United Kingdom Prospective Diabetes Study Research Articles

Strict glycemic control: a literature review

Diabetes mellitus is a disease that is difficult to control worldwide. Since the better understanding of the pathophysiology of the disease by modern medicine, several ways to control the evolution of the pathology in question have been proposed. As an example, we can mention a study published in 1993 by the Diabetes Control and Complications Trial (DCCT) and, later, in 1998, validated by the United Kingdom Prospective Diabetes Study (UKPDS), which established glycated hemoglobin as one of the main markers evolution and prognosis of the disease. Since the publication of these studies, goals such as: strict glycemic control (corresponding to glycated hemoglobin goals less than or equal to 6.5 mg/dL), have been accepted by the world medical community as references in the control and follow-up of the disease. In this context, the present article has as its guiding question: should strict glycemic control be desired for all patients? Aiming to find out, through literature review, whether glycemic control should be required for all patients. Therefore, a literature review was carried out on published articles on the subject in question, aiming to focus on quaternary prevention and the importance of good clinical practice collaborated by evidence-based medicine. The results indicate that, in the case of strict glycemic control, there is no evidence of benefits in general in its use, being reported in the literature that, in certain populations, especially those over 80 years of age, its use is linked to increased effects. adverse effects and morbidity caused by the disease.

Effect of bariatric surgery versus medical therapy on long-term cardiovascular risk in low BMI Chinese patients with type 2 diabetes: a propensity score-matched analysis.

Reducing the risk of death due to cardiovascular disease (CVD) is an important direction for diabetes prevention and treatment. The Chinese population with type 2 diabetes (T2D) has a high risk of developing CVD at relatively low body mass index (BMI) levels. Currently, no studies have evaluated the effect of bariatric surgery versus medical therapy on long-term CVD risk in patients with T2D and low BMI. To compare bariatric surgery versus medical therapy for long-term CVD risk in Chinese patients with T2D and low BMI by using the China Prediction for ASCVD Risk equations and the United Kingdom Prospective Diabetes Study risk engine. University hospital, China. Medical records of patients with T2D with a BMI <35 kg/m2 undergoing bariatric surgery or medical therapy from May 2010 to December 2018 were reviewed. A 1:1 propensity score matching was performed by using 7 preoperative characteristics. Variables for calculating CVD risk scores over the 5-year follow-up were assessed. A total of 684 patients with T2D underwent bariatric surgery (n = 75) or medical therapy (n = 609), and 52 pairs of matched subjects were selected from both groups after propensity score matching. The 10-year and lifetime atherosclerotic CVD risk by using the China Prediction for ASCVD Risk equation at 5 years follow-up period in the bariatric surgery group improved significantly compared with the medical therapy group. In the fifth year of follow-up, the 10-year risk of coronary heart disease, fatal coronary heart disease, stroke, and fatal stroke by using the United Kingdom Prospective Diabetes Study risk engine were much lower in the bariatric surgery group than in the medical therapy group (10.37 ± 5.64% versus 27.25 ± 7.28%, P = .004; 6.3 ± 4.5% versus 22.3 ± 7.35%, P = .002; 4.97 ± 3.73% versus 15.05 ± 3.63%, P = .001; .59 ± .45% versus 1.52 ± .14%, P < .001. respectively). The use of glucose-lowering medications, including insulin, was reduced from baseline in both groups, and patients in the bariatric surgery group required significantly fewer of these medications than those in the medical therapy group. Bariatric surgery in patients with T2D and low BMI conferred a lower calculated risk of CVD compared with medical therapy over 5 years of follow-up.

IDF21-0201 Cost-utility of an online education platform and diabetes personal health record: Analysis over ten years

Background: My Diabetes My Way (MDMW) is Scotland’s interactive website and mobile app for people with diabetes and carers. The aim of MDMW is to support people with their self-management, by providing an accessible resource that encourages active participation in routine care. The website contains multimedia resources for diabetes education and offers people with diabetes access to their electronic personal health record (ePHR), facilitating personalised advice. The MDMW ePHR contains test results from general practice, secondary care systems, labs and specialist screening systems, based on a clearly defined, patient-focused dataset. Aim: The purpose of this study is to assess the cost-utility of a data-driven education platform and ePHR for diabetes, compared to routine diabetes care. It focuses on a clearly defined cohort of people with type 2 diabetes who are not prescribed insulin. Method: Analysis used the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model2. Clinical parameters of MDMW users (n = 2576) were compared with a matched cohort of individuals receiving routine care alone (n = 11,628). Matching criteria: age, diabetes duration, sex and socio-economic status. Impact on life expectancy, quality-adjusted life years (QALYs) and costs of treatment and complications were simulated over ten years, including a 10% sensitivity analysis. Results: MDMW cohort: 1,670 (64.8%) men; average age 64.3 years; duration of diabetes 5.5 years. 906 (35.2%) women: average age 61.6; duration 4.7 years. The cumulative mean QALY (95% CI) gain: 0.054 (0.044; 0.062) years. Mean difference in cost: −£118.72 (v£150.16; −£54.16) over ten years. Increasing MDMW costs (10%): −£50.49 (−£82.24; £14.14). Decreasing MDMW costs (10%): −£186.95 (−£218.53; −£122.51). Discussion: The result of this analysis indicates that use of MDMW is expected to be ‘dominant’ over usual care, (both cost-saving and life improving) in supporting self-management in people with type 2 diabetes not treated with insulin. Operating costs at the time of analysis were approximately £3.42 per registered diabetes patient per annum. This equates to a potential return on investment of well over 3:1 during a ten-year period based on the results shown from the UKPDS outcomes model. Wider use of the MDMW service could result in significant cost savings through delay or reduction of long-term complications and increased life expectancy in health care systems where it is used and adopted. This study demonstrates for the first time the potential of a low-cost, scalable digital intervention to deliver population-based benefits and cost savings.

COVID-19 Pandemic and Diabetes Care.

COVID-19 Pandemic and Diabetes Care.

Associations between diabetes-related distress and predicted cardiovascular complication risks in patients with type 2 diabetes.

Diabetes-related distress (DRD) is experienced by nearly 50% of people with diabetes at any given time in their diagnosis. The effects of low socioeconomic status (SES) and lacking access to resources can increase DRD. In addition, cardiovascular (CV) complications associated with diabetes are associated with higher DRD scores. This study evaluated the associations between DRD and predicted CV risks in participants with type 2 diabetes. This cross-sectional study included 234 individuals with low SES who were Medi-Cal (California version of Medicaid) beneficiaries and sought medical care at a safety-net clinic system. The Problem Areas in Diabetes (PAID) questionnaire assessed DRD levels. The United Kingdom Prospective Diabetes Study Risk Engine was utilized to predict 10-year risks for coronary heart disease (CHD), fatal CHD, stroke, and fatal stroke. A multivariate linear regression model was constructed between the two variables, including other variables to control for potential confounding factors, for assessing the associations. After controlling for potential confounders, participants' total PAID questionnaire scores were significantly associated with their 10-year predicted fatal CHD risks (B=0.060, 95% CI: [0.00084, 0.12], p=0.047). After controlling for covariates, DRD levels exhibited a significant association with increased 10-year predicted fatal CHD risks in patients with type 2 diabetes and lower SES. Screening for DRD and provision of appropriate psychosocial interventions may reduce the risks of CHD in those with type 2 diabetes.

Change of cardiovascular risk associated serologic biomarkers after gastric bypass: A comparison of diabetic and non-diabetic Asian patients

BackgroundWhile clinical findings demonstrate a superior benefit of cardiovascular (CV) risk reduction in obese patients with type 2 diabetes mellitus (T2D) receiving bariatric surgery over non-T2D patients, the mechanism is unclear. This study aimed to investigate the changes in the CV risk score and five CV-associated biomarkers after gastric bypass surgery. MethodWe enrolled 80 obese subjects who underwent gastric bypass (40 T2D and 40 non-T2D). CV risks were assessed using the United Kingdom Prospective Diabetes Study (UKPDS) engine before and after surgery. Levels of five biomarkers —fasting serum fibroblast growth factor (FGF)-19, FGF-21, corin, oxidized low-density lipoprotein (ox-LDL), and soluble receptor for advanced glycation end-products (sRAGE)—were measured before surgery and one year after surgery. ResultsThe T2D group was significantly older and had a higher CV risk score than the non-T2D group, but body mass index (BMI) was similar between the groups. Preoperative biomarker levels were similar in both the T2D and the non-T2D groups. One year after surgery, the percentage of total weight loss (%TWL) was similar between the two groups (32.2 ± 19.5% versus 34.1% ± 8.8%, p = 0.611). Complete T2D remission (hemoglobin A1c (HbA1c) < 6.0%) was achieved in 29 patients (72.5%). The 10-year CV risk scores by the UKPDS risk engine reduced significantly in both the T2D and the non-T2D groups, but more in the T2D group. Three of five biomarkers changed significantly after surgery: the FGF-19 increased from 195.6 ± 249.1 pg/mL to 283.2 ± 211.8 pg/mL, corin increased from 3.3 ± 2.3 ng/mL to 4.6 ± 3.7 ng/mL, and ox-LDL decreased from 148.5 ± 71.7–107.9 U/L; the P values were 0.002, 0.002 and < 0.001, respectively. The T2D group showed a significantly different change in FGF-19 increase and FGF-21 decrease compared to the non-T2D group. The changes in corin and ox-LDL levels were not different between the T2D and non-T2D groups. ConclusionGastric bypass surgery resulted in a higher UKPDS CV risk score reduction in obese T2D Asians than in those without. FGF-19 and FGF-21 may be associated with the underlying mechanism of this difference.

Cost-Utility of an Online Education Platform and Diabetes Personal Health Record: Analysis Over Ten Years.

My Diabetes My Way (MDMW) is Scotland's interactive website and mobile app for people with diabetes and their caregivers. It contains multimedia resources for diabetes education and offers access to electronic personal health records. This study aims to assess the cost-utility of MDMW compared with routine diabetes care in people with type 2 diabetes who do not use insulin. Analysis used the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model 2. Clinical parameters of MDMW users (n = 2576) were compared with a matched cohort of individuals receiving routine care alone (n = 11 628). Matching criteria: age, diabetes duration, sex, and socioeconomic status. Impact on life expectancy, quality-adjusted life years (QALYs), and costs of treatment and complications were simulated over ten years, including a 10% sensitivity analysis. MDMW cohort: 1670 (64.8%) men; average age 64.3 years; duration of diabetes 5.5 years. 906 (35.2%) women: average age 61.6 years; duration 4.7 years. The cumulative mean QALY (95% CI) gain: 0.054 (0.044-0.062) years. Mean difference in cost: -£118.72 (-£150.16 to -£54.16) over ten years. Increasing MDMW costs (10%): -£50.49 (-£82.24-£14.14). Decreasing MDMW costs (10%): -£186.95 (-£218.53 to -£122.51). MDMW is "dominant" over usual care (cost-saving and life improving) in supporting self-management in people with type 2 diabetes not treated with insulin. Wider use may result in significant cost savings through delay or reduction of long-term complications and improved QALYs in Scotland and other countries. MDMW may be among the most cost-effective interventions currently available to support diabetes.

Insulin Centennial: Milestones influencing the development of insulin preparations since 1922.

During 1921 to 1922, a team effort by Banting, Macleod, Collip and Best isolated and purified insulin and demonstrated its life-giving properties, giving rise to the birth of insulin therapy. In the early years (1922-1950), priorities revolved around the manufacture of insulin to meet demand, improving purity to avoid allergic reactions, establishing insulin standards and increasing its duration of action to avoid multiple daily injections. Shortly after the emergence of insulin, Joslin and Allen advocated the need to achieve and maintain good glycaemic control to realize its full potential. Although this view was opposed by some during a dark period in the history of insulin, it was subsequently endorsed some 60 years later endorsed by the Diabetes Control and Complications Trial and United Kingdom Prospective Diabetes Study. Major scientific advances by the Nobel Laureates Sanger, Hodgkin, Yalow and Gilbert and also by Steiner have revolutionized the understanding of diabetes and facilitated major advances in insulin therapy. The more recent advent of recombinant technology over the last 40 years has provided the potential for unlimited source of insulin, and the ability to generate various insulin 'analogues', in an attempt to better replicate normal insulin secretory patterns. The emerging biosimilars now provide the opportunity to improve availability at a lower cost.

Validating the UK prospective diabetes study outcome model 2 using data of 94,946 Israeli patients with type 2 diabetes

AimsTo externally validate the United Kingdom Prospective Diabetes Study (UKPDS) Outcome Model 2 (OM2) in contemporary Israeli patient populations. MethodsDe-identified patient data on demographics, time-varying risk factors, and clinical events of newly diagnosed type 2 diabetes patients were extracted from the Maccabi Healthcare Services (MHS) diabetes registry over years 2000–2013. Depending on the baseline risk, patients were categorized into low-risk and intermediate-risk groups. In addition to assessing discriminatory performance, the predicted and observed 15-year cumulative incidences of diabetes complications and death were compared among all patients and for the two risk-groups. ResultsThe discriminatory capability of OM2 was moderate to good, C-statistic ranging 0.71–0.95. The model overpredicted the risk for MI, blindness and death (Predicted/Observed events (P/O: 1.32–2.31)), and underpredicted the risk of IHD (P/O: 0.5). In patients with a low baseline risk, overpredictions were even more pronounced. OM2 performed well in predicting renal failure and ulcer risk in patients with a low risk but predicted well the risk of death, stroke, CHF, and amputation in patients with an intermediate risk. ConclusionOM2 demonstrated good to moderate discrimination capability for predicting diabetes complications and mortality risks in Israeli diabetes population. The prediction performance differed between patients with different baseline risks.

Risk of coronary heart disease and stroke based on United Kingdom prospective diabetes study in type 2 DM patients in Medan

Cardiovascular disease is one of the most prevalent diabetic consequences that can lead to death. The purpose of this study was to use The United Kingdom Prospective Diabetes Study (UKPDS) Risk Engine to determine the risk of CVD complications in type 2 DM patients. The study’s design is analytic using a cross-sectional approach, and the samples include 108 type 2 diabetes patients in Medan who fulfill the inclusion and exclusion criteria. The results showed that most patients had a high risk for CHD and a low risk for stroke. Education must be carried out intensively to patients that blood sugar is more controlled to reduce the risk of complications.

Estimating risk factor progression equations for the UKPDS Outcomes Model 2 (UKPDS 90).

To estimate 13equations that predict clinically plausible risk factor time paths to inform the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model version 2 (UKPDS-OM2). Data from 5102 UKPDS participants from the 20-year trial, and the 4031survivors with 10years further post-trial follow-up, were used to derive equations for the time paths of 13clinical risk factors: HbA1c , systolic blood pressure, LDL-cholesterol, HDL-cholesterol, BMI, micro- or macro-albuminuria, creatinine, heart rate, white blood cell count, haemoglobin, estimated glomerular filter rate, atrial fibrillation and peripheral vascular disease (PVD). The incidence of events and death predicted by the UKPDS-OM2 when informed by the new risk factor equations was compared with the observed cumulative rates up to 25years. The new equations were based on 24years of follow-up and up to 65,252 person-years of data. Women were associated with higher values of all continuous risk factors except for haemoglobin. Older age and higher BMI at diagnosis were associated with higher rates of PVD (HR 1.06 and 1.02), atrial fibrillation (HR 1.10 and 1.08) and micro- or macro-albuminuria (HR 1.01 and 1.18). Smoking was associated with higher rates of developing PVD (HR 2.38) and micro- and macro-albuminuria (HR 1.39). The UKPDS-OM2, informed by the new risk factor equations, predicted event rates for complications and death consistent with those observed. The new equations allow risk factor time paths beyond observed data, which should improve modelling of long-term health outcomes for people with type 2 diabetes when using the UKPDS-OM2 or other models.

Cost-effectiveness of empagliflozin in patients with type 2 diabetes and established cardiovascular disease in China

BackgroundIn several cardiovascular outcome trials (CVOTs), empagliflozin (SGLT-2 inhibitor), sitagliptin (DPP-4 inhibitor) and liraglutide (GLP-1 receptor agonist) + standard of care (SoC) were compared to SoC in patients with type 2 diabetes and established cardiovascular disease (CVD). This study assessed the cost-effectiveness (CE) of empagliflozin + SoC in comparison to sitagliptin + SoC and liraglutide + SoC based on the respective CVOT.MethodsThe IQVIA Core Diabetes Model (CDM) was calibrated to reproduce the CVOT outcomes. EMPA-REG OUTCOME baseline characteristics and CVOT specific treatment effects on risk factors for cardiovascular disease (HbA1c, BMI, blood pressure, lipids) were applied. Three-year observed cardiovascular events of empagliflozin + SoC versus sitagliptin + SoC and liraglutide + SoC were derived from EMPA-REG OUTCOME and an indirect treatment comparison. Relative risk adjustments to calibrate the CDM were obtained after a trial and error process to match as closely the observed and CDM-predicted outcomes. The drug-specific treatment effects were considered up until HbA1c reached 8.5% and treatment switch occurred. After this switch, the United Kingdom Prospective Diabetes Study 82 risk equations predicted events based on co-existing risk factors and treatment intensification to basal bolus insulin were applied. The analysis was conducted from the perspective of the Chinese healthcare system applying 3% discounting. The time horizon was lifelong.ResultsEmpagliflozin + SoC provides additional Quality Adjusted Life years (QALY + 0.564) for an incremental cost of 42,497RMB (US$6053) compared to sitagliptin + SoC, resulting in an Incremental Cost Utility Ratio of 75,349RMB (US$10,732), thus below the willingness-to-pay threshold of 212,676RMB, corresponding to three times the Gross Domestic Product in China (2019). Compared to liraglutide + SoC, empagliflozin + SoC use leads to 0.211QALY gained and cost savings of 71,427RMB (US$10,173) and is as such dominant. Scenario and probabilistic sensitivity analyses demonstrated the robustness of the results.ConclusionResults suggest that empagliflozin + SoC is cost-effective compared to sitagliptin + SoC and liraglutide + SoC at a willingness-to-pay threshold of 212,676RMB ($30,292)/QALY.

Development and validation of the CHIME simulation model to assess lifetime health outcomes of prediabetes and type 2 diabetes in Chinese populations: A modeling study.

Existing predictive outcomes models for type 2 diabetes developed and validated in historical European populations may not be applicable for East Asian populations due to differences in the epidemiology and complications. Despite the continuum of risk across the spectrum of risk factor values, existing models are typically limited to diabetes alone and ignore the progression from prediabetes to diabetes. The objective of this study is to develop and externally validate a patient-level simulation model for prediabetes and type 2 diabetes in the East Asian population for predicting lifetime health outcomes. We developed a health outcomes model from a population-based cohort of individuals with prediabetes or type 2 diabetes: Hong Kong Clinical Management System (CMS, 97,628 participants) from 2006 to 2017. The Chinese Hong Kong Integrated Modeling and Evaluation (CHIME) simulation model comprises of 13 risk equations to predict mortality, micro- and macrovascular complications, and development of diabetes. Risk equations were derived using parametric proportional hazard models. External validation of the CHIME model was assessed in the China Health and Retirement Longitudinal Study (CHARLS, 4,567 participants) from 2011 to 2018 for mortality, ischemic heart disease, cerebrovascular disease, renal failure, cataract, and development of diabetes; and against 80 observed endpoints from 9 published trials using 100,000 simulated individuals per trial. The CHIME model was compared to United Kingdom Prospective Diabetes Study Outcomes Model 2 (UKPDS-OM2) and Risk Equations for Complications Of type 2 Diabetes (RECODe) by assessing model discrimination (C-statistics), calibration slope/intercept, root mean square percentage error (RMSPE), and R2. CHIME risk equations had C-statistics for discrimination from 0.636 to 0.813 internally and 0.702 to 0.770 externally for diabetes participants. Calibration slopes between deciles of expected and observed risk in CMS ranged from 0.680 to 1.333 for mortality, myocardial infarction, ischemic heart disease, retinopathy, neuropathy, ulcer of the skin, cataract, renal failure, and heart failure; 0.591 for peripheral vascular disease; 1.599 for cerebrovascular disease; and 2.247 for amputation; and in CHARLS outcomes from 0.709 to 1.035. CHIME had better discrimination and calibration than UKPDS-OM2 in CMS (C-statistics 0.548 to 0.772, slopes 0.130 to 3.846) and CHARLS (C-statistics 0.514 to 0.750, slopes -0.589 to 11.411); and small improvements in discrimination and better calibration than RECODe in CMS (C-statistics 0.615 to 0.793, slopes 0.138 to 1.514). Predictive error was smaller for CHIME in CMS (RSMPE 3.53% versus 10.82% for UKPDS-OM2 and 11.16% for RECODe) and CHARLS (RSMPE 4.49% versus 14.80% for UKPDS-OM2). Calibration performance of CHIME was generally better for trials with Asian participants (RMSPE 0.48% to 3.66%) than for non-Asian trials (RMPSE 0.81% to 8.50%). Main limitations include the limited number of outcomes recorded in the CHARLS cohort, and the generalizability of simulated cohorts derived from trial participants. Our study shows that the CHIME model is a new validated tool for predicting progression of diabetes and its outcomes, particularly among Chinese and East Asian populations that has been lacking thus far. The CHIME model can be used by health service planners and policy makers to develop population-level strategies, for example, setting HbA1c and lipid targets, to optimize health outcomes.

Exploring the Appropriate Price of Semaglutide for Type 2 Diabetes Patients Based on Cost-Utility Analysis in China.

Introduction: Semaglutide is the first and only oral version of a glucagon-like peptide-1 analogue approved by the FDA for the treatment of type 2 diabetes (T2D). This research was designed to explore the appropriate price of once-weekly (OW) semaglutide for T2D patients in China based on cost-utility analysis. Methods: The baseline patient cohorts of OW semaglutide and once-daily (OD) empagliflozin were sourced from a patient-level meta-analysis integrating the SUSTAIN 2, SUSTAIN 3, SUSTAIN 8 and PIONEER 2 trials. The long-term health and economic outcomes were simulated using the United Kingdom Prospective Diabetes Study Outcome Model 2 from the Chinese healthcare provider’s perspective. The appropriate price of semaglutide was explored by binary search. One-way sensitivity analysis (one-way SA), probabilistic sensitivity analysis and scenario analysis were applied to solve the uncertainty. Results: Under the assumption that the annual cost of semaglutide is equal to that of OD empagliflozin, OW semaglutide was superior to OD empagliflozin due to its higher quality adjusted life years and lower total costs. After binary search, the incremental cost-utility ratio of OW semaglutide vs. OD empagliflozin was approximately equal to 3λ with an annual cost of semaglutide of $1,007.18 and approximately equal to λ with an annual cost of semaglutide of $708.11. Subsequently, the incremental cost-utility ratio of OW semaglutide vs. OD empagliflozin was approximately 3λ and λ, with annual costs of semaglutide of $877.43 and $667.04, respectively, adjusted by one-way SA. Ultimately, the cost-utility results with annual costs of semaglutide of $877.43 and $667.04 were robust to probabilistic sensitivity analysis and scenario analysis. Conclusion: In conclusion, the annual cost of semaglutide appears to be appropriate between $667.04 and $877.43 for T2D patients in China.

How We Got Where We Are in Blood Pressure Targets.

While we started clinical trials evaluating the benefit of lowering systolic BP's >160 mm Hg and diastolic BPs of <130 mm Hg, the latest guideline suggests a target of <130/80 mm Hg in those with hypertension. This article summarizes exactly how we got to where we are looking over the last half-century. Our understanding of systolic and diastolic blood pressure targets to improve cardiovascular outcomes has changed substantially over the past 5 decades. Regarding diastolic blood pressure targets to improve cardiovascular outcomes, initially the VA1 in 1967 had set the goal to <115 mmHg. Over time, several studies including the VA2, Hypertension Optimal Treatment (HOT), and United Kingdom Prospective Diabetes Study Group 38 (UKPDS38) highlighted even greater cardiovascular benefit with lower diastolic targets <80 mmHg, especially in diabetic patients. Of equal importance, multiple studies have focused the attention to systolic blood pressure targets. Starting in 1948 with the Framingham study, passing through the Systolic Hypertension in the Elderly Program (SHEP), Syst-Eur and Syst-China trials, all have set the systolic blood pressure goal <150 mmHg. Most recently, the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showed an improved cardiovascular outcome with a systolic blood pressure target <140 mmHg in patients with type 2 diabetes, while the Systolic Blood Pressure Intervention Trial (SPRINT) in non-diabetic patients moved it closer to 120 mmHg. There is "no one size fits all" when it comes to blood pressure targets to improve cardiovascular outcomes. To progress our understanding of individual blood pressure goals, future studies might develop a more standardized approach to highlight characteristics such as design and end point definitions while allowing clinical practitioners greater latitude to adapt guideline recommendations to individual patient characteristics and clinical needs.

Alphabet strategy for diabetes care: A checklist approach in the time of COVID-19 and beyond.

Chronic disease management requires achievement of critical individualised targets to mitigate again long-term morbidity and premature mortality associated with diabetes mellitus. The responsibility for this lies with both the patient and health care professionals. Care plans have been introduced in many healthcare settings to provide a patient-centred approach that is both evidence-based to deliver positive clinical outcomes and allow individualised care. The Alphabet strategy (AS) for diabetes is based around such a care plan and has been evidenced to deliver high clinical standards in both well-resourced and under-resourced settings. Additional patient educational resources include special care plans for those people with diabetes undertaking fasting during Ramadan, Preconception Care, Prevention and Remission of Diabetes. The Strategy and Care Plan has facilitated evidence-based, cost-efficient multifactorial intervention with an improvement in the National Diabetes Audit targets for blood pressure, cholesterol levels and glycated haemoglobin. Many of these attainments were of the standard seen in intensively treated cohorts of key randomized controlled trials in diabetes care such as the Steno-2 and United Kingdom Prospective Diabetes Study. This is despite working in a relatively under-resourced service within the United Kingdom National Health Service. The AS for diabetes care is a useful tool to consider for planning care, education of people with diabetes and healthcare professional. During the time of the coronavirus disease 2019 pandemic the risk factors for the increased mortality observed have to be addressed aggressively. The AS has the potential to help with this aspiration.

Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS).

BackgroundDespite effective treatments, more than 30% of patients with diabetes will present with diabetic kidney disease (DKD) at some point. Patients with DKD are among the most complex as their care is multifactorial and involves different groups of health care providers. Suboptimal adherence to polypharmacy is frequent and contributes to poor outcomes. As self-management is one of the keys to clinical success, structured medication adherence programs are crucial. The PANDIA-IRIS (patients diabétiques et insuffisants rénaux: un programme interdisciplinaire de soutien à l’adhésion thérapeutique) study is based on a routine medication adherence program led by pharmacists.ObjectiveThe aim of this study is to define the impact of the duration of this medication adherence program on long-term adherence and clinical outcomes in patients with DKD.MethodsThis monocentric adherence program consists of short, repeated motivational interviews focused on patients’ medication behaviors combined with the use of electronic monitors containing patients’ medications. When patients open the electronic monitor cap to take their medication, the date and hour at each opening are registered. In total, 73 patients are randomized as 1:1 in 2 parallel groups; the adherence program will last 6 months in the first group versus 12 months in the second group. After the intervention phases, patients continue using their electronic monitors for a total of 24 months but without receiving feedback. Electronic monitors and pill counts are used to assess medication adherence. Persistence and implementation will be described using Kaplan-Meier curves and generalized estimating equation multimodeling, respectively. Longitudinal adherence will be presented as the product of persistence and implementation and modelized by generalized estimating equation multimodeling. The evolution of the ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified-Release Controlled Evaluation) and UKPDS (United Kingdom Prospective Diabetes Study) clinical scores based on medication adherence will be analyzed with generalized estimating equation multimodeling. Patients’ satisfaction with this study will be assessed through qualitative interviews, which will be transcribed verbatim, coded, and analyzed for the main themes.ResultsThis study was approved by the local ethics committee (Vaud, Switzerland) in November 2015. Since then, 2 amendments to the protocol have been approved in June 2017 and October 2019. Patients’ recruitment began in April 2016 and ended in October 2020. This study was introduced to all consecutive eligible patients (n=275). Among them, 73 accepted to participate (26.5%) and 202 (73.5%) refused. Data collection is ongoing and data analysis is planned for 2022.ConclusionsThe PANDIA-IRIS study will provide crucial information about the impact of the medication adherence program on the adherence and clinical outcomes of patients with DKD. Monitoring medication adherence during the postintervention phase is innovative and will shed light on the duration of the intervention on medication adherence.Trial RegistrationClinicaltrials.gov NCT04190251_PANDIA IRIS; https://clinicaltrials.gov/ct2/show/NCT04190251International Registered Report Identifier (IRRID)DERR1-10.2196/25966

Diabetic retinopathy in newly diagnosed Type 2 diabetes mellitus: Prevalence and predictors of progression; a national primary network study

AimsTo determine, inreal-world primary care settings, the prevalence of, and risk factors for, retinopathy atType 2 diabetes mellitus diagnosis and report cumulative incidence and progression of retinopathy seven years after diabetes diagnosis. MethodsRetrospective cohort analysis of people with newly diagnosed Type 2 diabetesrecorded bythe Royal College of General Practitioners Research and Surveillance Centre(between 2005 and 2009, n=11,399).Outcomes included; retinopathy prevalence atdiabetesdiagnosis (baseline) and cumulative incidence or progression of retinopathy at seven years. Retinopathy prevalence was compared with the United Kingdom Prospective Diabetes Study (UKPDS-1998). Factors influencing retinopathy incidence and progression were analysed using logistic regression. ResultsBaseline retinopathy prevalencewas 18% (n=2,048) versus 37% in UKPDS. At seven years, 11.6% (n=237) of those with baseline retinopathyhad progression of retinopathy. In those without baseline retinopathy, 46.4% (n=4,337/9,351) developed retinopathy by seven years. Retinopathy development (OR: 1.05 [95%CI: 1.02–1.07] per mmol/mol increase) and progression (OR: 1.05 [1.04–1.06]) at seven years was associated with higher HbA1catdiabetesdiagnosis. Obesity (OR: 0.88 [0.79–0.98]) and high socioeconomic status (OR: 0.63 [0.53–0.74]) were negatively associated with retinopathy development at seven years. ConclusionsBaseline retinopathy prevalence has declined since UKPDS. Additionally, HbA1c at diabetes diagnosis remains important for retinopathy development and progression.

An Intuitive Risk Communication Tool to Enhance Patient–Provider Partnership in Diabetes Consultation

This technology report introduces an innovative risk communication tool developed to support providers in communicating diabetes-related risks more intuitively to people with type 2 diabetes mellitus (T2DM). The development process involved three main steps: (1) selecting the content and format of the risk message; (2) developing a digital interface; and (3) assessing the usability and usefulness of the tool with clinicians through validated questionnaires. The tool calculates personalized risk information based on a validated simulation model (United Kingdom Prospective Diabetes Study Outcomes Model 2) and delivers it using more intuitive risk formats, such as "effective heart age" to convey cardiovascular risks. Clinicians reported high scores for the usability and usefulness of the tool, making its adoption in routine care promising. Despite increased use of risk calculators in clinical care, this is the first time that such a tool has been developed in the diabetes area. Further studies are needed to confirm the benefits of using this tool on behavioral and health outcomes in T2DM populations.

Macrovascular Risk Equations Based on the CANVAS Program.

Widely used risk equations for cardiovascular outcomes for individuals with type 2 diabetes mellitus (T2DM) have been incapable of predicting cardioprotective effects observed in recent cardiovascular outcomes trials (CVOTs) involving individuals with T2DM at high risk for or with established cardiovascular disease (CVD). We developed cardiovascular and mortality risk equations using patient-level data from the CANVAS (CANagliflozin cardioVascular Assessment Study) Program to address this shortcoming. Data from 10,142 patients with T2DM at high risk for or with established CVD, randomized to canagliflozin + standard of care (SoC) or SoC alone and followed for a mean duration of 3.6 years in the CANVAS Program were used to derive parametric risk equations for myocardial infarction (MI), stroke, hospitalization for heart failure (HHF), and death. Accumulated knowledge from the widely used UKPDS-OM2 (United Kingdom Prospective Diabetes Study Outcomes Model 2) was leveraged, and any departures in parameterization were limited to those necessary to provide adequate goodness of fit. Candidate explanatory covariates were selected using only the placebo arm to minimize confounding effects. Internal validation was performed separately by study treatment arm. UKPDS-OM2 predicted CANVAS Program outcomes poorly. Recalibrating UKPDS-OM2 intercepts improved calibration in some cases. Refitting the coefficients but otherwise preserving the UKPDS-OM2 structure improved the fit substantially, which was sufficient for stroke and death. For MI, reselecting UKPDS-OM2 covariates and functional form proved sufficient. For HHF, selection from a broad set of candidate covariates and inclusion of a canagliflozin indicator was required. These risk equations address some of the limitations of widely used risk equations, such as the UKPDS-OM2, for modeling cardioprotective treatments for individuals with T2DM and high cardiovascular risk, including derivation from overly healthy patients treated with agents that lack cardioprotection and have been described as reflecting a different therapeutic era. Future work is needed to examine external validity.