Diabetes In Primary Care Research Articles

Improving frequency of urinary albumin testing in type 2 diabetes in primary care — An analysis of cross-sectional studies in Denmark

BackgroundTo ensure high quality standards in chronic care of type 2 diabetes, it is paramount to ensure regular measurement of clinical risk factors. For prevention of diabetic kidney disease, testing for albuminuria and kidney function is vital. The majority of individuals with type 2 diabetes in Denmark are treated in general practice, and given the recent development of kidney-protective treatments, a renewed focus on renal risk factors is important. ObjectiveTo assess the frequency of albuminuria and kidney function testing in general practice in Denmark and describe developments over the last decade. The proportion of patients with the recommended annual measurements of albuminuria and kidney function was the primary variable. MethodsWe used data from subjects with type 2 diabetes in three cross-sectional general practice studies from 2009 to 2017. ResultsData from 5592 individuals were available. Almost all subjects (96–99%) in the studies had annual measurement of kidney function performed. During the combined observation period there was a clear increase in the proportion of subjects that had albuminuria measured, from 57.2% to 68.0% to 82.8%. ConclusionThe regular assessment of renal risk factors in individuals with type 2 diabetes attending primary care in Denmark has seemingly improved over the last decade. This provides the required base for renal risk assessment and appropriate therapy selection.

Evaluation of a package of risk-based pharmaceutical and lifestyle interventions in patients with hypertension and/or diabetes in rural China: A pragmatic cluster randomised controlled trial.

Primary prevention of cardiovascular disease (CVD) requires adequate control of hypertension and diabetes. We designed and implemented pharmaceutical and healthy lifestyle interventions for patients with diabetes and/or hypertension in rural primary care, and assessed their effectiveness at reducing severe CVD events. We used a pragmatic, parallel group, 2-arm, controlled, superiority, cluster trial design. We randomised 67 township hospitals in Zhejiang Province, China, to intervention (34) or control (33). A total of 31,326 participants were recruited, with 15,380 in the intervention arm and 15,946 in the control arm. Participants had no known CVD and were either patients with hypertension and a 10-year CVD risk of 20% or higher, or patients with type 2 diabetes regardless of their CVD risk. The intervention included prescription of a standardised package of medicines, individual advice on lifestyle change, and adherence support. Control was usual hypertension and diabetes care. In both arms, as usual in China, most outpatient drug costs were out of pocket. The primary outcome was severe CVD events, including coronary heart disease and stroke, during 36 months of follow-up, as recorded by the CVD surveillance system. The study was implemented between December 2013 and May 2017. A total of 13,385 (87%) and 14,745 (92%) participated in the intervention and control arms, respectively. Their mean age was 64 years, 51% were women, and 90% were farmers. Of all participants, 64% were diagnosed with hypertension with or without diabetes, and 36% were diagnosed with diabetes only. All township hospitals and participants completed the 36-month follow-up. At 36 months, there were 762 and 874 severe CVD events in the intervention and control arms, respectively, yielding a non-significant effect on CVD incidence rate (1.92 and 2.01 per 100 person-years, respectively; crude incidence rate ratio = 0.90 [95% CI: 0.74, 1.08; P = 0.259]). We observed significant, but small, differences in the change from baseline to follow-up for systolic blood pressure (-1.44 mm Hg [95% CI: -2.26, -0.62; P < 0.001]) and diastolic blood pressure (-1.29 mm Hg [95% CI: -1.77, -0.80; P < 0.001]) in the intervention arm compared to the control arm. Self-reported adherence to recommended medicines was significantly higher in the intervention arm compared with the control arm at 36 months. No safety concerns were identified. Main study limitations include all participants being informed about their high CVD risk at baseline, non-blinding of participants, and the relatively short follow-up period available for judging potential changes in rates of CVD events. The comprehensive package of pharmaceutical and healthy lifestyle interventions did not reduce severe CVD events over 36 months. Improving health system factors such as universal coverage for the cost of essential medicines is required for successful risk-based CVD prevention programmes. ISRCTN registry ISRCTN58988083.

Prescribing sodium-glucose co-transporter-2 inhibitors for type 2 diabetes in primary care: influence of renal function and heart failure diagnosis

BackgroundSodium-glucose co-transporter-2 inhibitors (SGLT-2is) are licenced for initiation for glucose lowering in people with type 2 diabetes (T2DM) with an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2). However, recent trial data have shown that these medications have renal and cardio-protective effects, even for impaired kidney function. The extent to which trial evidence and updated guidelines have influenced real-world prescribing of SGLT-2is is not known, particularly with co-administration of diuretics.MethodsWe performed a cross-sectional analysis of people with T2DM registered with practices in the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database on the 31st July 2019. We calculated the percentage of people prescribed SGLT-2is according to eGFR categories (< 45, 45–59, and ≥ 60 mL/min/1.73m2), with a heart failure diagnosis and stratified by body mass index categories (underweight, normal weight, overweight, obese), and with concomitant prescription of a diuretic. Multilevel logistic regression analysis was performed to determine whether heart failure diagnosis and renal function were associated with SGLT-2i prescribing.ResultsFrom a population of 242,624 people with T2DM across 419 practices, 11.0% (n = 26,700) had been prescribed SGLT-2is. The majority of people initiated SGLT-2is had an eGFR ≥ 60 mL/min/1.73m2 (93.2%), and 4.3% had a heart failure diagnosis. 9,226 (3.8%) people were prescribed SGLT-2is as an add-on to their diuretic prescription. People in the highest eGFR category (≥ 60 mL/min/1.73m2) were more likely to be prescribed SGLT-2is than those in eGFR lower categories. Overweight (OR 2.05, 95% CI 1.841–2.274) and obese people (OR 3.84, 95% CI 3.472–4.250) were also more likely to be prescribed these medications, whilst use of diuretics (OR 0.74, 95% CI 0.682–0.804) and heart failure (OR 0.81, 95% CI 0.653–0.998) were associated with lower odds of being prescribed SGLT-2is.ConclusionsPrescribing patterns of SGLT-2is for glucose lowering in T2DM in primary care generally concur with licenced indications according to recommended renal thresholds. A small percentage of people with heart failure were prescribed SGLT-2is for T2DM. An updated analysis is merited should UK National Institute for Health Care and Excellence prescribing guidelines for T2DM be revised to incorporate new data on the benefits for those with reduced renal function or with heart failure.

Efectividad de la ratio TG/c-HDL en la mejora de la prescripción de GLP-1 en pacientes con diabetes tipo 2 en atención primaria

AimsCheck the usefulness of ratio TG/HDL-C≥2.5 to improve the effectiveness of GLP-1 prescribing in patients with type 2 diabetes (DM2) in primary care, and determine whether any patient profile would higher benefit. DesignDescriptive cross-sectional study. LocationBarranco Grande Health Center, Tenerife. ParticipantsRandom selection of patients with DM2 attended by 12 family doctors and 12 nurses. Main measurementsPoor control according to the current criteria was compared to poor control according to the proposed rule. To determine who would benefit, the sociodemographic, clinical, therapeutic and follow-up characteristics were analyzed. Descriptive, bivariate and multivariate statistical analysis was performed. ResultsNo predominant characteristics were found in the patients who would be prescribed GLP-1 according to the proposed rule, but those that reached a significance P<.20 were included as potential explanatory factors in a multivariate binary logistic regression model. The adjustment of the model retained the factors of therapeutic non-compliance (OR 3.40 [1.58-5.02]; P=.003), evolution of DM2 less than 15 years (OR 2.74 [1.10-4.89]; P=.031), number of prescribed anti-diabetes drugs (OR 2.30 [1.88-2.81]; P<.001) and age under 65 years (OR 1.67 [1.08-2.58]; P=.021). ConclusionsThe use of the rule that we propose for the prescription of GLP-1 (2018 recommendations of the GDPS network combined with the TG/HDL-C ratio≥2.5 or BMI≥30kg/m2), instead of the current criterion adopted by the National Health System, would allow to broaden the spectrum of application of the drug in patients with poor control of their DM2.

The Women's Leadership Gap in Diabetes: A Call for Equity and Excellence.

Women are broadly underrepresented in scientific leadership positions and their accomplishments are not provided equal recognition compared with those of men, but the imbalance in the field of diabetes is unknown. Hence, we analyzed multiple aspects of historical and present-day female representation in the diabetes field.We quantified gender representation at annual American Diabetes Association (ADA) meetings; editorial board service positions for ADA and the European Association for the Study of Diabetes (EASD) journals; principal investigators for ADA, JDRF, and National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases P30 grant funding; and ADA, JDRF, and EASD award recipients. There are many women in the field of diabetes: registration for the ADA Scientific Sessions has been 43% female since 2016, and for over five decades, women comprised 83% of ADA Presidents of Health Care and Education. Yet, only 9% of ADA Presidents of Medicine and Science have been women. Women were well represented on editorial boards for journals focused on diabetes education (Diabetes Spectrum, 89% female) and primary care (Clinical Diabetes, 49% female) but not for the more academically targeted Diabetes Care (34% female), Diabetes (21% female), and Diabetologia (30% female). Only one-third of ADA Pathway to Stop Diabetes and JDRF grants have been awarded to women, and females only lead 2 of 18 (11%) of the P30-supported Diabetes Research Centers. Finally, only 2-12% of major ADA, JDRF, and EASD awards were given to women, without significant change over time. Despite increasing recognition of gender imbalance in research and medicine, many disparities in the field of diabetes persist. We call for decreasing barriers for advancement of female investigators and creating environments that promote their retention and equitable recognition for their contributions to the field.

The Women’s Leadership Gap in Diabetes: A Call for Equity and Excellence

Women are broadly underrepresented in scientific leadership positions and their accomplishments are not provided equal recognition compared with those of men, but the imbalance in the field of diabetes is unknown. Hence, we analyzed multiple aspects of historical and present-day female representation in the diabetes field. We quantified gender representation at annual American Diabetes Association (ADA) meetings; editorial board service positions for ADA and the European Association for the Study of Diabetes (EASD) journals; principal investigators for ADA, JDRF, and National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases P30 grant funding; and ADA, JDRF, and EASD award recipients. There are many women in the field of diabetes: registration for the ADA Scientific Sessions has been 43% female since 2016, and for over five decades, women comprised 83% of ADA Presidents of Health Care and Education. Yet, only 9% of ADA Presidents of Medicine and Science have been women. Women were well represented on editorial boards for journals focused on diabetes education (Diabetes Spectrum, 89% female) and primary care (Clinical Diabetes, 49% female) but not for the more academically targeted Diabetes Care (34% female), Diabetes (21% female), and Diabetologia (30% female). Only one-third of ADA Pathway to Stop Diabetes and JDRF grants have been awarded to women, and females only lead 2 of 18 (11%) of the P30-supported Diabetes Research Centers. Finally, only 2-12% of major ADA, JDRF, and EASD awards were given to women, without significant change over time. Despite increasing recognition of gender imbalance in research and medicine, many disparities in the field of diabetes persist. We call for decreasing barriers for advancement of female investigators and creating environments that promote their retention and equitable recognition for their contributions to the field.

Self-Monitoring of Blood Glucose for Patients With Type 2 Diabetes in Primary Care: A Single-Centre, 10-Year Retrospective Analysis.

BackgroundWhile type 1 diabetics often require self-monitoring of blood glucose (SMBG), the evidence for tight blood glucose monitoring in non-insulin treated type 2 diabetes mellitus (T2DM) patients is limited. In addition to its lack of cost-effectiveness, unnecessary blood glucose monitoring may also result in anxiety and decreased quality of life. In this retrospective audit, we assessed SMBG prescribing practice at one general practice against guidelines from the National Institute for Health and Care Excellence (NICE).MethodsA systematic search of T2DM patients diagnosed at a general practice in London, United Kingdom, in the last 10 years was undertaken. A total of 146 patients fulfilled these criteria, of which 100 patients were randomly selected for inclusion in this audit. Medical notes were reviewed and collated for analysis.ResultsOnly 85% of patients with T2DM were being managed in accordance with the NICE guidelines on SMBG, while 15% were not. It was more common for patients who did not need monitoring to be inappropriately prescribed SMBG (10%) than it was for patients who needed monitoring to be under-prescribed SMBG (5%). The reasons for prescribing SMBG were often left undocumented.ConclusionAdherence to the NICE guidelines is subpar. Recommended solutions include educating healthcare professionals involved in the prescribing of SMBGs, regular reviews of the continued necessity of SMBG, and digital alerts on e-prescribing systems.

Serum Albumin Modifies the Effect of Peripheral Blood Monocytes on Severity of Diabetic Nephropathy in an Adult Population

BackgroundOur aim in this study was to characterize clinical associations between peripheral blood immune populations and diabetic kidney disease (DKD) in patients with type 2 diabetes mellitus. MethodsWe queried hospital records from an outpatient diabetes primary care clinic between 2018 and 2019 for clinical and laboratory data, including complete blood counts with differentials, serum albumin and globulin, glycated hemoglobin (A1C) and urine albumin-to-creatinine ratio. One hundred ninety-eight patients had complete cross-sectional data with temporally proximate complete blood counts and urine albumin-to-creatinine ratios. After univariable correlation assessment, we used a forward multivariable linear regression model to test the hypothesis that higher numbers of circulating innate immune populations would be associated with DKD, while accounting for known demographic, clinical and laboratory risk factors. We defined DKD as an albumin-to-creatinine ratio of >3 mg/mmol or an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2 from the Chronic Kidney Disease Epidemiology Collaboration. ResultsAdjusted analyses demonstrated significant (p<0.01) associations between higher urine albumin-to-creatinine ratio and peripheral circulating monocytes, independent of other established significant risk factors, including blood pressure, A1C, age and sex. We also identified serum albumin as a potentially important modifying factor of albuminuric kidney disease, which interacts with monocytes in more advanced disease. In contrast, the variable most strongly predictive of eGFR was age. ConclusionsCirculating monocytes and serum albumin are significantly associated with albuminuria, but not eGFR in DKD. These results support the potential role of the innate immune system in diabetic microvascular end-organ damage and urinary protein loss, and may be readily translatable clinical markers to incorporate into risk-assessment models for prognostication in diabetes.

Glycemic Control for Colorectal Cancer Survivors Compared to Those without Cancer in the Dutch Primary Care for Type 2 Diabetes: A Prospective Cohort Study.

Simple SummaryA growing number of colorectal cancer survivors live with type 2 diabetes, as a result of improved cancer diagnosis and treatment. These patients might have worse glycemic control after their cancer diagnosis, which may increase the risk of cardiovascular diseases. This prospective cohort study evaluated the quality of glycemic control for colorectal cancer survivors, as compared to those without cancer in Dutch primary care for diabetes. During a 10-year follow-up for 57,330 patients, there were 705 patients diagnosed with colorectal cancer. No clinically relevant difference on the probability of reaching the target HbA1c was observed between colorectal cancer survivors and patients with no history of cancer. These results showed a robust diabetes care system, implying that the glycemic control for colorectal cancer survivors can be delegated to the primary care professionals.Cancer survivors with diabetes tend to have worse glycemic control after their cancer diagnosis, which may increase the risk of cardiovascular diseases. We aimed to investigate whether glycemic control differs between colorectal cancer (CRC) survivors and those without cancer, among patients with type 2 diabetes being treated in the Dutch primary care. The Zwolle Outpatient Diabetes project Integrating Available Care database was linked with the Dutch Cancer Registry (n = 71,648, 1998–2014). The cases were those with stage 0–III CRC, and the controls were those without cancer history. The primary and secondary outcomes were the probability of reaching the glycated hemoglobin (HbA1c) target and the mean of HbA1c during follow-up, respectively. Mixed linear modeling was applied, where the status of CRC was a time-varying variable. Among the 57,330 patients included, 705 developed CRC during follow-up. The mean probability of reaching the HbA1c target during follow-up was 73% versus 74% (p = 0.157) for CRC survivors versus those without cancer, respectively. The mean HbA1c was 51.1 versus 50.8 mmol/mol (p = 0.045) among CRC survivors versus those without cancer, respectively. We observed a clinically comparable glycemic control among the CRC survivors without cancer, indicating that glycemic control for CRC survivors can be delegated to primary care professionals.

Visit Content Analysis: Doctor-Patient Communication in Patients with Type 2 Diabetes.

The primary care visit is an important opportunity to discuss and modify diabetes management. To gain insight into doctor-patient communication during primary care visits among English and Spanish speaking patients with type 2 diabetes and suboptimal glycemic control (HbA1c > 7%). We conducted a quantitative content analysis of audiotaped primary care visits in 2 patient cohorts. In Study 1 (31 English-speaking patients), we examined factors associated with management changes, and in Study 2 (20 Spanish-speaking patients and their Spanish-speaking providers), we examined the association of question asking with HbA1c control. This study was conducted between November 2017 and January 2020 across 8 primary care practices within Kaiser Permanente Northern California. In Study 1, the only factor significantly associated with a diabetes management change was patient identification of diabetes as a priority prior to the visit (91.7% had a management change vs 52.6% of patients who did not identify diabetes as a priority; p = 0.02). In Study 2, patients with poorer glycemic control (HbA1c ≥ 10.0) asked significantly fewer questions (3.4 ± 1.8 vs 10.7 ± 6.9 questions per 15 minutes; p = 0.004). Overall, despite receiving primary care from language-concordant providers, Spanish-speaking Study 2 patients asked fewer questions than English-speaking Study 1 patients (4.5 ± 2.9 vs 7.5 ± 3.7 questions per 15 minutes, respectively; p = 0.004). Our results highlight 2 potential strategies (preparing patients for their visits through identifying priorities and learning how to ask more questions during visits) for improving diabetes primary care.

ABCD position statement on risk stratification of adult patients with diabetes during COVID-19 pandemic

At the time of submission of this manuscript, the COVID-19 pandemic had cost nearly 60,000 lives in the UK. This number currently stands at over 120,000 deaths. A high proportion (one third) of these lived with diabetes. The huge acute and emergency medicine effort to support people with COVID-19 has had a major knock-on impact on the delivery of routine clinical care, especially for long-term conditions like diabetes.Challenges to the delivery of diabetes services during this period include a reduction in medical and nursing staff, limitations placed by social distancing on physical clinical space, and balancing virtual vs face-to-face care. There is a need to re-group and re-organise how we deliver routine out-patient adult diabetes services during the ongoing COVID-19 pandemic. We offer some suggestions for how patients can be stratified into red (urgent), amber (priority) and green (routine) follow up with suggestions of how often people should be seen. We also offer recommendation on how we can identify those at highest risk and try and minimise the long- term impact of COVID on diabetes careDuring the COVID pandemic we have seen things happen in days that previously took years. The restart of diabetes services has triggered a more widespread use of virtual consultations and data management systems, but also offers an opportunity for more joined-up and cohesive working between primary and specialist care. While we do our best to keep our patients and colleagues safe, this pandemic is already proving to be a catalyst for change, accelerating the appropriate use of technology in diabetes care and implementing innovative solutions. To achieve this aspiration, further work – currently led by the Association of British Clinical Diabetologists in collaboration with Diabetes UK and the Primary Care Diabetes Society – to make recommendations on future proofing diabetes care in UK is in progress.

Diabetic Polyneuropathy Early in Type 2 Diabetes Is Associated With Higher Incidence Rate of Cardiovascular Disease: Results From Two Danish Cohort Studies.

Symptoms indicative of diabetic polyneuropathy (DPN) early in type 2 diabetes may act as a marker for cardiovascular disease (CVD) and death. We linked data from two Danish type 2 diabetes cohorts, the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen-Detected Diabetes in Primary Care (ADDITION-Denmark) and the Danish Centre for Strategic Research in Type 2 Diabetes (DD2), to national health care registers. The Michigan Neuropathy Screening Instrument questionnaire (MNSIq) was completed at diabetes diagnosis in ADDITION-Denmark and at a median of 4.6 years after diagnosis of diabetes in DD2. An MNSIq score ≥4 was considered as indicative of DPN. Using Poisson regressions, we computed incidence rate ratios (IRRs) of CVD and all-cause mortality comparing MNSIq scores ≥4 with scores <4. Analyses were adjusted for a range of established CVD risk factors. In total, 1,445 (ADDITION-Denmark) and 5,028 (DD2) individuals were included in the study. Compared with MNSIq scores <4, MNSIq scores ≥4 were associated with higher incidence rate of CVD, with IRRs of 1.79 (95% CI 1.38-2.31) in ADDITION-Denmark, 1.57 (CI 1.27-1.94) in the DD2, and a combined IRR of 1.65 (CI 1.41-1.95) in a fixed-effect meta-analysis. MNSIq scores ≥4 did not associate with mortality; combined mortality rate ratio was 1.11 (CI 0.83-1.48). The MNSIq may be a tool to identify a subgroup within individuals with newly diagnosed type 2 diabetes with a high incidence rate of subsequent CVD. MNSIq scores ≥4, indicating DPN, were associated with a markedly higher incidence rate of CVD, beyond that conferred by established CVD risk factors.

Mal control de la diabetes tipo 2 en un centro de salud de atención primaria: factores modificables y población diana

AimsTo detect modifiable factors and target populations associated with uncontrolled type 2 diabetes in primary care. DesignRetrospective cross-sectional descriptive study. LocationHealth center of Barranco Grande, Tenerife. ParticipantsRandom selection of patients with DM2 attended by 12 family doctors and 12 nurses. Main MeasurementsIn addition to the control of DM2, sociodemographic, clinical data, lifestyle and follow-up of preventive and therapeutic measures were obtained. After bivariate analysis, a multilevel multivariate model was adjusted by taking the quota of patients assisted by each physician as a second-level mixed-effect variable and the rest as first-level variables. Results587 patients were recruited (46.5% female), treated with 1.9-1.1 antidiabetic drugs, with 4.1% therapeutic non-compliance, and suffering 13.8% therapeutic inertia. 23.7% showed poor DM2 control, being significantly worse (p<0.05) in male sex, age <65 years, evolution DM2 -5 years, work-active, upper-middle studies, inadequate diet, metabolic syndrome, ratio TG/HDL-3, complications of DM2, Charlson index<5, nursing visits <3/year, without ECG in the last year, and more drugs prescribed for DM2. The doctor-nurse quota was associated with poor control with an intraclass coefficient of 0.01. ConclusionsMen under 65 years of age with DM2 evolution longer than 5 years are a target population to intensify interventions. Therapeutic non-compliance, inadequate diet, lack of adherence protocols and ratio TG/HDL>3 are the main modifiable factors on which to intervene. The association of the doctor-nurse quota with the control of DM2 is weak, probably due to adequate follow-up of preventive programs.

Plasma lipid metabolites associate with diabetic polyneuropathy in a cohort with type 2 diabetes.

ObjectiveThe global rise in type 2 diabetes is associated with a concomitant increase in diabetic complications. Diabetic polyneuropathy is the most frequent type 2 diabetes complication and is associated with poor outcomes. The metabolic syndrome has emerged as a major risk factor for diabetic polyneuropathy; however, the metabolites associated with the metabolic syndrome that correlate with diabetic polyneuropathy are unknown.MethodsWe conducted a global metabolomics analysis on plasma samples from a subcohort of participants from the Danish arm of Anglo‐Danish‐Dutch study of Intensive Treatment of Diabetes in Primary Care (ADDITION‐Denmark) with and without diabetic polyneuropathy versus lean control participants.ResultsCompared to lean controls, type 2 diabetes participants had significantly higher HbA1c (p = 0.0028), BMI (p = 0.0004), and waist circumference (p = 0.0001), but lower total cholesterol (p = 0.0001). Out of 991 total metabolites, we identified 15 plasma metabolites that differed in type 2 diabetes participants by diabetic polyneuropathy status, including metabolites belonging to energy, lipid, and xenobiotic pathways, among others. Additionally, these metabolites correlated with alterations in plasma lipid metabolites in type 2 diabetes participants based on neuropathy status. Further evaluating all plasma lipid metabolites identified a shift in abundance, chain length, and saturation of free fatty acids in type 2 diabetes participants. Importantly, the presence of diabetic polyneuropathy impacted the abundance of plasma complex lipids, including acylcarnitines and sphingolipids.InterpretationOur explorative study suggests that diabetic polyneuropathy in type 2 diabetes is associated with novel alterations in plasma metabolites related to lipid metabolism.

Comparative effectiveness of team-based care with a clinical decision support system versus team-based care alone on cardiovascular risk reduction among patients with diabetes: Rationale and design of the D4C trial

Diabetes has become a major public health challenge worldwide, especially in low- and middle-income countries (LMICs). Uncontrolled hyperglycemia, hypertension, and dyslipidemia major risk factors for all-cause mortality and cardiovascular disease (CVD) are common in patients with diabetes in China. We propose to compare the effectiveness of team-based care plus a clinical decision support system (CDSS) with team-based care alone on glycemic, blood pressure (BP), and lipid control, and clinical CVD reduction among patients with type-2 diabetes and at high risk for CVD. The Diabetes Complication Control in Community Clinics (D4C) study is a cluster-randomized trial conducted among 38 community health centers in Xiamen City, China. Nineteen clinics have been randomly assigned to team-based care plus CDSS and 19 to team-based care alone. Team-based care includes primary care providers, health coaches, and diabetes specialists working collaboratively with patients to achieve shared treatment goals for CVD risk factor reduction. The CDSS integrates guideline-based treatment algorithms for glycemic, BP, and lipid control, along with a patient's medical history and insurance policy, to recommend treatment and follow-up plans. In phase 1, the co-primary outcomes are mean reduction in glycated hemoglobin (HbA1c), systolic BP (SBP), and low-density lipoprotein (LDL)-cholesterol over 18 months, and the proportion of patients with controlled HbA1c, SBP, and LDL-cholesterol at 18 months' between the 2 comparison groups. In phase 2, the primary outcome is the difference in major CVD incidence (non-fatal stroke, non-fatal myocardial infarction, hospitalized heart failure, and CVD mortality) between the 2 comparison groups. Mean reduction in HbA1c, SBP, and LDL-cholesterol levels will be simultaneously modeled for a single overall treatment effect. The D4C trial will generate evidence on whether a CDSS will further reduce the CVD burden among patients with diabetes beyond team-based care at community clinics. If proven effective, this implementation strategy could be scaled up within primary care settings in China and other LMICs to reduce CVD incidence and mortality among patients with diabetes.

Examining Variations in Action Plan Quality Among Adults With Type 2 Diabetes in Primary Care.

Collaborative goal setting and action-planning are key elements of self-management support for people with type 2 diabetes mellitus (T2DM), however little is known regarding action plan quality or correlation of quality in primary T2DM care. T2DM patients from 12 primary care sites participated in either: Connection to Health (CTH; 6 practices), consisting of a health survey followed by collaborative action planning, or Enhanced Engagement CTH (EE-CTH; 6 practices), including additional training in relationship building promoting patient engagement. Action plan quality was rated using an adapted version of the Goal-Setting Evaluation Tool for Diabetes (GET-D) (dual coding of 20%, inter-rater reliability [IRR] >80%). Associations with patient characteristics were examined using generalized linear mixed models adjusting for clustering by clinic and intervention arm. With a mean score ± standard deviation (SD) of 14.62 ± 3.87 on a 0 to 20 scale (n = 725), overall action plan quality was moderate-high. Higher health literacy (β = 1.184, 95% CI, 0.326-2.041; P = .007), and having no social risks (β = 0.416; 95% CI, 0.062-0.770; P = .021) were associated with higher action plan quality, whereas sex, age, language, education level, depression, stress, and health distress were unrelated to quality (P value not significant). Higher quality was associated with greater patient confidence in the plan (β = 0.050; 95% CI, 0.016-0.084, P = .004). Although there was a considerable difference in action plan quality ratings, ratings did not systematically differ based on most patient demographic or mental health measures. Results suggest that action planning should be tailored to health literacy and social risks. Further research should examine associations between quality and longer-term clinical outcomes.

Implementation of an Oral Care Protocol for Primary Diabetes Care: A Pilot Cluster-Randomized Controlled Trial

Although diabetes care guidelines recommend paying attention to oral health, the effect on daily practice has been limited, and patients with diabetes have yet to benefit. We investigated whether implementation of an oral care protocol for general practitioners (GPs [family physicians]) can improve patient-centered outcomes for patients with type 2 diabetes. Twenty-four GP offices were randomly assigned to the experimental or control group (12 offices each). In the experimental group, GPs and nurse practitioners implemented an oral care protocol. No extra attention was given to oral health in the control group. The primary outcome parameter was oral health-related quality of life (QoL) assessed with the 14-item Oral Health Impact Profile at baseline and 1 year later. Other outcomes were self-reported oral health complaints and general health-related QoL (36-item Short Form Health Survey). Of 764 patients with type 2 diabetes, 543 (71.1%) completed the 1-year follow-up. More patients reported improved oral health-related QoL in the experimental group (35.2%) compared to the control group (25.9%) (P = .046; P adj = .049). In a secondary post hoc analysis including GP offices with ≥60% patient follow-up (n = 18), improvement was 38.3% and 24.9%, respectively (P and P adj = .011). Improvement of self-reported oral health complaints did not differ between groups. The intervention had no effect on general health-related QoL, with the exception of the concept scale score for changes in health over time (P adj = .033). Implementation of an oral care protocol in primary diabetes care improved oral health-related QoL in patients with type 2 diabetes.

Effects of a Technology-Assisted Integrated Diabetes Care Program on Cardiometabolic Risk Factors Among Patients With Type 2 Diabetes in the Asia-Pacific Region

Many health care systems lack the efficiency, preparedness, or resources needed to address the increasing number of patients with type 2 diabetes, especially in low- and middle-income countries. To examine the effects of a quality improvement intervention comprising information and communications technology and contact with nonphysician personnel on the care and cardiometabolic risk factors of patients with type 2 diabetes in 8 Asia-Pacific countries. This 12-month multinational open-label randomized clinical trial was conducted from June 28, 2012, to April 28, 2016, at 50 primary care or hospital-based diabetes centers in 8 Asia-Pacific countries (India, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam). Six countries were low and middle income, and 2 countries were high income. The study was conducted in 2 phases; phase 1 enrolled 7537 participants, and phase 2 enrolled 13 297 participants. Participants in both phases were randomized on a 1:1 ratio to intervention or control groups. Data were analyzed by intention to treat and per protocol from July 3, 2019, to July 21, 2020. In both phases, the intervention group received 3 care components: a nurse-led Joint Asia Diabetes Evaluation (JADE) technology-guided structured evaluation, automated personalized reports to encourage patient empowerment, and 2 or more telephone or face-to-face contacts by nurses to increase patient engagement. In phase 1, the control group received the JADE technology-guided structured evaluation and automated personalized reports. In phase 2, the control group received the JADE technology-guided structured evaluation only. The primary outcome was the incidence of a composite of diabetes-associated end points, including cardiovascular disease, chronic kidney disease, visual impairment or eye surgery, lower extremity amputation or foot ulcers requiring hospitalization, all-site cancers, and death. The secondary outcomes were the attainment of 2 or more primary diabetes-associated targets (glycated hemoglobin A1c <7.0%, blood pressure <130/80 mm Hg, and low-density lipoprotein cholesterol <100 mg/dL) and/or 2 or more key performance indices (reduction in glycated hemoglobin A1c≥0.5%, reduction in systolic blood pressure ≥5 mm Hg, reduction in low-density lipoprotein cholesterol ≥19 mg/dL, and reduction in body weight ≥3.0%). A total of 20 834 patients with type 2 diabetes were randomized in phases 1 and 2. In phase 1, 7537 participants (mean [SD] age, 60.0 [11.3] years; 3914 men [51.9%]; 4855 patients [64.4%] from low- and middle-income countries) were randomized, with 3732 patients allocated to the intervention group and 3805 patients allocated to the control group. In phase 2, 13 297 participants (mean [SD] age, 54.0 [11.1] years; 7754 men [58.3%]; 13 297 patients [100%] from low- and middle-income countries) were randomized, with 6645 patients allocated to the intervention group and 6652 patients allocated to the control group. In phase 1, compared with the control group, the intervention group had a similar risk of experiencing any of the primary outcomes (odds ratio [OR], 0.94; 95% CI, 0.74-1.21) but had an increased likelihood of attaining 2 or more primary targets (OR, 1.34; 95% CI, 1.21-1.49) and 2 or more key performance indices (OR, 1.18; 95% CI, 1.04-1.34). In phase 2, the intervention group also had a similar risk of experiencing any of the primary outcomes (OR, 1.02; 95% CI, 0.83-1.25) and had a greater likelihood of attaining 2 or more primary targets (OR, 1.25; 95% CI, 1.14-1.37) and 2 or more key performance indices (OR, 1.50; 95% CI, 1.33-1.68) compared with the control group. For attainment of 2 or more primary targets, larger effects were observed among patients in low- and middle-income countries (OR, 1.50; 95% CI, 1.29-1.74) compared with high-income countries (OR, 1.20; 95% CI, 1.03-1.39) (P = .04). In this 12-month clinical trial, the use of information and communications technology and nurses to empower and engage patients did not change the number of clinical events but did reduce cardiometabolic risk factors among patients with type 2 diabetes, especially those in low- and middle-income countries in the Asia-Pacific region. ClinicalTrials.gov Identifier: NCT01631084.

La imperiosa necesidad de telemedicina en la atención de diabetes durante la pandemia de COVID-19. Un estudio de abordaje integral

Introduction: Patients with diabetes experience difficulties to maintain glycemic control during the confinement due to the COVID-19 pandemic, with the risk of developing diabetes chronic complications and severe COVID-19. Objective: The purpose of this study was to evaluate the conversion of an outpatient diabetes primary care center from a face-to-face care modality to a telemedicine care service by telephone. Methods: Medical consultations were made by telephone during the initial phase of confinement (April to June 2020), to then continue the follow-up of patients admitted to a multicomponent diabetes care program. Results: A total of 1,118 consultations were made by telephone and follow-up was subsequently continued in 192 patients with type 2 diabetes. Different professionals from different health areas participated, including medical care, diabetes education, nutrition, psychology and podiatry. Conclusions: Multicomponent diabetes care was successfully transformed from a face-to-face care modality to a telemedicine service. Many primary care patients may be candidates for telemedicine. A redesign of the care model that incorporates telemedicine should be considered to mitigate chronic diseases burden of morbidity and mortality imposed by COVID-19 pandemic, but also for the post-COVID-19 era.

Associations between attainment of incentivised primary care indicators and emergency hospital admissions among type 2 diabetes patients: a population-based historical cohort study.

England has invested considerably in diabetes care over recent years through programmes such as the Quality and Outcomes Framework and National Diabetes Audit. However, associations between specific programme indicators and key clinical endpoints, such as emergency hospital admissions, remain unclear. We aimed to examine whether attainment of Quality and Outcomes Framework and National Diabetes Audit primary care diabetes indicators is associated with diabetes-related, cardiovascular, and all-cause emergency hospital admissions. Historical cohort study. A total of 330 English primary care practices, 2010-2017, using UK Clinical Practice Research Datalink. A total of 84,441 adults with type 2 diabetes. The primary outcome was emergency hospital admission for any cause. Secondary outcomes were (1) diabetes-related and (2) cardiovascular-related emergency admission. There were 130,709 all-cause emergency admissions, 115,425 diabetes-related admissions and 105,191 cardiovascular admissions, corresponding to unplanned admission rates of 402, 355 and 323 per 1000 patient-years, respectively. All-cause hospital admission rates were lower among those who met HbA1c and cholesterol indicators (incidence rate ratio = 0.91; 95% CI 0.89-0.92; p < 0.001 and 0.87; 95% CI 0.86-0.89; p < 0.001), respectively), with similar findings for diabetes and cardiovascular admissions. Patients who achieved the Quality and Outcomes Framework blood pressure target had lower cardiovascular admission rates (incidence rate ratio = 0.98; 95% CI 0.96-0.99; p = 0.001). Strong associations were found between completing 7-9 (vs. either 4-6 or 0-3) National Diabetes Audit processes and lower rates of all admission outcomes (p-values < 0.001), and meeting all nine National Diabetes Audit processes had significant associations with reductions in all types of emergency admissions by 22% to 26%. Meeting the HbA1c or cholesterol Quality and Outcomes Framework indicators, or completing 7-9 National Diabetes Audit processes, was also associated with longer time-to-unplanned all-cause, diabetes and cardiovascular admissions. Attaining Quality and Outcomes Framework-defined diabetes intermediate outcome thresholds, and comprehensive completion of care processes, may translate into considerable reductions in emergency hospital admissions. Out-of-hospital diabetes care optimisation is needed to improve implementation of core interventions and reduce unplanned admissions.