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Levit S.,Institute of Endocrinology | Toledano Y.,Hillel Yaffe Medical Center | Wainstein J.,Diabetes Unit
International Journal of Clinical Practice | Year: 2011

Objective: The primary goal of the study was to evaluate retrospectively efficacy of long-term modern premixed insulin (MPI) administration. The secondary aims were to monitor weight gain, hypoglycaemia and compliance during MPI therapy. Research design and methods: One hundred and fifteen outpatients with type 2 diabetes (64 male patients, 51 female patients; mean age 62.4 ± 12.2 years; mean duration of diabetes 10 ± 8 years; mean weight 84.3 ± 14.8 kg) were included in this study. Patients were prescribed one of three MPIs thrice-daily: biphasic insulin lispro 25, biphasic insulin lispro 50, or biphasic insulin aspart 30. Metformin was combined with MPI in 81 patients. Data prior to and during MPI treatment were retrieved from computerised patient medical files. Results: After a mean treatment period of 2.9 ± 0.9 years, mean A1C levels and fasting blood glucose decreased from 8.7 ± 1.4% and 193 ± 59 mg/dl to 7.3 ± 1.1% and 141 ± 41 mg/dl (p < 0.001 for both), respectively. Thirty-six per cent of the cohort achieved target A1C level of ≤ 7%. Serum triglycerides decreased from 183 A;circ± 109 mg/dl to 151 ± 76 mg/dl (p < 0.001). Weight did not change during MPI treatment. Frequency of minor hypoglycaemic episodes decreased significantly during MPI administration. No major hypoglycaemic event was reported. Number of incompliant patients decreased significantly from 39 to 25 (p = 0.001) during MPI treatment. Conclusions: Modern premixed insulins represent an effective and safe long-term therapy for patients with type 2 diabetes. Specifically, the regimen of thrice-daily injections combined with metformin is a viable treatment option. © 2010 Blackwell Publishing Ltd.


News Article | December 20, 2016
Site: www.eurekalert.org

The bionic pancreas system developed by Boston University (BU) investigators proved better than either conventional or sensor-augmented insulin pump therapy at managing blood sugar levels in patients with type 1 diabetes living at home, with no restrictions, over 11 days. The report of a clinical trial led by a Massachusetts General Hospital (MGH) physician is receiving advance online publication in The Lancet. "For study participants living at home without limitations on their activity and diet, the bionic pancreas successfully reduced average blood glucose, while at the same time decreasing the risk of hypoglycemia," says Steven Russell, MD, PhD, of the MGH Diabetes Unit. "This system requires no information other than the patient's body weight to start, so it will require much less time and effort by health care providers to initiate treatment. And since no carbohydrate counting is required, it significantly reduces the burden on patients associated with diabetes management." Developed by Edward Damiano, PhD, and Firas El-Khatib, PhD, of the BU Department of Biomedical Engineering, the bionic pancreas controls patients' blood sugar with both insulin and glucagon, a hormone that increases glucose levels. After a 2010 clinical trial confirmed that the original version of the device could maintain near-normal blood sugar levels for more than 24 hours in adult patients, two follow-up trials - reported in a 2014 New England Journal of Medicine paper - showed that an updated version of the system successfully controlled blood sugar levels in adults and adolescents for five days. Another follow-up trial published in The Lancet Diabetes and Endocrinology in 2016 showed it could do the same for children as young as 6 years of age. While minimal restrictions were placed on participants in the 2014 trials, participants in both spent nights in controlled settings and were accompanied at all times by either a nurse for the adult trial or remained in a diabetes camp for the adolescent and pre-adolescent trials. Participants in the current trial had no such restrictions placed upon them, as they were able to pursue normal activities at home or at work with no imposed limitations on diet or exercise. Patients needed to live within a 30-minute drive of one of the trial sites - MGH, the University of Massachusetts Medical Center, Stanford University, and the University of North Carolina at Chapel Hill - and needed to designate a contact person who lived with them and could be contacted by study staff, if necessary. The bionic pancreas system - the same as that used in the 2014 studies - consisted of a smartphone (iPhone 4S) that could wirelessly communicate with two pumps delivering either insulin or glucagon. Every five minutes the smartphone received a reading from an attached continuous glucose monitor, which was used to calculate and administer a dose of either insulin or glucagon. The algorighms controlling the system were updated for the current trial to better respond to blood sugar variations. While the device allows participants to enter information about each upcoming meal into a smartphone app, allowing the system to deliver an anticipatory insulin dose, such entries were optional in the current trial. If participants' blood sugar dropped to dangerous levels or if the monitor or one of the pumps was disconnected for more than 15 minutes, the system would alerted study staff, allowing them to check with the participants or their contact persons. Study participants were adults who had been diagnosed with type 1 diabetes for a year or more and had used an insulin pump to manage their care for at least six months. Each of 39 participants that finished the study completed two 11-day study periods, one using the bionic pancreas and one using their usual insulin pump and any continous glucose monitor they had been using. In addition to the automated monitoring of glucose levels and administered doses of insulin or glucagon, participants completed daily surveys regarding any episodes of symptomatic hypoglycemia, carbohydrates consumed to treat those episodes, and any episodes of nausea. On days when participants were on the bionic pancreas, their average blood glucose levels were significantly lower - 141 mg/dl versus 162 mg/dl - than when on their standard treatment. Blood sugar levels were at levels indicating hypoglycemia (less than 60 mg/dl) for 0.6 percent of the time when participants were on the bionic pancreas, versus 1.9 percent of the time on standard treatment. Participants reported fewer episodes of symptomatic hypoglycemia while on the bionic pancreas, and no episodes of severe hypoglycemia were associated with the system. The system performed even better during the overnight period, when the risk of hypoglycemia is particularly concerning. "Patients with type 1 diabetes worry about developing hypoglycemia when they are sleeping and tend to let their blood sugar run high at night to reduce that risk," explains Russell, an assistant professor of Medicine at Harvard Medical School. "Our study showed that the bionic pancreas reduced the risk of overnight hypoglycemia to almost nothing without raising the average glucose level. In fact the improvement in average overnight glucose was greater than the improvement in average glucose over the full 24-hour period." Damiano, whose work on this project is inspired by his own 17-year-old son's type 1 diabetes, adds, "The availability of the bionic pancreas would dramatically change the life of people with diabetes by reducing average glucose levels - thereby reducing the risk of diabetes complications - reducing the risk of hypoglycemia, which is a constant fear of patients and their families, and reducing the emotional burden of managing type 1 diabetes." A co-author of the Lancet report, Damiano is a professor of Biomedical Engineering at Boston University. The BU patents covering the bionic pancreas have been licensed to Beta Bionics, a startup company co-founded by Damiano and El-Khatib. The company's latest version of the bionic pancreas, called the iLet, integrates all components into a single unit, which will be tested in future clinical trials. People interested in participating in upcoming trials may contact Russell's team at the MGH Diabetes Research Center in care of Llazar Cuko. El-Khatib is the lead author of the Lancet paper, and additional co-authors include David Harlan, MD, of the University of Massachusetts Medical Center, Bruce Buckingham,MD, of Stanford University, and John Buse, MD, of the University of North Carolina at Chapel Hill. Support for the study includes National Institute of Health grants R01DK097657 and DP3DK101084 and National Center for Advancing Translational Sciences awards UL1TR001453, UL1TR001085 and UL1TR001111. Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 16 schools and colleges, along with a number of multi-disciplinary centers and institutes integral to the University's research and teaching mission. In 2012, BU joined the Association of American Universities, a consortium of 62 leading research universities in the United States and Canada. Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $800 million and major research centers in HIV/AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, photomedicine and transplantation biology. The MGH topped the 2015 Nature Index list of health care organizations publishing in leading scientific journals and earned the prestigious 2015 Foster G. McGaw Prize for Excellence in Community Service. In August 2016 the MGH was once again named to the Honor Roll in the U.S. News & World Report list of "America's Best Hospitals."


Harrison C.L.,Monash University | Lombard C.B.,Monash University | Strauss B.J.,Monash University | Teede H.J.,Diabetes Unit
Obesity | Year: 2013

Objective: Optimizing gestational weight gain (GWG) in early pregnancy is of clinical and public health importance, especially in higher risk pregnancies. Design and Methods: In a robustly designed, randomized controlled trial, 228 pregnant women at risk of developing gestational diabetes mellitus (GDM) were allocated to either control (written health information only) or intervention (four-session lifestyle program). All women received standard maternal care. Measures were completed at 12-15 and 26-28 weeks gestation. Measures included anthropometrics (weight and height), physical activity (pedometer and International Physical Activity Questionnaire), questionnaires (risk perception), and GDM screening. Results: The mean (SD) age [31.7 (4.5) and 32.4 (4.7) years] and body mass index [BMI; 30.3 (5.9) and 30.4 (5.6) kg/m 2] were similar between control and intervention groups, respectively. By 28 weeks, GWG was significantly different between control and intervention groups [6.9 (3.3) vs. 6.0 (2.8) kg, P < 0.05]. When stratified according to baseline BMI, overweight women in the control group gained significantly more weight compared to overweight women in the intervention group [7.8 (3.4) vs. 6.0 (2.2) kg, P < 0.05], yet in obese women, GWG was similar in both groups. Physical activity levels declined by 28 weeks gestation overall (P < 0.01); however, the intervention group retained a 20% higher step count compared to controls [5,203 (3,368) vs. 4,140 (2,420) steps/day, P < 0.05]. Overall, GDM prevalence was 22%, with a trend toward less cases in the intervention group (P = 0.1). Conclusions: Results indicate that a low-intensity lifestyle intervention, integrated with antenatal care, optimizes healthy GWG and attenuates physical activity decline in early pregnancy. Efficacy in limiting weight gain was greatest in overweight women and in high-risk ethnically diverse women. Copyright © 2013 The Obesity Society.


Harrison C.L.,Monash University | Thompson R.G.,Monash University | Teede H.J.,Monash University | Teede H.J.,Diabetes Unit | Lombard C.B.,Monash University
International Journal of Behavioral Nutrition and Physical Activity | Year: 2011

Background: Currently, little is known about physical activity patterns in pregnancy with prior estimates predominantly based on subjective assessment measures that are prone to error. Given the increasing obesity rates and the importance of physical activity in pregnancy, we evaluated the relationship and agreement between subjective and objective physical activity assessment tools to inform researchers and clinicians on optimal assessment of physical activity in pregnancy.Methods: 48 pregnant women between 26-28 weeks gestation were recruited. The Yamax pedometer and Actigraph accelerometer were worn for 5-7 days under free living conditions and thereafter the International Physical Activity Questionnaire (IPAQ) was completed. IPAQ and pedometer estimates of activity were compared to the more robust and accurate accelerometer data.Results: Of 48 women recruited, 30 women completed the study (mean age: 33.6 ± 4.7 years; mean BMI: 31.2 ± 5.1 kg/m2) and 18 were excluded (failure to wear [n = 8] and incomplete data [n = 10]). The accelerometer and pedometer correlated significantly on estimation of daily steps (ρ = 0.69, p < 0.01) and had good absolute agreement with low systematic error (mean difference: 505 ± 1498 steps/day). Accelerometer and IPAQ estimates of total, light and moderate Metabolic Equivalent minutes/day (MET min-1day-1) were not significantly correlated and there was poor absolute agreement. Relative to the accelerometer, the IPAQ under predicted daily total METs (105.76 ± 259.13 min-1day-1) and light METs (255.55 ± 128.41 min-1day-1) and over predicted moderate METs (-112.25 ± 166.41 min-1day-1).Conclusion: Compared with the accelerometer, the pedometer appears to provide a reliable estimate of physical activity in pregnancy, whereas the subjective IPAQ measure performed less accurately in this setting. Future research measuring activity in pregnancy should optimally encompass objective measures of physical activity.Trial Registration: Australian New Zealand Clinical Trial Registry Number: ACTRN12608000233325. Registered 7/5/2008. © 2011 Harrison et al; licensee BioMed Central Ltd.


Teede H.,Monash University | Teede H.,Diabetes Unit | Deeks A.,Monash University | Moran L.,Monash University
BMC Medicine | Year: 2010

Polycystic ovary syndrome (PCOS) is of clinical and public health importance as it is very common, affecting up to one in five women of reproductive age. It has significant and diverse clinical implications including reproductive (infertility, hyperandrogenism, hirsutism), metabolic (insulin resistance, impaired glucose tolerance, type 2 diabetes mellitus, adverse cardiovascular risk profiles) and psychological features (increased anxiety, depression and worsened quality of life). Polycystic ovary syndrome is a heterogeneous condition and, as such, clinical and research agendas are broad and involve many disciplines. The phenotype varies widely depending on life stage, genotype, ethnicity and environmental factors including lifestyle and bodyweight. Importantly, PCOS has unique interactions with the ever increasing obesity prevalence worldwide as obesity-induced insulin resistance significantly exacerbates all the features of PCOS. Furthermore, it has clinical implications across the lifespan and is relevant to related family members with an increased risk for metabolic conditions reported in first-degree relatives. Therapy should focus on both the short and long-term reproductive, metabolic and psychological features. Given the aetiological role of insulin resistance and the impact of obesity on both hyperinsulinaemia and hyperandrogenism, multidisciplinary lifestyle improvement aimed at normalising insulin resistance, improving androgen status and aiding weight management is recognised as a crucial initial treatment strategy. Modest weight loss of 5% to 10% of initial body weight has been demonstrated to improve many of the features of PCOS. Management should focus on support, education, addressing psychological factors and strongly emphasising healthy lifestyle with targeted medical therapy as required. Monitoring and management of long-term metabolic complications is also an important part of routine clinical care. Comprehensive evidence-based guidelines are needed to aid early diagnosis, appropriate investigation, regular screening and treatment of this common condition. Whilst reproductive features of PCOS are well recognised and are covered here, this review focuses primarily on the less appreciated cardiometabolic and psychological features of PCOS. © 2010 Teede et al; licensee BioMed Central Ltd.


Harrison C.L.,Monash University | Lombard C.B.,Monash University | Lombard C.B.,Diabetes Unit | Moran L.J.,Monash University | And 2 more authors.
Human Reproduction Update | Year: 2011

Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder, affecting 8-12% of women. Lifestyle modification, including increased physical activity, is the first-line approach in managing PCOS. A systematic review was performed to identify and describe the effect of exercise as an independent intervention on clinical outcomes in PCOS. Methods: Five databases were searched with no time limit. A pre-specified definition of PCOS was not used. Studies were included if exercise therapy (aerobic and/or resistance) could be evaluated as an independent treatment against a comparison group. Outcomes measured included cardiovascular risk factors [insulin resistance (IR), lipid profiles, blood pressure and weight] and reproductive measures (ovulation, menstrual regularity and fertility outcomes). Quality analysis was performed based on the Cochrane Handbook of Systematic Reviews and the Quality of Reporting of Meta-Analyses checklist. Results: Eight manuscripts were identified (five randomized controlled trials and three cohort studies). All studies involved moderate intensity physical activity and most were of either 12 or 24 weeks duration with frequency and duration of exercise sessions ranging between studies. The most consistent improvements included improved ovulation, reduced IR (9-30%) and weight loss (4.5-10%). Improvements were not dependant on the type of exercise, frequency or length of exercise sessions. Conclusions: Exercise-specific interventions in PCOS are limited. Studies vary considerably in design, intensity and outcome measures; therefore conclusive results remain elusive. Larger, optimally designed studies are needed to both gain insights into the mechanisms of exercise action and to evaluate the public health impact of exercise of PCOS. © The Author 2010. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.


Francia P.,University of Florence | Gulisano M.,University of Florence | Anichini R.,Diabetes Unit | Seghieri G.,Tuscany Regional Health Agency ARS
Current Diabetes Reviews | Year: 2014

Lower extremity ulcers represent a serious and costly complication of diabetes mellitus. Many factors contribute to the development of diabetic foot. Peripheral neuropathy and peripheral vascular disease are the main causes of foot ulceration and contribute in turn to the growth of additional risk factors such as limited joint mobility, muscular alterations and foot deformities. Moreover, a deficit of balance, posture and biomechanics can be present, in particular in patients at high risk for ulceration. The result of this process may be the development of a vicious cycle which leads to abnormal distribution of the foot's plantar pressures in static and dynamic postural conditions. This review shows that some of these risk factors significantly improve after a few weeks of exercise therapy (ET) intervention. Accordingly it has been suggested that ET can be an important weapon in the prevention of foot ulcer. The aim of ET can relate to one or more alterations typically found in diabetic patients, although greater attention should be paid to the evaluation and possible correction of body balance, rigid posture and biomechanics. Some of the most important limitations of ET are difficult access to therapy, patient compliance and the transitoriness of the results if the training stops. Many proposals have been made to overcome such limitations. In particular, it is important that specialized centers offer the opportunity to participate in ET and during the treatment the team should work to change the patient’s lifestyle by improving the execution of appropriate daily physical activity. © 2014 Bentham Science Publishers.


Toperoff G.,Hebrew University of Jerusalem | Aran D.,Hebrew University of Jerusalem | Kark J.D.,Hebrew University of Jerusalem | Rosenberg M.,Hebrew University of Jerusalem | And 7 more authors.
Human Molecular Genetics | Year: 2012

Inter-individual DNA methylation variations were frequently hypothesized to alter individual susceptibility to Type 2 Diabetes Mellitus (T2DM). Sequence-influenced methylations were described in T2DM-associated genomic regions, but evidence for direct, sequence-independent association with disease risk is missing. Here, we explore disease-contributing DNA methylation through a stepwise study design: first, a pool-based, genome-scale screen among 1169 case and control individuals revealed an excess of differentially methylated sites in genomic regions that were previously associated with T2DM through genetic studies. Next, in-depth analyses were performed at selected top-ranking regions. A CpG site in the first intron of the FTO gene showed small (3.35%) but significant (P = 0.000021) hypomethylation of cases relative to controls. The effect was independent of the sequence polymorphism in the region and persists among individuals carrying the sequence-risk alleles. The odds of belonging to the T2DM group increased by 6.1% for every 1% decrease in methylation (OR = 1.061, 95% CI: 1.032-1.090), the odds ratio for decrease of 1 standard deviation of methylation (adjusted to gender) was 1.5856 (95% CI: 1.2824-1.9606) and the sensitivity (area under the curve = 0.638, 95% CI: 0.586-0.690; males = 0.675, females = 0.609) was better than that of the strongest known sequence variant. Furthermore, a prospective study in an independent population cohort revealed significant hypomethylation of young individuals that later progressed to T2DM, relative to the individuals who stayed healthy. Further genomic analysis revealed co-localization with gene enhancers and with binding sites for methylation-sensitive transcriptional regulators. The data showed that low methylation level at the analyzed sites is an early marker of T2DM and suggests a novel mechanism by which early-onset, inter-individual methylation variation at isolated non-promoter genomic sites predisposes to T2DM. © The Author 2011. Published by Oxford University Press. All rights reserved.


Zenari L.,Diabetes Unit | Marangoni A.,Ospedale San Bassiano
Diabetes, Obesity and Metabolism | Year: 2013

The aim of therapy in type 2 diabetes in terms of blood glucose control is to reduce to target levels HbA1c and to reduce glycaemic variability in order to avoid both hypoglycaemia and wide excursions of postprandial glucose. The first approach to reduce glycaemic variability should consider a dietary and behavioural approach aiming to limit the glycaemic index and the glycaemic load of food and the prescription and implementation of a physical activity plan appropriate for the subject. From the pharmacological point of view, the diabetes specialist has now a much richer therapeutic armamentarium. The therapeutic algorithms can help the physician to choose the most appropriate drug. The traditional approach involves: i) metformin, acting mainly on fasting blood glucose; ii) sulphonylureas, that have shown a number of drawbacks, including the high risk of hypoglycemia; iii) pioglitazone, with a substantial effect on fasting and postprandial glucose and a low risk of hypoglycaemia; iv) insulin, that can be utilized with the basal or prandial approach. The new drugs belonging to the class of dipeptidyl peptidase-4 inhibitors have shown the reduction of postprandial glucose, a neutral effect on weight increase, a good safety profile and preliminary positive cardiovascular effects. When excess weight prevails, the glucagon-like peptide-1 agonists may be the preferred choice for their effect on weight reduction, reduction of hyperinsulinism and glycaemic variability. © 2013 John Wiley & Sons Ltd.


Deeks A.A.,Monash Institute of Medical Research | Gibson-Helm M.E.,Monash Institute of Medical Research | Teede H.J.,Monash Institute of Medical Research | Teede H.J.,Diabetes Unit
Fertility and Sterility | Year: 2010

Polycystic ovary syndrome (PCOS) is associated with high levels of depression, which impact quality of life and limit self-efficacy, yet less is known about prevalence of anxiety. This cross-sectional, observational study of community-based women with PCOS comprehensively examined mood and found that anxiety existed at higher levels than depression, anxiety was underdiagnosed, and more women with PCOS who reported infertility were depressed. © 2010 by American Society for Reproductive Medicine.

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