STYLCONNECT Study: An Assessment of Automatic Data Collection Devices by People Living with Diabetes and Using an Insulin Pen.

INTRODUCTION: The use of devices to connect insulin pens could facilitate management and improve glycaemic control in people with type 1 (PwT1D) and type 2 diabetes (PwT2D). However, their acceptance seems little studied. We conducted an online survey with the main objective of assessing the level of interest among insulin-treated people with diabetes (PwD) in a device connected to a disposable pen and secondary objectives of assessing the perceived benefits and important features expected of a connected device and identifying factors associated with interest scores. METHODS: An ad-hoc questionnaire, validated by PwD, was used. Responses from 1798 PwD (975 PwT1D and 823 PwT2D) were analysed. RESULTS: The mean interest rating was 7.4/10 (PwT1D: 7.2 vs PwT2D: 7.7; p < 0.001). PwD perceived that the device would make it easier to record their diabetes-related information (7.7/10) and keep all insulin and diabetes data in a single location (7.7/10). It was particularly important for PwD that this type of device could integrate data from glucose-measuring devices (7.8/10) and could set an alarm when all insulin in the body had been metabolised (7.7/10). CONCLUSION: Our study highlighted PwD's strong interest in automating the collection of their insulin therapy data, with significantly more interest among PwT2D than PwT1D, and the importance of interoperability between glucose measurement devices and interchangeability between the different brands of insulin. More generally, for the first time and on a large scale, our study provided a greater understanding of the expectations of PwD regarding these devices.

Epidemiology and health impact of diabetes in France.

OBJECTIVES: Diabetes is a growing health concern. An update on epidemiology and health outcomes is mandatory to devise strategies to alleviate the burden of diabetes. The objective of this study was to assess the prevalence of diabetes and associated complications in France in 2017. METHODS: Demographics and healthcare data from a representative permanent secondary database were analyzed. Patients with at least 2 national health insurance payments for anti-diabetic drugs in 2017 were selected, with the index date set to the last payment date. Patients were grouped as diabetes treated with insulin only (DTi), diabetes treated with anti-diabetic drugs other than only insulin (DT2) or gestational diabetes. Comorbidities, diabetes-related complications and hospital admissions, healthcare consumption and medical follow-up were extracted for a 5- or 2-year period prior to the index date and summarized using descriptive statistics. RESULTS: Overal, 29,288 patients were included in the study population: 1964 (6.7%) were categorized as DTi and 27,243 (93.0%) as DT2. Patients with gestational diabetes (81 [0.3%]) are not further described here. Prevalence was estimated at 4.9%. For DT2, marked geographic disparities were observed, with prevalence being highest in the northeast France. Diabetes-related complications were more frequent in DTi than in DT2 over a 5-year period (52.2% vs 34.7%). Diabetes-related admissions were also more common in DTi than in DT2 over a 2-year period (29.8% vs 16.9%). In the DT2 category, another antidiabetic drug was added during the 3 months prior to the index date in 16.5% of cases overall and in 25% of patients with recent hospital admission or diabetes-related complications. Although more than 80% of patients in the DTi and DT2 categories had at least 1 healthcare consultation during 2 years prior to the index date, only 10% to 20% of patients complied with guidelines for all 5 recommended examinations. CONCLUSIONS: Prevalence of diabetes is high in the French population, while compliance with recommended healthcare consultations falls short of the 80% goal set by regulations. New strategies are mandatory in order to reduce the burden of diabetes-related complications and admissions, focusing on patient and physician information and education in order to increase proactive treatment adjustment and reduce therapeutic inertia.

What value do digital health solutions bring, what are the funding mechanisms and evaluations?

Digital health is currently booming, providing major innovations, particularly in terms of changing the practices of the stakeholders in the healthcare system as a whole. It allows our healthcare system to draw on new synergies between independent, hospital and medico-social professionals, as well as on high-performance digital tools for the benefit of all, users, patients and professionals. These tools, or digital solutions, have a strong potential to improve the healthcare system but also a strong potential for economic development. In this respect, the great diversity of existing and future digital solutions, as well as their vast fields of application, are prompting public and private stakeholders in the sector to question their integration into our healthcare system. The resulting challenges concern the identification of the targets they are intended for, the values they embody and, as a result, the methods of funding and evaluation. At a time when the first reimbursement terms for digital solutions are taking shape in the context of the Social Security Financing Bill for 2022, the roundtable wished to propose 8 recommendations to help structure exchanges between the various stakeholders and initiate avenues of work around the integration of digital solutions into the healthcare system. The main orientations are based on the proposal of a common and transparent reflection methodology around the technical scope of these solutions, the values they bring and the funding mechanisms. Other work will be necessary beyond the points addressed by the round table in order to go into greater depth on certain themes such as the adaptation of existing funding methods to the momentum and specificities of digital technology or the development of research work on the evaluation of the value claimed by these digital solutions.

The COVID-19 lockdown as an opportunity to change lifestyle and body weight in people with overweight/obesity and diabetes: Results from the national French COVIDIAB cohort.

BACKGROUND AND AIMS: To analyze lifestyle habits and weight evolution during the COVID-19 pandemic-associated lockdown, in diabetes and overweight/obesity patients (body mass index (BMI) [25-29.9] and ≥30 kg/m2, respectively). METHODS AND RESULTS: We collected information on participants' characteristics and behavior regarding lifestyle before and during the lockdown, through the CoviDIAB web application, which is available freely for people with diabetes in France. We stratified the cohort according to BMI (≥25 kg/m2vs < 25 kg/m2) and examined the determinants of weight loss (WL), WL > 1 kg vs no-WL) in participants with a BMI ≥25 kg/m2, in both univariate and multivariate analyses. Of the 5280 participants (mean age, 52.5 years; men, 49%; diabetes, 100% by design), 69.5% were overweight or obese (mean BMI, 28.6 kg/m2 (6.1)). During the lockdown, patients often quit or decreased smoking; overweight/obese participants increased alcohol consumption less frequently as compared with normal BMI patients. In addition, overweight/obese patients were more likely to improve other healthy behaviors on a larger scale than patients with normal BMI: increased intake of fruits and vegetables, reduction of snacks intake, and reduction of total dietary intake. WL was observed in 18.9% of people with a BMI ≥25 kg/m2, whereas 28.6% of them gained weight. Lifestyle favorable changes characterized patients with WL. CONCLUSIONS: A significant proportion of overweight/obese patients with diabetes seized the opportunity of lockdown to improve their lifestyle and to lose weight. Identifying those people may help clinicians to personalize practical advice in the case of a recurrent lockdown.

Predictors of hospital discharge and mortality in patients with diabetes and COVID-19: updated results from the nationwide CORONADO study.

AIMS/HYPOTHESIS: This is an update of the results from the previous report of the CORONADO (Coronavirus SARS-CoV-2 and Diabetes Outcomes) study, which aims to describe the outcomes and prognostic factors in patients with diabetes hospitalised for coronavirus disease-2019 (COVID-19). METHODS: The CORONADO initiative is a French nationwide multicentre study of patients with diabetes hospitalised for COVID-19 with a 28-day follow-up. The patients were screened after hospital admission from 10 March to 10 April 2020. We mainly focused on hospital discharge and death within 28 days. RESULTS: We included 2796 participants: 63.7% men, mean age 69.7 ± 13.2 years, median BMI (25th-75th percentile) 28.4 (25.0-32.4) kg/m2. Microvascular and macrovascular diabetic complications were found in 44.2% and 38.6% of participants, respectively. Within 28 days, 1404 (50.2%; 95% CI 48.3%, 52.1%) were discharged from hospital with a median duration of hospital stay of 9 (5-14) days, while 577 participants died (20.6%; 95% CI 19.2%, 22.2%). In multivariable models, younger age, routine metformin therapy and longer symptom duration on admission were positively associated with discharge. History of microvascular complications, anticoagulant routine therapy, dyspnoea on admission, and higher aspartate aminotransferase, white cell count and C-reactive protein levels were associated with a reduced chance of discharge. Factors associated with death within 28 days mirrored those associated with discharge, and also included routine treatment by insulin and statin as deleterious factors. CONCLUSIONS/INTERPRETATION: In patients with diabetes hospitalised for COVID-19, we established prognostic factors for hospital discharge and death that could help clinicians in this pandemic period. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04324736.

Correction to: Phenotypic characteristics and prognosis of inpatients with COVID-19 and diabetes: the CORONADO study.

The authors regret a mistake in Table 1.

Phenotypic characteristics and prognosis of inpatients with COVID-19 and diabetes: the CORONADO study.

AIMS/HYPOTHESIS: Coronavirus disease-2019 (COVID-19) is a life-threatening infection caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus. Diabetes has rapidly emerged as a major comorbidity for COVID-19 severity. However, the phenotypic characteristics of diabetes in COVID-19 patients are unknown. METHODS: We conducted a nationwide multicentre observational study in people with diabetes hospitalised for COVID-19 in 53 French centres in the period 10-31 March 2020. The primary outcome combined tracheal intubation for mechanical ventilation and/or death within 7 days of admission. Age- and sex-adjusted multivariable logistic regressions were performed to assess the prognostic value of clinical and biological features with the endpoint. ORs are reported for a 1 SD increase after standardisation. RESULTS: The current analysis focused on 1317 participants: 64.9% men, mean age 69.8 ± 13.0 years, median BMI 28.4 (25th-75th percentile: 25.0-32.7) kg/m2; with a predominance of type 2 diabetes (88.5%). Microvascular and macrovascular diabetic complications were found in 46.8% and 40.8% of cases, respectively. The primary outcome was encountered in 29.0% (95% CI 26.6, 31.5) of participants, while 10.6% (9.0, 12.4) died and 18.0% (16.0, 20.2) were discharged on day 7. In univariate analysis, characteristics prior to admission significantly associated with the primary outcome were sex, BMI and previous treatment with renin-angiotensin-aldosterone system (RAAS) blockers, but not age, type of diabetes, HbA1c, diabetic complications or glucose-lowering therapies. In multivariable analyses with covariates prior to admission, only BMI remained positively associated with the primary outcome (OR 1.28 [1.10, 1.47]). On admission, dyspnoea (OR 2.10 [1.31, 3.35]), as well as lymphocyte count (OR 0.67 [0.50, 0.88]), C-reactive protein (OR 1.93 [1.43, 2.59]) and AST (OR 2.23 [1.70, 2.93]) levels were independent predictors of the primary outcome. Finally, age (OR 2.48 [1.74, 3.53]), treated obstructive sleep apnoea (OR 2.80 [1.46, 5.38]), and microvascular (OR 2.14 [1.16, 3.94]) and macrovascular complications (OR 2.54 [1.44, 4.50]) were independently associated with the risk of death on day 7. CONCLUSIONS/INTERPRETATIONS: In people with diabetes hospitalised for COVID-19, BMI, but not long-term glucose control, was positively and independently associated with tracheal intubation and/or death within 7 days. TRIAL REGISTRATION: clinicaltrials.gov NCT04324736.

Hospital case volume and appropriate prescriptions at hospital discharge after acute myocardial infarction: a nationwide assessment.

BACKGROUND: In acute myocardial infarction, the relationship between volume and quality indicators (QIs) is poorly documented. Through a nationwide assessment of QIs at discharge repeated for 3 years, we aimed to quantify the relationship between volume and QIs in survivors after acute myocardial infarction. METHODS AND RESULTS: Almost all healthcare centers in France participated. Medical records were randomly selected. Data collection was performed by an independent group. QIs for acute myocardial infarction were defined by an expert consensus group as appropriate prescription at discharge of aspirin, clopidogrel, ß-blocker, statin, and an angiotensin-converting enzyme inhibitor in patients with left ventricular ejection fraction <0.40. A composite QI was calculated through the use of the all-or-none method. Volume was classified into 7 categories based on the number of admissions for acute myocardial infarctions in 2008 (centers with <10 acute myocardial infarctions were excluded). Odds ratios adjusted for age and sex with 95% confidence interval for volume categories were calculated by use of logistic regression for each QI. Temporal changes were tested in centers that participated in all 3 campaigns. A total of 46 390 records were examined: 18 159 in 2008, 12 837 in 2009, and 15 394 in 2010. Two hundred ninety-one centers were eligible for the temporal analysis. There was a significant increase between 2008 and 2009 in appropriate prescription of antiplatelet agents, ß-blockers, angiotensin-converting enzyme inhibitor, statins at discharge, and the composite indicator. Similarly, a significant increase was observed between 2009 and 2010 in appropriate prescription of angiotensin-converting enzyme inhibitor and ß-blockers and in the composite QI. Compared with a volume of >300, a significantly lower rate of all QIs was observed in centers with the lowest volume. Odds ratios progressively decreased with increasing volume. Despite a significant increase in the composite QI over the 3 years, a significant relationship persisted between volume and quality of care. CONCLUSIONS: Analysis of QIs at discharge demonstrates the existence of a relationship between volume and appropriate prescriptions at discharge. Centers with the highest volume perform better on quality measures than centers with lower volumes. Temporal analysis over 3 consecutive years confirms this relationship and shows that it persists despite improvement in QIs between 2008 and 2010.

Optimization of heart FailUre medical Treatment after hospital discharge according to left ventricUlaR Ejection fraction: the FUTURE survey.

BACKGROUND: No clinical practice guidelines are available for the treatment of heart failure (HF) in patients with preserved left ventricular ejection fraction (LVEF). AIMS: To determine how cardiologists manage medical treatment in HF patients after hospital discharge, according to LVEF. METHODS: The FUTURE study was a cross-sectional survey conducted in HF outpatients by French private cardiologists between September 2007 and August 2008. Patients had to have been hospitalized within the previous 18 months with a diagnosis of HF. Clinical data and HF treatments (angiotensin-converting enzyme inhibitors [ACEIs], angiotensin receptor blockers [ARBs], beta-blockers, diuretics and aldosterone antagonists) were recorded retrospectively, with precise information on drug doses, at two successive time points (at hospital discharge and at the index consultation). HF treatment was compared in patients with reduced (less than or equal to 40%) versus preserved (more than 40%) LVEF. RESULTS: Completed data were available for 1137 HF patients enrolled by 424 cardiologists. Mean patient age was 72±11 years; LVEF was reduced in 56% and preserved in 44%. The therapeutic approach was similar in the two groups, both at hospital discharge and at the index consultation. At the index consultation, HF treatment was: beta-blocker (74%); ACEI/ARB (83%); loop diuretic (86%); aldosterone antagonist (31%). The majority of patients (62%) received a beta-blocker plus an ACEI or an ARB; 56% reached more than or equal to 50% of the target dose for each treatment. There were no major differences in treatments and dosages between the groups with low and preserved LVEF. In 15% of cases where the drug dose was not increased, fear of adverse events was reported as the reason. CONCLUSION: The FUTURE survey showed a similar approach to HF treatment irrespective of LVEF. Compared with previous studies, we saw an improvement in the use of recommended HF drugs, especially beta-blockers. However, achievement of target doses could be improved.

Implantable cardioverter-defibrillators in France: practices and regional variability.

AIMS: The rates of cardiac defibrillator implantation (ICD) in Europe and within countries are heterogeneous. We examined the characteristics of ICD recipients and device implantation rates in France, with the goal of identifying patterns and regional differences in medical practices. METHODS AND RESULTS: We compiled the information available on devices and patients from a manufacturer's database for the years 2008 and 2009 and the Stidefix national registry from January 2008 to April 2010 and reported the descriptive statistics and comparisons of implantation practices among regions. We analysed data from 10 766 patients enrolled in Stidefix (mean age=63 ± 13 years; 83% men) after implantation of single-chamber (24%), dual-chamber (33%), or triple-chamber (43%) ICD. Implantation was for primary prevention in 63% of patients. Between 2008 and 2009, the national implant rate increased from 126 to 147 per million inhabitants, with regional variations related to the number of cardiologists and of implant centres. Patients were significantly older and more likely to undergo implantation for primary prevention or for cardiac resynchronization therapy (CRT) in higher-volume regions. In Ile de France (Paris and its suburbs), patients tended to be younger, as in low-implantation regions, but with a high rate of CRT implants, as in high-implantation regions. A comparison of the Stidefix data with the manufacturer's database revealed that only 57% of all ICD implanted in 2009 were reported to Stidefix. CONCLUSION: Despite an increasing rate of ICD implantation in France, important regional disparities persist, with a median position occupied by Ile de France.

Improvement in the management of chronic heart failure since the publication of the updated guidelines of the European Society of Cardiology. The Impact-Reco Programme.

AIMS: Recent studies have shown that prescription rates and doses of recommended drugs for chronic heart failure (CHF) are not optimal in daily practice. The aim of the Impact-Reco programme was to analyse prescription rates of CHF drugs in stable outpatients with CHF related to left ventricular (LV) systolic dysfunction in two similar surveys in France. METHODS AND RESULTS: The two surveys, which included 1917 and 1974 patients, were performed between September 2004 to March 2005 and September 2005 to May 2006, respectively. Prescription rates of angiotensin-converting enzyme-inhibitors (ACE-I) remained stable (71 vs. 68%, respectively), whereas the proportion of patients receiving angiotensin receptor blockers (21 vs. 30%, P < 0.0001) and beta-blockers (65 vs. 70% P < 0.0001) increased significantly. Doses of ACE-I and beta-blockers increased significantly between the two surveys. However, the improvement was of lesser magnitude in some subgroups of patients, such as elderly patients or patients with renal failure. CONCLUSION: The Impact-Reco programme found an improvement in prescription rates and in the dosage of neurohumoral antagonists in French outpatients with stable CHF. However, there is still room for improvement, especially regarding the doses of medications and the treatment of some subgroups of patients such as the elderly and patients with renal failure.

Predictors of long-term use of evidence-based therapies after non-ST-segment elevation acute coronary syndrome. The S-Témoin survey.

BACKGROUND: We evaluated correlates of prolonged use of evidence-based therapies in patients discharged after non-ST-segment elevation acute coronary syndrome (NSTE ACS). METHODS: 598 cardiologists enrolled 2443 patients at outpatient clinics 2-12 months after discharge for NSTE ACS. The use of cardiac medications for secondary prevention (antiplatelets, beta-blockers, angiotensin-converting enzymes, and statins) was evaluated. RESULTS: A total of 2386 (97.7%) patients were on either antiplatelet monotherapy (n=623, 26.1%) or combination therapy (n=1763, 73.9%) at follow-up. Combination antiplatelet therapy declined by 23 percentage points (82.3% to 59.4%) 9-12 months after discharge, whereas use of other cardiac medications remained constant or increased. After multivariable analysis, the strongest predictors of combination antiplatelet therapy were PCI with a stent (odds ratio [OR] 3.75, 95% confidence interval [CI] 2.12-6.67), drug-eluting stents (OR 3.25, 95% CI 1.73-6.08), late PCI (OR 3.21, 95% CI 2.12-4.87) and statins at discharge (OR 1.98, 95% CI 1.40-2.80). Among the independent predictors of beta-blocker and statin use were extent of coronary artery disease and cardiac medications prescribed at discharge. CONCLUSIONS: After NSTE ACS, implementation of recommendations on long-term use of evidence-based therapies depends largely on in-hospital management. A variety of clinical characteristics are also predictive of long-term use.