Association Of British Clinical Diabetologists Research Articles

Real-world outcomes of Omnipod DASH system use in people with type 1 diabetes: Evidence from the Association of British Clinical Diabetologists (ABCD) study

AimsTo evaluate real-world outcomes in people with Type 1 Diabetes (PwT1D) initiated on Omnipod DASH® Insulin Management System. MethodsAnonymized clinical data were submitted to a secure web-based tool within the National Health Service network. Hemoglobin A1c (HbA1c), sensor-derived glucometrics, total daily dose of insulin (TDD), and patient-reported outcome changes between baseline and follow-up were assessed. Individuals were classified to “new-to-pump” (switched from multiple daily injections) and “established-on-pump” (switched from a tethered insulin pump) groups. Results276 individuals from 11 centers [66.7 % female; 92 % White British; median age 41 years (IQR 20–50); diabetes duration 20 years (IQR 11–31); 49.3 % within “new-to-pump” group] were included. Baseline HbA1c was 8.0 ± 1.3 % (64 ± 14 mmol/mol). At follow-up [3 years (IQR 1.5–3.2)], HbA1c reduced by 0.3 % [(3 mmol/mol); p = 0.002] across the total population, 0.4 % [(5 mmol/mol); p = 0.001] in those “new-to-pump” and remained unchanged in those “established-on-pump”. TDD decreased in the “new-to-pump” cohort (baseline:44.9 ± 21.0units vs follow-up:38.1 ± 15.4units, p = 0.002). Of those asked, 141/143 (98.6 %) stated Omnipod DASH had a positive impact on quality of life. ConclusionsOmnipod DASH was associated with improvements in HbA1c in PwT1D “new-to-pump” and maintained previous HbA1c levels in those “established-on-pump”. User satisfaction in all groups and TDD reduction in those “new-to-pump” were reported.

Factors predicting glucose and weight response to injectable semaglutide (Ozempic): real-world data from the Association of British Clinical Diabetologists’ audit programme

Background: Previous randomised controlled trials have observed individual differences in response to Glucagon-Like Peptide-1 Receptor Agonists (GLP1RA) according to baseline characteristics such as glycated haemoglobin (HbA1c) and weight. The Association of British Clinical Diabetologists (ABCD) launched a nationwide UK audit in January 2019 to assess the clinical utility, efficacy and safety of injectable semaglutide in routine practice. The aim of this analysis was to investigate associations between baseline characteristics and HbA1c and weight reductions with semaglutide in real-world use. Methods: Data were extracted from the secure online tool and individuals who had baseline and follow-up data available within a defined 6 (3-9) month window were included. Variables were assessed as both continuous variables and categorical variables in a multivariate regression model. Missing data were multiply imputed. Results: In total, 620 individuals were included. Baseline characteristics: (mean±SD) age was 58.7±10.7 years, HbA1c 81.6±18.5 mmol/mol (9.5±1.7%), weight 108.2±24.2 kg and body mass index (BMI) 37.6±7.6 kg/m2. Median diabetes duration was 11.2 years (IQR 6.6-16) and 50.5% (313/620) of subjects were male. The median follow-up time was 0.5 years. HbA1c reduced by 14.9 mmol/mol (95% CI 13.5, 16.1) [-1.4% (95% CI - 1.2, -1.5)]; p<0.001; and weight reduced by 4.2kg (95% CI 3.6, 4.8; p<0.001). Higher HbA1c, younger age and GLP1RA naïvety were associated with larger HbA1c reduction. Higher baseline weight/BMI and GP1RA naïvety were associated with larger weight reduction. Conclusion: In this real-world study, baseline HbA1c and weightwere important predictors of HbA1c and weight reduction outcomes following initiation of semaglutide in routine clinical practice. Our data mirror existing randomised controlled trial data, but further evidence is being collected over a longer follow-up period.

Intermittently scanned continuous glucose monitoring and hypoglycaemia awareness in drivers with diabetes: Insights from the Association of British Clinical Diabetologists Nationwide audit.

Frequent hypoglycaemia results in disruption to usual hypoglycaemic autonomic responses leading to impaired awareness of hypoglycaemia, which is associated with an increased risk of severe hypoglycaemia requiring third-party assistance (SH). The UK Driving and Vehicle Licensing Agency (DVLA) does not permit car driving if they have either a complete loss of hypoglycaemia awareness or more than one SH event a year. The FreeStyle Libre (FSL) Association of British Clinical Diabetologists (ABCD) Nationwide Audit consists of data collected by clinicians during routine clinical work, submitted into a secure web-based tool held within the National Health Service (NHS) N3 network. Analysis of paired baseline and follow-up data for people with type 1 diabetes who also held a driving licence was undertaken. The study consisted of 6304 people who had data recorded about driving status from 102 UK specialist diabetes centres, of which 4218 held a driving licence: 4178 a group 1, standard licence, 33 a group 2, large lorries and buses, seven a taxi licence; 1819 did not drive. Paired baseline and follow-up data were available for a sub-cohort of 1606/4218. At a mean follow-up of 6.9 months [95% CI (6.8, 7.1)], the Gold score had improved (2.3 ± 1.5 vs. 2.0 ± 1.3 p < .001), and the number of people who experienced an SH episode was also significantly lower (12.1% vs. 2.7%, p < .001). This study suggests that intermittently scanned continuous glucose monitoring may improve impaired awareness of hypoglycaemia and reduce the number of people with type 1 diabetes with a driving licence experiencing a severe hypoglycaemic episode.

907-P: Glycaemic Outcomes Associated with Omnipod DASH Use in the Real World—Results from the Association of British Clinical Diabetologists (ABCD) Omnipod Worldwide Audit

Introduction: The ABCD Omnipod® Worldwide Audit launched in 2021 with the aim of capturing routine clinical outcomes from users in the real-world. This analysis reports glucose outcomes, including comparisons between pump-naïve and established pump-users starting on Omnipod DASH® Insulin Management System. Methods: Individuals were included in the analysis if relevant baseline and follow-up data were available. Change in HbA1c, time-in-range (TIR, 70-180mg/dL), time below range (TBR, &amp;lt;70mg/dL) and total daily dose of insulin were assessed using paired T-tests. For glucose outcomes, stratified analyses were performed to compare the outcomes between those new to pump therapy (“new”) and those already established (“established”). Results: Over a median follow-up of 2.3years (IQR 1.2-3) we included 235 individuals from the UK with baseline mean±SD HbA1c 8.1±1.4%; age 36.0±16.5years; diabetes duration 21.7±14.9years; 34.0% (n=82/235) were new to pump therapy. Across the whole population HbA1c reduced by 0.3% (95%CI 0.1, 0.5; P&amp;lt;0.01). Stratified by previous therapy, HbA1c reductions were statistically significant in the “new” group (0.5%; 95%CI 0.1, 0.8; P=0.01). TIR, TBR and HbA1c levels were maintained in those in the “established” group. Total daily dose decreased from 41.4units to 36.9units (-4.4; 95%CI 0.8, 8.1; P=0.018) between baseline and follow-up. Of those asked to rate on a 7-point Likert scale, 82/84 (97.6%) stated Omnipod DASH had improved their quality of life and 83/86 (96.5%) would recommend the system to other people with diabetes. Conclusion: In individuals new to pump therapy, Omnipod DASH is associated with clinically meaningful reductions in HbA1c, reduced insulin requirements and improved quality of life. Individuals switching to Omnipod DASH from other pumps maintained previous HbA1c levels, TIR and TBR. Disclosure T.S.J.Crabtree: Speaker's Bureau; Abbott Diabetes, Novo Nordisk, Lilly, Sanofi, Insulet Corporation. E.G.Wilmot: Advisory Panel; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, Roche Diabetes Care, Embecta, Consultant; Springer Healthcare, Research Support; Abbott Diabetes, Diabetes UK, Insulet Corporation, Novo Nordisk, NIH - National Institutes of Health, Speaker's Bureau; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, Ypsomed AG, Glooko, Inc. M.Haq: None. N.Hasan: None. D.M.Williams: None. E.R.Gatdula: None. E.Chinnasamy: None. J.Varghese: None. G.Modgil: None. R.E.Ryder: Other Relationship; Novo Nordisk, Speaker's Bureau; GI Dynamics, BioQuest. Funding Insulet Corporation

1708-P: Comparing 9- vs. 12-Month Implantation in the Worldwide EndoBarrier (EB) Registry

Uncertainty exists re risk: benefit of proximal intestinal exclusion with EB, a novel endoscopic duodenal jejunal liner device for obesity, both with and without diabetes. In view of this, during 2017, an independent, secure, on line registry was established under the auspices of the Association of British Clinical Diabetologists, for the collection of safety and efficacy data worldwide. As of December 2022, data had been entered on 1022 patients, of whom 195 (age 51.6±10.3 years, 53% male, 81% white ethnicity, BMI 39.9±6.9kg/m2) had both 9- and 12-month data entered. EB had considerable impact on weight and HbA1c (Table). There was no difference between the mean±SD reduction in HbA1c or weight at 9- vs 12-months (HbA1c: 1.39±1.67% vs 1.38±1.66% (p=0.98); weight: 11.7±8.3kg vs 12.0±8.3kg (p=0.44). The higher the HbA1c the greater the fall but again no difference between 9- and 12-months (Table). In the full registry, 43/1022 (4.2%) experienced serious adverse events (SAE). 15/43 (34.9%) SAE would have been avoided by removal at 9-months (9 liver abscess, 4 GI bleed, one cholecystitis). It was particularly noteworthy that 9/13 (69.2%) liver abscess SAEs would have been avoided by removal at 9-months. This international data from the EB registry suggests that the benefits of EB are achieved in 9-months and a reduction in the recommended implantation period from 12- to 9-months would reduce SAEs, especially the liver abscess SAE. Disclosure R.E.Ryder: Other Relationship; Novo Nordisk, Speaker's Bureau; GI Dynamics, BioQuest. J.J.Mcmaster: None. J.Chisholm: None. L.Kow: None. J.C.Mason: None. R.V.Cohen: Advisory Panel; GI Dynamics, Research Support; Medtronic, Johnson &amp; Johnson Medical Devices Companies. P.Sen gupta: Other Relationship; Novo Nordisk. M.Yadagiri: None. L.Munro: None. H.Frydenberg: None. S.Fishman: None. J.P.Byrne: Advisory Panel; Oxford Medical Products, Join Embla, Stock/Shareholder; Join Embla. J.P.Teare: None. C.De jonge: None. J.Greve: Advisory Panel; GI Dynamics. Funding Association of British Clinical Diabetologists

787-P: Glucose and Weight Outcomes Associated with Oral Semaglutide in the Real-World—Initial Results from the Association of British Clinical Diabetologists’ (ABCD) Audit

Semaglutide is the first glucagon like peptide-1 receptor agonist (GLP1-RA) available in an oral preparation. Weight and HbA1c outcomes with injectable semaglutide in the real-world are well established. The aim of this analysis is to assess weight and HbA1c response to oral semaglutide. Methods: Data were extracted from the secure online ABCD audit tool. Individuals were included if baseline and follow-up weight and/or HbA1c data were available. Change in HbA1c, body mass index (BMI) and weight from baseline was assessed using a multivariate linear regression model and change in the numbers achieving an endpoint HbA1c≤7.5% [58mmol/mol] were assessed using Chi2 tests in Stata 16. Results: Data were available for 350 individuals with baseline mean±SD HbA1c 9.2%±1.7 [76.6mmol/mol±18.3], weight 101.8kg±21.9, BMI 34.3kg/m2±6.9, median diabetes duration 11years (IQR 6-16) and age 59 years (IQR 51-68); 63.0% were male and 79.7% were white. Median follow-up was 0.5years (IQR 0.3-0.8). Significant reductions in HbA1c of 0.7% (95%CI 0.4, 0.9; P&amp;lt;0.001) [7.4mmol/mol; 95%CI 4.7, 10.0; P&amp;lt;0.001] were observed. Weight decreased by 3.3kg (95%CI 2.3, 4.3; P&amp;lt;0.001) and BMI fell by 1.1kg/m2 (95%CI 0.6, 1.6; P&amp;lt;0.001). Twice as many people achieved a HbA1c≤7.5% at follow-up compared to baseline (28.6% [52/182] vs 14.3% [26/182]) - this change was statistically significant (P&amp;lt;0.001). Conclusion: In the real-world, oral semaglutide is associated with statistically significant and clinically meaningful reductions in HbA1c, weight and BMI. The numbers achieving a HbA1c≤7.5% also increased. In the light of this, further data collection and analysis should be undertaken, including comparisons between oral and injectable GLP1-RAs and analysis of switches between them Disclosure T.S.J.Crabtree: Speaker's Bureau; Abbott Diabetes, Novo Nordisk, Lilly, Sanofi, Insulet Corporation. K.Adamson: None. S.Krishnasamy: Other Relationship; Novo Nordisk, Sanofi, Eli Lilly and Company, AstraZeneca. M.Khine: None. P.De: Speaker's Bureau; Novo Nordisk, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Takeda Canada, Daiichi Sankyo, Napp Pharmaceuticals Limited, Lilly Diabetes. R.Peter: None. R.E.Ryder: Other Relationship; Novo Nordisk, Speaker's Bureau; GI Dynamics, BioQuest. Funding Novo Nordisk

Dapagliflozin and euglycaemic diabetic ketoacidosis – ‘But doctor my sugars were normal!’

Dear Editor, A ‘Dear Doctor Letter’ was issued by the manufacturer of Forxiga (dapagliflozin) in November 2021; this followed reviews by the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency. The letter stated that ‘The removal of the T1DM indication is not due to any safety concern for dapagliflozin in any indication, including T1DM’ but must be discontinued ‘in patients with T1DM by or in consultation with a physician specialised in diabetes care and be conducted as soon as clinically practical.’1 Dapagliflozin was previously approved in the treatment of diabetes for combination with insulin therapy in type 1 diabetes and with oral medications and insulin in type 2 patients. The pathogenesis of EuDKA occurs as a consequence of absolute insulin deficiency leading to reduced glucose utilisation and enhanced lipolysis; increased delivery of free fatty acids (FFAs) to the liver coupled with raised glucagon levels promotes FFA oxidation, and subsequent production of ketone bodies.2 Rosenstock and Ferrannini also reported that following a US FDA safety communication, the majority of reports of EuDKA between 2014 and 2015 in the US were actually in patients with type 2 diabetes.2 The UK Yellow Card report did not specify the type of diabetes. A review of the UK MHRA Yellow Card reporting system on dapagliflozin in October 20223 showed the following results: total number of adverse drug reactions (ADRs) reports, 2155; serious ADR reports, 1371; fatal ADR reports, 26 (cut-off 31 August 2022). Details of ADRs which could be related to EuDKA are shown in Table 1. The number of reports submitted had risen following the letter from the manufacturer. It is expected that a large number of these reports could be related to the concomitant use of dapagliflozin and insulin therapy in patients with type 2 diabetes. Appropriate monitoring and awareness on the part of health care professionals and patients are necessary to prevent potentially harmful and fatal consequences. The advice from both the manufacturer and the medicines regulatory agencies surrounding the actions required in patients with type 1 diabetes is clear and we may prevent problems by close monitoring of patients in diabetes specialist units. Such task is facilitated by the use of electronic medical records and access to the list of all medications used by these patients. Following the research findings on the occurrence of EuDKA in patients with type 2 diabetes, we may argue that these patients should also be included in a review for EuDKA. From personal and documented reports, patients with type 2 diabetes often react negatively to the introduction of insulin therapy to their medications.4 Part of the rationale to include insulin therapy usually includes improved glycaemic control. Following a period of improvement in their self-monitored blood glucose, some patients might react by stopping or reducing their use of insulin. The resulting ketonaemia in patients with insulin deficiency taking SGLT2 inhibitors is initially asymptomatic or clinically undetectable and could gradually lead to severe ketoacidosis. There are data which document the increased incidence of chronic heart failure, especially in people with type 2 diabetes;5 as this diagnosis is also included in the newer indications for dapagliflozin it will be important to communicate the association of EuDKA and dapagliflozin use to specialists who might not necessarily be expert in managing this complication of diabetes. Most patients with type 2 diabetes are managed in primary care and initiating a community-wide alert would take time to complete and require significant human resource, increased budget, and likely lead to increased patient anxiety. Blood tests to detect low endogenous insulin secretion would also take time and increased resources. A more rapid and simple approach is required. One option could be to request that all patients with long-standing type 2 diabetes who are treated with insulin in combination with dapagliflozin or any other SGLT2 inhibitors should be advised to use blood or urine ketone testing to detect EuDKA, particularly when insulin doses are being reduced or withdrawn. Awareness of these such parameters would help health professionals to quickly identify and treat patients at risk. The Association of British Clinical Diabetologists and Diabetes UK have produced joint guidance on communication and education requirements to be provided to patients who were prescribed an SGLT2 inhibitor for the first time.6 This provides useful and practical suggestions for minimising adverse reaction to the use of these medicines. Michael Stacey, MD, FRCP, Senior Lecturer, Royal Centre for Defence Medicine, UK There are no conflicts of interest declared.

Associations of microvascular complications with all-cause death in patients with diabetes and COVID-19: The CORONADO, ABCD COVID-19 UK national audit and AMERICADO study groups.

AimTo provide a detailled analysis of the microvascular burden in patients with diabetes hopitalized for COVD‐19.Materials and MethodsWe analysed data from the French CORONADO initiative and the UK Association of British Clinical Diabetologists (ABCD) COVID‐19 audit, two nationwide multicentre studies, and the AMERICADO, a multicentre study conducted in New York area. We assessed the association between risk of all‐cause death during hospital stay and the following microvascular complications in patients with diabetes hospitalized for COVID‐19: diabetic retinopathy and/or diabetic kidney disease and/or history of diabetic foot ulcer.ResultsAmong 2951 CORONADO, 3387 ABCD COVID‐19 audit and 9327 AMERICADO participants, microvascular diabetic complications status was ascertained for 1314 (44.5%), 1809 (53.4%) and 7367 (79.0%) patients, respectively: 1010, 1059 and 1800, respectively, had ≥1 severe microvascular complication(s) and 304, 750 and 5567, respectively, were free of any complications. The patients with isolated diabetic kidney disease had an increased risk of all‐cause death during hospital stay: odds ratio [OR] 2.53 (95% confidence interval [CI] 1.66‐3.83), OR 1.24 (95% CI 1.00‐1.56) and OR 1.66 (95% CI 1.40‐1.95) in the CORONADO, the ABCD COVID‐19 national audit and the AMERICADO studies, respectively. After adjustment for age, sex, hypertension and cardiovascular disease (CVD), compared to those without microvascular complications, patients with microvascular complications had an increased risk of all‐cause death during hospital stay in the CORONADO, the ABCD COVID‐19 diabetes national audit and the AMERICADO studies: adjusted OR (adjOR) 2.57 (95% CI 1.69‐3.92), adjOR 1.22 (95% CI 1.00‐1.52) and adjOR 1.33 (95% CI 1.15‐1.53), respectively. In meta‐analysis of the three studies, compared to patients free of complications, those with microvascular complications had an unadjusted OR for all‐cause death during hospital stay of 2.05 (95% CI 1.42‐2.97), which decreased to 1.62 (95% CI 1.19‐2.119) after adjustment for age and sex, and to 1.50 (1.12‐2.02) after hypertension and CVD were further added to the model.ConclusionMicrovascular burden is associated with an increased risk of death in patients hospitalized for COVID‐19.

756-P: The Effect of Semaglutide on Alanine Aminotransferase (ALT) Levels: Results from the Association of British Clinical Diabetologists (ABCD) Audit

Obesity and type 2 diabetes are important drivers for the development of nonalcoholic fatty liver disease (NAFLD) . Glucagon-like peptide-1 receptor agonists (GLP1RAs) are efficacious for these conditions, but their potential as treatments for NAFLD remains unclear. As serum ALT concentration is routinely measured in clinical care, we evaluated the impact of the GLP1RA, semaglutide, on ALT in those at risk of NAFLD. Methods: Data submitted to the ABCD semaglutide audit (launched in 2019) were analysed. Change in ALT from baseline was assessed and corrected for change in covariates and concomitant medications using a multiple linear regression in Stata 16 . Baseline ALT levels were used to perform a stratified analysis as follows: normal (ALT 0-29U/L) , mildly elevated (30-59 U/L) and significantly elevated (≥60U/L) . Missing data were multiply imputed. Results: Data for 1,623 individuals (50.2% men) were included with baseline (mean±SD) : age 58.9±11.0 years, HbA1c9.4±1.7%, weight 104.6±2.8kg, BMI 37.1±7.4kg/m2 and median (IQR) diabetes duration 10.9 years (6-15.4) and ALT 26U/L (19-36) . Median (IQR) follow-up was 8.2 months (5-12) . At follow-up, changes in HbA1c and weight were -1.2% (95%CI -1.0, -1.3; p&amp;lt;0.001) and -2.4kg (95%CI -1.7, -3.1; p&amp;lt;0.001) respectively. No significant change in ALT was seen across the entire cohort (p=0.172) . However, ALT rose in the normal group (+14.6U/L; 95%CI 10.4, 18.8; p&amp;lt;0.001) and fell in the significantly elevated group (-16.2U/L; 95%CI -11.8, -20.5; p&amp;lt;0.001) . No change was noted in the mildly elevated group (p=0.33) . The differences between groups were statistically significant (p&amp;lt;0.0001) . Conclusion: Among patients with significantly raised ALT, semaglutide was associated with ALT reduction, but this finding may result from regression to the mean. Measurement in parallel of further biomarkers of liver fibrosis will be required to assess the potential of semaglutide as a NAFLD therapy. Disclosure T.S.J. Crabtree: Other Relationship; Abbott Diabetes, Novo Nordisk, Sanofi. D.K. Sennik: Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi. D. Barnes: None. S. Sivappriyan: None. K. Adamson: None. S.M. Phillips: None. A. Evans: None. N. Larsen: None. A. Panesar: None. I.W. Gallen: None. I.R. Idris: None. R.E. Ryder: None. Funding The ABCD audit is support by an unrestricted grant from NovoNordisk

90-OR: FreeStyle Libre (FSL) Time in Range (TIR) and Time Below Range (TBR) : Impact on HbA1c, Diabetes-Related Distress (DRD) , and Resource Utilisation in the Association of British Clinical Diabetologists (ABCD) National Audit

Introduction: With increasing access to intermittently scanned continuous glucose monitoring (isCGM) , with the FSL, it is essential to understand the effect of TIR and TBR on HbA1c, DRD, and resource utilisation in people living with diabetes Methods: Clinicians from 1NHS UK hospitals submitted FSL user data for16,034 participants, (96% type 1 diabetes) of whom 6859 had follow-up data, collected during routine clinical care and submitted to a web-based secure tool. Linear regression analysis was used to estimate the age, gender and baseline HbA1c adjusted reduction in HbA1c in the TIR categories. Results: Follow up TIR data were available for 3250 (47%) participants of which, 1241 (38%) reported TIR in line with the international consensus (3.9-mmol/l) . After adjustments for age gender, baseline HbA1c and duration of diabetes follow-up TIR ≥50% was associated with an 0.8% (8.75 mmol/mol) reduction in HbA1c (P&amp;lt;0.0001) and -0.29 reduction in DRD (P&amp;lt;0.0001) , while follow-up TIR ≥70% was associated with a 1.3% (14.mmol/mol) reduction in HbA1c (P&amp;lt;0.0001) and 0.40 reduction (P&amp;lt;0.0001) in DRD vs. those with TIR &amp;lt;50%. With the use of FSL, there was a 67% reduction in hospital admissions due to hypoglycaemia (none in those with TIR≥50) , a 63% reduction in hospital admissions related to hyperglycaemia/DKA and an 85% reduction in paramedic outcalls. The reduction in hospital admissions for hyperglycaemia/DKA and paramedic callouts was independent of the TIR achieved during follow-up. The incidence of severe hypoglycaemia was lower in those with TBR ≤5% as compared to those with TBR &amp;gt;5% (7% vs. 11%) but was not statistically significant (P=0.31) . Conclusion: In a large cohort of UK FSL users, we demonstrate a significant reduction in HbA1c, diabetes-related distress and resource utilisation which was associated with improved TIR Disclosure H.Deshmukh: None. T.Sathyapalan: n/a. B.Pieri: None. E.G.Wilmot: Advisory Panel; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Sanofi, Research Support; Insulet Corporation, Novo Nordisk, Speaker's Bureau; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. N.Shah: None. V.Tsatlidis: None. A.N.Lumb: Advisory Panel; Abbott, Dexcom, Inc., Research Support; Abbott, Novo Nordisk, Speaker's Bureau; Abbott, Dexcom, Inc., Insulet Corporation, Novo Nordisk. R.E.Ryder: None. C.Walton: None. Funding NIHR clinical lectureship

1415-P: Risk–Benefit Data from the Worldwide EndoBarrier (EB) Registry

Uncertainty exists re risk:benefit of proximal intestinal exclusion with EB, a novel endoscopic duodenal jejunal liner device for obesity, both with and without diabetes. In view of this, during 2017, an independent, secure, on line registry was established under the auspices of the Association of British Clinical Diabetologists, for the collection of safety and efficacy data worldwide. As of December 2021, data had been entered on 10patients {age 52.1 ± 10.3 year, 53% male, 87% diabetes, BMI 41.1 ± 8.9 kg/m2} and showed many benefits (Table 1) . There were 43 (4.2%) SAEs and 139 (13.9%) less serious AEs (Table 2) . All SAE patients made a full recovery and most derived significant benefit. The benefits of EB therapy are likely to reduce the complications of diabetes. This international data from the EB registry suggests that the likely benefits of EB, far outweigh the risks Disclosure R.E.J. Ryder: None. J.P. Teare: None. A. Ruban: None. M. Haluzik: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Abbott Diabetes, AstraZeneca, Lilly Diabetes, Novartis AG. L. Munro: None. H. Frydenberg: None. J.J. McMaster: None. S. Fishman: None. R.V. Cohen: Advisory Panel; GI Dynamics. Research Support; Johnson &amp; Johnson, Medtronic. C.M. Aboud: None. G.J. Holtmann: Research Support; AbbVie Inc., Allergan, Arena Pharmaceuticals, Inc., Bayer, Bristol Myers, Datapharm Australia Pty Ltd Commonwealth Laboratories, Pty Limited, Eli Lilly Australia Pty Limited, F.Hoffmann-La Roche Limited, Falk Foundation, Falk GmbH and Co Kg, GI Therapies Pty Ltd, Gilead Sciences Pty Limited, MedImmune Ltd Celgene Pty Limited, Mylan, Nestle Pty Ltd, Prometheus Laboratories, Quintiles Pty Limited, Servatus, Takeda Development Center Asia, Pty Ltd, Vital Food Processors Ltd. C. de Jonge: None. J. Greve: Advisory Panel; GI Dynamics. Other Relationship; Bariatric Solutions International, Ethicon, Inc. J.C. Mason: None. H. Sourij: Advisory Panel; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Daiichi Sankyo, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk. Research Support; Boehringer Ingelheim International GmbH, Sanofi. Speaker's Bureau; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novartis AG, Novo Nordisk. R. Drummond: Research Support; Fractyl Health, Inc. Speaker's Bureau; AstraZeneca, Bristol-Myers Squibb Company. B. McGowan: Advisory Panel; Johnson &amp; Johnson, Lilly, Novo Nordisk. Research Support; Novo Nordisk. Speaker's Bureau; AstraZeneca, Novo Nordisk. Stock/Shareholder; Reset Health. S.A. Amiel: Advisory Panel; Medtronic, Novo Nordisk. Other Relationship; Sanofi. M. Yadagiri: None. P. Sen Gupta: None. K. Laubner: None. J. Seufert: Advisory Panel; Abbott, Sanofi-Aventis Deutschland GmbH. Research Support; Boehringer Ingelheim International GmbH. Speaker's Bureau; Abbott Diabetes, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Lilly, Novo Nordisk, Sanofi-Aventis Deutschland GmbH. Funding Association of British Clinical Diabetologists

FreeStyle Libre Flash Glucose Monitoring system for people with type 1 diabetes in the UK: a budget impact analysis.

IntroductionThis study aims to estimate the budget impact of increased uptake of the FreeStyle Libre Flash Glucose Monitoring system in people with type 1 diabetes mellitus (T1DM) in the UK.Research design and methodsA budget impact model was developed, applying real-world data collected in the Association of British Clinical Diabetologists (ABCD) FreeStyle Libre Nationwide Audit. Costs of diabetes glucose monitoring in a T1DM population (n=1790) using self-monitoring of blood glucose (SMBG) or the FreeStyle Libre system were compared with a scenario with increased use of the FreeStyle Libre system.ResultsThe ABCD audit demonstrates FreeStyle Libre system use reduces diabetes-related resource utilization. The cost analysis found that higher acquisition costs are offset by healthcare costs avoided (difference £168 per patient per year (PPPY)). Total costs were £1116 PPPY with FreeStyle Libre system compared with £948 PPPY with SMBG. In an average-sized UK local health economy, increasing FreeStyle Libre system uptake from 30% to 50% increased costs by 3.4% (£1 787 345–£1 847 618) and when increased to 70% increased by a further 3.3%.ConclusionIncreased uptake of the FreeStyle Libre system in the T1DM population marginally increases the cost to UK health economies and offers many system benefits.

Association of British Clinical Diabetologists, Diabetes Technology Network UK and Association of Children's Diabetes Clinicians Survey of UK Healthcare Professional Attitudes Towards Open-Source Automated Insulin Delivery Systems.

IntroductionAutomated insulin delivery (AID) systems can enable improved glycaemic outcomes with reduced mental burden. Open-source AID (OS-AID) systems overcome some of the developmental and access barriers enabling a wider use of these systems. Limited data are available on healthcare professional (HCP) opinions and current practice regarding these systems. The aim of this survey was to gain insight into HCP perceptions and practices around OS-AID.MethodsThis survey was developed collaboratively with OS-AID users and distributed to adult and children’s teams, using an online survey tool. Results were received between February and April 2019. Responses were assessed using simple descriptive statistics with analyses stratified by respondent characteristics.Results317 responses were obtained from a range of HCPs in both adult and paediatric services. Key results include: HCP perception of OS-AID as “risky in the wrong hands” (43%); 91% felt uncomfortable initiating discussions around OS-AID because of lack of regulation (67%) and/or their own lack of knowledge (63%). Half of HCPs (47%) reported that they would choose OS-AID if they themselves had type 1 diabetes.ConclusionsHCPs are generally supportive of OS-AID users but many feel uncomfortable with the technicalities of the systems given the lack of approval. Knowledge around the use of these systems was limited. Re-assessment of HCP perceptions should be performed in the future given the evolving landscape of diabetes technology, recent consensus statements and emerging ethical and legal perspectives.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01203-5.

Етіологія, патогенез та інтенсивна терапія метаболічного ацидозу

У статті надані дані щодо етіології, патогенезу, клінічних проявів, принципів діагностики та лікування метаболічних ацидозів: діабетичного і недіабетичного кетоацидозу, лактатацидозу в дорослих і дітей. Викладено сучасні напрямки інфузійної терапії кетоацидозу і лактатацидозу із застосуванням новітніх вітчизняних інфузійних засобів. У своїй статті автори зіставили алгоритми лікування кетоацидозу і лактатацидозу з рекомендаціями Британського товариства клінічної діабетології і Американської асоціації нефрологів, роблячи поправку на можливості вітчизняних лабораторних досліджень. Характерною особливістю деяких форм кислотно-основного дисбалансу, що часто зустрічаються, є тісне переплетення ушкоджуючих або пристосувальних елементів, чіткої межі між якими не існує. Багатофакторність і патогенетична неоднозначність порушень кислотно-основного гомео­стазу зумовлюють значні розбіжності в оцінці прогностичної значимості і стратегії лікування його складних форм. У клінічній практиці це часто призводить до невиправданої схематизації, «знеособлення» терапії, або, що ще гірше, до прагнення враховувати параметри кислотно-основного стану тільки при зміщенні рН в області загрожуючих життю значень.

Clinical practice guidelines for management of hyperglycaemia in adults with diabetic kidney disease.

A significant percentage of people with diabetes develop chronic kidney disease and diabetes is also a leading cause of end-stage kidney disease (ESKD). The term diabetic kidney disease (DKD) includes both diabetic nephropathy (DN) and diabetes mellitus and chronic kidney disease (DM CKD). DKD is associated with high morbidity and mortality, which are predominantly related to cardiovascular disease. Hyperglycaemia is a modifiable risk factor for cardiovascular complications and progression of DKD. Recent clinical trials of people with DKD have demonstrated improvement in clinical outcomes with sodium glucose co-transporter-2 (SGLT-2) inhibitors. SGLT-2 inhibitors have significantly reduced progression of DKD and onset of ESKD and these reno-protective effects are independent of glucose lowering. At the time of this update Canagliflozin and Dapagliflozin have been approved for delaying the progression of DKD. The Association of British Clinical Diabetologists (ABCD) and UK Kidney Association (UKKA) Diabetic Kidney Disease Clinical Speciality Group have undertaken a literature review and critical appraisal of the available evidence to inform clinical practice guidelines for management of hyperglycaemia in adults with DKD. This 2021guidance is for the variety of clinicians who treat people with DKD, including GPs and specialists in diabetes, cardiology and nephrology.

Safety and effectiveness of do-it-yourself artificial pancreas system compared with continuous subcutaneous insulin infusions in combination with free style libre in people with type 1 diabetes.

The use of do-it-yourself artificial pancreas systems (DIYAPS) among people with type 1 diabetes is increasing. At present, it is unclear how DIYAPS compares with other technologies such as FreeStyle Libre (FSL) and continuous subcutaneous insulin infusion (CSII). The aim of this analysis is to compare safety, effectiveness and quality-of-life outcomes of DIYAPS use with the addition of FSL to CSII. Data from two large UK hospitals were extracted from the Association of British Clinical Diabetologists (ABCD) DIYAPS and FSL audits. Outcomes included HbA1c , glucose TBR (time-below-range), TIR (time-in-range), Diabetes Distress Score (DDS), and Gold hypoglycaemia score. Any adverse events were noted. Changes at follow-up were assessed using paired t-tests and ANOVA in Stata; TIR/TBR at follow-up assessed using unpaired t-tests; chi-square tests assessed the change in frequency of health utilisation (e.g. hospital admissions). DIYAPS (n=35) and FSL+CSII (n=149) users, with median follow-up duration of 1.4 (IQR 0.8-2.1) and 1.3 (IQR 0.7-1.8) years, respectively, were included. HbA1c with DIYAPS use changed by -10mmol/mol [0.9%] (p<0.001, 95% CI 5, 14 [0.5, 1.3%]) significantly lower (p<0.001) than in the FSL+CSII group -3mmol/mol [0.25%] (p<0.001, 95% CI 1, 4 [0.1, 0.4%]). TIR was higher and TBR was lower in the DIYAPS group. Adverse events were rare in both groups and no significant differences were observed in the frequency of healthcare utilisation. DIYAPS use was associated with a lower HbA1c levels, higher TIR and lower TBR compared with FSL+CSII. There was no significant increase in adverse events, although this should be interpreted cautiously given the low numbers of users. Full results from the ABCD DIYAPS audit are awaited.

Clinical practice guidelines for management of hyperglycaemia in adults with diabetic kidney disease

A significant percentage of people with diabetes develop chronic kidney disease and diabetes is also a leading cause of end-stage kidney disease (ESKD). The term diabetic kidney disease (DKD) includes both diabetic nephropathy (DN) and diabetes mellitus and chronic kidney disease (DM CKD). DKD is associated with high morbidity and mortality, which are predominantly related to cardiovascular disease. Hyperglycaemia is a modifiable risk factor for cardiovascular complications and progression of DKD. Recent clinical trials of people with DKD have demonstrated improvement in clinical outcomes with sodium glucose co-transporter-2 (SGLT-2) inhibitors. SGLT-2 inhibitors have significantly reduced progression of DKD and onset of ESKD and these reno-protective effects are independent of glucose lowering. At the time of this update Canagliflozin and Dapagliflozin have been approved for delaying the progression of DKD. The Association of British Clinical Diabetologists (ABCD) and UK Kidney Association (UKKA) Diabetic Kidney Disease Clinical Speciality Group have undertaken a literature review and critical appraisal of the available evidence to inform clinical practice guidelines for management of hyperglycaemia in adults with DKD. This 2021 guidance is for the variety of clinicians who treat people with DKD, including GPs and specialists in diabetes, cardiology and nephrology.

Management of hypertension and renin-angiotensin-aldosterone system blockade in adults with diabetic kidney disease: Association of British Clinical Diabetologists and the Renal Association UK guideline update 2021

People with type 1 and type 2 diabetes are at risk of developing progressive chronic kidney disease (CKD) and end-stage kidney failure. Hypertension is a major, reversible risk factor in people with diabetes for development of albuminuria, impaired kidney function, end-stage kidney disease and cardiovascular disease. Blood pressure control has been shown to be beneficial in people with diabetes in slowing progression of kidney disease and reducing cardiovascular events. However, randomised controlled trial evidence differs in type 1 and type 2 diabetes and different stages of CKD in terms of target blood pressure. Activation of the renin-angiotensin-aldosterone system (RAAS) is an important mechanism for the development and progression of CKD and cardiovascular disease. Randomised trials demonstrate that RAAS blockade is effective in preventing/ slowing progression of CKD and reducing cardiovascular events in people with type 1 and type 2 diabetes, albeit differently according to the stage of CKD. Emerging therapy with sodium glucose cotransporter-2 (SGLT-2) inhibitors, non-steroidal selective mineralocorticoid antagonists and endothelin-A receptor antagonists have been shown in randomised trials to lower blood pressure and further reduce the risk of progression of CKD and cardiovascular disease in people with type 2 diabetes. This guideline reviews the current evidence and makes recommendations about blood pressure control and the use of RAAS-blocking agents in different stages of CKD in people with both type 1 and type 2 diabetes.

Integrated diabetes care: The Association of British Clinical Diabetologists (ABCD) national survey report

Executive Summary A national survey on integrated diabetes services was carried out by the Association of British Clinical Diabetologists (ABCD) during the COVID-19 pandemic and has provided some very useful insights into the current state of integration to deliver a joined-up diabetes service in the UK. This survey was carried out during the second half of 2020 and explored three main areas: (1) current state of clinical integration between primary and secondary (specialist) diabetes services; (2) the state of IT integration among the diabetes IT systems and hospital-based electronic patient records (EPR) and between hospital and primary care; (3) to ascertain the membership of their views on a ‘one-stop service’ for collecting annual review data for diabetes and the potential barriers to achieve this. The results presented are a summary of the survey, while the full unedited survey report, especially on the qualitative aspects, is available to ABCD members. The survey was mailed to 518 individuals, of which 431 (83.2%) were consultants and 53 (10.2%) were specialist registrars. Of the 83 replies received, 98% were from consultants and the responses represented a total of 73 hospital diabetes services. The findings of this survey revealed that full integration of clinical services among primary care and specialist diabetes teams is uncommon, although there are good examples of clinical integration in different formats. In a number of areas, primary care and specialist diabetes services continue to work in silos despite a universal recognition that integrated services are desirable and are likely to improve quality of care. Clinical leadership, resources and buy-in from those who commission services were deemed important factors to help improve the development of integrated care systems. In hospitals with dedicated diabetes IT systems the information flow from these diabetes systems to the EPR was not universal, raising concerns that vital information about an individual’s diabetes may not be available to other hospital clinical specialities at the time of delivery of care, posing a significant clinical risk. IT integration among primary and specialist diabetes teams in England was only available in certain areas and was mostly based around the use of SystmOne. The survey also identified a diversity of opinions regarding the current arrangements of the Quality Outcome Framework (QOF), where GPs are incentivised to collect data for annual review of routine diabetes care. Many were of the opinion that annual review processes should be performed by clinical teams who are tasked to deliver diabetes care to the individual, while others felt that the status quo should continue with primary care GPs being responsible. A one-stop service for eye screening for diabetes and other annual measurements nearer to people’s homes was identified as an improvement, but several logistic barriers were identified. We recognise the limitations of any survey which expresses opinions of participants. However, we believe the present survey represents a significant proportion of diabetes units in the UK and provides insights into the current state of integrated services in diabetes. There are significant learnings for diabetes communities, and the information can be used to improve and galvanise delivery of integrated diabetes care in the UK.

COVID-19 outcomes in people with diabetes in Wales: a secondary analysis of the ABCD audit

Background: People with diabetes and coronavirus disease 2019 (COVID-19) have a significantly greater risk of death and/or intensive care unit (ICU) admission. The Association of British Clinical Diabetologists (ABCD) recently audited outcomes for people hospitalised in the UK with diabetes and COVID-19. Methods: The ABCD COVID-19 and diabetes audit was a retrospective audit of patients admitted to UK hospitals with diabetes and COVID-19 between March and December 2020. Data related to patients admitted in Wales were compared with patients admitted in England and Scotland. Results: In Wales, 40/82 (48.7%) patients with diabetes had COVID-19-related mortality compared with 1,149/2,916 (39.1%) in the UK group (p=0.08). The Welsh cohort were more likely to be Caucasian, have a higher body mass index and HbA1c, be diagnosed with diabetic retinopathy and prescribed a sodium-glucose co-transporter 2 inhibitor or insulin than those in England and Scotland. Patients admitted to the ICU in Wales were more likely to be male and have type 2 diabetes. Conclusions: Patients admitted to hospital with diabetes and COVID-19 in Wales had a poorer outcome compared with England and Scotland. This disparity may reflect social inequality, differences in cardiovascular risk factors and/or differences in diabetes medications between hospitalised patients in Wales and the UK.