Abstracts from ATTD 2016 9th International Conference on Advanced Technologies & Treatments for Diabetes Milan, Italy-February 3-6, 2016.

Abstract

Diabetes Technology & TherapeuticsVol. 18, No. S1 AbstractsFree AccessAbstracts from ATTD 2016 9th International Conference on Advanced Technologies & Treatments for Diabetes Milan, Italy–February 3–6, 2016Published Online:2 Feb 2016https://doi.org/10.1089/dia.2016.2525AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail ATTD 2016 Invited Speakers001 DEVELOPING DISEASE-MODIFYING THERAPIES IN CHILDREN WITH TYPE 1 DIABETESSchatz D.USAType 1a (autoimmune) diabetes remains a tremendous burden both to individuals and society. Glycemic targets both in children (and adolescents especially) as well as adults are met only by a minority of patients. Changing the course of the disease by preventing or slowing down beta cell destruction rather than managing hyperglycemia would significantly impact the burden.Studies aimed at both preventing the disease in at-risk pre-Type 1 subjects as well as intervening not only in new-onset cases, but also in established disease have been conducted over the past 30 years. Success has been limited.Progress in our understanding of the genetics and natural history of the disease, incidence and prevalence, complications, quality of life, neurocognitive impact and response to therapy among others are critical to the design of disease modifying therapies.Clear data have emerged there are differences between adult-onset and pediatric-onset Type 1 disease.Advances in our understanding of the natural history of Type 1 Diabetes throughout the lifespan have led to recent publications related to broader acceptance of a classification system for the presymptomatic stages of Type 1 diabetes and, importantly, more defined pathways for the development of disease modifying therapies in children.002 CSII AND OTHER TECHNOLOGIES FOR PREVENTING BETA CELL FAILURE IN TYPE 2 DIABETESPozzilli P.ItalyThe value and the utility of applying technology in the management of patients with poorly controlled insulin-treated type 2 diabetes (T2D) remain controversial. The OpT2mise randomized trial was designed to compare the effects of continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) on glucose profiles in patients with T2D. The results showed that CSII significantly improved selected glucometrics, compared with MDI, without increasing the risk of hypoglycemia. Another recent study looking at newly diagnosed T2D patients via the use of either CSII or CSII + sitagliptin therapy in controlling glucose variability and to prevent secondary complications of T2D showed that this treatment is superior to CSII monotherapy in terms of glucose variability. Oxidative stress is a detrimental feature of diabetes implicated in the progression of the disease and its complications. A study tested the hypothesis that improved glucose control, rather than insulin dose, is central to reduced oxidative stress in patients with T2D following CSII. CSII induces reduction of plasma ox-LDL in T2D patients as compared to patients on MDI suggesting that CSII may have an impact on factors associated with progression to complications. Finally, protection of beta cell function in T2D using CSII has been reported. Regarding glucose monitoring, recent studies utilizing self monitoring blood glucose (SMBG) as an integral component of diabetes care showed improvement in mean glucose, glycemic variability, metabolic risk factors, depression and diabetes-related distress, and health behaviors. The PRISMA study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Noninsulin-Treated Type 2 Diabetes Mellitus Patients), to our knowledge the largest study of the effects of SMBG in patients with T2D, confirms the clinical usefulness and overall safety of using structured SMBG to provide guidance in the prescription of diabetes medications and lifestyle changes in non insulin-treated T2D. The effectiveness of continuous glucose monitoring (CGM) in the management of type 1 diabetic patients is well known. Differently in T2D its use is still a matter of debate because clinical trials in well-selected patient groups are lacking and less convincing evidence is available. Although many studies have evaluated glucose variability through different indices, MAGE, assessed by CGM, may be considered the best method to quantify glycaemic excursion. An improvement on glycaemic excursion in insulin-treated T2D patients by using RT-CGM has been reported, showing a significant reduction of the time spent in hypoglycaemic and hyperglycaemic ranges. Short-term intermittent use of RT-CGM appears effective in improving glycaemic control over a 12-week period without increasing the risk of hypoglycaemia. The effectiveness of RT-CGM is sustained during follow-up period compared with SMBG and without a greater intensification of medication over the course of the study. Larger clinical trials with longer follow-up are needed to evaluate not only the effectiveness of CGM in terms of improving glycaemic control but also the impact on quality of life and the adherence to the use of CGM as well as related cost issues. Even if it is too early to reach a general conclusion on the specific clinical indications, we believe that the RT-CGM can be used as a powerful motivational device to change patients lifestyle. We also suggest that short-term retrospective CGM use may be beneficial in certain clinical situations such as to detect nocturnal hypoglycaemia, to assist in the management of hypoglycaemia in T2D unawareness and when significant therapeutic changes are performed. In conclusion, modern technological devices including short message service reminder, online educational programs and clinician-patient electronic communication supporting coping and management are increasingly popular and represent very useful healthcare tools for T2D patients.003 IS TYPE 1 DIABETES MELLITUS AN AUTOIMMUNE DISEASE?Sperling M.USAType 1 diabetes mellitus (T1DM) is considered to be an autoimmune disease based on genetic and clinical associations. Several of the most common associated genes including HLA, Insulin VNTR, CTLA4, AIRE, PTPN22, are immune regulators. Circulating islet and β-cell antibodies are hallmarks of autoimmunity present in ∼85% of patients considered T1DM.Yet more people harbor the same alleles and/or mutations without clinical diabetes. For example, inactivating mutations in the AIRE gene are responsible for APS1 in which Addison disease and hypoparathyroidism are common, yet T1DM is not. In APS2, Addison disease and Hashimoto thyroiditis accompany T1DM, yet co-existence of Addison with T1DM is rare. Markers of autoimmunity and various β cell Ab may exist for variable periods without clinical abnormalities. Autoimmune disease is more common in women, but the male: female of T1DM is equal. To initiate autoimmunity, an “environmental trigger” is proposed; to study genetics and autoimmune processes, the NOD mouse (female predominance of DM) has been extensively investigated. Whereas almost all immune regulatory approaches succeeded in the NOD mouse, almost 40 years of clinical trials with immune interventions failed to prevent, arrest, or reverse DM for extended periods. This dilemma has raised the question as to whether the β-cell is the “target of homicide”, i.e. autoimmune destruction by T cells, or has characteristics predisposing to its own demise as the “target of suicide”. This presentation discusses these competing narratives and proposes that self-destruct mechanism(s) explain the transitory success of modulating the autoimmune “cleanup” of a primary insult to the β-cells.004 MULTI-CENTER RANDOMIZED CROSS-OVER ITALIAN PEDIATRIC SUMMER CAMP: AP VS SAP IN 5–9 YEAR OLD CHILDRENDel Favero S.1,13, Boscari F.2,13, Messori M.3,13, Rabbone I.4, Bonfanti R.5, Sabbion A.6, Iafusco D.7, Schiaffini R.8, Visentin R.1, Calore R.1, Leal Y.1, Galasso S.2, Galderisi A.9, Vallone V.2, Di Palma F.3, Losiouk E.10, Lanzola G.10, Tinti T.4, Rigamonti A.5, Marigliano M.6, Zanfardino A.7, Rapini N.11, Avogaro A.2, Chernavvsky D.12, Magni L.3,13, Cobelli C.1,13, Bruttomesso D.2,131Department of Information Engineering, University of Padova, Padova, Italy2Unit of Metabolic Diseases, Department of Internal Medicine-DIM, University of Padova, Padova, Italy3Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy4Department of Pediatrics, University of Turin, Turin, Italy5Pediatric Department and Diabetes Research Institute, Scientific Institute, Hospital San Raffaele, Milan, Italy6Regional Center for Pediatric Diabetes, Clinical Nutrition & Obesity, Department of Life & Reproduction Sciences, University of Verona, Verona, Italy7Department of Pediatrics, Second University of Naples, Naples, Italy8Unit of Endocrinology and Diabetes, Bambino Gesu, Children's Hospital, Rome, Italy9Department of Woman's and Child's Health, University of Padua, Padua, Italy10Department of Industrial and Information Engineering, University of Pavia, Pavia, Italy11Pediatric Diabetology Unit, Policlinico di TorVergata, University of Rome TorVergata, Rome, Italy12Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA13equally contributedBackground and Aims: The Artificial Pancreas (AP) system based on the Modular Model Predictive Control algorithm (MMPC) running on the wearable platform Diabetes Assistant (DiAs, University of Virginia) has been successfully used for 2 months in adults patients reducing time-in-hypo (CGM <70 mg/dL) and increasing time-in-target (70-180 mg/dL) with respect to Sensor Augmented Pump therapy (SAP).Here we report the first outpatient AP trial in 5–8 year old children, using MMPC on DiAs in the PedArPan (PEDiatric ARtificial PANcreas) project.Methods: Thirty children with type 1 diabetes, 5–8 years old, and their parents were recruited in 5 Italian pediatric centers and completed a randomized cross-over trial in a summer camp.Glucose control achieved in 3 days of AP use was compared against 3 days of parents-managed SAP.Results:Overnight (00:00–07:30)The AP significantly reduced time-in-hypo with respect to SAP, 0.00%[0.00–2.22] vs 2.19%[0–12.3], p-value = 0.002, without significant worsening of time-in-target, 55.97%(22.53) vs 59.69% (21.24), p-value = 0.422, nor of time-in-tight-target (80–140 mg/dl), 31.27% (20.23) vs 33.02%(19.80), p-value = 0.668.Overall (00:00–24:00)A statistically significant 3-fold reduction of time-in-hypo, 1.93%[1.17–4.54] vs 6.67%[2.26–11.54], p-value <0.001, was recorded with the AP at the expenses of a statistically significant deterioration of time-in-target, 56.79%(13.47) vs 63.09%(10.98), p-value = 0.015.Parents initiated manual interventions (via correction boluses or temporary basal rate settings) occurred 0[0-0] times with the AP vs 3.5[1–7] times in SAP. Closed-loop functioned for 96.97%[93.47-98.43] of the time.Conclusions: This study shows feasibility and safety of a wearable MMPC in young children. Next steps will include overnight testing at-home and re-tuning of the algorithm to improve efficacy during daytime.005 JDRF MULTI-CENTER 6-MONTH TRIAL OF 24/7 CLOSED-LOOP CONTROLKovatchev B.USAIn the summer of 2014, we initiated a two-phase long-term (6 months) trial evaluating at home a control-to-range closed-loop system – the wireless portable Diabetes Assistant (DiAs) developed at the University of Virginia. Phase 1 (1 month) recruited 30 patients with T1DM at 6 centers: the Universities of Virginia, Padova, Montpellier, Santa Barbara, Stanford University, and the Schneider Children's Medical Center of Israel. Phase 2 (5 months) continued with N = 14 patients at 5 sites; the study was coordinated by the Jaeb Center for Health Research.Median subject characteristics: age = 45 years; duration of diabetes = 27 years; total daily insulin = 0.54 (U/kg/day); basal daily insulin = 0.22 (U/kg/day); 10/4 male/female.HbA1c was reduced from 7.22% at the baseline to 7.03% (p = 0.25) at the end of the study. This was accompanied by a significant 3-fold reduction in the frequency of hypoglycemia from baseline to the last three months of CGM monitoring 4.1% vs. 1.3% (p < 0.001). Improvement in HbA1c was highly correlated with the percent time of system use, r = 0.59; in particular those with above-median system use (>70% of the time) achieved HbA1c reduction of 0.44%, from 7.19% at the baseline to 6.74% at the end of study.We conclude that DiAs technology has matured enough, and is safe and effective for prolonged use at patient's homes. Excellent baseline glucose control (HbA1c) was preserved and further improved in the majority of patients. This was accompanied by a very significant reduction in the frequency and extent of hypoglycemia. Improvement in glucose control was tightly related to the degree of system use.006 FLAT-SUGAR (GLYCEMIC VARIABILITY)Hirsch I.11University of Washington, Seattle, USAIn short-duration diabetes, the DCCT and UKPDS have clearly shown that in glucose control defined as HbA1c can predict microvascular complications and longer term macrovascular disease. However, a closer look at the data suggests there is more than HbA1c, or mean glucose responsible for the complications of diabetes. The “glycemic variability (GV) hypothesis” notes that glucose fluctuation is at least one other etiologic factor. At a cellular level, GV has been shown to result in both reactive oxygen species accumulation and inflammatory activation. There are also several clinical trials suggesting GV is an important mechanism resulting in vascular complications. The problem is to date definitive data for the GV hypothesis is lacking. The study FLAT-SUGAR (FLuctuATion reduction with inSUlin and Glp-1 Added together) was designed as a feasibility study to prove it is possible to randomize two groups of patients while keeping HbA1c levels equivalent, yet show differences in GV. This was accomplished by using basal bolus insulin (BBI) in one group of “ACCORD-like” patients with type 2 diabetes and basal insulin with the GLP-1 RA exenatide (GLIPULIN) in the other group. The study was successful by showing similar HbA1c levels with more variability with the BBI therapy group. Many secondary endpoints were examined, and both ALT and SAA levels were shown to be lower with GLIPULIN. There was surprisingly little hypoglycemia and no severe hypoglycemia, so not surprisingly there were no differences between the groups in cardiac arrhythmias. FLAT-SUGAR was a successful study and we now feel it is possible to move forward to perform a definitive outcomes study to examine the role of GV in the complications of diabetes.007 ADJUNCTIVE THERAPY WITH INSULIN IN TYPE 1 DIABETESGarg S.11Pediatrics, University of Colorado Denver, USAThe majority of patients with T1D do not meet A1C goals established by major diabetes organizations. Hypoglycemia risks especially that of severe and a rising incidence of obesity along with associated morbidity in the T1D population limit intensification of insulin therapy in several cases. Noninsulin antihyperglycemic agents may enable T1D patients to achieve target A1C levels while using lower insulin dosages, which may reduce the risk of hypoglycemia. Several recently introduced antihyperglycemic classes hold promise as additional adjunctive therapy options that may help patients overcome barriers to optimal glucose control.In the recent study from T1D Exchange participants, only 2% of adults reported taking pramlintide, the only agent approved by the U.S. Food and Drug Administration (FDA) for this purpose. The studies have reported significant improvement in A1c and weight loss with adjunctive pramlintide use. However most patients report significant upper GI side effects and increase in hypoglycemic episodes and thus limiting its use in clinical practice. Gradually increasing the dose of pramlintide may facilitate the use of this drug in T1D.Studies of metformin have shown significant reductions in weight, insulin dose, and A1C, although in a meta-analysis, A1C reductions were not statistically significant.Meanwhile, other older agents, such as colesevelam, a-glucosidase inhibitors, and thiazolidinediones (TZDs), have shown little or no promise in terms of glycemic control for patients with T1D.In pilot studies, the SGLT2 inhibitor dapagliflozin and the GLP-1 receptor agonist liraglutide reduced blood glucose, weight, and insulin dose in patients with T1D. Phase 2 studies with the SGLT2 inhibitor empagliflozin and the dual SGLT1 and SGLT2 inhibitor sotagliflozin, which acts in the gut and the kidney, have demonstrated reductions in A1C, weight, and glucose variability without an increased incidence of hypoglycemia.The sodium-glucose cotransporter (SGLT) inhibitors and the glucagon-like peptide 1 (GLP-1) receptor agonists may provide an effective approach to reducing some of the risks associated with intensive insulin therapy for T1D. Recent data on liragutide in T1D showed only modest effect and Novo-Nordisk has decided not to file with the FDA for its indication in T1D. Recent reports on DKA with SGLT 2 inhibitors and the FDA warning have cautioned the use of such medications in T1D. The drugs having combo SGLT 1&2 inhibitor effects may eliminate the DKA risk but are being currently evaluated. The role of many of these medications will be discussed during my talk.008 TOWARDS PERSONALIZED MEDICINE: THE IMPACT OF BLACK ETHNICITY ON METABOLIC DYSREGULATION IN EARLY TYPE 2 DIABETESAmiel S.11London, United KingdomThe International Diabetes Federation predicts that the fastest rise in prevalence of type 2 diabetes over the next decade will be in its African region. Although current rates of type 2 diabetes are relatively low in sub-Saharan African countries, people of African origin living abroad have significantly higher rates of diabetes than people of white ethnicity in the same environment. In on study in North East London, England, rates of diabetes were as high in the black communities as in the South Asians. In a recent study in South London, where approximately 20% of local residents are of black ethnicity, about 40% of people with new onset diabetes came from that group. They were younger at diagnosis and had higher HbA1c. By two years, HbA1c was not different between groups, but people of Black West African and Caribbean background were prescribed more medication to achieve this. Till now, relative cardio-protection has been noted in Black people with diabetes, associated with differences in lipid profile, but newer studies from the US suggest that this has changed. A greater prevalence of hypertension is thought to be associated with an observed higher risk of stroke. There is also a higher risk of atypical ketosis prone diabetes.Differences in metabolic phenotype should help us tailor therapeutic and preventive interventions so it is important to understand them. There is evidence for hyperinsulinaemia in young people at high risk for diabetes in the black populations but the mechanisms of this are not fully understood. Whether early hyperinsulinism drives earlier diabetes through earlier beta cell exhaustion is also not proven. Studies are on-going to clarify the role of insulin resistance/sensitivity, both for carbohydrate and fat metabolism, and intra-organ fat deposition in the ethnic differences in metabolic phenotype. It is expected that such studies will underpin more focussed interventions to reduce the burden of type 2 diabetes in this high risk population.009 ARTIFICIAL PANCREAS PSYCHOSOCIAL MEASURES PROJECTBarnard K.5, Bergenstal R.7, Laffel L.1, Weissberg-Benchell J.2, Hood K.3, Heinemann L.8, Sullivan S.6, Miller K.M.41Genetics and Epidemiology Section, Harvard Medical School, Joslin Diabetes Centerl2Northwestern University's Feinberg School of Medicine, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois 60611, USA3Psychiatry & Behavioral Sciences, Stanford University School of Medicine, USA4Jaeb Center for Health Research, 15310 Amberly Drive, Tampa FL. 336475Bournemouth University, United Kingdom6The Leona M. and Harry B. Helmsley Charitable Trust, 230 Park Avenue, Suite 659, New York, NY 101697International Diabetes Center, 3800 Park Nicollet Blvd., Minneapolis, MN 554168Partner and Scientific ConsultantBackground: Addressing and improving psychosocial outcomes complement biomedical improvements, and looking to the future, are crucial to enhance patient acceptance of automated insulin delivery systems.Methods: Development of novel psychosocial patient reported outcome measures for children with T1D, adolescents with T1D, parents, adults with T1D and partners to assess the impact of automated insulin delivery systems. Focus groups and interviews with PWD, as well as surveys of HCPs and collaboration with the research community are informing content with piloting as the next phase. We will present preliminary qualitative data and HCP survey data at the workshop and invite delegates to discuss these in the context of device development and future use.Results: Data will be used to achieve the primary outcome of developing five novel psychosocial patient reported outcome (PRO) measures to enable regulatory approvals bodies and reimbursement agencies to critically appraise PROs alongside medical efficacy and safety.Conclusions: Input from collective stakeholders are needed to inform the PROs in order to maximize their future utility in appraising psychosocial outcomes of automated insulin delivery systems.010 BIOSIMILARS IN PUMPS AND PENS, DO THE DEVICES MATTER?Kuhlmann M.11Nephrologe, Diabetologe, Hypertensiologe Ärztlicher Direktor Chefarzt Innere Medizin – Nephrologie Vivantes Klinikum im Friedrichshain Landsberger Allee 49 10249 BerlinWith the expiry of patent protection for several originator insulin analogue molecules, the availability of biosimilar insulin analogues will increase in the future. Current EMA guidelines for the approval of biosimilar insulin analogues specifically address the requirements for demonstration of comparability in structure, pharmacokinetics and pharmacodynamics, efficacy, safety, and immunogenicity of the active ingredient as well as the final formulated biosimilar product. However, insulin application devices are not addressed in these guidelines, although these devices, be it a pre-filled syringe, pen, or pump, are of particular importance for dosing accuracy and reproducibility as well as long-term patient compliance and adherence. Since the combinations of insulin and device may differ widely in their dosing characteristics, it cannot be assumed that an insulin biosimilar will be compatible with an existing administration device. In general, the EMA Medical Devices Directive (MDD) applies to all general medical devices. As a minimum requirement for an insulin biosimilar it is plausible that the device through which a biosimilar is administered must at least be able to match the reference medicine's device for convenience and comfort. Inferior usability could reduce treatment adherence and product uptake by the patients. On the other hand, current guidelines for biosimilars may be interpreted as to leave freedom to improve on the reference product's delivery devices. Therefore the design and user experience of the delivery device may serve as a key market differentiator to the reference or competing products even if they are clinically equivalent.011 INSULIN ACCESS IN THE DEVELOPING WORLDSaldanha J.11Saldanha and Santamore Pharma Consultants, Private Practice, Bel Air, USAMuch of the developing world has seen a significant rise in the treatment of diabetes primarily due to increasing awareness, which has led to larger rates of diagnosis and more willingness to seek treatment. Access to insulin is therefore more important than ever. The three major insulin manufacturers continue to dominate the landscape despite the availability of biosimilars in many countries. The market share they enjoy is similar to the more developed world. Many parties play a role in the acceptance and use of biosimilar insulins, from the respective Ministries of Health who approve the products and often provide them free of charge to patients, to the health care providers, and the ultimate consumers.There are several factors that have contributed towards this situation. Barriers to entry and sustainability in the insulin business are significant. Pharmaceutical companies use a different business model and market segmentation when it comes to insulins in the developing world. Some of the factors that will be addressed include intellectual property, financial, clinical/regulatory, pricing, distribution, local partnerships and local manufacturing.012 EVIDENCE BASE FOR CGMDe Vries H.NetherlandsSome 15 years after its introduction in clinical practice, Continuous Glucose Monitoring (CGM) has become an established modality for diabetes treatment. There is sound evidence that patients can lower their HbA1c when using this technology, and spend less time in hypoglycaemia. Emerging evidence supports the notion that CGM can decrease the incidence of severe hypoglycemia, although the evidence for this indication is less abundant and has been criticized. The added value of CGM during pregnancy is unclear, but larger trials are under way. All this evidence has translated into a wide range of reimbursement status in various countries. In many countries reimbursement is still on a case-by-case basis. In those countries where there are formal reimbursement criteria, the interpretation and translation of the evidence base varies. An overview of the evidence supporting the use of CGM and its reimbursement will be given.013 A BREAKTHROUGH IN GERMANY?Hermanns N.11Research Instiute Diabetes FIDAM, Bad Mergentheim, GermanyIn Germany, the Federal Joint Committee (G-BA) is responsible for legally binding decisions regarding the reimbursement of medical procedures (e.g., drugs, non-drug interventions, medical devices, etc.). Since 2004, the German Institute for Quality and Efficiency in Health Care (IQWiG) assesses the advantages and disadvantages of medical procedures on behalf of the G-BA. The IQWiG uses methods of evidence-based medicine for conducting systematic searches for studies which provide sufficiently reliable results, and for selecting and assessing those studies. Based on this research IQWiG produces evidence-based reports. IQWiG reports usually have a large impact on reimbursement decisions made by the Federal Joint Committee.In May 2015, the IQWiG released a report about potential benefits of “continuous interstitial glucose monitoring (CGM) with real-time measurement devices in insulin-dependent diabetes mellitus”. The IQWiG included a total of 15 studies. The IQWiG report concluded that while there was evidence that CGM is beneficial with regard to HbA1c improvement in adults with type 1 diabetes, there was less clear evidence for the avoidance of severe hypoglycemia in this patient group. Furthermore, the IQWiG found an indication that CGM might be beneficial with regard to hypoglycemia avoidance and HbA1c improvement in children with type 1 diabetes.Given the rather positive conclusion of the IQWIG report regarding the advantages of CGM there is a guarded optimism in Germany that reimbursement of decision will significantly improve. But the final assessment by the Federal Joint Committee regarding reimbursement of CGM use is still pending. In this presentation an overview about key results of the IQWIG Report will be presented along with the current development of the reimbursement situation of CGM in Germany.014 A NICE REASSESSMENTHammond P.Harrogate, United KingdomContinuous glucose monitoring (CGM) is currently not funded routinely in the UK. The National Institute for Health and Care Excellence (NICE) has previously published technology appraisals (TA) for insulin pump therapy, but has not carried out a TA for CGM. Commissioners have a legal mandate to fund NICE TA recommendations, but not other NICE recommendations. NICE are due to publish a diagnostic assessment review of integrated sensor augmented pump systems in early 2016 but it is unlikely to have a significant impact on funding of these technologies. In August 2015 NICE published updated clinical guidelines for the management of children and young people with diabetes (NG18), and adults with type 1 diabetes (NG17). In NG18 NICE advised that children and young people with hypoglycaemic problems should be offered CGM, which is the strongest form of recommendation. In NG17 the advice was that CGM should be considered for adults with hypoglycaemic problems, a weaker recommendation. NICE performed a number of health economic analyses to define the cost-effectiveness of CGM for optimising control in those with an elevated HbA1c. Following these analyses it was recommended that CGM be considered if HbA1c >75 mmol/mol [9%] despite testing at least 10 times a day, and continued only if HbA1c can be sustained at or below 53 mmol/mol (7%) and/or there has been a fall in HbA1c of 27 mmol/mol (2.5%) or more. This guidance will form the basis for ongoing discussions about funding CGM for small groups of patients with type 1 diabetes.015 WILL MEDICARE DELIVER?Graham C.11Dexcom, Global Access, San Diego, USAMedicare is the largest insurance program in the US, with over 50,000,000 beneficiaries; it is intended for people over the age of 65 or are disabled.Despite the recognized clinical benefits, and the fact that nearly all commercial payors in the US have positive coverage policies for Type 1 patients and CGM, the fact that Medicare does not have provide coverage is perplexing. The coverage process is dictated by Federal Law, and is therefore bound by statute, and to a certain degree by interpretation by the Centers for Medicaid and