treatment during follow-up.
The authors also felt that their observations may have been due to residual confounding and that potentially, the associations may not have been causal. They called for further studies to validate this association.
Citation
Zhong W, Moa Y. Daily Insulin Dose and Cancer Risk Among Patients With Type 1 Diabetes JAMA Oncol 2022
7th December 2021
Rates of diabetes-associated ocular complications (DAOC) in children have been found to be much higher in children diagnosed with type 2 as opposed to type 1 disease over the first 15 years after diagnosis. This was the finding of a retrospective analysis by a team from the Department of Ophthalmology, Mayo Clinic,
Rochester, US.
Diabetes is a common childhood condition, with a recent UK study finding that in 2019, there were an estimated 36,000 children with diabetes under the age of 19, an increase from from 31,500 in 2015. In children, type 1 disease accounts for the vast majority of cases although there is evidence to suggest that the prevalence of type 2 diabetes has increased between 2001 and 2009, in 10 – 19 year olds. Diabetes is associated with the development of micro-vascular complications including retinopathy, which remains the most common cause of blindness in working-age adults in the developed world. While sight loss in children due to diabetic retinopathy is much less common, guidance does recommend retinopathy screening of children with type 1 diabetes. However, far less is known about the development and progression of diabetic retinopathy among children with type 2 diabetes.
For the present study, the US researchers were interested in comparing the DAOC rates in children with both forms of diabetes. They turned to the medical records of children newly diagnosed with diabetes between 1970 and 2019 in Minnesota. They collected demographic and clinical data such as HbA1C and whether the individuals had undergone an eye examination and followed-up on these examinations. The researchers catalogued diabetic-associated ocular complications including non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), diabetic macular oedema (DME), a visually significant cataract (VSC) and the need for pars plana vitrectomy (PPV).
Findings
A total of 606 children were diagnosed with diabetes during the 50-year period, of whom, 525 (87.8%) had undergone at least one eye examination and were diagnosed with either type 1 (461) or type 2 (64) diabetes. The mean age of diagnosis among those with type 1 disease was 10.8 years (53.4% male) and 17.3 years (28.1% male) for type 2 disease. A DAOC occurred in 147 (31.9%) of those with type 1 disease,14 years after diagnosis and in 17 (26.6%) of those with type 2 disease. The hazard ratio, HR for developing any diabetic retinopathy between type 2 and type 1 disease was 1.88 (95% CI 1.13 – 3.12, p = 0.02).
Overall, 30.6% of those with type 1 disease developed a DAOC within 15 years compared to 52.7% of those with type 2 disease. While the risk of developing any of the other retinopathy complications included in the analysis was numerically higher among those with type 2 disease, the only statistically significant effect was the need for pars plana vitrectomy (HR = 4.06, 95% CI 1.34 – 12.33, p = 0.07), 15 years after the initial diagnosis.
The authors concluded that children with type 2 diabetes developed vision threatening retinopathy a shorter time after diagnosis than those with type 1 disease and suggested that such children should have ophthalmoscopy evaluations at least as frequently, or even more frequently, than those with type 1 disease.
Citation
Bai P et al. Ocular Sequelae in a Population-Based Cohort of Youth Diagnosed With Diabetes During a 50-Year Period. JAMA Ophthalmol 2021
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