Abstracts from ATTD 20158th International Conference on Advanced Technologies & Treatments for DiabetesParis, France—February 18–21, 2015

Abstract

Diabetes Technology & TherapeuticsVol. 17, No. S1 AbstractsFree AccessAbstracts from ATTD 20158th International Conference on Advanced Technologies & Treatments for DiabetesParis, France—February 18–21, 2015Published Online:13 Feb 2015https://doi.org/10.1089/dia.2015.1525AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail ATTD 2015 Invited Speakers1 CSII IN TYPE 2 DIABETES: EVOLUTION OR REVOLUTION?Reznik Y.11Endocrinology and Diabetes, Caen University Hospital, Caen, FranceThe use of external pumps in patients with type 2 diabetes is a much more recent practice than for type 1 diabetes. In only a few countries, continuous subcutaneous insulin infusion (CSII) using an external pump is an alternative in type 2 diabetes that is reimbursed by health authorities. Very few randomized controlled studies have looked at the comparative effectiveness of CSII versus multiple daily injections (MDI) and until recently their results were controversial. Recent data from the randomized, open-label, controlled OPT2MISE trial have changed the approach of insulin intensification when multiple daily injections fail to reach the glycaemic targets. The study has demonstrated that pump therapy is beneficial for a group of patients who fail to respond to MDI after active insulin titration. Observational long term studies have also suggested the durability of pump efficacy in type 2 diabetes cohorts and have emphasized that complete autonomy with the device is not a prerequisite for obtaining the anti-hyperglycemic effect of pump therapy in these older populations. Careful selection of the good candidate is of paramount importance since it guarantees the anti-hyperglycemic action and the safety of pump therapy, as observed in randomized and real-life studies. This demonstration of the safety and efficacy of pump therapy offers a realistic treatment alternative for type 2 diabetes and opens to patients a new way for thriving with technology and devices aimed to prevent them from diabetes complications.2 THE IMPACT OF NEW TECHNOLOGY IN TYPE 2 DIABETESPozzilli P.11Endocrinology & Diabetes, University Campus Bio-Medico, Rome, ItalyRecent evidence from clinical trials indicates that technology applied to type 2 diabetes (T2D) can indeed be very useful to improve metabolic control in affected patients. The first study using CSII and published by Weng in the Lancet in 2008 demonstrated that the use of CSII may induce clinical remission and protect residual beta cell function. In a recent study published in 2014 in the Lancet it was shown that in patients with poorly controlled T2D despite using multiple daily insulin injections, pump treatment can be considered as a safe and valuable treatment option.Intensive glucose monitoring in T2D is also useful to improve metabolic control. In the PRISMA study published in Diabetes Care in 2013 we aimed to evaluate the added value of intensive self-monitoring of blood glucose (SMBG), structured in timing and frequency, in noninsulin-treated patients with T2D. The use of structured SMBG improves glycemic control and provides guidance in prescribing diabetes medications in patients with relatively well-controlled noninsulin-treated T2D.Barriers to use technology in T2D include older age in some patients and lack of proper patient education regarding the advantage of using technology in disease management. Diabetes technology is therefore an example of personalized medicine, which should be designed according to patient features and therapeutic target. This is particularly true for the new patch pumps, closed-loop insulin delivery systems and applications in nanomedicine.3 LATE COMPLICATIONS OF BARIATRIC SURGERYPories W.1,2, Pender J.1,2, Spaniolas K.1,2, Stefan D.1,2, Wohlgemuth S.1,2, Mozer A.1,2, Sippey M.1,2, Hounshell K.1,21Department of Surgery, Brody School of Medicine, East Carolina University, Greenville, NC2Sentara Comprehensive Weight Solutions, Norfolk, VATHREE DIMENSIONAL AND FUNCTIONAL QUANTIFICATION OF OBESITYBackground: The quantification of obesity has been limited by the unreliability of the Body Mass Index (BMI = Kg/M2) and the expense and X-ray exposures CT and DEXA scans. White light scanning, a technology that constructs a three dimensional avatar of the human body, permits, for the first time, the calculation of body surface area, volume and shape to relate these measures to the manifestations of the metabolic syndrome. The scans are safe and can be carried out with a patient, dressed in underclothes, in less than a minute.Methodology: Patients were scanned before and after bariatric surgery 1) to determine the accuracy of the methodology vs. body measurements by RN's, 2) to follow weight loss and body shape, 3) to assess the three dimensional shape of the lost fat, 4) to determine whether the surgery changed the shape of patients from “apple” to “pear” and 5) to identify whether the shapes of the patients could be correlated with expressions of the metabolic syndrome.Results: White light scanning 1) measures body circumference levels more accurately than nurses with tape 2) documents loss of adiposity following bariatric surgery in three dimensions 3) allows three dimensional representation of lost fat (Fig. 1), 4) documents that the body shape, i.e. “apple” vs. “pear” is not changed by bariatric surgery and 5) predicts the presence or absence of diabetes (p < 0.07), hypertension (p < 0.0007) and dyslipidemia (p < 0.07).Conclusions: White light scanning offers a new, inexpensive, rapid and safe technology to assess body shape, volume and surface area and to examine correlations between the relationships of fat distribution to the development of the metabolic syndrome.4 PSYCHOLOGICAL MEASURES USED IN DIABETES TECHNOLOGIES RESEARCHBarnard K.D.11Human Development and Health, University of Southampton, Southampton, United KingdomQuality of life (QoL) is widely recognized as an important health outcome in diabetes, where the burden of self-management is demanding. Optimal diabetes management goes beyond glycaemic control, with broader psychological factors having an important role to play. As such, psychosocial assessment is crucial. The devil is, of course, in the detail. What should we measure, how can we measure it, what will it tell us and how will that inform the regulatory approvals process and best clinical practice? These are all questions that will be addressed in my talk.In order to develop diabetes devices that are inclusive, accessible, effective, safe, and integrated into routine diabetes care with acceptance from people with diabetes requires a clearer view of outcomes other than glucose and key questions remain unanswered. Regulatory and commissioning bodies such as NICE and FDA expect psychosocial evaluation and outcomes to support the implementation of devices into routine care. Comparability across clinical trials is crucial in this regard. Transparent, robust, evidence-based and theory driven psychological assessment is required alongside engineering and biomedical evaluation. These issues will be addressed.5 REPORTING OF GLUCOSE CONTROL METRICSPreiser J.C.11Intensive Care, Erasme University Hospital, Brussels, BelgiumAfter one decade on intense clinical research on glycemic control in critically ill patients hospitalized in an Intensive Care Unit, several issues are still unanswered, including the optimal blood glucose target range in various categories of patients and the presence of causality between dysglycaemia and poor outcome. New technological developments, including intravascular or interstitial continuous glucoe monitoring and closed-loop systems for insulin titration require an evalaution of their reliability and clinical usefulness.The answers to these issues will need an accurate and uniform definition of the performance of glucose control, implying the use of standard metrics.This talk will describe the available indices of hyperglycaemia, hypoglycaemia and glycaemic variability that were used and validated in ICU patients. The adoption of uniform metrics will hopefully improve the quality of care, and will allow the estimation of the magnitude of outcome improvement when blood glucose can be maintained within a narrow range. Quite importantly, different therapeutic interventions will be unequivocally comparable, using a single metrics.6 GLUCOSE CONTROL IN THE ICU USING CONTINUOUS GLUCOSE MONITORING: WHAT LEVEL OF MEASUREMENT ERROR IS ACCEPTABLE?Wilinska M.E.1, Hovorka R.11Paediatrics, University of Cambridge, Cambridge, United KingdomSafe and efficacious glucose control in the intensive care unit (ICU) depends on accuracy and frequency of blood glucose measurements. Accuracy standards to determine adequate devices are subject of ongoing debate. At present, majority of glucose measurements in ICU are carried out intermittently using YSI, arterial blood gas analysers or point of care devices. Emerging continuous glucose monitors (CGM) offer potential benefits by providing frequent measurements, trending information, threshold and predictive alarms. These potential benefits need to be evaluated and documented. In this study we utilized a validated virtual population of the critically ill to contrast the outcomes from three established insulin titrating protocols informed by either continuous or intermittent glucose measurements. Results showed similar efficacy of CGM-informed and BG-informed protocols but lower risk of hypoglycaemia using CGM with MARD up to 10%. Type of protocol had a larger effect on glucose outcomes than the measurement method.7 PERIOPERATIVE GLUCOSE CONTROL IN CARDIAC SURGERY PATIENTS: ANOTHER POSSIBILITY TO IMPROVE THE OUTCOMES?Haluzik M.113rd Dept. of Medicine, 1st Faculty of Medicine and General University Hospital, Praha, Czech RepublicDuring the last two decades, the treatment of hyperglycemia in critically ill patients has become one of the most discussed topics in the intensive medicine field. The initial data suggesting significant benefit of normalization of blood glucose levels in all critically ill patients using intensive intravenous insulin therapy have been challenged or even neglected by some later studies. At the moment, the need for glucose control in critically ill patients is generally accepted yet the target glucose values are still the subject of ongoing debates. Current data suggest that certain subgroups of critically ill, in particular the cardiac surgery patients, may benefit from tight glucose control while this may not be generally true for other groups of critically ill patients. We have recently demonstrated that even short-term perioperative tight glucose control in cardiac surgery patients significantly reduced their morbidity suggesting the patophysiological importance of this parameter. The morbidity reduction in our study was primarily driven by improved morbidity in patients without previous history of diabetes while much less benefit could be seen in diabetics. Since increased risk of hypoglycemia appears to be the major obstacle of tight glucose control, the novel technological approaches including continuous glucose monitoring and its combination with computer-based algorithms may help to overcome some this hurdle. Additionally, a combination of insulin with other glucose lowering medications such as intravenously administered glucagon like peptide-1 agonists may improve glucose control without increasing the risk of hypoglycemia or other significant side effects. The benefits of these approaches need to be further tested not only in cardiac surgery patients but also in other subgroups of critically ill.Ackowledgements: Supported by RVO VFN64165.8 MARKET ACCESS OF ANTIDIABETICS IN GERMANY: ASSESSMENT OF ANTIDIABETICS BY THE FEDERAL JOINT COMMITTEE (G-BA)Petschulies M.1, Loebker W.11Pharmaceuticals department of the G-BA, GermanyDiabetes affects several million people in Germany and is a major contributor to the ever increasing spending in healthcare. This talk will give an overview of the reimbursement of antidiabetic drugs, blood glucose measurement devices and treatment appliances in Germany and which rules and regulations apply to them. Furthermore a brief introduction will be given to the structure and function of the G-BA, Germany's highest decision-making body in the statutory health insurance system. The early benefit assessment according to the AMNOG law (introduced in 2011) will also be presented as well as experiences with the assessment of new antidiabetic drugs since 2011, assessment criteria and some results of the G-BA assessment of new drugs. Thus far, the G-BA determined a minor additional benefit over the appropriate comparator in 4 out of 14 assessments, because a reduction of non-severe hypoglycemias was shown. As long-term data regarding mortality, cardiovascular morbidity and safety were not available, several resolutions of the G-BA were time-limited.9 DIADVISORRenard E.11Dept of Endocrinology Diabetes Nutrition, Montpellier University Hospital, Montpellier, FranceThe key goal of diabetes treatment is to maintain blood glucose (BG) at near to normal level. This is a demanding and difficult task for the individual patient and requires extensive support from Health Care Providers. The objective of the DIAdvisor Project, funded by a FP7 EC Grant, was to provide a medical device technology that minimises the diabetes-related burden to patients and to healthcare systems by increased patient empowerment. From a data base gathering information on glucose levels, insulin doses, food intakes, physical activity in a large series of patients with Type 1 or Type 2 diabetes treated by various insulin regimens, algorithms were developed aiming at prediction of glucose evolution at various horizons. Besides, a controller was connected to the prediction algorithms in order to deliver online advices to the patients aiming at the reduction of out-of-range glucose excursions. A wearable tablet platform was developed to collect continuous glucose monitoring inputs, compute predicted glucose evolution and deliver advices when needed, also serving as patient interface with the system so that insulin doses and food intakes could be introduced by the patient. After two iterations tested in patients, the DIAdvisor device was shown to be able to predict accurately BG at 20-min horizon and to deliver safe advices to patients with insulin-treated (basal-bolus regimen) diabetes. A final multicentre clinical study has demonstrated that DIAdvisor use can help patients with Type 1 diabetes under basal-bolus insulin regimen to keep BG in target range and reduce hypoglycemia. These results support the development of this device and its further evaluation on longer term in outpatient conditions.10 HYPOGLYCEMIA REDUCTION WITH CLOSED-LOOP SYSTEMS BY AGEChase H.P.1, Maahs D.1, Wadwa P.1, Buckingham B.2, Wilson D.2, Ly T.2, Lum J.3, Calhoun P.3, Raghinaru D.3, Cameron F.4, Bequette B.W.4,7, Hramiak I.5, Beck R.3, J.D.R.F. In Home Closed-Loop Study Group61Barbara Davis Center for Diabetes, University of Colorado, Denver, USA2Dept of Peds Endo, Stanford, Stanford, USA3JDRF Artificial Pancreas Project, JAEB, Tampa, USA4Bio Statistics, Rensselaer Polytechnic Inst., Troy, USA5Internal Medicine, St. Joseph's Healthcare, London, Canada6ROI, NIDDK, Bethesda, USA7Chemical and Biological Engineering, Rensselaer Polytechnic Inst., Troy, USARANDOMIZED TRIALS OF A HOME SYSTEM TO REDUCE HYPOGLYCEMIA USING A PREDICTIVE LOW GLUCOSE SUSPEND (PLGS) ALGORITHM IN DIFFERENT AGED SUBJECTS WITH TYPE 1 DIABETESThe effects of temporarily (up to 3 hrs/night) suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on CGM glucose levels was previously described for 1,912 home-study nights in 45 people, ages 15–45 yrs with T1D (Diabetes Care 37, 1885, 2014). These studies are now extended to evaluate 1,524 home-study nights in 36 subjects 4–10 yrs old and in 1,896 study-nights in 45 subjects 11–14 yrs old.Median time below 70 mg/dl was reduced significantly on intervention nights versus control nights in both the 11–14 year olds (54% reduction) and the 4–10 year olds (50% reduction), comparable to the reduction previously reported in 15–45 year olds. The percent of nights with a pump suspension decreased with the age of the participants (76%, 70%, 65% respectively for 15–45, 11–14, and 4–10 year olds). Hypoglycemia reduction came at the cost of increased mean sensor glucose overnight between 7 and 8 mg/dl for each age group on intervention nights versus control nights. However, in all three age groups, there was no increase in morning serum ketones ≥0.6 mmol/L following intervention nights compared with control nights.11 PATCH PUMPS VS. DURABLE PUMPS IN CHILDREN WITH TYPE 1 DIABETESDanne T.1, Remus K.1, Blaesig S.1, Biester T.1, Fath M.1, Lange K.2, Kordonouri O.11Diabetes centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany2Department of medical Psychology, Hannover Medical School, Hannover, GermanyInsulin pumps (CSII) are the most physiologic means currently available for insulin delivery. Today's pumps are available as durable pumps (with external tubing) and disposable (without external tubing, e.g., OmniPod) versions. In German pediatric diabetology, the change from a conventional twice daily regimen of former years, to multiple dose injections and more recently, insulin pumps, has been associated with a continuous improvement of glycaemic control. The durable pumps are attached to the body using an infusion set. The current second-generation OmniPod is the only patch pump available for type 1 diabetes in Germany and is attached directly to the body. A small catheter is inserted subcutaneously from the underside of the patch pump by pressing a button on the remote control. This serves as the patch pump's infusion set. Durable pumps can be detached from the site for activities. Currently available patch pumps remain on the body for 3 days and are waterproof. According to the German/Austrian pediatric DPV-registry approximately 48% of the 25,000 children with type 1 diabetes are currently using CSII with 1214 cumulative patients using the Omipod (R. Holl, Ulm, personal communication). Today, basal rates can be titrated in small increments as needed particularly for children. There is controversy regarding the clinical relevance of the accuracy of insulin delivery between different pump models and patch pumps vs. durable pumps. We have therefore undertaken a 12 week cohort study of 30 consecutive type 1 diabetes patients switching to Omnipod (age: 7 to 17 years, baseline HbA1c: 6.2–8.9%, 15 previously using pens, 15 using durable pumps) to assess the effects of patch pump therapy on glycemic control and treatment satisfaction. The results will become available at ATTD 2015.12 APPROACHES TO BEHAVIORAL INTERVENTIONS TO ENCOURAGE CGM USE IN PEDIATRIC PATIENTSLaffel L.11Genetics and Epidemiology, Joslin Diabetes Center, Boston, USAModern intensive insulin therapy uses advanced therapeutics and diabetes technologies, including insulin analogs, pumps with bolus calculators, and continuous glucose monitors (CGM). Intensive therapy aims to achieve target levels of glycemic control. Yet, the majority of pediatric patients fail to achieve the A1c target of <7.5%, with only 1 out of 4 youth with type 1 diabetes succeeding.Adults utilizing CGM generally achieve a greater proportion of glucose values in range (70–150 mg/dL; 3.8–8.3 mM), hemoglobin A1c reduction of 0.5%, and either reduced occurrence of severe hypoglycemia or no increase in severe hypoglycemia compared to standard therapy. Pediatric patients do not achieve the same benefits. The age of the pediatric patient predicts use of CGM and CGM use, in turn, predicts glycemic benefits. For patients who consistently use CGM, hemoglobin A1c can improve by at least 0.5% without increased risk of severe hypoglycemia. However, the school age child, the adolescent, and the young adult continue to demonstrate significant challenges in sustaining CGM use.In the JDRF CGM study, only 30% of patients ages 15–24 and 50% of patients ages 8–14 utilized CGM consistently. A recent study has demonstrated that self-efficacy related to CGM predicts CGM use and improved A1c. Therefore, there are opportunities to increase CGM use in pediatric patients by assessing self-efficacy and supporting pediatric patients and families with low confidence related to CGM use. Newer CGM devices have increased accuracy yet they continue to require care with insertion, calibration, responding to alerts/alarms, and ongoing blood glucose monitoring. Therefore, it is important to recognize and overcome behavioral barriers to CGM implementation so that pediatric patients can achieve the CGM benefits related to improved glycemic control without severe hypoglycemia.13 WHAT SHOULD BE THE GLYCEMIC GOALS IN PREGNANCY COMPLICATED BY DIABETES?Yariv Y.11Obstetrics and Gynecology, Helen Schneider Hospital for Women, Petach Tiqva, IsraelThe association between diabetes during pregnancy and the risk of adverse maternal and fetal outcome is well established. Maternal complications include spontaneous abortions, preterm deliveries, pre-eclampsia, nephropathy, cesarean section and among others birth trauma. The main fetal and neonatal complications are congenital anomalies, deviant fetal growth, birth related trauma, metabolic abnormalities and still birth. Moreover, evolving evidence indicate that diabetes, among other components of the metabolic syndrome, is a significant risk factor for childhood and adult obesity, cardiovascular disease, and diabetes, due to in utero programming mechanisms including altered organ development, cellular signalling responses, and epigenetic modifications of gene expression.Not only that improving glycemic control reduces the risk for adverse outcome in pre-gestational diabetes, but also ingestational diabetes mellitus (GDM), treatment and achieving desired level of glycemic status effectively diminishes the risk for complications. Yet, several issues should be addressed when discussing the relation between glycemic control and adverse pregnancy outcome. First, how is good glycemic control defined? What is the glucose threshold that should be reached in order to diminish the risk for adverse outcome? Second, is maintaining glycemic control according to the recommendations and guidelines can truly abolish the increased risk for complications as compared to the general population? Finally, how glucose status should be monitored during pregnancy in regards to the methods used, diurnal occasions and frequencies?14 FASTER-ACTING INSULIN ASPART IMPROVES POSTPRANDIAL GLYCAEMIA VERSUS INSULIN ASPART IN PATIENTS WITH TYPE 1 DIABETES MELLITUSHeise T.1, Haahr H.2, Jensen L.2, Erichsen L.3, Hompesch M.41Institut für Stoffwechselforschung, Profil, Neuss, Germany2Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark3Pharmacokinetics, Novo Nordisk A/S, Søborg, Denmark4Institute for Clinical Research, Profil, Chula Vista, USABackground: Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation containing excipients nicotinamide and arginine, resulting in faster initial absorption after s.c. injection.Methods: Thirty six patients with T1D (mean ± standard deviation age: 38.6 ± 12.5 years; HbA1c: 7.8 ± 0.81%) received a single dose (0.2 U/kg s.c.) of faster aspart or IAsp immediately (≤2 minutes) before a standardised liquid meal test (600 kcal) in a randomised, crossover design.Results: Compared with IAsp, faster aspart had a faster onset of appearance (time from drug administration until first time serum insulin aspart concentration was >30 pmol/l; median difference [95% confidence interval (CI)]: −6.6 minutes [−8.0;−5.0]) and greater exposure during the first 2 hours, with the largest difference in the first 15 minutes, whereas overall pharmacokinetic exposure was similar between the two insulins (mean ratio [95% CI] AUC0–15 minutes: 3.14 [2.59;3.80]; AUC0–30 minutes: 1.93 [1.64;2.26]); AUC0–1 hour: 1.30 [1.15;1.46]; AUC0–2 hours: 1.13 [1.03;1.24]; AUC0–10 hours: 0.99 [0.93;1.06]). Faster absorption led to a greater reduction in postprandial blood glucose (BG) with faster aspart versus IAsp, with lower post-meal AUCBG over 2 and 6 hours (26% and 33% reduction, respectively; Figure), and by lower BG values 1 and 2 hours postprandially (mean difference [95%CI] BG1 hour: −1.24 mmol/l [−2.01;−0.46]; BG2 hours: −1.45 mmol/l [−2.49;−0.42]). No safety/tolerability issues were identified, including no injection site reactions.Conclusions: Faster aspart was absorbed faster, with an increased early exposure, leading to improved postprandial glycaemic control versus insulin aspart.15 INTRODUCTIONRenard E.11Dept of Endocrinology Diabetes Nutrition, Montpellier University Hospital, Montpellier, FranceThe availability of a system allowing a closed-loop insulin treatment of diabetes, also called artificial pancreas (AP), has been a dream for many patients with Type 1 diabetes since the first bedside versions have been developed in the 1970s concomitantly in Europe and North America. The development of wearable, miniaturized, safe and reliable insulin pumps from the 1980s and the emergence of ambulatory continuous glucose monitoring (CGM) systems from 1999 have made feasible the concept of an AP system usable in free-life. The third needed component is a controller which computes insulin delivery rate from CGM data so that blood glucose can be kept in a safe near-normal range. The two challenges to address were (i) the development of algorithms for the controller with the main hurdle being related to the delays of insulin action when infused subcutaneously and (ii) the availability of a wearable platform allowing wireless connections to the CGM and to the insulin pump, also serving as patient interface with the device system. Initiated by the JDRF-sponsored Artificial Pancreas Initiative, prolonged by the EC-funded AP at Home Project, further deployed by NIH- and Hemsley Trust-granted research, tight collaborations between European and US teams working on AP occurred. In the present session, the main achievements from 5 research studies performed in 2014 on both and/or each sides of the Atlantic Ocean will be presented. All of them use the wearable DiAs (for Diabetes Assistant) AP system whose elaboration has been coordinated by the Diabetes Technology Centre at UVA. The presentations of DiAs and the recent study results will demonstrate how current AP investigations pave the way toward a new paradigm for the care of Type 1 diabetes.16 STUDY 3 (JDRF-3)Cobelli C.11Information Engineering, University of Padova, Padova, ItalyI will present the results of two trials: the completed AP@home transitional and the ongoing JDRF3 Europe.The AP@home transitional trial has been performed in Montpellier (August 2013), Padova (September 2013) and Amsterdam (October 2013). 13 patients with type 1 diabetes were involved in this non-randomized 42-hours trial aimed to preliminary test safety and efficacy of Modular Model Predictive Control (MMPC) in outpatient conditions, in view of the larger final AP@home trial. The study included two dinner & overnight periods, the first day spent under CSII driven by the patient and the second day spent with the pump driven by MMPC. Results showed statistically significant improvement of both time-in-target and time-in-hypo in closed-loop with respect to open-loop, suggesting that this AP prototype is safe and effective. This trial opened the door for sustained home use, performed in the recently completed AP@home final trial.The JDRF3 is a trial performed in six centers in Europe and USA under the coordination of the JAEB center for Health Research, (Tampa, Florida). I will focus on the European data, collected in Montpellier, Padova and Tel-Aviv. This non-randomized clinical trial first tests for a 3-week period the glycemic control achieved by the patient with Sensor Augment Pump (SAP) therapy. During the last of the 3-week period, SAP is delivered by the patient through the DiAs system. Then, the patients undergo a second 3-week period where closed-loop control is active during the night, while throughout the day the patient is still in charge to handle her/his glycemia through standard SAP. Finally, the patients undergo a third 3-week period, where closed-loop control is active throughout the whole day. Preliminary results of the patients that completed the study will be presented.17 CONCLUSIONKovatchev B.P.11Center for Diabetes Technology, University of Virginia, Charlottesville, USASince the initiation of the JDRF Artificial Pancreas Consortium, research initiatives got under way supported by the National Institutes of Health (NIH), the European Commission (AP@Home), and the Helmsley Charitable Trust (HCT). Following a successful multi-center international study of control-to-range in the hospital, our next logical step was transition to outpatient trials, which we initiated by introducing in 2011 the first smart phone running closed-loop control – the Diabetes Assistant (DiAs).In this presentation we summarize the timeline of our 2014–2015 studies. To date, DiAs has received 8 Investigational Device Exemptions from FDA, as well as regulatory approvals in 3 European countries and in Israel. Five-night NIH trials were done at the University of Virginia (UVA), Padova, Mount Sinai Medical School in New York, and the Mayo Clinic. One-week 24/7 HCT summer camp studies in children were completed at Stanford and at UVA. The latest AP@Home trials in Italy, France, and Holland included 2 months of overnight DiAs use at home. A 1-month JDRF study combining overnight and 24/7 control was concluded