Liver cirrhosis and antibiotic therapy but not TIPS application leads to a shift of the intestinal bacterial communities: A controlled, prospective study.

OBJECTIVES: The gut-liver axis is discussed to play an important role in hepatic cirrhosis. Decompensated liver cirrhosis is associated with portal hypertension, which can lead to a variety of complications. Transjugular intrahepatic portosystemic shunt (TIPS) is an established treatment option for the complications of portal hypertension. In this study we focused on the effect of TIPS on intestinal microbial composition in cirrhotic patients. METHODS: Thirty patients with liver cirrhosis were compared to 18 healthy adults. Seventeen patients with cirrhosis and portal hypertension received a TIPS. Clinical characteristics, including age, sex, and liver function measured with a Child-Pugh score and model for end-stage liver disease score, were obtained. Intestinal microbial composition was assessed via 16S rRNA gene amplicon sequencing from stool probes before and after TIPS. RESULTS: TIPS led to a reduction of hepatic venous pressure gradient. However, TIPS did not cause a shift in the intestinal bacterial communities. Independent from the application of TIPS, antibiotic therapy was associated with a significant difference in the intestinal bacterial microbiota and also a reduced α-diversity. In addition, a significant difference was observed in the intestinal bacterial composition between patients with liver cirrhosis and healthy controls. CONCLUSION: The presence of liver cirrhosis and the use of antibiotic therapy, but not the application of TIPS, were associated with a significant shift of the intestinal bacterial communities, showing a high impact on the microbiota of patients with liver cirrhosis.

Transjugular intrahepatic portosystemic shunt vs conservative treatment for recurrent ascites: A propensity score matched comparison.

BACKGROUND: Transjugular intrahepatic portosystemic shunt (TIPS) placement is an effective intervention for recurrent tense ascites. Some studies show an increased risk of acute on chronic liver failure (ACLF) associated with TIPS placement. It is not clear whether ACLF in this context is a consequence of TIPS or of the pre-existing liver disease. AIM: To better understand the risks of TIPS in this challenging setting and to compare them with those of conservative therapy. METHODS: Two hundred and fourteen patients undergoing their first TIPS placement for recurrent tense ascites at our tertiary-care center between 2007 and 2017 were identified (TIPS group). Three hundred and ninety-eight patients of the same time interval with liver cirrhosis and recurrent tense ascites not undergoing TIPS placement (No TIPS group) were analyzed as a control group. TIPS indication, diagnosis of recurrent ascites, further diagnoses and clinical findings were obtained from a database search and patient records. The in-hospital mortality and ACLF incidence of both groups were compared using 1:1 propensity score matching and multivariate logistic regressions. RESULTS: After propensity score matching, the TIPS and No TIPS groups were comparable in terms of laboratory values and ACLF incidence at hospital admission. There was no detectable difference in mortality (TIPS: 11/214, No TIPS 13/214). During the hospital stay, ACLF occurred more frequently in the TIPS group than in the No TIPS group (TIPS: 70/214, No TIPS: 57/214, P = 0.04). This effect was confined to patients with severely impaired liver function at hospital admission as indicated by a significant interaction term of Child score and TIPS placement in multivariate logistic regression. The TIPS group had a lower ACLF incidence at Child scores < 8 points and a higher ACLF incidence at ≥ 11 points. No significant difference was found between groups in patients with Child scores of 8 to 10 points. CONCLUSION: TIPS placement for recurrent tense ascites is associated with an increased rate of ACLF in patients with severely impaired liver function but does not result in higher in-hospital mortality.

Continuous Glucose Monitoring and Physical Activity.

Continuous glucose monitoring (CGM) use has several potential positive effects on diabetes management. These benefits are, e.g., increased time in range (TIR), optimized therapy, and developed documentation. Physical activity is a recommended intervention tool in diabetes management, especially for people with type 2 diabetes (T2D). The benefits of physical activity for people with diabetes can be seen as an improvement of glycemic control, glycemic variability, and the reduction of insulin resistance. In relation to the physical activity of people with T2D, the benefits of CGM use can even be increased, and CGM can be a helpful tool to prevent adverse events due to physical activity of people with diabetes, such as hypoglycemic events and nocturnal hypoglycemia after sports. This narrative review aims to provide solid recommendations for the use of CGM in everyday life physical activities based on the noted benefits and to give a general overview of the guidelines on physical activity and CGM use for people with diabetes.

Treatment of an Infected TEVAR with Extra- and Endovascular Bacteriophage Application.

Introduction: Graft infections are severe complications. Surgical resection of infected aortic stent grafts is associated with high mortality and morbidity. Therefore, alternatives or adjuncts to antibiotic treatment and extensive surgery are urgently needed. Report: A 67 year old woman was admitted with a methicillin sensitive Staphylococcus aureus infected stent graft in the thoracic aorta. Local infection was confirmed by PET-CT imaging. Surgical resection of the stent graft was not feasible because of comorbidities. Therefore, a three step approach for local bacteriophage treatment was performed as a last resort treatment. Firstly, the para-aortic tissue was debrided via left thoracotomy, a bacteriophage suspension was applied on the outer surface of the aorta, and a vacuum irrigation system was installed. After repeated alternating instillation of the bacteriophage suspension for three days, as a second step, the vacuum sponges were removed and a bacteriophage containing gel was applied locally on the outer surface of the aorta. In the third step, the bacteriophage containing gel was applied to a thoracic stent graft, which in turn was placed endovascularly into the infected stent. Discussion: After 28 days, the patient was discharged from hospital with normalised infection parameters. PET-CT imaging at three and 12 months post-intervention did not show signs of infection in or around the thoracic aorta. This Case demonstrates successful treatment of an infected endovascular stent graft by application of bacteriophages both to extravascular and, as a novel approach, endovascular sites using a bacteriophage coated stent graft.

Negative Venous Leg Ultrasound in Acute Pulmonary Embolism: Prevalence, Clinical Characteristics and Predictors.

The purpose of this study was to investigate the prevalence, clinical characteristics, and predictors of negative venous leg ultrasound in acute pulmonary embolism (PE). We retrospectively analyzed a cohort of 168 patients with acute PE (median age 73 years, 44% women) evaluated with complete venous leg ultrasound. A multivariate logistic regression analysis was performed to identify the independent predictors of negative venous ultrasound in acute PE. Venous leg ultrasound was negative for deep venous thrombosis (DVT) in 78 patients (46.4%). Patients with negative venous ultrasound were less likely to have a history of DVT (7.7% vs. 20.0%, p = 0.0273) and had significantly lower D-dimer levels (median 2.5 vs. 6.2 mg/dL p < 0.0001). Negative venous ultrasound was more frequent in PE diagnosed with V/P-SPECT than in PE diagnosed with CT (66.2% vs. 34.0%, p < 0.0001). The prevalence of negative venous ultrasound increased with more peripherally located PE (29.5% for central/lobar, 43.1% for segmental, and 60.6% for subsegmental PE, p = 0.0049). For the multivariate analysis, a diagnosis of PE with V/P-SPECT rather than CT (OR 3.2, p = 0.0056) and lower D-dimer levels (OR 0.94, p = 0.0266) were independent predictors of negative venous ultrasound. In conclusion, venous leg ultrasound was negative for DVT in almost half of patients with acute PE. Negative venous ultrasound was more common in patients with no history of DVT, lower D-dimer levels, PE diagnosed with V/P-SPECT rather than CT, and more peripherally located PE.

Level of Digitalization in Germany: Results of the Diabetes Digitalization and Technology (D.U.T) Report 2020.

BACKGROUND: New diagnostic and therapeutic technologies are increasingly changing the treatment of people with diabetes (PWD), along with increased usage of digital tools. To date, however, there is little data to which level and how diabetologists and PWD implement digitalization. Also, not much is known about the view of diabetologists on the current status and future developments in this respect. METHOD: In an online survey, diabetologists working in clinics and practices across Germany provided responses regarding their view on digitalization and the adoption of new technologies in diabetology to 56 questions. These comments reflect the opinion of several experts about the current importance and use of specific digital/technological topics. RESULTS: Overall, 326 diabetologists took part in the survey. They reported a positive attitude (75.8%) toward new technologies and digitalization, and they see more advantages rather than disadvantages. Younger age of the diabetologists was significantly associated with a more positive attitude (r = -0.176; P < .01), and there was no gender effect (P = .738). On average, in each practice, 5.5% of PWD are using an insulin pump for therapy, 4.8% a real-time continuous glucose monitoring system, 16.9% an intermittent scanning continuous glucose monitoring system, and 0.3% an automated insulin delivery (AID) system. With respect to digitalization, the three most important current topics are software for glucose data analysis (average rank on a scale from one to six, with one being the most important: 2.4), compatibility with other systems (2.9), and AID systems (3.8)). CONCLUSIONS: This survey, which is going to be repeated annually, showed that the diabetologists who participated predominantly have a positive attitude toward new technologies and digital applications and were aware of the associated advantages. However, perceived disadvantages need to be addressed to enable wider adoption of new technologies and digital solutions.

Isolated calf deep venous thrombosis: frequency on venous ultrasound and clinical characteristics.

BACKGROUND: It remains controversial whether to include calf veins in the initial ultrasound evaluation of suspected deep venous thrombosis (DVT). We sought to investigate the frequency and clinical characteristics of isolated calf DVT. MATERIALS AND METHODS: In this retrospective analysis, we investigated a cohort of 596 patients (median age 69 years, 52.3% women) who had been imaged with complete lower extremity venous duplex ultrasound for suspected acute DVT. Radiology reports were analyzed for the presence and localization of DVT. Clinical information was collected from patients' electronic charts. RESULTS: DVT was found in 157 patients (26.3%), of which 74 patients (47.1%) had isolated calf DVT. Isolated calf DVTs were located in the posterior tibial veins (22 patients, 29.7%), peroneal veins (41 patients, 55.4%) and muscle veins (19 patients, 25.7%). There were no differences in age or sex between patients with isolated calf DVT and patients with proximal DVT. Isolated calf DVT was more commonly associated with leg pain (52.7% vs. 33.7%, p = 0.0234) and less commonly associated with subjective leg swelling (35.1% vs. 55.4%, p = 0.0158) and objectively measured difference in leg circumference (23% vs. 39.8%, p = 0.0268). D-Dimers were significantly lower in patients with isolated lower leg DVT (median 2.3 vs. 6.8 mg/L, p < 0.0001) compared to patients with proximal DVT. CONCLUSIONS: Isolated calf DVT represents approximately half of DVT cases and has different clinical characteristics than proximal DVT.

AGP and Nutrition - Analysing postprandial glucose courses with CGM.

Nutritional therapies are one of the fundamentals of effective management of diabetes type 1 and type 2. Lifestyle interventions, including nutritional recommendations, are also part of the basic therapy for people with prediabetes or obesity. It is recommended that the diet should be individually adapted to personal circumstances, preferences and metabolic goals. In the age of digitalisation, mHealth interventions, like continuous glucose monitoring systems (CGM), are increasingly finding their way into nutrition therapy. The ambulatory glucose profile (AGP), a structured and graphical compilation of the obtained CGM data, can also be used as a support for dietary adjustment. After assessment of the glycaemic situation (hypoglycaemia, variability and stability of glucose levels). This publication aims to provide a general overview of nutritional recommendations, especially in Germany, and to describe the benefits of CGM measurements with regard to nutrition.

Prevalence and predictors of alternative diagnoses on whole-leg ultrasound negative for acute deep venous thrombosis.

BACKGROUND: To investigate the prevalence, spectrum, and predictors of alternative diagnoses explaining leg symptoms in patients negative for suspected acute deep venous thrombosis (DVT), which can be detected with whole-leg ultrasound. METHODS: We retrospectively analyzed a cohort of 789 patients (median age 70 years, 50.6% women) evaluated with a whole-leg ultrasound examination for suspected acute DVT within one year. All findings in the radiology report were analyzed and electronic chart review was performed to collect clinical information. RESULTS: Ultrasound was negative for acute DVT in 531 patients (67.3%). Among these, alternative diagnoses explaining leg symptoms were seen in 349 patients (65.7%). The most frequent alternative diagnoses were chronic venous insufficiency (147 patients, 27.7%), followed by lymphedema (48 patients, 9.0%) and chronic post-thrombotic changes (41 patients, 7.7%). Patients with alternative diagnoses were older (median 71 vs. 66 years, p = 0.0226), as well as more likely to present with leg swelling (39.5% vs. 23.1%, p = 0.0002), difference in leg circumference (25.5% vs. 14.8%, p = 0.0055) and redness (7.7% vs. 2.7%, p = 0.0213) than patients without alternative diagnosis. Independent predictors of finding alternative diagnoses on whole-leg ultrasound were older age (odds ratio 1.014 per year, p = 0.0119), leg swelling (OR 1.949, p = 0.0020) and history of previous DVT (OR 2.235, p = 0.0154). CONCLUSIONS: Alternative diagnoses explaining leg symptoms can be detected on whole-leg ultrasound in two thirds of patients with no evidence of acute DVT. Our data supports performing a comprehensive ultrasound evaluation beyond the venous system, particularly, in older patients, who present with leg swelling and a past history of DVT.

Clinical Recommendations for the Use of the Ambulatory Glucose Profile in Diabetes Care.

BACKGROUND: The ambulatory glucose profile (AGP) uses the wealth of data that are generated by continuous glucose monitoring, including flash glucose monitoring technologies, to provide a visual representation of glucose levels over a typical standard day of usually the most recent two weeks for a person with diabetes and helps to identify patterns and trends in glucose control. The AGP allows certain patterns of glucose levels to be identified and analyzed, such that treatment adjustments can be made, and new individual treatment goals can be defined. This helps to ensure increased treatment satisfaction and adherence, quality of life, and an improvement in metabolic management for people with diabetes. OBJECTIVE: To date, a range of approaches exists for interpreting the information contained in an AGP, with different priorities given to identifying and targeting patterns of hypoglycemia and the degree of variability and stability underlying the glucose levels. The objective of the present recommendation is to describe the steps for assessing an AGP in detail and to illustrate these steps using visual examples. CONCLUSION: This paper describes the consensus recommendations from a group of German expert diabetologists on the necessary steps for assessing an AGP in a structured and detailed way and to explain these steps using practical clinical examples.

Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes.

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 < 0.0001), 8.9 ± 12.5 mmol/mol (France [0.8% ± 1.1], p < 0.0001) and 10.1 ± 12.2 mmol/mol (Germany [0.9% ± 1.1], p < 0.0001). No significant differences were detected between age group, sex, BMI or duration of insulin use. CONCLUSIONS: Three European real-world, chart review studies in people with type 2 diabetes managed using basal bolus insulin therapy each concluded that HbA1c was significantly reduced after changing to use of flash glucose monitoring for 3-6 months in a real-world setting.

Prevalence of May-Thurner Syndrome in Patients with Deep Vein Thrombosis at a Large Medical Referral Center. / Prävalenz des May-Thurner-Syndroms bei Patienten mit iliofemoraler tiefer Venenthrombose an einem universitären Zentrum.

OBJECTIVE: We set out to investigate the prevalence of May-Thurner syndrome (MTS) in a cohort of patients diagnosed with iliofemoral deep vein thrombosis at a large medical referral center. MATERIALS AND METHODS: We retrospectively analyzed a cohort of 496 patients who were referred to the emergency unit of a large medical referral center with suspected venous thromboembolism (VTE) and were diagnosed with deep vein thrombosis of the iliac veins and/or the thigh on ultrasound. We retrospectively assessed the presence of MTS in the primary ultrasound examination and on additional imaging (available in n = 193 patients). RESULTS: Across all 496 patients with iliofemoral deep vein thrombosis, the median age was 70 years. 238 patients (48 %) were female. The thrombosis was left-sided in 263 cases (53 %), right-sided in 208 cases (42 %) and bilateral in 24 cases (5 %). In the subgroup of patients with left-sided and bilateral thrombosis, the growth pattern was classified as ascending in 142 patients (50 %), descending in 104 patients (36 %) and unclear in 41 patients (14 %). Additional imaging tests were available in 193 patients: 119 patients (41 %) underwent CT, 18 patients (6 %) MRI and 30 patients (10 %) underwent phlebography. Within the subgroup of patients with left-sided and bilateral thrombosis, MTS was confirmed in 88 patients (31 %), and the imaging findings in 17 patients (6 %) were highly suspicious of MTS. Differentiation was not possible in 86 patients (30 %) and MTS was excluded in 96 patients (33 %). CONCLUSION: Underlying MTS is not uncommon in the selected cohort of patients with deep iliofemoral vein thrombosis at a large referral center and should be excluded by imaging. KEY POINTS: · May-Thurner syndrome (MTS) is a relatively frequent cause of deep vein thrombosis.. · MTS should be excluded in patients with left-sided or bilateral iliofemoral thrombosis.. · Cross-sectional imaging is helpful in this setting.. · Approximately one third of patients in this subgroup show signs of MTS.. CITATION FORMAT: · Heller T, Teichert C, Hafer J et al. Prevalence of May-Thurner Syndrome in Patients with Deep Vein Thrombosis at a Large Medical Referral Center. Fortschr Röntgenstr 2019; 191: 1107 - 1117.

Patient radiation dose in percutaneous biliary interventions: recommendations for DRLs on the basis of a multicentre study.

OBJECTIVE: Percutaneous biliary interventions (PBIs) can be associated with a high patient radiation dose, which can be reduced when national diagnostic reference levels (DRLs) are kept in mind. The aim of this multicentre study was to investigate patient radiation exposure in different percutaneous biliary interventions, in order to recommend national DRLs. METHODS: A questionnaire asking for the dose area product (DAP) and the fluoroscopy time (FT) in different PBIs with ultrasound- or fluoroscopy-guided bile duct punctures was sent to 200 advanced care hospitals. Recommended national DRLs are set at the 75th percentile of all DAPs. RESULTS: Twenty-three facilities (9 interventional radiology depts. and 14 gastroenterology depts.) returned the questionnaire (12%). Five hundred sixty-five PBIs with 19 different interventions were included in the analysis. DAPs (range 4-21,510 cGy·cm2) and FTs (range 0.07-180.33 min) varied substantially depending on the centre and type of PBI. The DAPs of initial PBIs were significantly (p < 0.0001) higher (median 2162 cGy·cm2) than those of follow-up PBIs (median 464 cGy·cm2). There was no significant difference between initial PBIs with ultrasound-guided bile duct puncture (2162 cGy·cm2) and initial PBIs with fluoroscopy-guided bile duct puncture (2132 cGy·cm2) (p = 0.85). FT varied substantially (0.07-180.33 min). CONCLUSIONS: DAPs and FTs in percutaneous biliary interventions showed substantial variations depending on the centre and the type of PBI. PBI with US-guided bile duct puncture did not reduce DAP, when compared to PBI with fluoroscopy-guided bile duct puncture. National DRLs of 4300 cGy·cm2 for initial PBIs and 1400 cGy·cm2 for follow-up PBIs are recommended. KEY POINTS: • DAPs and FTs in percutaneous biliary interventions showed substantial variations depending on the centre and the type of PBI. • PBI with US-guided bile duct puncture did not reduce DAP when compared to PBI with fluoroscopy-guided bile duct puncture. • DRLs of 4300 cGy·cm2for initial PBIs (establishing a transhepatic tract) and 1400 cGy·cm2for follow-up PBIs (transhepatic tract already established) are recommended.

The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial.

AIMS: Flash sensor-based glucose monitoring (FSGM) provides people with diabetes considerably more information on their glycaemic control. We have developed and evaluated a structured education and treatment programme, termed FLASH, to assist FSGM users to understand and use the available glycaemic information for optimization of their diabetes treatment. METHODS: We report on a multi-centre, randomized, parallel trial with a six-month follow-up involving 216 eligible participants (16-75 years old) on intensive insulin therapy. The primary outcome was HbA1c change from baseline to six months. Secondary outcomes were measures of glucose control as assessed by FSGM, as well as changes in behavioural and psychosocial measures. RESULTS: At six months, the between-group difference in HbA1c reduction was significant, favouring FLASH education compared to the control group receiving no FLASH education (-0.28%, 95% CI -0.16% to -0.40% vs.-0.11%, 95% CI 0.00% to -0.22%; with a between-group difference of -0.17%, 95% CI -0.01% to -0.33%; p = 0.033). Participation in FLASH education also resulted in significant improvements in time spent in the target glucose range, in diabetes-related distress scores and in satisfaction with the glucose monitoring method. FLASH education also resulted in significant improvements in the use of glycaemic information provided by FSGM and in reduced self-monitoring of blood glucose (SMBG) fingerstick testing. CONCLUSION: FLASH is an effective programme to improve glycaemic control and lower diabetes-related distress in users of FSGM. The study was registered in ClinicalTrials: NCT03175315.

Therapy Adjustments Based on Trend Arrows Using Continuous Glucose Monitoring Systems.

Continuous glucose monitoring (CGM) systems use trend arrows to accurately display the anticipated glucose curve for the user. These are used for both "real-time" glucose monitoring and for intermittent scanning glucose monitoring. Trend arrow data are used by people with diabetes to make corrections to their glucose control. It is essential that they are correctly interpreted when adjusting insulin doses and to ensure that appropriate treatment decisions are made. The aim of this article is to provide general treatment guidance for diabetes teams and for people with diabetes using CGM in the context of trend arrows. This is based on previous recommendations for interpreting trend arrows without losing sight of the need for individual therapy adjustment.

The glass walls of Samarra (Iraq): Ninth-century Abbasid glass production and imports.

Capital of the Abbasid Caliphate between 836 and 892 CE, the palace-city of Samarra offers a precise window into early Islamic art and architecture. Excavations conducted more than 100 years ago are seen as the beginnings of scientific Islamic archaeology, and have yielded an exceptional array of finds including a wealth of glass artefacts. The chemical composition of glass reflects the nature of the raw materials and their geological provenance and can therefore reveal past technologies and economic and cultural interactions. Through high-resolution analysis of a comprehensive glass assemblage from Samarra we have new evidence that points to the existence of an advanced Abbasid glass industry, as well as the import of specific glass objects for the thriving new capital city. Quantitative analytical data of 58 elements by laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS) show a striking correlation between object types and glass compositions. The compositional profiles of two related plant ash groups of architectural glass point to a local production, destined for the decoration of the famed glass walls of Abbasid palaces. The selective use of objects, materials and colours to create reflective and luminous glass walls are indicative of the great cultural and economic value of glass during the Abbasid period. Our findings thus confirm the veracity of written sources that stipulate the production of glass in the vicinity of Samarra, as well as the import of selected artefacts such as Byzantine mosaic tesserae.

Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial.

BACKGROUND: Tight control of blood glucose in type 1 diabetes delays onset of macrovascular and microvascular diabetic complications; however, glucose levels need to be closely monitored to prevent hypoglycaemia. We aimed to assess whether a factory-calibrated, sensor-based, flash glucose-monitoring system compared with self-monitored glucose testing reduced exposure to hypoglycaemia in patients with type 1 diabetes. METHOD: In this multicentre, prospective, non-masked, randomised controlled trial, we enrolled adult patients with well controlled type 1 diabetes (HbA1c ≤58 mmol/mol [7·5%]) from 23 European diabetes centres. After 2 weeks of all participants wearing the blinded sensor, those with readings for at least 50% of the period were randomly assigned (1:1) to flash sensor-based glucose monitoring (intervention group) or to self-monitoring of blood glucose with capillary strips (control group). Randomisation was done centrally using the biased-coin minimisation method dependent on study centre and type of insulin administration. Participants, investigators, and study staff were not masked to group allocation. The primary outcome was change in time in hypoglycaemia (<3·9 mmol/L [70 mg/dL]) between baseline and 6 months in the full analysis set (all participants randomised; excluding those who had a positive pregnancy test during the study). This trial was registered with ClinicalTrials.gov, number NCT02232698. FINDINGS: Between Sept 4, 2014, and Feb 12, 2015, we enrolled 328 participants. After the screening and baseline phase, 120 participants were randomly assigned to the intervention group and 121 to the control group, with outcomes being evaluated in 119 and 120, respectively. Mean time in hypoglycaemia changed from 3·38 h/day at baseline to 2·03 h/day at 6 months (baseline adjusted mean change -1·39) in the intervention group, and from 3·44 h/day to 3·27 h/day in the control group (-0·14); with the between-group difference of -1·24 (SE 0·239; p<0·0001), equating to a 38% reduction in time in hypoglycaemia in the intervention group. No device-related hypoglycaemia or safety issues were reported. 13 adverse events were reported by ten participants related to the sensor-four of allergy events (one severe, three moderate); one itching (mild); one rash (mild); four insertion-site symptom (severe); two erythema (one severe, one mild); and one oedema (moderate). There were ten serious adverse events (five in each group) reported by nine participants; none were related to the device. INTERPRETATION: Novel flash glucose testing reduced the time adults with well controlled type 1 diabetes spent in hypoglycaemia. Future studies are needed to assess the effectiveness of this technology in patients with less well controlled diabetes and in younger age groups. FUNDING: Abbott Diabetes Care.