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Erratum inCorrection to: Cost-Effectiveness Evaluation of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Study.Mounié M, Costa N, Gourdy P, Latorre C, Schirr-Bonnans S, Lagarrigue JM, Roussel H, Martini J, Buisson JC, Chauchard MC, Delaunay J, Taoui S, Poncet MF, Cosma V, Lablanche S, Coustols-Valat M, Chaillous L, Thivolet C, Sanz C, Penfornis A, Lepage B, Colineaux H, Hanaire H, Molinier L, Turnin MC; Educ@dom Study Group, Benhamou PY, Rodier M, Ayon F, Puel-Olivier F, Fontaine S, Perron M, Arrivié J, Cousty-Pech F, Rouby C, Lafon F, Moura I.Diabetes Ther. 2022 May;13(5):1131-1132. doi: 10.1007/s13300-022-01248-6.PMID: 35316510 Free PMC article. No abstract available.; International audience; INTRODUCTION: Telemedicine programs using health technological innovation to remotely monitor the lifestyles of patients with type 2 diabetes (T2D) can improve glycaemic control and thus reduce the incidence of complications as well as management costs. In this context, an assessment was made of the 1-year and 2-year cost-effectiveness of the EDUC@DOM telemonitoring and tele-education program. METHODS: The EDUC@DOM study was a multicentre randomized controlled trial conducted between 2013 and 2017 that compared a telemonitoring group (TMG) to a control group (CG) merged with health insurance databases to extract economic data on resource consumption. Economic analysis was performed from the payer perspective, and direct costs and indirect costs were considered. The clinical outcome used was the intergroup change in glycated haemoglobin (HbA1c) levels from baseline. Missing economic data were imputed using multiple imputation, and fitted values from a generalized linear mixed model were used to calculate the incremental cost-effectiveness ratio (ICER). Bootstrapped 95% confidence ellipses were drawn in the cost-effectiveness plan. RESULTS: The main analysis included data from 256 patients: 126 in the TMG and 130 in the CG. Incremental costs over 1 and 2 years were equal to €2129 and €5101, respectively, in favour of the TMG. Once imputed and adjusted for confounding factors, the TMG trends to a 21% cost decrease over 1 and 2 years of follow-up (0.79 [0.58; 1.08], p = 0.1452 and 0.79 [0.61; 1.03], p = 0.0879, respectively). The EDUC@DOM program led to a €1334 cost saving and a 0.17 decrease in HbA1c over 1 year and a €3144 cost saving and a 0.14 decrease in HbA1c over 2 years. According to the confidence ellipse, EDUC@DOM was a cost-effective strategy. CONCLUSION: This study provides additional economic information on telemonitoring and tele-education programs to enhance their acceptance and promote their use. In the light of this work, the EDUC@DOM program is a cost-saving strategy in T2D management. TRIAL REGISTRATION: This trial was registered in the Clinical Trials Database on 27 September 2013 under no. NCT01955031 and bears ID-RCB no. 2013-A00391-44.

OBJECTIVE To compare the risk of severe adverse pregnancy complications in women with preexisting diabetes. RESEARCH DESIGN AND METHODS Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations or perinatal or neonatal death (primary end point) following treatment with insulin detemir (detemir) versus other basal insulins. RESULTS Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations or perinatal or neonatal death was similar between detemir (97.0%) and other basal insulins (95.5%) (crude risk difference 0.015 [95% CI −0.01, 0.04]; adjusted risk difference −0.003 [95% CI −0.03, 0.03]). The crude prevalence of one or more congenital malformations (major plus minor) was 9.4% vs. 12.6%, with a similar risk difference before (−0.032 [95% CI −0.064, 0.000]) and after (−0.036 [95% CI –0.081, 0.009]) adjustment for confounders. Crude data showed lower maternal HbA1c during the first trimester (6.5% vs. 6.7% [48 vs. 50 mmol/mol]; estimated mean difference −0.181 [95% CI −0.300, −0.062]) and the second trimester (6.1% vs. 6.3% [43 vs. 45 mmol/mol]; −0.139 [95% CI −0.232, −0.046]) and a lower prevalence of major hypoglycemia (6.0% vs. 9.0%; risk difference −0.030 [95% CI −0.058, −0.002]), preeclampsia (6.4% vs. 10.0%; −0.036 [95% CI −0.064, −0.007]), and stillbirth (0.4% vs. 1.8%; −0.013 [95% CI −0.024, −0.002]) with detemir compared with other basal insulins. However, differences were not significant postadjustment. CONCLUSIONS Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, preeclampsia, and stillbirth.

International audience; Objective: To investigate the efficacy of the Diabeloop Generation-1 (DBLG1) closed-loop system to control the hypoglycaemia induced by physical activity (PA) in real-life conditions.Methods: This was a post-hoc analysis of the Diabeloop WP7 multicentre randomized controlled trial. Glycaemic outcomes were compared between days with and without PA in 56 patients with type 1 diabetes (T1D) using DBLG1 for 12 weeks. After the patient announces a PA, DBLG1 reduces insulin delivery and, if necessary, calculates the amount of preventive carbohydrates (CHO).Results: Daily time spent in the interstitial glucose range

Pregnancy after gastric bypass (RYGB) surgery remains at high risk for gestational diabetes mellitus, prematurity, and small for gestational age infants (SGA). Our objective was to describe the interstitial glucose (IG) profiles and weight changes during such pregnancies, and the association of these factors with adverse pregnancy outcomes. One hundred twenty two pregnancies were analyzed in a monocentric retrospective study. IG profiles were evaluated by continuous glucose monitoring for 4 days. Maternal (hypertension, hospitalizations, and caesarean section) and neonatal outcomes (prematurity, weight for gestational age, hospitalizations, and malformations) were recorded. A logistic stepwise regression model assessed the influence of weight gain and impaired IG on pregnancy outcomes. Pregnancies occurred 33 (SD 21 months) after surgery. 73% of the women had IG abnormalities (55% with an increased % of time >140 mg/dl and 69% with an increased % of time 140 mg/dl and an excessive maternal weight gain. Prematurity was associated with a high % of time

Resume Les donnees concernant les alarmes des dispositifs de mesure continue du glucose sont peu nombreuses dans la litterature. L’objectif de cette etude etait d’obtenir un consensus sur les avantages et inconvenients des alarmes de seuil de glucose a travers un panel Delphi. Cette methode est un outil d’aide a la decision permettant de rassembler des avis d’experts sur un sujet precis. De nombreux benefices des alarmes ont ete demontres, pour le patient, lui permettant un meilleur controle de sa maladie, ou pour son entourage qui se sent rassure, et egalement dans de nombreuses situations du quotidien : au travail, a l’ecole et pendant le sport. Ces benefices sont a mettre en perspective avec les inconvenients que peuvent engendrer les alarmes. Trop nombreuses, elles peuvent gener le patient, le decourager ou entrainer une prise de decision inadaptee. Enfin, l’optionalite de l’alarme apparait essentielle, car elle permet l’adaptation aux besoins particuliers du patient.

Introduction The impact of flash glucose monitoring technology on HbA1c in type 2 diabetes managed by basal bolus insulin is uncertain. Three parallel European retrospective non-interventional chart review studies collected data reported in medical records. Each country’s study aim was to determine the effectiveness of the device on HbA1c when used by their population for 3–6 months as their standard of care for management of glycaemia in a real-world setting. Methods Medical records were eligible for adult patients with type 2 diabetes, on a basal bolus insulin regimen for 1 year or more, device use for 3 months or more before the start of the study, an HbA1c concentration up to 3 months prior to starting device use (patients were using blood glucose monitoring for self-management) between 64 and 108 mmol/mol (8.0–12.0%) plus an HbA1c determination 3–6 months after commencing flash glucose monitoring use. Results Records were analysed from 18 medical centres in Austria (n = 92), France (n = 88) and Germany (n = 183). Baseline HbA1c results, recorded up to 90 days before the start of device use, were comparable across the three countries and were reduced significantly by 9.6 ± 8.8 mmol/mol mean ± SD (Austria [0.9 ± 0.8%], p

Aims To compare closed-loop (CL) and open-loop (OL) systems for glycaemic control in patients with type 1 diabetes (T1D) exposed to real-life challenging situations (gastronomic dinners or sustained physical exercise). Methods Thirty-eight adult patients with T1D were included in a three-armed randomized pilot trial (Diabeloop WP6.2 trial) comparing glucose control using a CL system with use of an OL device during two crossover 72-hour periods in one of the three following situations: large (gastronomic) dinners; sustained and repeated bouts of physical exercise (with uncontrolled food intake); or control (rest conditions). Outcomes included time in spent in the glucose ranges of 4.4-7.8 mmol/L and 3.9-10.0 mmol/L, and time in hypo- and hyperglycaemia. Results Time spent overnight in the tight range of 4.4 to 7.8 mmol/L was longer with CL (mean values: 63.2% vs 40.9% with OL; P ≤ .0001). Time spent during the day in the range of 3.9 to 10.0 mmol/L was also longer with CL (79.4% vs 64.1% with OL; P ≤ .0001). Participants using the CL system spent less time during the day with hyperglycaemic excursions (glucose >10.0 mmol/L) compared to those using an OL system (17.9% vs 31.9%; P ≤ .0001), and the proportions of time spent during the day with hyperglycaemic excursions of those using the CL system in the gastronomic dinner and physical exercise subgroups were of similar magnitude to those in the control subgroup (18.1 ± 6.3%, 17.2 ± 8.1% and 18.4 ± 12.5%, respectively). Finally, times spent in hypoglycaemia were short and not significantly different among the groups. Conclusions The Diabeloop CL system is superior to OL devices in reducing hyperglycaemic excursions in patients with T1D exposed to gastronomic dinners, or exposed to physical exercise followed by uncontrolled food and carbohydrate intake.

Summary: Background: Closed-loop insulin delivery systems are expected to become a standard treatment for patients with type 1 diabetes. We aimed to assess whether the Diabeloop Generation 1 (DBLG1) hybrid closed-loop artificial pancreas system improved glucose control compared with sensor-assisted pump therapy. Methods: In this multicentre, open-label, randomised, crossover trial, we recruited adults (aged ≥18 years) with at least a 2 year history of type 1 diabetes, who had been treated with external insulin pump therapy for at least 6 months, had glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol), and preserved hypoglycaemia awareness. After a 2-week run-in period, patients were randomly assigned (1:1) with a web-based system in randomly permuted blocks of two, to receive insulin via the hybrid closed-loop system (DBLG1; using a machine-learning-based algorithm) or sensor-assisted pump therapy over 12 weeks of free living, followed by an 8-week washout period and then the other intervention for 12 weeks. The primary outcome was the proportion of time that the sensor glucose concentration was within the target range (3·9–10·0 mmol/L) during the 12 week study period. Efficacy analyses were done in the modified intention-to-treat population, which included all randomly assigned patients who completed both 12 week treatment periods. Safety analyses were done in all patients who were exposed to either of the two treatments at least once during the study. This trial is registered with ClinicalTrials.gov, number NCT02987556. Findings: Between March 3, 2017, and June 19, 2017, 71 patients were screened, and 68 eligible patients were randomly assigned to the DBLG1 group (n=33) or the sensor-assisted pump therapy group (n=35), of whom five dropped out in the washout period (n=1 pregnancy; n=4 withdrew consent). 63 patients completed both 12 week treatment periods and were included in the modified intention-to-treat analysis. The proportion of time that the glucose concentration was within the target range was significantly higher in the DBLG1 group (68·5% [SD 9·4] than the sensor-assisted pump group (59·4% [10·2]; mean difference 9·2% [95% CI 6·4 to 11·9]; p

CONTEXT While the only curative treatment for patients with endogenous hypoglycaemia related to inappropriate insulin or to insulin growth factor 2 (IGF2) secretion is surgery, medical treatment to normalize plasma glucose levels can be useful. OBJECTIVE The aim of this prospective single centre study was to assess whether patients with endogenous hypoglycaemia, considered euglycaemic with medical treatments, experienced asymptomatic hypo- or hyperglycaemic excursions. PATIENTS AND METHODS All patients with endogenous hypoglycaemia related to inappropriate insulin or to IGF2 secretion between 2012 and 2016 and considered normoglycaemic with medical treatment (absence of clinical hypoglycaemia and self-monitoring blood glucose in the normal range) were enroled and underwent a six-day continuous glucose monitoring (CGM) recording. RESULTS Twenty-seven patients (inappropriate insulin secretion n = 25 and IGF2 secretion n = 2), treated with diazoxide (n = 16), somatostatin analogues (n = 7), glucocorticoids (n = 3) or a combination of these treatments (n = 1) were enroled. Twenty-five CGMs were analysed. CGM confirmed normoglycaemia in 11/25 patients (44%). Hypoglycaemias below 0.60 g/L were present in seven patients (28%) and were associated with hyperglycaemic excursions above 1.40 g/L in five patients. Seven patients (28%) had only hyperglycaemic excursions. Based on these results, treatment was modified in 14 patients (56%). CONCLUSION Despite the disappearance of hypoglycaemia-related clinical symptoms and normalization of blood glucose self-monitoring data, 56% of the patients with endogenous hypoglycaemia treated with medical therapy experienced asymptomatic hypo- and/or hyperglycaemia. Continuous glucose monitoring could be a useful approach to reveal and prevent hypo- or hyperglycaemic excursions.

Benefits of telemedicine have been proven in the field of diabetes. Among a number of technical solutions, Diabeo® has been studied in both type 1 and type 2 diabetes with intensive insulin therapy. This digital therapeutic system contains a self-monitoring glucose logbook and offers automated insulin dose recommendations thanks to a fully customizable algorithm. In addition, the cloud-based dedicated software also has features to facilitate remote monitoring, including a platform for diabetes nurses who perform coaching and treatment adjustment. A detailed description of this telemedicine system is provided, as well as results of completed clinical studies. In particular, TeleDiab 1’s positive results on HbA1c in type 1 diabetes are detailed. We conclude with a discussion of the role of this telemedicine system within the landscape of mobile apps for diabetes.

Type 1 diabetes mellitus (T1DM) is associated with a high risk of cardiovascular (CV) complications, even after controlling for traditional CV risk factors. Therefore, determinants of the residual increased CV morbidity and mortality remain to be discovered. This prospective cohort of people living with T1DM in France (SFDT1) will include adults and children aged over six years living with T1DM, recruited throughout metropolitan France and overseas French departments and territories. The primary objective is to better understand the parameters associated with CV complications in T1DM. Clinical data and biobank samples will be collected during routine visits every three years. Data from connected tools, including continuous glucose monitoring, will be available during the 10-year active follow-up. Patient-reported outcomes, psychological and socioeconomic information will also be collected either at visits or through web questionnaires accessible via the internet. Additionally, access to the national health data system (Health Data Hub) will provide information on healthcare and a passive 20-year medico-administrative follow-up. Using Health Data Hub, SFDT1 participants will be compared to non-diabetic individuals matched on age, gender, and residency area. The cohort is sponsored by the French-speaking Foundation for Diabetes Research (FFRD) and aims to include 15,000 participants.

International audience; Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes. To improve access to this innovation for both patients and healthcare professionals (HCPs), and to promote adherence to its requirements in terms of safety, regulations, ethics and practice, the French Diabetes Society (SFD) brought together a French Working Group of experts to discuss the current practical consensus. The result is the present statement describing the indications for CL therapy with emphasis on the idea that treatment expectations must be clearly defined in advance. Specifications for expert care centres in charge of initiating the treatment were also proposed. Great importance was also attached to the crucial place of high-quality training for patients and healthcare professionals. Long-term follow-up should collect not only metabolic and clinical results, but also indicators related to psychosocial and human factors. Overall, this national consensus statement aims to promote the introduction of marketed CL devices into standard clinical practice.

Aims: To examine clinical parameters, glycemic control, folic acid supplementation, and the presence of other chronic diseases during early pregnancy in the EVOLVE study population (women with pre-existing diabetes treated with injectable glucose-lowering drugs). Methods: Cross-sectional baseline evaluation of EVOLVE: an international, multicenter, non-interventional study investigating the safety of injectable glucose-lowering drugs in pregnant women with pre-existing type 1 (T1D) or type 2 diabetes (T2D). Data were collected at enrollment visit interviews before gestational week 16. Results: In total, 2383 women from 17 mainly European countries were enrolled in the study: 2122 with T1D and 261 with T2D; mean age was 31 and 33 years, and duration of diabetes was 15 and 6 years, respectively. For women with T1D or T2D, 63% and 75%, respectively, received basal and rapid-acting insulin, 36% and 3% rapid-acting insulin only, 0.7% and 14.0% basal insulin only, 0.2% and 5.4% premix insulin, 0.0% and 1.2% injectable glucagon-like peptide-1 receptor agonist treatment without insulin. In women with T1D or T2D, respectively, during early pregnancy, 59% and 62% had HbA1c 40% of women had ≥1 chronic concomitant condition (predominantly thyroid disease or hypertension). Retinopathy was the most commonly reported diabetic complication. The most commonly reported previous pregnancy complication was miscarriage. Conclusions: Baseline data from this large multinational population of women with pre-existing diabetes indicate that sub-optimal glycemic control, poor pregnancy planning, and chronic concomitant conditions were common in early pregnancy.

Medico-economic data of patients suffering from chronic nausea and vomiting are lacking. In these patients, gastric electrical stimulation (GES) is an effective, but costly treatment. The aim of this study was to assess the efficacy, safety and medico-economic impact of Enterra therapy in patients with chronic medically refractory nausea and vomiting.Data were collected prospectively from patients with medically refractory nausea and/or vomiting, implanted with an Enterra device and followed for two years. Gastrointestinal quality of life index (GIQLI) score, vomiting frequency, nutritional status and safety were evaluated. Direct and indirect expenditure data were prospectively collected in diaries.Complete clinical data were available for142 patients (60 diabetic, 82 non-diabetic) and medico-economic data were available for 96 patients (36 diabetic, 60 non-diabetic), 24 months after implantation. GIQLI score increased by 12.1 ± 25.0 points (p.001), with a more significant improvement in non-diabetic than in diabetic patients (+15.8 ± 25.0 points, p.001 versus 7.3 ± 24.5 points, p = .027, respectively). The proportion of patients vomiting less than once per month increased by 25.5% (p.001). Hospitalisations, time off work and transport were the main sources of costs. Enterra therapy decreased mean overall healthcare costs from 8873 US$ to 5525 US$ /patient/year (p = .001), representing a saving of 3348 US$ per patient and per year. Savings were greater for diabetic patients (4096 US$ /patient/year) than for non-diabetic patients (2900 US$ /patient/year).Enterra therapy is an effective, safe and cost-effective option for patients with refractory nausea and vomiting.gov Identifier: NCT00903799.

Background: The DIABEO® system (DS) is a telemedicine solution that combines a mobile app for patients with a web portal for health care providers. DS allows real-time monitoring of basal-bolus insulin therapy as well as therapeutic decision-making, integrating both basal and bolus dose calculation. Real-life studies have shown a very low rate of use of mobile health applications by patients. Therefore, we conducted a large randomized controlled trial study to investigate the efficacy of DS in conditions close to real life (TELESAGE study). Methods: TELESAGE was a multicenter, randomized, open study with three parallel arms: arm 1 (standard care), arm 2 (DIABEO alone), and arm 3 (DIABEO+telemonitoring by trained nurses). The primary outcome assessed the reduction in HbA1c levels after a 12-month follow-up. Results: Six hundred sixty-five patients were included in the study. Participants who used DIABEO once or more times a day (DIABEO users) showed a significant and meaningful reduction of HbA1c versus standard care after a 12-month follow-up: mean difference −0.41% for arm 2—arm 1 (P = 0.001) and −0.51% for arm 3—arm 1 (P ≤ 0.001). DIABEO users included 25.1% of participants in arm 2 and 37.6% in arm 3. In the intention-to-treat population, HbA1c changes and incidence of hypoglycemia were comparable between arms. Conclusions: A clinical and statistically significant reduction in HbA1c levels was found in those patients who used DIABEO at least once a day.

There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis.For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 μs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes.During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P.001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P.01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life.In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.

Resume Cinq etudes controlees de plus d'un mois et deux meta-analyses ont etabli l'efficacite et la securite de l'insulinotherapie continue en boucle fermee, chez l'adulte ou l'enfant de plus de 5 ans atteint de diabete de type 1. Le temps passe dans la bonne cible glycemique (70-180 mg/dL) augmente de 2 a 3 heures par jour, et le temps passe en hypoglycemie est reduit de moitie, soit de 20 a 30 minutes par jour. Ce traitement revolutionnaire est mur pour sa mise sur le marche. Des propositions en matiere d'indications, de modalites d'initiation, de formation des patients et des professionnels de sante, de surveillance, sont ici exposees.

Le cadre juridique des pratiques en sante va etre adapte aux progres de la science et de la technologie avec notamment l’encadrement des tests genetiques, des diagnostics preconceptionnels, la maitrise de l’impact de la revolution numerique, la tracabilite des donnees collectees en masse, la redefinition du consentement eclaire du patient face a des systemes complexes, le recadrage des recherches sur l’embryon.

Despite the availability of a large number of therapeutic options throughout the world, rates of optimal glycaemic control in adult patients with type 2 diabetes mellitus remain low. Delays in treatment intensification to insulin and low adherence to insulin regimes, which are well-documented contributors to poor glycaemic control, are in many cases driven by fear of hypoglycaemic events, weight gain and injections. Over the last 10 years, injectable glucagon-like peptide-1 receptor agonists (GLP1-RAs) have emerged as alternatives to basal insulin for treatment intensification in patients inadequately controlled with oral antidiabetic drugs. As a class, GLP1-RAs are associated with weight loss and fewer hypoglycaemic events than insulin. In addition, some of them are available in once-a-week formulations and therefore require fewer injections. However, as randomized controlled trials are not representative of everyday practice, physicians should consider the results of real-life studies to guide their treatment decisions. In this review, while significant variations in efficacy, tolerability and adherence data were noted from one study to another, rates of glycaemic control overall were low. Indeed, our present analysis has suggested that regular re-evaluations of treatment, including response, tolerability, adherence, cost and quality of life, are necessary.

Three retrospective chart review studies evaluated the effectiveness of the FreeStyle Libre Flash Glucose Monitoring SystemTM on HbA1c when used by adults with type 2 diabetes (T2DM) as their standard of care in a real-world setting. Each study aimed to determine the effect of FreeStyle Libre when used for between 3 months to 6 months on HbA1c. Each study population included adults on a basal-bolus insulin regimen for at least 1 year who had been using FreeStyle Libre regularly for at least 3 months (either self-funded or prescribed) and with HbA1c between 8.0 and 12.0% (64 to 108 mmol/mol). Pregnant patients were excluded, as were patients on dialysis. This meta-analysis comprised of a total of 363 records from insulin using patients with T2DM from 18 medical centres in Austria, France and Germany. On average, HbA1c was 8.9±0.9% (73.3±9.8 mmol/mol) prior to FreeStyle Libre use, age was 63.5±11.0 years and average duration of insulin use 8.3±5.8 years (mean±SD), 67.8% of patients were on oral antidiabetic medications (metformin, SU, TZD, DPP-4 or SGLT2) and 56.4% were male. CVD, renal and retinopathy complications were reported by 36.4%, 33.9% and 19.6% of patients, respectively. HbA1c results were recorded between 90 and 194 days from the start of use of FreeStyle Libre, between January 2015 and August 2018. Overall mean change in HbA1c, after at least 3 months of using FreeStyle Libre, was significantly reduced by 0.9±0.05% (mean±SE); p Disclosure J. Kroeger: Board Member; Self; Abbott. Consultant; Self; Abbott. P. Fasching: None. H. Hanaire: Research Support; Self; Abbott, Eli Lilly and Company, LifeScan, Inc., Novo Nordisk A/S. Other Relationship; Self; Eli Lilly and Company, Novo Nordisk A/S.

This retrospective, real-world, chart review study determined the effectiveness of the FreeStyle Libre Flash Glucose Monitoring SystemTM on HbA1c when used by adults with type 2 diabetes (T2DM) as their standard of care in a real-world setting for between 3 months to 6 months. The study population included adults on a basal-bolus insulin regimen for at least 1 year, with HbA1c between 8.0 and 12.0% (64 to 108 mmol/mol), who had been prescribed and using FreeStyle Libre regularly for at least 3 months. Pregnant patients were excluded, as were patients on dialysis. A total of 88 records from insulin using patients with T2DM from 6 hospital sites in France were included in this chart review. On average, HbA1c was 9.0±0.9% (74.7±9.7 mmol/mol), prior to FreeStyle Libre use, age was 64.4±10.6 years, BMI was 32.9±5.5 kg/m2 and average duration of insulin use 9.9±6.4 years (mean±SD), 24.1% were CSII users, 58.0% of patients were on oral antidiabetic medications (metformin, SU or DPP-4) in addition to basal-bolus and 56.8% were male. CVD, renal and retinopathy complications were reported by 40.9%, 37.5% and 37.5% of patients, respectively. HbA1c results were recorded between 91 to 183 days from the start of use of FreeStyle Libre, between May 2017 and July 2018. To minimise selection bias records were selected on a systematic basis. After at least 3 months of using FreeStyle Libre, HbA1c (primary outcome) was significantly reduced by 0.8±1.1% (mean±SD); p Disclosure H. Hanaire: Research Support; Self; Abbott, Eli Lilly and Company, LifeScan, Inc., Novo Nordisk A/S. Other Relationship; Self; Eli Lilly and Company, Novo Nordisk A/S. P.Y. Benhamou: Board Member; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi. Consultant; Self; Abbott. C. Bures: Employee; Self; Abbott Laboratories. Employee; Spouse/Partner; Alere Inc. S. Favre: None. S. Fendri: None. M. Joubert: Board Member; Self; Abbott, Air Liquide, AstraZeneca, Lilly Diabetes, Medtronic, Novo Nordisk A/S. Consultant; Self; Voluntis France. Research Support; Self; Boehringer Ingelheim International GmbH. Speaker’s Bureau; Self; Amgen Inc., LifeScan, Inc., Merck Sharp & Dohme Corp., Sanofi.

Resume L'utilisation optimale des insulines developpees au xxe siecle a fait appel a des competences multiples : physiologie, avec la mise au point des principes de l'insulinotherapie fonctionnelle ; technologie, avec l'optimisation des pompes a insuline et le developpement des capteurs de glucose ; communication et education therapeutique, avec l'introduction de la telemedecine et telesurveillance ; intelligence artificielle (IA), avec l'avenement des boucles fermees (BF). Ces performances technologiques ont permis des progres tres significatifs sur le controle metabolique du diabete. L'avenir dira si cela se traduit en termes qualitatifs, et sur le pronostic des patients. Face a ces progres techniques impressionnants, la question de l'organisation optimale des soins demeure cruciale : delivrer le meilleur soin disponible a tous ceux qui en relevent dans les meilleurs delais devrait etre le prochain defi.

Introduction Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG). Methods This open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction. Results Participants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: −3.1 ± 0.75 mmol/mol, [−0.29 ± 0.07% (mean ± SE)] and −3.4 ± 1.04 mmol/mol (−0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged

Introduction : Les couts lies au diabete de type 2 (DT2) et a ses complications sont en progression constante en France. Ces couts sont particulierement eleves chez certains patients traites par insuline. L’etude de leur dynamique avant et apres l’initiation de l’insulinotherapie permet d’apprehender les raisons de cette situation.Methode : Une analyse des donnees de l’Echantillon generaliste de beneficiaires de l’Assurance maladie a identifie les patients DT2 ayant beneficie de l’initiation d’un traitement par insuline en 2011 et 2012. Les consommations de soins ont ete evaluees et comparees sur trois annees avant et une annee apres cette initiation.Resultats : L’analyse a porte sur 1 233 patients DT2 du regime general. Le passage a l’insuline s’accompagne d’une augmentation du montant moyen annuel de soins presentes au remboursement, d’environ 3 650 € pour atteindre 11 000 €/an (schema avec insuline basale seule). Trois postes representent 86 % de l’augmentation observee (hospitalisations 29 %, soins infirmiers 44 %, dispositifs medicaux 13 %). L’augmentation est surtout importante chez les patients beneficiant de soins infirmiers reguliers sur une longue duree (> 90 jours) apres l’initiation et dans une moindre mesure chez les patients hospitalises.Conclusion : L’augmentation des couts ne peut pas etre imputee uniquement a la prescription d’insuline. On peut penser que toute initiative visant a favoriser l’acquisition de l’autonomie du patient pourrait reduire les couts observes apres le passage a l’insuline si elle est adaptee a la nature de la demande, au profil medico-social du patient, a son parcours et aux ressources medicales qui l’entourent.

Background After Roux-en-Y gastric bypass (RYGB), hypoglycemia can occur and be associated with adverse events such as intense malaise and impaired quality of life. Objective To compare insulin secretion, sensitivity, and clearance between two groups of patients, with or without hypoglycemia, after an oral glucose tolerance test (OGTT 75-g), and also to compare real-life glucose profiles within these two groups. Setting Bariatric surgery referral center. Methods This study involves a prospective cohort of 46 consecutive patients who complained of malaise compatible with hypoglycemia after RYGB, in whom an OGTT 75-g was performed. A plasma glucose value of lower than 2.8 mmol/L (50 mg/dl) between 90 and 120 min after the load was considered to be a significant hypoglycemia. The main outcome measures were insulin sensitivity, beta-cell function, and glycemic profiles during the test. Glucose parameters were also evaluated by continuous glucose monitoring (CGM) in a real-life setting in 43 patients. Results Twenty-five patients had plasma glucose that was lower than 2.8 mmol/L between 90 and 120 from the load (HYPO group). Twenty-one had plasma glucose that was higher than 2.8 mmol/L (NONHYPO group). The HYPO patients were younger, had lost more weight after RYGB, were less frequently diabetic before surgery, and displayed higher early insulin secretion rates compared with the NONHYPO patients after the 75-g OGTT, and they had lower late insulin secretion rates. The HYPO patients had lower interstitial glucose values in real life, which suggests that a continuum exists between observations with an oral glucose load and real-life interstitial glucose concentrations. Conclusions This study suggests that HYPO patients after RYGB display an early increased insulin secretion rate when tested with an OGTT. CGM shows that HYPO patients spend more time below 3.3 mmol/L when compared with NONHYPO patients. This phenotype of patients should be monitored carefully after RYGB.

Continuous glucose monitoring (CGM) and sensor-augmented pump (SAP) therapy improve glucose control provided good adherence. In France, not only diabetologists, nurses, and dieticians but also nurses employed by homecare providers (HCPNs) are together involved in the initiation and/or follow-up of continuous subcutaneous insulin injection (CSII) and SAP training. The SENLOCOR Study is an observational study designed to assess SAP adherence over 6 months (primary objective). Secondary objectives included the impact of SAP on metabolic control and patients' satisfaction.CGM initiation (M0) was performed within 3 months after CSII. CGM adherence, defined by sensor wear70% of the time, glycated hemoglobin (HbA1c) levels, and satisfaction questionnaires were collected at inclusion and at 3 (M3) and 6 (M6) months.The analysis population was 234 patients, including 27 children. Of the physicians, 88.0% were involved in SAP education for the whole cohort (median time, 45 min), whereas HCPNs were involved in CGM training for 190 patients (81.2%) (median time: at M0, 156 min; at M3, 20 min). Good adherence was obtained in 86.1% (M0-M3) and 68.9% (M3-M6) of the patients. The HbA1c level decreased from 8.16 ± 1.35% (M0) to 7.67 ± 1.01% (M6) in 189 patients (change, -0.48%; 95% confidence interval, -0.64, -0.33). The percentage of patients who experienced severe hypoglycemia decreased from 20.7% (M0) to 13.6% (M3) and 13.3% (M6). Satisfaction scores were high.In patients with type 1 diabetes, a 6-month training on SAP involving a multidisciplinary team, and especially HCPNs, improved metabolic control with a high level of adherence and satisfaction.

Sensor-augmented pump therapy (SAP) provides a useful adjunct relative to continuous subcutaneous insulin infusion (CSII) alone. It can provide early warning of the onset of hyperglycemia and hypoglycemia and has the functionality to suspend insulin delivery if sensor glucose levels fall below a predefined threshold. The aim was to assess the cost-effectiveness of SAP with low glucose suspend (LGS) versus CSII alone in type 1 diabetes.Cost-effectiveness analysis was performed using the CORE Diabetes Model, using published clinical input data. The analysis was performed in two cohorts: one with uncontrolled glycated hemoglobin at baseline and one at elevated risk for hypoglycemic events. The analysis was conducted from a healthcare payer perspective over a lifetime time horizon; future costs and clinical outcomes were discounted at 4% per annum.In patients with uncontrolled glycated hemoglobin at baseline, SAP + LGS resulted in improved discounted quality-adjusted life expectancy (QALE) versus CSII (10.55 quality-adjusted life-years [QALYs] vs. 9.36 QALYs) but higher mean lifetime direct costs (€84,972 vs. €49,171) resulting in an incremental cost-effectiveness ratio (ICER) of €30,163 per QALY gained. In patients at elevated risk for hypoglycemia, the ICER was €22,005 per QALY gained for SAP + LGS versus CSII as lifetime costs were higher (€88,680 vs. €57,097), but QALE was also higher (18.46 QALYs vs. 18.30 QALYs).In France, projected improvements in outcomes with SAP + LGS versus CSII translated into an ICER generally considered as good value for money, particularly in patients who experience frequent and/or problematic hypoglycemic events.

Because type 2 diabetes (T2D) is related to obesity, it is often associated with obstructive sleep apnoea syndrome (OSAS), although OSAS is also frequently diagnosed in patients with type 1 diabetes (T1D) and may promote gestational diabetes. Thus, this systematic review of the scientific evidence aimed to evaluate the epidemiological association between OSAS and all forms of diabetes, the current understanding of the pathophysiological mechanisms behind these associations, the expected benefits and limitations of OSAS treatment in patients with diabetes and, finally, to propose which patients require screening for OSAS.A panel comprising French expert endocrinologists and pneumologists was convened. Two of these experts made a search of the relevant literature for each subpart of the present report; all panel experts then critically reviewed the entire report separately as well as collectively.There is little evidence to support the notion that OSAS treatment improves glycated haemoglobin, although it may improve nighttime blood glucose control and insulin sensitivity. However, there is robust evidence that OSAS treatment lowers 24-h blood pressure.The high prevalence of OSAS in patients with T1D and T2D justifies screening for the syndrome, which should be based on clinical symptoms, as the benefits of OSAS treatment are mainly improvement of symptoms related to sleep apnoea. There are also several clinical situations wherein screening for OSAS seems justified in patients with diabetes even when they have no symptoms, particularly to optimalize control of blood pressure in cases of resistant hypertension and microvascular complications.

International audience

AIM: To assess whether periodontal treatment can lead to clinical, glycaemic control and quality of life improvements in metabolically unbalanced diabetic patients (type 1 or type 2) diagnosed with periodontitis. METHODS: In this open-labelled randomized controlled trial, diabetic subjects (n = 91) were given "immediate" or "delayed" periodontal treatment (full-mouth non-surgical scaling and root planing, systemic antibiotics, and oral health instructions). The main outcome was the effect on glycated haemoglobin (HbA1C ) and fructosamine levels. The General Oral Health Assessment Index and the SF-36 index were used to assess quality of life (QoL). RESULTS: Periodontal health significantly improved after periodontal treatment (p < 0.001). Periodontal treatment seemed to be safe but had no significant effects on glycaemic control based on HbA1C (adjusted mean difference with a 95% confidence interval (aMD) of 0.04 [-0.16;0.24]) and fructosamine levels (aMD 5.0 [-10.2;20.2]). There was no obvious evidence of improvement in general QoL after periodontal treatment. However, there was significant improvement in oral health-related QoL (aMD 7.0 [2.4;11.6], p = 0.003). CONCLUSION: Although periodontal treatment showed no clinical effect on glycaemic control in this trial, important data were provided to support periodontal care among diabetic patients. Periodontal treatment is safe and improves oral health-related QoL in patients living with diabetes. ISRCTN15334496.

While either pancreas or pancreatic islet transplantation can restore endogenous insulin secretion in patients with diabetes, no beta-cell replacement strategies are recommended in the literature. For this reason, the aim of this national expert panel statement is to provide information on the different kinds of beta-cell replacement, their benefit-risk ratios and indications for each type of transplantation, according to type of diabetes, its control and association with end-stage renal disease. Allotransplantation requires immunosuppression, a risk that should be weighed against the risks of poor glycaemic control, diabetic lability and severe hypoglycaemia, especially in cases of unawareness. Pancreas transplantation is associated with improvement in diabetic micro- and macro-angiopathy, but has the associated morbidity of major surgery. Islet transplantation is a minimally invasive radiological or mini-surgical procedure involving infusion of purified islets via the hepatic portal vein, but needs to be repeated two or three times to achieve insulin independence and long-term functionality. Simultaneous pancreas-kidney and pancreas after kidney transplantations should be proposed for kidney recipients with type 1 diabetes with no surgical, especially cardiovascular, contraindications. In cases of high surgical risk, islet after or simultaneously with kidney transplantation may be proposed. Pancreas, or more often islet, transplantation alone is appropriate for non-uraemic patients with labile diabetes. Various factors influencing the therapeutic strategy are also detailed in this report.

Objective: Availability of closed-loop insulin delivery systems is expected by patients with type 1 diabetes. Our main objective was to assess whether patients using the Diabeloop artificial pancreas system could achieve a better glucose control compared to sensor-assisted pump therapy, as measured by percentage time in range 70-180 mg/dl. Methods: A multicenter clinical trial was conducted in a home setting, using an MPC-based algorithm, a hybrid monohormonal system (CellNovo® pump and Dexcom G5® sensor) and centralised remote monitoring. Adult patients with T1D for ≥ 2 years, pump therapy for ≥ 6 months, HbA1c ≤ 10%, and preserved hypoglycemia awareness were included among 12 investigation centers. Design was a crossover trial with a 2-week run-in period, followed by 2 sequences of 12 weeks each separated with washout. Results of the first 12-week arm are reported. Results: 68 patients (27 men, age 47.2±13.4 years, HbA1c 7.6±0.9%, duration of disease 27.9±13.2 years) were randomised between closed-loop (CL, n=33) and open-loop (OL, n=35) first. During the first 12-week period, time spent in the 70-180 mg/dl range was 69.5% [62.4;75.6] in CL vs. 58.7% [45.2;64.9] in OL. Time in hypoglycaemia Conclusion: The Diabeloop closed-loop system was efficient regarding metabolic outcomes. Disclosure S. Franc: Consultant; Self; Animas Corporation, Roche Diabetes Care Health and Digital Solutions, Johnson & Johnson Diabetes Institute, LLC. P.Y. Benhamou: Consultant; Self; Abbott, Sanofi, Novo Nordisk Inc.. Other Relationship; Self; Eli Lilly and Company, Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Diabeloop S.A. S. Borot: Consultant; Self; Abbott, Animas Corporation, Johnson & Johnson Diabetes Institute, LLC., Medtronic, Roche Diabetes Care Health and Digital Solutions. L. Chaillous: None. B. Delemer: Other Relationship; Self; Sanofi-Aventis, Eli Lilly and Company. B. Guerci: None. H. Hanaire: Consultant; Self; Abbott, Animas Corporation, Johnson & Johnson Diabetes Institute, LLC., Medtronic, Roche Diabetes Care Health and Digital Solutions. N.M. Jeandidier: Board Member; Self; Sanofi-Aventis. E. Renard: Advisory Panel; Self; Abbott. Board Member; Self; Eli Lilly and Company, Insulet Corporation, Novo Nordisk A/S, Sanofi, Roche Pharma. Consultant; Self; Air Liquide. Research Support; Self; Roche Pharma, Dexcom, Inc., TypeZero Technologies, Inc.. Y. Reznik: None. P. Schaepelynck: Consultant; Self; Roche Diabetes Care Health and Digital Solutions. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Board Member; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Sanofi-Aventis, Abbott, Eli Lilly and Company. C. Thivolet: Advisory Panel; Self; Abbott, Sanofi-Aventis, Medtronic MiniMed, Inc. G. Charpentier: Consultant; Self; Abbott, Dexcom, Inc., Medtronic.

The impact of a 7-day real-time continuous glucose monitoring (RT-CGM) on type 1 diabetes (T1D) management remains unclear in patients suboptimally controlled by multiple daily injections (MDI). The DIACCOR Study aimed to describe treatment decisions and glucose outcomes after a short-term RT-CGM sequence.This French multicenter longitudinal observational study included T1D patients with HbA1c7.5% or history of severe hypoglycemia (SH) or recurrent documented hypoglycemia. A sensor was inserted at the inclusion visit, treatment changes were proposed by the investigator within 7-15 days ("INT" = MDI intensification, "CSII" = switch to continuous insulin infusion, or "ER" = educational reinforcement with no change in insulin regimen), and a 4-month follow-up visit (M4) was scheduled.Four hundred fifty-nine patients were recruited by 155 diabetologists, 17.0% had SH history, and 24.2% had recurrent hypoglycemia. Baseline HbA1c was 8.34% ± 1.21% (7.5% in 79.6%). Overall, 253 (64.4%), 64 (16.3%), and 76 patients (19.3%) were, respectively, included in the "INT," "CSII," and "ER" subgroups. The number of patients who experienced SH or recurrent hypoglycemia dropped dramatically (7.9% vs. 17.0% and 10.8% vs. 24.2%, respectively). The same trend was observed for ketoacidosis and ketosis (0.3% vs. 3.3% and 2.2% vs. 4.8%). At M4, HbA1c was significantly reduced in the whole cohort to 7.98% ± 1.01% (P 0.0001). The adjusted differences in HbA1c level in the INT, CSII, and ER subgroups were, respectively, -0.32%, -0.69%, and -0.50% (P 0.0001 for all).In real-life setting, a 1-week diagnostic RT-CGM supports appropriate treatment changes in patients with uncontrolled T1D resulting in better glucose control and less hypoglycemia.

Resume Les hypoglycemies apres une chirurgie de l’obesite sont parfois severes, mais rares, parfois seulement revelees par le monitoring de la glycemie, et alors plus frequentes. La variabilite des definitions dans les etudes plaide en faveur d’une definition unique, qui est celle de Whipple, avec une glycemie inferieure a 0,55 g/l. Les femmes, ayant perdu le plus de poids, avec un bypass gastrique, et longtemps apres cette intervention, non diabetiques avant la chirurgie, sont le plus a risque. Ces hypoglycemies sont hyperinsuliniques, par anomalies histologiques du pancreas (neisidioblastose), et/ou par stimulation de la secretion d’insuline par les incretines, dont le glucagon-like peptide-1 (GLP-1). L’absorption du glucose est a la fois acceleree et exageree du fait de la communication directe entre estomac et duodenum. C’est une exageration apres la chirurgie d’un phenomene d’adaptation qui existe chez les non operes a qui le glucose est infuse directement dans le duodenum. La semiologie des patients n’est pas toujours accompagnee des anomalies biologiques. Cependant, si l’hypoglycemie est severe et a symptomes neuroglucopeniques, l’hyperinsulinemie est constante. On evoque, pour les autres cas, la possibilite que le stress et l’exercice physique majorent la semiologie. Faute de mieux, le traitement consiste en mesures dietetiques : fractionner l’alimentation en 5 ou 6 repas, ralentir la vidange gastrique, reduire la charge glycemique et l’index glycemique des aliments, eviter le stress au moment du repas. L’acarbose est efficace, les autres traitements (insuline, glucagon, inhibiteurs calciques, sulfamides hyperglycemiants, analogues de la somatostatine, analogues du GLP-1) n’ont pas ete valides sur un nombre suffisant de sujets pour etre recommandes. Si l’option chirurgicale est finalement choisie, le demontage du bypass , ou le bandage de la petite poche, est assez efficace, la pancreatectomie partielle ne resout pas tous les cas. Ces options chirurgicales conduisent a une reprise de poids.

International audience; Rationale, aim, and objective: There are several ways to establish an accurate medication list in the hospital admission medication reconciliation (MedRec). The challenge for MedRec lies in the availability, reliability, and completeness of the data used. In France, the Electronic Pharmaceutical Record (ePR) was developed to register each medication taken by ambulatory patients, primarily to make dispensation in community pharmacies safe. We evaluated the suitability of this tool in the MedRec when patients were admitted to the hospital. Method: We conducted a 6-month pilot study of 249 MedRec files from a hospital diabetology department. The analysis was supplemented by the ePR for any patient for whom this information was recorded. The study evaluated the ePR as a new MedRec tool, as well as the clinical impact (CI) of the new data collected. Results: The ePR was contributory for 28% of the patients. Discrepancies were associated with polypharmacy, most of which had a CI = 1. Medication omission was the most frequently found discrepancy (72%), but self-medication (8%) and lack of medication adherence (9%) were also observed. Conclusion: This tool provided added value for reconciliation, as it quickly identifies regular medications, adherence, and self-medication behaviour. The ePR is essential for conducting a thorough MedRec.

Aim. The prevalence of cardiovascular autonomic neuropathy (CAN) in diabetes mellitus is well documented. However, the rate and predictors of both the development and progression of CAN have been less studied. Hereby, we assessed the rate and the major risk factors for CAN initiation and progression in a cohort of type 1 diabetic patients followed over a three-year period. Methods. 175 type 1 diabetic patients (mean age: 50 ± 11 years; female/male: 76/99) with positive bedside screening for CAN were included and underwent 2 standardized autonomic testings using 4 standardized tests (deep breathing, Valsalva maneuver, 30/15 ratio, and changes in blood pressure during standing), separated by 3 ± 1 years. CAN staging was achieved according to the Toronto Consensus Panel on Diabetic Autonomic Neuropathy into 4 categories: absent, possible, confirmed, or severe CAN. Results. Out of the 175 patients included, 31.4% were free of CAN, 34.2% had possible CAN, 24.6% had confirmed CAN, and 9.7% exhibited severe CAN at the first assessment. Among the 103 patients with nonsevere CAN at inclusion, forty-one (39.8%) had an increase of at least one category when reassessed and 62 (60.2%) remained stable. A bivariate analysis indicated that only BMI and exposure to selective serotonin reuptake inhibitors (SSRIs) were significantly different in both groups. A multivariate analysis indicated that lower BMI (OR: 0.15, CI 95%: 0.05-0.48, p = 0 003) and SSRI exposure (OR: 4.18, CI 95%: 1.03-16.97, p = 0 04) were the sole predictors of CAN deterioration. In the 55 patients negative for CAN at the first laboratory assessment, 12 became positive at the second assessment. Conclusion. No clear predictive factor for CAN onset was identified. However, once present, CAN progression was related to low BMI and SSRI exposure. Fil: Matta, M.. Centre Hospitalier Universitaire de Toulouse; Francia Fil: Pavy Le Traon, Anne. Institut des Maladies Métaboliques et Cardiovasculaires; Francia. Hôpital Pierre-Paul Riquet; Francia Fil: Pérez Lloret, Santiago. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Investigaciones Cardiológicas. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Investigaciones Cardiológicas; Argentina Fil: Laporte, C.. Centre Hospitalier Universitaire de Toulouse; Francia Fil: Berdugo, I.. Centre Hospitalier Universitaire de Toulouse; Francia Fil: Nasr, N.. Hôpital Pierre-Paul Riquet; Francia. Institut des Maladies Métaboliques et Cardiovasculaires; Francia Fil: Hanaire, H.. Centre Hospitalier Universitaire de Toulouse; Francia Fil: Senard, J. M.. Centre Hospitalier Universitaire de Toulouse; Francia. Institut des Maladies Métaboliques et Cardiovasculaires; Francia

BACKGROUND Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. OBJECTIVE Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. METHODS TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. RESULTS The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. CONCLUSIONS The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. CLINICALTRIAL ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd)

Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Objective: Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabetiques de type 1 et de type 2 sous schema insulinique basal bolus par la TELEmedecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. Methods: TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. Results: The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. Conclusions: The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. Trial Registration: ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd)