Search

ObjectiveTo compare glycemic control and treatment preference in children with type 1 diabetes (T1D) using sensor augmented pump (SAP) with predictive low glucose suspend (SmartGuard®) or pump with independent intermittent scanning continuous glucose monitoring (iscCGM, Freestyle libre ®).MethodsIn this open label, cross-over study, children 6 to 14 years of age, treated with insulin pump for at least 6 months, were randomized to insulin pump and iscCGM (A) or SAP with SmartGuard® (B) for 5 weeks followed by 5 additional weeks. The difference in percentages of time in glucose target (TIT), (3.9 – 8.0 mmol/l), 8 and 10 mmol/l, were analyzed using linear mixed models during the final week of each arm and were measured by blinded CGM (IPro2®).Results31 children (15 girls) finished the study. With sensor compliance > 60%, no difference in TIT was found, TIT: A 37.86%; 95% CI [33.21; 42.51]; B 37.20%; 95% CI [32.59; 41.82]; < 3 mmol/l A 2.27% 95% CI [0.71; 3.84] B 1.42% 95% CI [-0.13; 2.97]; > 8 mmol/l A 0.60% 95% CI [0.56, 0.67]; B 0.63% [0.56; 0.70]. One year after the study all participants were on CGM compared to 80.7% prior to the study, with a shift of 13/25 participants from iscCGM to SAP.ConclusionsIn this study, no significant difference in glycemic control was found whether treated with SAP (SmartGuard®) or pump with iscCGM. The decision of all families to continue with CGM after the study suggests a positive impact, with preference for SmartGuard®.Clinical Trial Registration[clinicaltrials.gov], identifier NCT03103867.

Background: Type 1 diabetes in young children is a heavy parental burden. As part of pilot phase of the KIDSAP01 study, we conducted a baseline assessment in parents to study the association between hypoglycemia fear, parental wellbeing and child behavior. Methods: All parents were invited to fill in baseline questionnaires: hypoglycemia fear survey (HFS), WHO-5, Epworth Sleepiness Scale and Strength and Difficulties Questionnaire (SDQ). Results: 24 children (median age: 5-year, range 1-7 years, 63% male, mean diabetes duration: 3 ± 1.7 years) participated. 23/24 parents filled out the questionnaires. We found a higher score for the hypoglycemia fear behavior 33.9 ± 5.6 compared to hypoglycemia worry 34.6 ± 12.2. Median WHO-5 score was 16 (8 - 22) with poor well-being in two parents. Median daytime sleepiness score was high in five parents (>10). For six children a high total behavioral difficulty score (>16) was reported. Pro social behavior score was lower than normal in six children (

Resume Les stenoses ou thromboses de la veine cave superieure (VCS) sont actuellement frequemment observees au decours de catheterismes veineux qui peuvent etre un catheter d’hemodialyse, une sonde de stimulation endocavitaire ou la mise en place d’une chambre implantable (CI). Les lesions de la veine cave superieure secondaires a la mise en place d’une CI sont plus souvent symptomatiques, liees a la severite des lesions et a la toxicite de la chimiotherapie. Nous rapportons notre experience de six patients traites entre 2007 et 2012, par voie endovasculaire (5 cas) ou par abord chirurgical direct (1 cas). Tous les malades presentaient un syndrome cave cliniquement symptomatique. Chez trois malades, le catheter etait en place lorsque les manifestations cliniques sont survenues. Les explorations morphologiques ont comporte une exploration hemodynamique et morphologique, par echotomographie Doppler et angioscanner. Les lesions etaient : une stenose isolee de la VCS (deux cas) ; une stenose de la VCS associee a une stenose du tronc de Pirogoff droit (un cas) ; une stenose de la VCS associee a une thrombose du tronc veineux innomine gauche et une stenose du confluent de Pirogoff (un) ; une thrombose de la VCS (deux cas). Chez une de ces malades, le thrombus debordait dans l’oreillette droite. Dans ces deux cas, le retour veineux azygos etait concerne. Cinq malades ont ete traites par voie endovasculaire, par un abord jugulaire droit (deux cas), par un abord bijugulaire (trois cas). Une angioplastie de la VCS avec mise en place d’un stent cave a ete realisee dans deux cas. Une angioplastie cave avec stent et angioplastie du tronc veineux droit ont ete realisees dans un cas. Une angioplastie en kissing, apres thrombolyse des deux troncs veineux innomines et de la VCS, avec mise en place d’un stent cave a ete realisee dans un cas. Une angioplastie simple a ete realisee dans un cas, en raison de l’obtention d’un resultat incomplet, avec une lumiere residuelle inferieure a 8 mm. Une malade presentait une thrombose complete de la VCS, avec extension du thrombus dans l’oreillette droite. Elle a ete traitee par un abord chirurgical par sternotomie mediane verticale, controle des deux troncs veineux innomines et clampage lateral de l’oreillette droite. Une thrombo-intimectomie a permis l’extraction du thrombus avec fermeture par une angioplastie en pericarde. Les suites postoperatoires ont ete satisfaisantes chez cinq patients. Un patient a presente une tamponnade postoperatoire qui a necessite un drainage pericardique. Le controle scanographique a montre un bon resultat morphologique dans cinq cas, un resultat incomplet dans un cas. Les malades ont ete suivis cliniquement et par echotomographie Doppler annuel. Le suivi va de deux a six ans. Une malade a presente une restenose au 7e mois, necessitant une nouvelle angioplastie, realisee par voie femorale et mise en place d’une nouvelle chambre implantable par voie cervicale. Les quatre autres malades ont conserve un resultat hemodynamique correct. Deux malades ont presente une evolutivite metastatique entrainant le deces au 8e et 36e mois. En conclusion, le traitement des lesions de la VCS apres mise en place d’une chambre implantable est actuellement souvent possible par voie endovasculaire. La chirurgie conventionnelle conserve des indications, lorsque les lesions sont tres etendues ou debordent dans l’oreillette droite.

Resume Les complications de l’irradiation iliofemorale au niveau du petit bassin et du triangle de Scarpa comportent des atteintes vasculaires (arterielles et veineuses), nerveuses et une atteinte des parties molles sous-cutanees et cutanees, pouvant aboutir au niveau du triangle de Scarpa a une radionecrose exposant les vaisseaux. Dans ce travail, nous rapportons une experience de cinq observations. Il s’agissait de trois hommes et de deux femmes, âges de 30 a 73 ans. La radiotherapie datait de plus de 15 ans dans trois cas et de deux ans dans deux cas. La symptomatologie arterielle etait en rapport avec des lesions occlusives iliofemorales (claudication intermittente serree dans un cas, une ischemie critique dans un cas). Une patiente a ete operee en urgence pour une rupture septique, d’une revascularisation in situ realisee deux mois plus tot. Deux patients ne presentaient aucune symptomatologie ischemique vasculaire. Chez ces deux patients, la radionecrose exposait les vaisseaux femoraux. Il n’y avait pas de stenose post-radique, mais un risque de rupture septique. Quatre patients ont ete operes de facon programmee, apres exploration complete cardiovasculaire. La revascularisation a consiste en un pontage iliofemoral trans-osseux (trois cas), transmusculaire (un cas), in situ (un cas). Un geste de recouvrement plastique a ete realise dans quatre cas. Trois patients ont eu un lambeau musculocutane de grand droit, controlateral (deux cas) et homolateral (un cas). Dans un cas, la couverture cutanee a ete realisee par un lambeau antebrachial, dit « chinois », sevre a la sixieme semaine. Les suites postoperatoires ont ete satisfaisantes dans quatre cas. La patiente traitee par pontage in situ a presente une hemorragie infectieuse au 10e jour postoperatoire, qui a necessite une reintervention. Cette patiente est decedee de defaillance multiviscerale, malgre une revascularisation permeable et un lambeau viable. Les quatre autres patients n’ont pas presente de complications septiques precoces ou tardives. Ces patients ont ete suivis annuellement par une echographie-Doppler, et angio-scanner. Un patientest decede tardivement d’insuffisance coronarienne. Les trois autres patients sont vivants avec un pontage permeable, avec un recul de 11, 8 et 3 ans. Un patient a presente une thrombose tardive a la septieme annee et a la dixieme annee traitee par thrombectomie simple. En conclusion, les patients presentant une radionecrose du Scarpa interessant les vaisseaux femoraux doivent etre de preference traites par un pontage extra-anatomique, associe a un geste de recouvrement plastique. Les pontages trans-osseux constituent une modalite relativement plus simple et fiable que les pontages par le trou obturateur.

OBJECTIVE: To evaluate the experiences of families with very young children aged 1 to 7 years (inclusive) with type 1 diabetes using day-and-night hybrid closed-loop insulin delivery. METHODS: Parents/caregivers of 20 children aged 1 to 7 years with type 1 diabetes completed a closed-loop experience survey following two 3-week periods of unrestricted day-and-night hybrid closed-loop insulin therapy using Cambridge FlorenceM system at home. Benefits, limitations, and improvements of closed-loop technology were explored. RESULTS: Responders reported reduced burden of diabetes management, less time spent managing diabetes, and improved quality of sleep with closed-loop. Ninety percent of the responders felt less worried about their child's glucose control using closed-loop. Size of study devices, battery performance and connectivity issues were identified as areas for improvement. Parents/caregivers wished for more options to input information to the system such as temporary glucose targets. CONCLUSIONS: Parents/caregivers of very young children reported important quality of life benefits associated with using closed-loop, supporting adoption of this technology in this population.

OBJECTIVE We aimed to assess the feasibility and safety of hybrid closed-loop insulin delivery in children with type 1 diabetes aged 1–7 years as well as evaluate the role of diluted insulin on glucose control. RESEARCH DESIGN AND METHODS In an open-label, multicenter, multinational, randomized crossover study, 24 children with type 1 diabetes on insulin pump therapy (median age 5 years [interquartile range 3–6] and mean ± SD HbA1c 7.4 ± 0.7% [57 ± 8 mmol/mol] and total insulin 13.2 ± 4.8 units/day) underwent two 21-day periods of unrestricted living and we compared hybrid closed-loop with diluted insulin (U20) and hybrid closed-loop with standard strength insulin (U100) in random order. During both interventions, the Cambridge model predictive control algorithm was used. RESULTS The proportion of time that sensor glucose was in the target range between 3.9 and 10 mmol/L (primary end point) was not different between interventions (mean ± SD 72 ± 8% vs. 70 ± 7% for closed-loop with diluted insulin vs. closed-loop with standard insulin, respectively; P = 0.16). There was no difference in mean glucose levels (8.0 ± 0.8 vs. 8.2 ± 0.6 mmol/L; P = 0.14), glucose variability (SD of sensor glucose 3.1 ± 0.5 vs. 3.2 ± 0.4 mmol/L; P = 0.16), or the proportion of time spent with sensor glucose 0.99). Total daily insulin delivery did not differ (17.3 ± 5.6 vs. 18.9 ± 6.9 units/day; P = 0.07). No closed-loop–related severe hypoglycemia or ketoacidosis occurred. CONCLUSIONS Unrestricted home use of day-and-night closed-loop in very young children with type 1 diabetes is feasible and safe. The use of diluted insulin during closed-loop does not provide additional benefits compared with standard strength insulin.

Background In attempting to achieve optimal metabolic control, the day-to-day management is challenging for a child with type 1 diabetes (T1D) and his family and can have a major negative impact on their quality of life. Augmenting an insulin pump with glucose sensor information leads to improved outcomes: decreased haemoglobin A1c levels, increased time in glucose target and less hypoglycaemia. Fear of nocturnal hypoglycaemia remains pervasive amongst parents, leading to chronic sleep interruption and lack of sleep for the parents and their children. The QUEST study, an open-label, single-centre randomized crossover study, aims to evaluate the impact on time in target, in hypoglycaemia and hyperglycaemia and the effect on sleep and quality of life in children with T1D, comparing a sensor-augmented pump (SAP) with predictive low glucose suspend and alerts to the use of the same insulin pump with a flash glucose measurement (FGM) device not interacting with the pump. Methods/design Subjects meeting the inclusion criteria are randomized to treatment with the SAP or treatment with an insulin pump and independent FGM for 5 weeks. Following a 3-week washout period, the subjects cross over to the other study arm for 5 weeks. During the week before and in the last week of treatment, the subjects and one of their caregivers wear a sleep monitor in order to obtain sleep data. The primary endpoint is the between-arm difference in percentage of time in glucose target during the final 6 days of each treatment arm, measured by a blinded continuous glucose measurement (CGM). Additional endpoints include comparison of quantity and quality of sleep as well as quality of life perception of the subjects and one of their caregivers in the two different treatment arms. Recruitment started in February 2017. A total of 36 patients are planned to be randomized. The study recruitment was completed in April 2018. Discussion With this study we will provide more information on whether insulin pump treatment combined with more technology (SmartGuard® feature and alerts) leads to better metabolic control. The inclusion of indicators on quality of sleep with less sleep interruption, less lack of sleep and perception of quality of life in both children and their primary caregivers is essential for this study and might help to guide us to further treatment improvement. Trial registration ClinicalTrials.gov, NCT03103867. Registered on 6 April 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-3034-4) contains supplementary material, which is available to authorized users.

Trial Protocol. (DOCX 46 kb)

Sleep Diaries. (DOC 81 kb)

Case Report Forms. (DOC 88 kb)

Sleep Diaries. (DOC 78 kb)

Questionnaires for children. (DOC 146 kb)

Questionnaires for parents. (DOC 119 kb)

Questionnaires for children. (DOC 152 kb)

Sleep Diaries. (DOC 77 kb)

Questionnaires for parents. (DOC 158 kb)

Long-term iliofemoral complications induced by radiation include vascular (arterial and venous) lesions, nervous lesions and soft tissue loss that can be cutaneous and subcutaneous and potentially lead to radionecrosis with vessel exposure. We present five cases of groin radionecrosis. There were three men and two women (age 30-73 years). Radiotherapy had been delivered 15 years earlier in three cases, and 2 years earlier in two cases. Symptoms were intermittent claudication (n=1), critical ischemia (n=1), and septic hemorrhage (n=1). Two patients had no vascular symptoms. Four patients underwent scheduled surgery after complete cardiac and cardiovascular evaluation with duplex-Doppler, CT scan and/or intra-arterial angiography. One woman underwent emergency surgery after septic hemorrhage of a previous in situ femoral revascularization fashioned 2 months earlier. Revascularization was achieved with trans-iliac (n=3), trans-muscular (n=1, and in situ (n=1) iliofemoral bypass. A retroperitoneal approach with section of large muscles was used. In three cases, a trans-iliac route was used by perforating the iliac wing with a 8-mm PTFE graft. Proximal anastomosis was done on the abdominal aorta (n=1) and the homolateral common iliac artery (n=2). Distal anastomosis was done on the distal profunda artery and popliteal artery (n=1) and on the distal femoral superficial artery (n=2). In two cases, an iliofemoral bypass was done with a 7-mm PTFE vascular graft. The proximal anastomosis was done on the proximal external iliac artery and the distal anastomosis on the proximal superficial femoral artery. A plastic procedure was performed in four cases. Three patients had a homolateral (n=1) or controlateral (n=2) rectus abdominis flap. In one case, plastic coverage was done with an antebrachial flap (Chinese flap), which has been released at 6 weeks. One patient had post-radiotherapy iliofemoral vascular disease, but there was no vascular exposure, and no plastic coverage was necessary. The postoperative course was uneventful in four cases. The patient treated with an in situ bypass developed septic hemorrhage at day 10, requiring revision. The patient died of multiple organ system failure, with a patent graft and a viable flap. The other four patients had no early or late complications. These patients have been followed annually for clinical examinations and duplex scans, and angio-scans. One patient died of ischemic heart disease. The three other patients are alive with a patent bypass with 11, 8 and 3 years follow-up. One patient had a late occlusion of the bypass treated by thrombectomy after 7 and 10 years. In conclusion, patients with femoral radionecrosis can be treated by an extra-anatomic bypass, with plastic coverage. The trans-iliac is a relatively simple and safe procedure.

Superior vena cava (SVC) stenosis or thrombosis is a well-known complication of central venous catheterization for endocavitary treatments, hemodialysis, or chemotherapy. In cancer patients, these SVC lesions are often symptomatic due to intimal damage and chemotherapy toxicity. We report our experience with six patients treated between 2007 and 2012 via an endovascular approach (n=5) or a direct surgical approach (n=1). All patients had SVC syndrome with facial edema, headache and upper limb edema. In three cases, the catheter was in place when the clinical symptoms occurred. Duplex Doppler and computed tomography (CT)-angiography identified the following lesions: isolated SVC stenosis (n=2); SVC stenosis with right Pirogoff confluence stenosis (n=1); SVC stenosis associated with left innominate vein thrombosis and right Pirogoff confluence stenosis (n=1); SVC thrombosis affecting azygos flow (n=2). In one patient, the thrombus extended into the right atrium. Five patients underwent endovascular repair via a right jugular approach (n=2) or a double jugular approach (n=3). Treatment involved: SVC angioplasty with stent (n=2); right Pirogoff angioplasty and SVC stent (n=1); kissing angioplasty of both innominate trunks with a SVC stent (n=1); and SVC angioplasty without stent because of an incomplete result with a residual lumen less than 8mm (n=1). One patient had a complete SVC occlusion with extension of thrombus into the right atrium. She was treated via a median sternotomy for open surgical control of both innominate trunks and lateral clamping of the right atrium. A long cavotomy prolonged on the right atrium allowed thrombo-intimectomy and pericardial patch angioplasty. Postoperative follow-up was uneventful in five cases. However, postoperative hemorrhage required pericardial drainage in one patient. The CT scan showed a good morphological aspect in five patients and an incomplete result in one case. Patients have been followed up annually with a duplex scan from two to six years. One patient had a restenosis at 7 months treated by a new angioplasty via a femoral approach. A new catheter was positioned via a cervical approach. Two patients died of metastatic diffusion at 8 and 32 months. The other four patients have remained asymptomatic, with a satisfactory duplex scan. In conclusion, VCS lesions after implanted central access for chemotherapy can often be treated endovascularly. Conventional surgery still has indications when lesions extend into the right atrium.

Les anévrysmes de la veine porte sont rares et représentent 3 % des anévrysmes veineux. Leur fréquence a été évaluée à 0.43 % sur 4186 malades. On distingue les anévrysmes congénitaux et les anévrysmes acquis. Les anévrysmes congénitaux résultent d’une perturbation de la fusion des veines vitellines droite et gauche, (70 % des observations publiées) et peuvent aboutir à un anévrysme sacciforme ou fusiforme. Les anévrysmes acquis sont secondaires à une affection hépatique chronique (cirrhose, hypertension portale) ou une pancréatite inflammatoire. Ils représentent 30 % des observations publiées. Nous rapportons une observation d’une patiente de 38 ans, sans antécédent particulier : pas d’antécédents familiaux, pas de grossesse, pas de prise d’anti contraceptif. Elle présentait un anévrysme de la veine porte, symptomatique avec des douleurs abdominales et un amaigrissement de 8 kg en six mois. Il n’y avait pas de troubles du transit. Les explorations biologiques montraient l’absence de cholestase et de cytolyse. L’échographie-doppler pulsé couleur et l’angio scanner montraient un anévrysme de la veine porte fusiforme mesurant 52 mm de long sur 38 mm de diamètre, respectant la bifurcation portale à 13 mm. Il y avait une évolutivité entre février et mai 2015, mesurée à 48 mm de diamètre. Après revue de la littérature et réunion de concertation multi disciplinaire, nous avons pris la décision d’opérer la patiente au centre hépato biliaire de l’hôpital Paul Brousse. Une mise à plat de l’anévrysme, avec reconstruction par une allogreffe aortique a été réalisé avec des suites postopératoires simples (Pr Castaing). Un traitement anticoagulant par HBPM a été institué, relayé par la coumadine après un mois. Le scanner à un mois a montré une bonne perméabilité de l’allogreffe avec une occlusion de la veine splénique reprise par la collatéralité. Ce traitement sera interrompu après six mois Le contrôle échographique et scanographique à 12 mois a montré une greffe perméable avec une occlusion courte de la veine splénique reprise par la collatéralité. Avec 18 mois de suivi, la patiente est asymptomatique. Elle a repris son poids initial. Elle a repris ses activités d’agricultrice. Nous présentons : • Une revue exhaustive de la littérature française et anglaise après une recherche bibliographique approfondie des 15 dernières années ; • Sous forme de tableaux : les 22 observations des malades opérés entre 2000 et 2015, en précisant les indications, les modalités thérapeutiques et les résultats ; • Nous analysons séparément le traitement des anévrysmes thrombosés ; • Cette observation rare et la revue de la littérature permet de présenter les indications thérapeutiques actuelles sous la forme d’un arbre décisionnel., • Anévrysme de la veine porte • Indication thérapeutique actuelle • Traitement par résection greffe • Revue de la littérature, Portal Vein Aneurysms (PVA) are rare and estimated to be 3% of venous aneurysms. Their frequency is estimated to be 0.43% in a review of 4186 patients. Two types of PVA are described: congenital aneurysm and acquired aneurysm. Congenital aneurysm is due to a wrong fusion of right and left vitelline veins, leading to a sacciform or fusiform aneurysm. Acquired aneurysms are related to a chronic hepatic disease (cirrhosis with or without portal hypertension) or a chronic pancreatitis. We present an observation of a 38 years old woman, without any background (no pregnancy, no oral anticonceptraceptive). A PVA was diagnosed by explorations of abdominal pains and weigh loss of 8 kg in six months. Biologic explorations did not show any abnormalyties of hepatic function. Color dupplex scan and angio CT scan showed a PVA. It was a fusiform aneurysm and measured 52mm / 38 mm. The portal bifurcation was respected on 13 mm before the bifurcation. Diameter evolutivity from 38 mm to 48 mm was diagnosed by duplex scan and RMI, between February and May 2015. After multi-disciplinary consensus conference and literature review, we decided to operate the patient in a reference center (Centre Hépato Biliaire - Hôpital Paul Brousse). The aneurysm was resected and the reconstruction was done with an aortic allograft (Pr Castaing). Post-operative course was uneventful. Anticoagulant therapy (HBPM), replaced by Coumadin after a month was used. This treatment was interrupted at six months. Dupplex scan and CT scan showed patency of the graft at 12 months, with a short occlusion of the splenic vein. With an 18 month follow up, patient was asymptomatic, has recovered her weight and returned to farmer activity. We present: • an exhaustive review of French and English literature by Pubmed Medline for the last 15 years; • with two tables, we review 22 clinical cases, according to indications, surgical technique and results; • we analyze the treatment of thrombosed aneurysms. • this clinical case and an extensive review of the literature allows to discuss the surgical modalitys of treatment., • Portal vein aneurysm • Actual surgical indications • Treatment by resection – allograft • Literature review