Senior Physician, Endocrinology, Diabetes and Metabolism, Citta della salute e della Scienza, Turin Italy. Main activity with type 1 diabetic patients intensively treated with insulin pump (CSII), SAP, rtCGM, telemedicine, diabetic pregnancy. Past-Coordinator of the Italian study group technologies for the treatment of diabetes.
Many primary care professionals manage injection or infusion therapies in patients with diabetes.... more Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015. Recommendations are organized around the themes of anatomy, physiology, pathology, psychology, and technology. Key among the recommendations are that the shortest needles (currently the 4-mm pen and 6-mm syringe needles) are safe, effective, and less painful and should be the first-line choice in all patient categories; intramuscular injections should be avoided, especially with long-acting insulins, because severe hypoglycemia may result; lipohypertrophy is a frequent complication of therapy that distorts insulin absorption, and, therefore, injections and infusions should not be given into these lesions and correct site rotation will help prevent them; effective long-term therapy with insulin is critically dependent on addressing psychological hurdles upstream, even before insulin has been started; inappropriate disposal of used sharps poses a risk of infection with blood-borne pathogens; and mitigation is possible with proper training, effective disposal strategies, and the use of safety devices. Adherence to these new recommendations should lead to more effective therapies, improved outcomes, and lower costs for patients with diabetes.
IntroductionThe availability of easily accessible continuous glucose monitoring (CGM) metrics can... more IntroductionThe availability of easily accessible continuous glucose monitoring (CGM) metrics can improve glycemic control in diabetes, and they may even become a viable alternative to hemoglobin A1c (HbA1c) laboratory tests in the next years. The REALISM-T1D study (REAl-Life glucoSe Monitoring in Type 1 Diabetes) was aimed at contributing, with real-world data, to a deeper understanding of these metrics, including the time in range (TIR)–HbA1c relationship, to facilitate their adoption by diabetologists in everyday practice.Research design and methods70 adults affected by type 1 diabetes were monitored for 1 year by means of either flash (FGM) or real-time (rtCGM) glucose monitoring devices. Follow-up visits were performed after 90, 180 and 365 days from baseline and percentage TIR70–180 evaluated for the 90-day time period preceding each visit. HbA1c tests were also carried out in the same occasions and measured values paired with the corresponding TIR data.ResultsA monovariate li...
To determine whether the use of continuous subcutaneous glucose monitoring will help in detecting... more To determine whether the use of continuous subcutaneous glucose monitoring will help in detecting unrecognized nocturnal hypoglycemia and in lowering hemoglobin A1c (HbA1c) levels (without increasing the risk for severe hypoglycemia) in children with type 1 diabetes. Eleven children with type 1 diabetes and HbA1c values consistently >8.0% were randomized either to the Continuous Glucose Monitoring System (CGMS) group or to the control group. The CGMS group used 6 3-day sensors within a 30-day period. Both groups self-monitored their blood glucose levels a minimum of 4 times daily. HbA1c levels were measured at the start, at 1-month, and after 3 months of study. The 5 children using the CGMS had 17 asymptomatic episodes (85%) of glucose levels below 60 mg/dL (3.25 mmol/L) and 3 symptomatic episodes (15%) during the night in the study month. The 6 control children had 4 symptomatic nocturnal low episodes during the month. After the 30-day period of wearing the CGMS, the 5 children had a significantly lower mean HbA1c value compared with their initial value (mean +/- standard error of the mean [SEM] decrease =.36% +/-.07%). The mean decrease for the controls was.2% +/-.2%. After 3 months, 4 of the 5 children who used the CGMS continued to have lower HbA1c values in comparison to their initial values (mean +/- SEM decrease = 1.04% +/-.43%). Three of the 6 control participants also had lower HbA1c values at 3 months (mean +/- SEM decrease for the group =.62% +/-.44%). No severe hypoglycemic events occurred in either the CGMS or the control groups. In this pilot trial, continuous subcutaneous glucose monitoring was helpful in detecting asymptomatic nocturnal hypoglycemia as well as in lowering HbA1c values without increasing the risk for severe hypoglycemia in children with type 1 diabetes.
IEEE Transactions on Control Systems Technology, 2015
Modeling, simulation and control have become effective tools for the treatment of type 1 diabetic... more Modeling, simulation and control have become effective tools for the treatment of type 1 diabetic patients in the last decades. The availability of reliable models able to predict and/or simulate the behavior of diabetic patients is thus fundamental in this context. Several models, based on first principles or black-box approaches, have been proposed to fulfill this need. However, a common problem to these approaches is that they are not able to recover or to systematically account for the various unmeasured signals which affect a diabetic patient (e.g. food, physical activity, emotions, etc.). In this paper, we propose a blind identification approach, which allows us to derive accurate models of type 1 diabetes patients and to efficiently recover the unmeasured input signals. A simulated example, regarding identification of the blood glucose concentration in type 1 diabetes patients, is presented to demonstrate the effectiveness of the proposed approach.
Research on Helicobacter pylori (H. pylori), a pathogenic bacterium that is widespread among huma... more Research on Helicobacter pylori (H. pylori), a pathogenic bacterium that is widespread among humans, is investigating the medical implications of the infection in many fields beyond gastroenterology. Because of the ubiquitous presence of the infection, there is an increasing interest in finding a relationship between this bacterium and diabetes mellitus (DM). It is not clear whether a significant relation between H. pylori and DM exists, whether the infection influences diabetes or vice versa, and the mechanisms underlying such a relationship. This review provides an analysis of new insights from studies published in more recent years. New research on this topic concentrated on the common pathogenic aspects between the bacterium and insulin resistance or autoimmunity, on the role of the bacterial infection in cardiovascular risk and whether the infection worsen glycemic outcomes in patients with DM. Research in this field still has to conclusively assess and explain the existence of a possible relationship between H. pylori and DM. Some studies have reached antithetic conclusions. Unless more robust data from studies using consistent research methods become available in the near future, people with diabetes should be compared to the general population when it comes to investigating and treating the presence of H. pylori.
Introduction: In persons with type 1 diabetes (T1D) insulin dosing can be adjusted based on trend... more Introduction: In persons with type 1 diabetes (T1D) insulin dosing can be adjusted based on trend arrows derived from continuous glucose monitoring (CGM). We propose a slide rule with narrower blood glucose intervals and more classes of insulin sensitivity than are available in current models. Methods: The slide rule was tested in silico, in which a meal was simulated in 100 virtual subjects and the insulin bolus was calculated either in the standard way based on the insulinto-carbohydrate ratio and the correction factor or according to the slide rule, following which
The purpose of the study is to estimate the financial impact on the Italian National Health Servi... more The purpose of the study is to estimate the financial impact on the Italian National Health Service of the use of BD Micro-Fine™ 4 mm 32G needles for insulin pens and of the BD Educational Starter Kit programme as compared to the use of longer pen needles, without the support of any educational programme. Methods: A budget impact model was developed to estimate the direct medical costs up to 12 months. The resource utilisation (insulin and complications associated with diabetes) was derived from literature. Only direct medical costs were considered. Ex-factory prices and National Tariffs were considered to estimate the costs of insulin and medical resource used to manage the complications associated with diabetes, respectively. The analysis was restricted to insulinised patients diagnosed with type 2 diabetes. Key variables were tested in the sensitivity analysis. Results: The cost per patient treated with BD needles presents a reduction of €32.08 of average annual cost (€690.02) compared to that associated with the patient treated with needles of other brands (€722.11). Given an increase in the percentage of use of BD needles that, compared to the base case, could involve 20%, 50% or 100% of patients, there would be a significant reduction in the expense incurred by the Italian National Health Service in the range of €2,536,710-€12,683,551. Conclusion: The use of the BD needles and the BD educational programme, as an alternative to the use of longer pen needles without the support of any educational programme, could represent an effective option to a low cost for the
Many primary care professionals manage injection or infusion therapies in patients with diabetes.... more Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015. Recommendations are organized around the themes of anatomy, physiology, pathology, psychology, and technology. Key among the recommendations are that the shortest needles (currently the 4-mm pen and 6-mm syringe needles) are safe, effective, and less painful and should be the first-line choice in all patient categories; intramuscular injections should be avoided, especially with long-acting insulins, because severe hypoglycemia may result; lipohypertrophy is a frequent complication of therapy that distorts insulin absorption, and, therefore, injections and infusions should not be given into these lesions and correct site rotation will help prevent them; effective long-term therapy with insulin is critically dependent on addressing psychological hurdles upstream, even before insulin has been started; inappropriate disposal of used sharps poses a risk of infection with blood-borne pathogens; and mitigation is possible with proper training, effective disposal strategies, and the use of safety devices. Adherence to these new recommendations should lead to more effective therapies, improved outcomes, and lower costs for patients with diabetes.
Anti-inflammatory or immunosuppressive treatment with glucocorticoids can disrupt glucose homeost... more Anti-inflammatory or immunosuppressive treatment with glucocorticoids can disrupt glucose homeostasis, a condition known as steroid-induced hyperglycaemia (SIH) [1-3]. SIH poses a serious challenge in patients with pre-existing diabetes mellitus [1, 2] and can undermine serious clinical conditions for which steroids are given, such as survival of transplanted organs or chronic inflammatory diseases [4]. Most of the time, when oral steroids are given in the early morning, blood glucose begins to deteriorate in the late morning, usually peaks in the afternoon and then falls overnight [2, 5]. While insulin is undoubtedly a well-established treatment for SIH, the best titration algorithm has not been defined. We present two cases of patients with type 1 diabetes (T1D) who struggled to control worsening of hyperglycaemia secondary to oral administration of dexamethasone and who were treated with advanced technologies, timely updated with the most sophisticated algorithms for automatic insulin delivery. Case 1 A 49-year-old man (body mass index, BMI = 27 kg/ m 2) with T1D since the age of 26 received a single-lung transplantation at 48 years, because of nonspecific interstitial pneumonia. The patient showed no chronic complications and was treated with long-term prednisone (25 mg/day) and immunosuppressive agents. Overall glucose control was good (HbA1c 7.3% or 56.3 mmol/mol), except for post-prandial levels, which ranged 250-400 mg/dl (13.9-22.2 mmol/l) around 3:00-4:00 pm. Case 2 A 51-year-old woman (BMI = 30 kg/m 2) with T1D since the age of 10, mild retinopathy, autoimmune hypothyroidism and Churg-Strauss syndrome, required long-term prednisone treatment (10 mg/day). Overall glucose control was acceptable (HbA1c 7.7%, 60.0 mmol/mol), but postprandial levels ranged 200-300 mg/dl (11.1-16.7 mmol/l) between 3:00 and 6:00 pm.
Background: New approaches to cope with clinical and psychosocial aspects of type 2 diabetes (T2D... more Background: New approaches to cope with clinical and psychosocial aspects of type 2 diabetes (T2DM) are needed; gender influences the complex interplay between clinical and non-clinical factors. We used data from the BENCH-D study to assess gender-differences in terms of clinical and person-centered measures in T2DM. Methods: Clinical quality of care indicators relative to control of HbA1c, lipid profile, blood pressure, and BMI were derived from electronic medical records. Ten self-administered validated questionnaires (SF-12 Health Survey; WHO-5 well-being index; Problem Areas in Diabetes (PAID) 5, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Diabetes Empowerment Scale, Diabetes Self-care Activities, Global Satisfaction for Diabetes Treatment, Barriers to Taking Medications, Perceived Social Support) were adopted as person-centered outcomes indicators. Results: Overall, 26 diabetes clinics enrolled 2,335 people (men: 59.7%; women: 40.3%). Lower percentages of women reached HbA1c levels < =7.0% (23.2% vs. 27.8%; p = 0.03), LDL-cholesterol < 100 mg/dl (48.3 vs. 57.8%; p = 0.0005), and BMI <27 Kg/m2 (27.2 vs. 31.6%; p = 0.04) than men. Women had statistically significant poorer scores for physical functioning, psychological well-being, self-care activities dedicated to physical activities, empowerment, diabetes-related distress, satisfaction with treatment, barriers to medication taking, satisfaction with access to chronic care and healthcare communication, and perceived social support than men; 24.8% of women and 8.8% of men had WHO-5 < =28 (likely depression) (p < 0.0001); 67.7% of women and 55.1% of men had PAID-5 > 40 (high levels of diabetes-related distress) (p < 0.0001). At multivariate analysis, factors associated with an increased likelihood of having elevated HbA1c levels (≥8.0%) were different in men and women, e.g. having PAID-5 levels >40 was associated with a higher likelihood of HbA1c ≥8.0% in women (OR = 1.15; 95%CI 1.05-1.25) but not in men (OR = 1.00; 95%CI 0.93-1.08). Conclusions: In T2DM, women show poorer clinical and person-centered outcomes indicators than men. Diabetesrelated distress plays a role as a correlate of metabolic control in women but not in men. The study provides new information about the interplay between clinical and person-centered indicators in men and women which may guide further improvements in diabetes education and support programs.
Nutrition, metabolism, and cardiovascular diseases, 2018
Background and aim: The objective of this cross-sectional study was to evaluate the degree of gly... more Background and aim: The objective of this cross-sectional study was to evaluate the degree of glycaemic control and the frequency of diabetic complications in Italian people with diabetes who were treated with continuous subcutaneous insulin infusion (CSII).
Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals' clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. <58 mmol/mol for age <18 years and <53 mmol/mol for age >18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis.
Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia. Keywords: Acute and chronic complications; Continuous subcutaneous insulin infusion (CSII); Diabetes mellitus; Metabolic control.
Background: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly becau... more Background: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly because of improved technology. The aim of this study was to evaluate the current status of CSII in Italy. Materials and Methods: Physicians from 272 diabetes centers received a questionnaire investigating clinical features, pump technology, and management of patients on CSII. Results: Two hundred seventeen centers (79.8%) joined the study and, by the end of April 2013, gave information about 10,152 patients treated with CSII: 98.2% with type 1 diabetes mellitus, 81.4% adults, 57% female, and 61% with a conventional pump versus 39% with a sensor-augmented pump. CSII advanced functions were used by 68% of patients, and glucose sensors were used 12 days per month on average. Fifty-eight percent of diabetes centers had more than 20 patients on CSII, but there were differences among centers and among regions. The main indication for CSII was poor glucose control. Dropout was mainly due to pump wearability or nonoptimal glycemic control. Twenty-four hour assistance was guaranteed in 81% of centers. A full diabetes team (physician + nurse + dietician + psychologist) was available in 23% of adult-care diabetes centers and in 53% of pediatric diabetes units. Conclusions: CSII keeps increasing in Italy. More work is needed to ensure uniform treatment strategies throughout the country and to improve pump use.
Objective: To evaluate the accuracy of a new subcutaneous glucose sensor (Glucoday; A. Menarini D... more Objective: To evaluate the accuracy of a new subcutaneous glucose sensor (Glucoday; A. Menarini Diagnostics) compared with venous blood glucose measurement in type 1 and type 2 diabetic patients.
Research design: A multicenter study was performed in 70 diabetic patients. A microdialysis fiber was inserted subcutaneously into the periumbelical region and perfused with a buffer solution. Glucose concentrations in the dialysate were then measured every 3 min by the glucose sensor over a 24-h period, during which nine venous blood samples were also collected throughout the day.
Results: Both the insertion of the fiber and the wearing of the device were well tolerated by the patients. Subcutaneous glucose levels were well correlated with venous glucose measurements (r = 0.9, P < 0.001) over a wide range (40-400 mg/dl) for up to 24 h, with a single-point calibration. An analysis of 381 data pairs showed a linear relationship between the GlucoDay and serial venous blood glucose levels, and 97% of the data fell in the A and B regions of the error grid analysis. Percentage bias between the GlucoDay and the blood venous levels was -2.0% in the hypoglycemic range (<70 mg/dl), 6.9% in the euglycemic range (70-180 mg/dl), and 11.2% in the hyperglycemic range (>180 mg/dl).
Conclusions: The GlucoDay system demonstrated high reliability and reported values that closely agreed with venous blood glucose measurements. The system was well tolerated and thus constitutes a relatively easy method to monitor glucose excursions in diabetic patients
ight type II (non-insulin-dependent) diabetic subjects (7 women, 1 man, aged 42-61 yr), initially... more ight type II (non-insulin-dependent) diabetic subjects (7 women, 1 man, aged 42-61 yr), initially treated with oral hypoglycemic agents and intermittently treated with conventional insulins, were identified as developing allergic reactions to porcine and mixed-species monocomponent insulin. Allergy was systemic (urticaria and nonthrombocytopenic purpura) and local delayed in two subjects and local immediate or biphasic in six subjects. Lipoatrophy was present in two subjects. After treatment with human semisynthetic insulin (Monotard HM and Actrapid HM), systemic allergy disappeared. Local allergy disappeared in five subjects and was reduced in three subjects. No lipoatrophy occurred in new injection areas. The clinical results were accompanied by a significant decrease in serum insulin-specific IgE after 6, 12, 18, 24, 30, and 36 mo. Insulin-specific IgG showed an evident decrease in five of eight patients, but the difference in mean values was not significant after 6, 18, 24, 30, and 36 mo. With one exception, intradermal skin tests were positive to human, bovine, and porcine insulin before and after human insulin treatment.
Modeling, simulation and control have become effective tools for the treatment of type 1 diabetic... more Modeling, simulation and control have become effective tools for the treatment of type 1 diabetic patients in the last decades. The availability of reliable models able to predict and/or simulate the behavior of diabetic patients is thus fundamental in this context. Several models, based on first principles or black-box approaches, have been proposed to fulfill this need. However, a common problem to these approaches is that they are not able to recover or to systematically account for the various unmeasured signals which affect a diabetic patient (e.g. food, physical activity, emotions, etc.). In this paper, we propose a blind identification approach, which allows us to derive accurate models of type 1 diabetes patients and to efficiently recover the unmeasured input signals. A simulated example, regarding identification of the blood glucose concentration in type 1 diabetes patients, is presented to demonstrate the effectiveness of the proposed approach.
BACKGROUND: Pre-emptive pancreas-kidney transplantation is increasingly considered the best thera... more BACKGROUND: Pre-emptive pancreas-kidney transplantation is increasingly considered the best therapy for irreversible chronic kidney disease (CKD) in type 1 diabetics. However, the best approach in the wait for transplantation has not yet been defined. AIM: To evaluate our experience with a low-protein (0.6 g/kg/day) vegetarian diet supplemented with alpha-chetoanalogues in type 1 diabetic patients in the wait for pancreas-kidney transplantation. METHODS: Prospective study. Information on the progression of renal disease, compliance, metabolic control, reasons for choice and for drop-out were recorded prospectively; the data for the subset of patients who underwent the diet while awaiting a pancreas-kidney graft are analysed in this report. RESULTS: From November 1998 to April 2004, 9 type 1 diabetic patients, wait-listed or performing tests for waitlisting for pancreas-kidney transplantation, started the diet. All of them were followed by nephrologists and diabetologists, in the context of integrated care. There were 4 males and 5 females; median age 38 years (range 27.9-45.5); median diabetes duration 23.8 years (range 16.6-33.1), 8/9 with widespread organ damage; median creatinine at the start of the diet: 3.2 mg/dl (1.2-7.2); 4 patients followed the diet to transplantation, 2 are presently on the diet, 2 dropped out and started dialysis after a few months, 1 started dialysis (rescue treatment). The nutritional status remained stable, glycemia control improved in 4 patients in the short term and in 2 in the long term, no hyperkalemia, acidosis or other relevant side effect was recorded. Proteinuria decreased in 5 cases, in 3 from the nephrotic range. Albumin levels remained stable; the progression rate was a loss of 0.47 ml/min of creatinine clearance per month (ranging from an increase of 0.06 to a decrease of 2.4 ml/min) during the diet period (estimated by the Cockroft-Gault formula). CONCLUSIONS: Low-protein supplemented vegetarian diets may be a useful tool to slow CKD progression whilst awaiting pancreas-kidney transplantation.
BACKGROUND In stressed people with diabetes (PWD) glycemia varies idiosyncratically. Coping is a ... more BACKGROUND In stressed people with diabetes (PWD) glycemia varies idiosyncratically. Coping is a relatively stable personality trait that assesses how individual deals with stress. Insulin pumps are considered the best insulin delivery system but require more attention from PWD, virtually increasing stress levels. Aim of our study was to evaluate the coping strategies adopted by a pool of participants with Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion (CSII) therapy. METHODS We collected data from 158 people with T1DM on CSII. COPE-NVI test was administered and we also collected: Hemoglobin A1c (HbA1c), 30 days of Self-Monitoring of Blood Glucose (SMBG) and Continuous Glucose Monitoring (CGM) records (the most recent). From SMBG and CGM records we computed Kovatchev indexes. We investigated bivariate correlations between HbA1c, indexes and the results of the COPE- NVI test; the analysis was performed on the total sample and on two sub-groups: men and women. The participants were then divided into clusters and non-parametric tests were performed. RESULTS Regarding bivariate correlation, at a level of significance of 95{\%}, several statistically significant correlations were found in the total sample and in both men and women sub-groups. Regarding non-parametric tests, we observed statistically significant results in clusters of the total sample and clusters of the sub-group formed by men, divided according to Low Blood Glucose Index (LBGI) risk, showing a different use of certain coping strategies. CONCLUSIONS Assessing coping strategies preferably used by PWD is useful to select PWD in need of counseling and empowerment-oriented training in order to improve glycemic outcomes and decrease severe hypo/hyperglycemic events.
Many primary care professionals manage injection or infusion therapies in patients with diabetes.... more Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015. Recommendations are organized around the themes of anatomy, physiology, pathology, psychology, and technology. Key among the recommendations are that the shortest needles (currently the 4-mm pen and 6-mm syringe needles) are safe, effective, and less painful and should be the first-line choice in all patient categories; intramuscular injections should be avoided, especially with long-acting insulins, because severe hypoglycemia may result; lipohypertrophy is a frequent complication of therapy that distorts insulin absorption, and, therefore, injections and infusions should not be given into these lesions and correct site rotation will help prevent them; effective long-term therapy with insulin is critically dependent on addressing psychological hurdles upstream, even before insulin has been started; inappropriate disposal of used sharps poses a risk of infection with blood-borne pathogens; and mitigation is possible with proper training, effective disposal strategies, and the use of safety devices. Adherence to these new recommendations should lead to more effective therapies, improved outcomes, and lower costs for patients with diabetes.
IntroductionThe availability of easily accessible continuous glucose monitoring (CGM) metrics can... more IntroductionThe availability of easily accessible continuous glucose monitoring (CGM) metrics can improve glycemic control in diabetes, and they may even become a viable alternative to hemoglobin A1c (HbA1c) laboratory tests in the next years. The REALISM-T1D study (REAl-Life glucoSe Monitoring in Type 1 Diabetes) was aimed at contributing, with real-world data, to a deeper understanding of these metrics, including the time in range (TIR)–HbA1c relationship, to facilitate their adoption by diabetologists in everyday practice.Research design and methods70 adults affected by type 1 diabetes were monitored for 1 year by means of either flash (FGM) or real-time (rtCGM) glucose monitoring devices. Follow-up visits were performed after 90, 180 and 365 days from baseline and percentage TIR70–180 evaluated for the 90-day time period preceding each visit. HbA1c tests were also carried out in the same occasions and measured values paired with the corresponding TIR data.ResultsA monovariate li...
To determine whether the use of continuous subcutaneous glucose monitoring will help in detecting... more To determine whether the use of continuous subcutaneous glucose monitoring will help in detecting unrecognized nocturnal hypoglycemia and in lowering hemoglobin A1c (HbA1c) levels (without increasing the risk for severe hypoglycemia) in children with type 1 diabetes. Eleven children with type 1 diabetes and HbA1c values consistently &gt;8.0% were randomized either to the Continuous Glucose Monitoring System (CGMS) group or to the control group. The CGMS group used 6 3-day sensors within a 30-day period. Both groups self-monitored their blood glucose levels a minimum of 4 times daily. HbA1c levels were measured at the start, at 1-month, and after 3 months of study. The 5 children using the CGMS had 17 asymptomatic episodes (85%) of glucose levels below 60 mg/dL (3.25 mmol/L) and 3 symptomatic episodes (15%) during the night in the study month. The 6 control children had 4 symptomatic nocturnal low episodes during the month. After the 30-day period of wearing the CGMS, the 5 children had a significantly lower mean HbA1c value compared with their initial value (mean +/- standard error of the mean [SEM] decrease =.36% +/-.07%). The mean decrease for the controls was.2% +/-.2%. After 3 months, 4 of the 5 children who used the CGMS continued to have lower HbA1c values in comparison to their initial values (mean +/- SEM decrease = 1.04% +/-.43%). Three of the 6 control participants also had lower HbA1c values at 3 months (mean +/- SEM decrease for the group =.62% +/-.44%). No severe hypoglycemic events occurred in either the CGMS or the control groups. In this pilot trial, continuous subcutaneous glucose monitoring was helpful in detecting asymptomatic nocturnal hypoglycemia as well as in lowering HbA1c values without increasing the risk for severe hypoglycemia in children with type 1 diabetes.
IEEE Transactions on Control Systems Technology, 2015
Modeling, simulation and control have become effective tools for the treatment of type 1 diabetic... more Modeling, simulation and control have become effective tools for the treatment of type 1 diabetic patients in the last decades. The availability of reliable models able to predict and/or simulate the behavior of diabetic patients is thus fundamental in this context. Several models, based on first principles or black-box approaches, have been proposed to fulfill this need. However, a common problem to these approaches is that they are not able to recover or to systematically account for the various unmeasured signals which affect a diabetic patient (e.g. food, physical activity, emotions, etc.). In this paper, we propose a blind identification approach, which allows us to derive accurate models of type 1 diabetes patients and to efficiently recover the unmeasured input signals. A simulated example, regarding identification of the blood glucose concentration in type 1 diabetes patients, is presented to demonstrate the effectiveness of the proposed approach.
Research on Helicobacter pylori (H. pylori), a pathogenic bacterium that is widespread among huma... more Research on Helicobacter pylori (H. pylori), a pathogenic bacterium that is widespread among humans, is investigating the medical implications of the infection in many fields beyond gastroenterology. Because of the ubiquitous presence of the infection, there is an increasing interest in finding a relationship between this bacterium and diabetes mellitus (DM). It is not clear whether a significant relation between H. pylori and DM exists, whether the infection influences diabetes or vice versa, and the mechanisms underlying such a relationship. This review provides an analysis of new insights from studies published in more recent years. New research on this topic concentrated on the common pathogenic aspects between the bacterium and insulin resistance or autoimmunity, on the role of the bacterial infection in cardiovascular risk and whether the infection worsen glycemic outcomes in patients with DM. Research in this field still has to conclusively assess and explain the existence of a possible relationship between H. pylori and DM. Some studies have reached antithetic conclusions. Unless more robust data from studies using consistent research methods become available in the near future, people with diabetes should be compared to the general population when it comes to investigating and treating the presence of H. pylori.
Introduction: In persons with type 1 diabetes (T1D) insulin dosing can be adjusted based on trend... more Introduction: In persons with type 1 diabetes (T1D) insulin dosing can be adjusted based on trend arrows derived from continuous glucose monitoring (CGM). We propose a slide rule with narrower blood glucose intervals and more classes of insulin sensitivity than are available in current models. Methods: The slide rule was tested in silico, in which a meal was simulated in 100 virtual subjects and the insulin bolus was calculated either in the standard way based on the insulinto-carbohydrate ratio and the correction factor or according to the slide rule, following which
The purpose of the study is to estimate the financial impact on the Italian National Health Servi... more The purpose of the study is to estimate the financial impact on the Italian National Health Service of the use of BD Micro-Fine™ 4 mm 32G needles for insulin pens and of the BD Educational Starter Kit programme as compared to the use of longer pen needles, without the support of any educational programme. Methods: A budget impact model was developed to estimate the direct medical costs up to 12 months. The resource utilisation (insulin and complications associated with diabetes) was derived from literature. Only direct medical costs were considered. Ex-factory prices and National Tariffs were considered to estimate the costs of insulin and medical resource used to manage the complications associated with diabetes, respectively. The analysis was restricted to insulinised patients diagnosed with type 2 diabetes. Key variables were tested in the sensitivity analysis. Results: The cost per patient treated with BD needles presents a reduction of €32.08 of average annual cost (€690.02) compared to that associated with the patient treated with needles of other brands (€722.11). Given an increase in the percentage of use of BD needles that, compared to the base case, could involve 20%, 50% or 100% of patients, there would be a significant reduction in the expense incurred by the Italian National Health Service in the range of €2,536,710-€12,683,551. Conclusion: The use of the BD needles and the BD educational programme, as an alternative to the use of longer pen needles without the support of any educational programme, could represent an effective option to a low cost for the
Many primary care professionals manage injection or infusion therapies in patients with diabetes.... more Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015. Recommendations are organized around the themes of anatomy, physiology, pathology, psychology, and technology. Key among the recommendations are that the shortest needles (currently the 4-mm pen and 6-mm syringe needles) are safe, effective, and less painful and should be the first-line choice in all patient categories; intramuscular injections should be avoided, especially with long-acting insulins, because severe hypoglycemia may result; lipohypertrophy is a frequent complication of therapy that distorts insulin absorption, and, therefore, injections and infusions should not be given into these lesions and correct site rotation will help prevent them; effective long-term therapy with insulin is critically dependent on addressing psychological hurdles upstream, even before insulin has been started; inappropriate disposal of used sharps poses a risk of infection with blood-borne pathogens; and mitigation is possible with proper training, effective disposal strategies, and the use of safety devices. Adherence to these new recommendations should lead to more effective therapies, improved outcomes, and lower costs for patients with diabetes.
Anti-inflammatory or immunosuppressive treatment with glucocorticoids can disrupt glucose homeost... more Anti-inflammatory or immunosuppressive treatment with glucocorticoids can disrupt glucose homeostasis, a condition known as steroid-induced hyperglycaemia (SIH) [1-3]. SIH poses a serious challenge in patients with pre-existing diabetes mellitus [1, 2] and can undermine serious clinical conditions for which steroids are given, such as survival of transplanted organs or chronic inflammatory diseases [4]. Most of the time, when oral steroids are given in the early morning, blood glucose begins to deteriorate in the late morning, usually peaks in the afternoon and then falls overnight [2, 5]. While insulin is undoubtedly a well-established treatment for SIH, the best titration algorithm has not been defined. We present two cases of patients with type 1 diabetes (T1D) who struggled to control worsening of hyperglycaemia secondary to oral administration of dexamethasone and who were treated with advanced technologies, timely updated with the most sophisticated algorithms for automatic insulin delivery. Case 1 A 49-year-old man (body mass index, BMI = 27 kg/ m 2) with T1D since the age of 26 received a single-lung transplantation at 48 years, because of nonspecific interstitial pneumonia. The patient showed no chronic complications and was treated with long-term prednisone (25 mg/day) and immunosuppressive agents. Overall glucose control was good (HbA1c 7.3% or 56.3 mmol/mol), except for post-prandial levels, which ranged 250-400 mg/dl (13.9-22.2 mmol/l) around 3:00-4:00 pm. Case 2 A 51-year-old woman (BMI = 30 kg/m 2) with T1D since the age of 10, mild retinopathy, autoimmune hypothyroidism and Churg-Strauss syndrome, required long-term prednisone treatment (10 mg/day). Overall glucose control was acceptable (HbA1c 7.7%, 60.0 mmol/mol), but postprandial levels ranged 200-300 mg/dl (11.1-16.7 mmol/l) between 3:00 and 6:00 pm.
Background: New approaches to cope with clinical and psychosocial aspects of type 2 diabetes (T2D... more Background: New approaches to cope with clinical and psychosocial aspects of type 2 diabetes (T2DM) are needed; gender influences the complex interplay between clinical and non-clinical factors. We used data from the BENCH-D study to assess gender-differences in terms of clinical and person-centered measures in T2DM. Methods: Clinical quality of care indicators relative to control of HbA1c, lipid profile, blood pressure, and BMI were derived from electronic medical records. Ten self-administered validated questionnaires (SF-12 Health Survey; WHO-5 well-being index; Problem Areas in Diabetes (PAID) 5, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Diabetes Empowerment Scale, Diabetes Self-care Activities, Global Satisfaction for Diabetes Treatment, Barriers to Taking Medications, Perceived Social Support) were adopted as person-centered outcomes indicators. Results: Overall, 26 diabetes clinics enrolled 2,335 people (men: 59.7%; women: 40.3%). Lower percentages of women reached HbA1c levels < =7.0% (23.2% vs. 27.8%; p = 0.03), LDL-cholesterol < 100 mg/dl (48.3 vs. 57.8%; p = 0.0005), and BMI <27 Kg/m2 (27.2 vs. 31.6%; p = 0.04) than men. Women had statistically significant poorer scores for physical functioning, psychological well-being, self-care activities dedicated to physical activities, empowerment, diabetes-related distress, satisfaction with treatment, barriers to medication taking, satisfaction with access to chronic care and healthcare communication, and perceived social support than men; 24.8% of women and 8.8% of men had WHO-5 < =28 (likely depression) (p < 0.0001); 67.7% of women and 55.1% of men had PAID-5 > 40 (high levels of diabetes-related distress) (p < 0.0001). At multivariate analysis, factors associated with an increased likelihood of having elevated HbA1c levels (≥8.0%) were different in men and women, e.g. having PAID-5 levels >40 was associated with a higher likelihood of HbA1c ≥8.0% in women (OR = 1.15; 95%CI 1.05-1.25) but not in men (OR = 1.00; 95%CI 0.93-1.08). Conclusions: In T2DM, women show poorer clinical and person-centered outcomes indicators than men. Diabetesrelated distress plays a role as a correlate of metabolic control in women but not in men. The study provides new information about the interplay between clinical and person-centered indicators in men and women which may guide further improvements in diabetes education and support programs.
Nutrition, metabolism, and cardiovascular diseases, 2018
Background and aim: The objective of this cross-sectional study was to evaluate the degree of gly... more Background and aim: The objective of this cross-sectional study was to evaluate the degree of glycaemic control and the frequency of diabetic complications in Italian people with diabetes who were treated with continuous subcutaneous insulin infusion (CSII).
Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals' clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. <58 mmol/mol for age <18 years and <53 mmol/mol for age >18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis.
Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia. Keywords: Acute and chronic complications; Continuous subcutaneous insulin infusion (CSII); Diabetes mellitus; Metabolic control.
Background: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly becau... more Background: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly because of improved technology. The aim of this study was to evaluate the current status of CSII in Italy. Materials and Methods: Physicians from 272 diabetes centers received a questionnaire investigating clinical features, pump technology, and management of patients on CSII. Results: Two hundred seventeen centers (79.8%) joined the study and, by the end of April 2013, gave information about 10,152 patients treated with CSII: 98.2% with type 1 diabetes mellitus, 81.4% adults, 57% female, and 61% with a conventional pump versus 39% with a sensor-augmented pump. CSII advanced functions were used by 68% of patients, and glucose sensors were used 12 days per month on average. Fifty-eight percent of diabetes centers had more than 20 patients on CSII, but there were differences among centers and among regions. The main indication for CSII was poor glucose control. Dropout was mainly due to pump wearability or nonoptimal glycemic control. Twenty-four hour assistance was guaranteed in 81% of centers. A full diabetes team (physician + nurse + dietician + psychologist) was available in 23% of adult-care diabetes centers and in 53% of pediatric diabetes units. Conclusions: CSII keeps increasing in Italy. More work is needed to ensure uniform treatment strategies throughout the country and to improve pump use.
Objective: To evaluate the accuracy of a new subcutaneous glucose sensor (Glucoday; A. Menarini D... more Objective: To evaluate the accuracy of a new subcutaneous glucose sensor (Glucoday; A. Menarini Diagnostics) compared with venous blood glucose measurement in type 1 and type 2 diabetic patients.
Research design: A multicenter study was performed in 70 diabetic patients. A microdialysis fiber was inserted subcutaneously into the periumbelical region and perfused with a buffer solution. Glucose concentrations in the dialysate were then measured every 3 min by the glucose sensor over a 24-h period, during which nine venous blood samples were also collected throughout the day.
Results: Both the insertion of the fiber and the wearing of the device were well tolerated by the patients. Subcutaneous glucose levels were well correlated with venous glucose measurements (r = 0.9, P < 0.001) over a wide range (40-400 mg/dl) for up to 24 h, with a single-point calibration. An analysis of 381 data pairs showed a linear relationship between the GlucoDay and serial venous blood glucose levels, and 97% of the data fell in the A and B regions of the error grid analysis. Percentage bias between the GlucoDay and the blood venous levels was -2.0% in the hypoglycemic range (<70 mg/dl), 6.9% in the euglycemic range (70-180 mg/dl), and 11.2% in the hyperglycemic range (>180 mg/dl).
Conclusions: The GlucoDay system demonstrated high reliability and reported values that closely agreed with venous blood glucose measurements. The system was well tolerated and thus constitutes a relatively easy method to monitor glucose excursions in diabetic patients
ight type II (non-insulin-dependent) diabetic subjects (7 women, 1 man, aged 42-61 yr), initially... more ight type II (non-insulin-dependent) diabetic subjects (7 women, 1 man, aged 42-61 yr), initially treated with oral hypoglycemic agents and intermittently treated with conventional insulins, were identified as developing allergic reactions to porcine and mixed-species monocomponent insulin. Allergy was systemic (urticaria and nonthrombocytopenic purpura) and local delayed in two subjects and local immediate or biphasic in six subjects. Lipoatrophy was present in two subjects. After treatment with human semisynthetic insulin (Monotard HM and Actrapid HM), systemic allergy disappeared. Local allergy disappeared in five subjects and was reduced in three subjects. No lipoatrophy occurred in new injection areas. The clinical results were accompanied by a significant decrease in serum insulin-specific IgE after 6, 12, 18, 24, 30, and 36 mo. Insulin-specific IgG showed an evident decrease in five of eight patients, but the difference in mean values was not significant after 6, 18, 24, 30, and 36 mo. With one exception, intradermal skin tests were positive to human, bovine, and porcine insulin before and after human insulin treatment.
Modeling, simulation and control have become effective tools for the treatment of type 1 diabetic... more Modeling, simulation and control have become effective tools for the treatment of type 1 diabetic patients in the last decades. The availability of reliable models able to predict and/or simulate the behavior of diabetic patients is thus fundamental in this context. Several models, based on first principles or black-box approaches, have been proposed to fulfill this need. However, a common problem to these approaches is that they are not able to recover or to systematically account for the various unmeasured signals which affect a diabetic patient (e.g. food, physical activity, emotions, etc.). In this paper, we propose a blind identification approach, which allows us to derive accurate models of type 1 diabetes patients and to efficiently recover the unmeasured input signals. A simulated example, regarding identification of the blood glucose concentration in type 1 diabetes patients, is presented to demonstrate the effectiveness of the proposed approach.
BACKGROUND: Pre-emptive pancreas-kidney transplantation is increasingly considered the best thera... more BACKGROUND: Pre-emptive pancreas-kidney transplantation is increasingly considered the best therapy for irreversible chronic kidney disease (CKD) in type 1 diabetics. However, the best approach in the wait for transplantation has not yet been defined. AIM: To evaluate our experience with a low-protein (0.6 g/kg/day) vegetarian diet supplemented with alpha-chetoanalogues in type 1 diabetic patients in the wait for pancreas-kidney transplantation. METHODS: Prospective study. Information on the progression of renal disease, compliance, metabolic control, reasons for choice and for drop-out were recorded prospectively; the data for the subset of patients who underwent the diet while awaiting a pancreas-kidney graft are analysed in this report. RESULTS: From November 1998 to April 2004, 9 type 1 diabetic patients, wait-listed or performing tests for waitlisting for pancreas-kidney transplantation, started the diet. All of them were followed by nephrologists and diabetologists, in the context of integrated care. There were 4 males and 5 females; median age 38 years (range 27.9-45.5); median diabetes duration 23.8 years (range 16.6-33.1), 8/9 with widespread organ damage; median creatinine at the start of the diet: 3.2 mg/dl (1.2-7.2); 4 patients followed the diet to transplantation, 2 are presently on the diet, 2 dropped out and started dialysis after a few months, 1 started dialysis (rescue treatment). The nutritional status remained stable, glycemia control improved in 4 patients in the short term and in 2 in the long term, no hyperkalemia, acidosis or other relevant side effect was recorded. Proteinuria decreased in 5 cases, in 3 from the nephrotic range. Albumin levels remained stable; the progression rate was a loss of 0.47 ml/min of creatinine clearance per month (ranging from an increase of 0.06 to a decrease of 2.4 ml/min) during the diet period (estimated by the Cockroft-Gault formula). CONCLUSIONS: Low-protein supplemented vegetarian diets may be a useful tool to slow CKD progression whilst awaiting pancreas-kidney transplantation.
BACKGROUND In stressed people with diabetes (PWD) glycemia varies idiosyncratically. Coping is a ... more BACKGROUND In stressed people with diabetes (PWD) glycemia varies idiosyncratically. Coping is a relatively stable personality trait that assesses how individual deals with stress. Insulin pumps are considered the best insulin delivery system but require more attention from PWD, virtually increasing stress levels. Aim of our study was to evaluate the coping strategies adopted by a pool of participants with Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion (CSII) therapy. METHODS We collected data from 158 people with T1DM on CSII. COPE-NVI test was administered and we also collected: Hemoglobin A1c (HbA1c), 30 days of Self-Monitoring of Blood Glucose (SMBG) and Continuous Glucose Monitoring (CGM) records (the most recent). From SMBG and CGM records we computed Kovatchev indexes. We investigated bivariate correlations between HbA1c, indexes and the results of the COPE- NVI test; the analysis was performed on the total sample and on two sub-groups: men and women. The participants were then divided into clusters and non-parametric tests were performed. RESULTS Regarding bivariate correlation, at a level of significance of 95{\%}, several statistically significant correlations were found in the total sample and in both men and women sub-groups. Regarding non-parametric tests, we observed statistically significant results in clusters of the total sample and clusters of the sub-group formed by men, divided according to Low Blood Glucose Index (LBGI) risk, showing a different use of certain coping strategies. CONCLUSIONS Assessing coping strategies preferably used by PWD is useful to select PWD in need of counseling and empowerment-oriented training in order to improve glycemic outcomes and decrease severe hypo/hyperglycemic events.
... Più di sessanta film in quasi cinquantanni di carriera, un carisma e una vitalità artistica c... more ... Più di sessanta film in quasi cinquantanni di carriera, un carisma e una vitalità artistica che beffardamente sopravvivono agli &amp;quot;assalti&amp;quot; dei divi più giovani e rampanti: Sean Connery rappresenta un caso decisamente inusuale nel panorama cinematografico internazionale, nel ...
New approaches to cope with clinical and psychosocial aspects of type 2 diabetes (T2DM) are neede... more New approaches to cope with clinical and psychosocial aspects of type 2 diabetes (T2DM) are needed; gender influences the complex interplay between clinical and non-clinical factors. We used data from the BENCH-D study to assess gender-differences in terms of clinical and person-centered measures in T2DM. Clinical quality of care indicators relative to control of HbA1c, lipid profile, blood pressure, and BMI were derived from electronic medical records. Ten self-administered validated questionnaires (SF-12 Health Survey; WHO-5 well-being index; Problem Areas in Diabetes (PAID) 5, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Diabetes Empowerment Scale, Diabetes Self-care Activities, Global Satisfaction for Diabetes Treatment, Barriers to Taking Medications, Perceived Social Support) were adopted as person-centered outcomes indicators. Overall, 26 diabetes clinics enrolled 2,335 people (men: 59.7%; women: 40.3%). Lower percentages of women reached Hb...
OBJECTIVE—To evaluate the accuracy of a new subcutaneous glucose sensor (Glucoday; A. Menarini Di... more OBJECTIVE—To evaluate the accuracy of a new subcutaneous glucose sensor (Glucoday; A. Menarini Diagnostics) compared with venous blood glucose measurement in type 1 and type 2 diabetic patients. RESEARCH DESIGN—A multicenter study was performed in 70 diabetic patients. A microdialysis fiber was inserted subcutaneously into the periumbelical region and perfused with a buffer solution. Glucose concentrations in the dialysate were then measured every 3 min by the glucose sensor over a 24-h period, during which nine venous blood samples were also collected throughout the day. RESULTS—Both the insertion of the fiber and the wearing of the device were well tolerated by the patients. Subcutaneous glucose levels were well correlated with venous glucose measurements (r = 0.9, P < 0.001) over a wide range (40–400 mg/dl) for up to 24 h, with a single-point calibration. An analysis of 381 data pairs showed a linear relationship between the GlucoDay and serial venous blood glucose levels, and...
Background: Clinical reactive hypoglycemic events are defined as the coexistence of plasma glucos... more Background: Clinical reactive hypoglycemic events are defined as the coexistence of plasma glucose <60 mg/dl and autonomic and/or neuroglycopenic symptoms occurring in fed conditions. The diagnosis is based on tests aiming to simulate the causative triggers (ie ...
In persons with type 1 diabetes (T1D) insulin dosing can be adjusted based on trend arrows derive... more In persons with type 1 diabetes (T1D) insulin dosing can be adjusted based on trend arrows derived from continuous glucose monitoring (CGM). We propose a slide rule with narrower blood glucose intervals and more classes of insulin sensitivity than are available in current models. The slide rule was tested in silico, in which a meal was simulated in 100 virtual subjects and the insulin bolus was calculated either in the standard way based on the insulin-to-carbohydrate ratio and the correction factor or according to the slide rule, following which the percentage time spent in range (70–180 mg/dl; %TIR), hypoglycemia (< 70 mg/dl; %THYPO), and hyperglycemia (> 180 mg/dl; %THYPER) was compared between the methods during the 4 h after the meal. Slide rule performance was also tested in real life by analyzing the same variables at during the 4 h postprandial period in 27 individuals with T1D. Only meals starting while the rate of change was at least 1 mg/dl per minute (increasing or...
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articles by G. Grassi
Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals' clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. <58 mmol/mol for age <18 years and <53 mmol/mol for age >18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis.
Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia.
Keywords: Acute and chronic complications; Continuous subcutaneous insulin infusion (CSII); Diabetes mellitus; Metabolic control.
Research design: A multicenter study was performed in 70 diabetic patients. A microdialysis fiber was inserted subcutaneously into the periumbelical region and perfused with a buffer solution. Glucose concentrations in the dialysate were then measured every 3 min by the glucose sensor over a 24-h period, during which nine venous blood samples were also collected throughout the day.
Results: Both the insertion of the fiber and the wearing of the device were well tolerated by the patients. Subcutaneous glucose levels were well correlated with venous glucose measurements (r = 0.9, P < 0.001) over a wide range (40-400 mg/dl) for up to 24 h, with a single-point calibration. An analysis of 381 data pairs showed a linear relationship between the GlucoDay and serial venous blood glucose levels, and 97% of the data fell in the A and B regions of the error grid analysis. Percentage bias between the GlucoDay and the blood venous levels was -2.0% in the hypoglycemic range (<70 mg/dl), 6.9% in the euglycemic range (70-180 mg/dl), and 11.2% in the hyperglycemic range (>180 mg/dl).
Conclusions: The GlucoDay system demonstrated high reliability and reported values that closely agreed with venous blood glucose measurements. The system was well tolerated and thus constitutes a relatively easy method to monitor glucose excursions in diabetic patients
Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals' clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. <58 mmol/mol for age <18 years and <53 mmol/mol for age >18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis.
Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia.
Keywords: Acute and chronic complications; Continuous subcutaneous insulin infusion (CSII); Diabetes mellitus; Metabolic control.
Research design: A multicenter study was performed in 70 diabetic patients. A microdialysis fiber was inserted subcutaneously into the periumbelical region and perfused with a buffer solution. Glucose concentrations in the dialysate were then measured every 3 min by the glucose sensor over a 24-h period, during which nine venous blood samples were also collected throughout the day.
Results: Both the insertion of the fiber and the wearing of the device were well tolerated by the patients. Subcutaneous glucose levels were well correlated with venous glucose measurements (r = 0.9, P < 0.001) over a wide range (40-400 mg/dl) for up to 24 h, with a single-point calibration. An analysis of 381 data pairs showed a linear relationship between the GlucoDay and serial venous blood glucose levels, and 97% of the data fell in the A and B regions of the error grid analysis. Percentage bias between the GlucoDay and the blood venous levels was -2.0% in the hypoglycemic range (<70 mg/dl), 6.9% in the euglycemic range (70-180 mg/dl), and 11.2% in the hyperglycemic range (>180 mg/dl).
Conclusions: The GlucoDay system demonstrated high reliability and reported values that closely agreed with venous blood glucose measurements. The system was well tolerated and thus constitutes a relatively easy method to monitor glucose excursions in diabetic patients