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Papers by Roberto Franceschi

International Journal of Molecular Sciences

No data are available on insulin clearance (ClI) trends during the pubertal transition. The aim o... more No data are available on insulin clearance (ClI) trends during the pubertal transition. The aim of this study was to investigate in 973 youths with obesity whether ClI in fasting and post-oral glucose challenge (OGTT) conditions varies at the pubertal transition in relation to the severity of obesity and the presence of steatosis liver disease (SLD). The severity of obesity was graded according to the Centers for Disease Control. SLD was graded as absent, mild and severe based on alanine amino transferase levels. ClI was defined as the molar ratio of fasting C-peptide to insulin and of the areas under the insulin to glucose curves during an OGTT. In total, 35% of participants were prepubertal, 72.6% had obesity class II, and 52.6% had mild SLD. Fasting ClI (nmol/pmol × 10−2) was significantly lower in pubertal [0.11 (0.08–0.14)] than in prepubertal individuals [0.12 (0.09–0.16)] and higher in class III [0.15 (0.11–0.16)] than in class I obesity [0.11 (0.09–0.14)]. OGTT ClI was highe...

54th Annual ESPE, Aug 28, 2014

Background: Several studies have examined the relationship between type 1 diabetes and bone mass,... more Background: Several studies have examined the relationship between type 1 diabetes and bone mass, which reported contradictory data on BMD, bone remodelling markers and bone quality. Nevertheless an incresead prevalence of osteopenia was observed among patients with duration of disease of O6 years. Objective and hypotheses: The aim of the study was to investigate the potential negative impact of type 1 diabetes on bone status in a group of children with type 1 diabetes, by evaluating bone geometry, quality and bone markers. Method: 82 children (47 males, 35 females), mean age 10.7G3.0 years, height SDS 0.05G0.94, BMI SDS K0.49G0.87 with a mean duration of type 1 diabetes of 4.4G2.9 years were studied. Bone geometry was evaluated on digitalized x-rays at the level of the 2nd metacarpal bone. The following parameters were investigated: outer diameter (D), inner diameter (d), cortical area (CA) and medullary area (MA), meanwhile bone quality was evaluated by ultrasound and expressed as amplitude dependent speed of sound (Ad-Sos) and bone transmission time (BTT). Data were converted to SDS and evaluated according to bone age. Bone markers (P1NP, CTX and BAP), sclerostin, Dkk-1, PTH and 25OHD were also assessed. Differences in bone geometry and quality were evaluated against zero, while the biochemical values of the patients were compared with a control group of 40 subjects of normal weight and height, which did not suffer of any chronic diseases. Results: D (K0.99G 1,03), d (K0.42G0.92), CA (K0.87G0.82) and MA (K0.46G 0.82) were all significantly smaller than in controls (P!0.01) while Ad-Sos (0.40G1.22) and BTT (0.05G0.92) were not significantly reduced. The bone markers were similar in children with type 1 diabetes and controls. When the patients were subdivided according to the HbA1c value (!7.5% and O7.5%) no differences where found except for a BAP (106.43G35.12 mg/l vs 84.99G 39.84 mg/l; P!0.01) which is a marker of bone formation. Conclusion: Type 1 diabetic children show a bone of reduced size but with conserved proportion and quality. Bone neoformation seems to be negatively affected by a suboptimal metabolic control.

Hormones, Apr 4, 2022

The aim was to verify in a pediatric population with Hashimoto’s thyroiditis whether there is a r... more The aim was to verify in a pediatric population with Hashimoto’s thyroiditis whether there is a relationship between antithyroid antibodies and inflammatory status on thyroid ultrasound and thyroid function. Subjects and methods. A total of 154 children and adolescents, aged 4 to 18 years, diagnosed with Hashimoto’s thyroiditis with normal body weight were followed up for 1 year. Patients with only antiperoxidase antibodies presented with higher TSH levels than subjects with only antithyroglobulin antibodies (p 0.027) but with similar FT4 levels and thyroid score. Prevalence of seronegative Hashimoto’s thyroiditis in this cohort was 12.3% (19/154). At diagnosis, the seronegative group presented with lower prevalence of overt hypothyroidism, symptoms of hypothyroidism, and thyroid score, meaning less severe thyroid involvement. In contrast, similar TSH and FT4 values were found at diagnosis and during follow-up in both the seronegative and seropositive groups. A comparison between patients with seronegative Hashimoto’s thyroiditis and an overweight/obese antibody-negative population, who presented superimposable altered parenchymal pattern on thyroid ultrasound without circulating antithyroid antibodies, presented similar clinical data. We report for the first time in the literature that seronegative Hashimoto’s thyroiditis in the pediatric age group has a less severe pattern. The seronegative group presents similar characteristics to those of overweight/obese children and adolescents with ultrasound changes, but, according to the established knowledge, the latter condition is reversible and does not need follow-up examinations.

Frontiers in Endocrinology, Jun 17, 2022

Background: Use of Continuous Glucose Monitoring (CGM) systems early in the course of diabetes ha... more Background: Use of Continuous Glucose Monitoring (CGM) systems early in the course of diabetes has the potential to help glycemic management and to improve quality of life (QoL). No previous research has examined these outcomes in children-adolescents with type 1 diabetes (T1D) who use intermittently scanned CGM (isCGM) starting within the first month after diagnosis. Aim: To evaluate the impact of isCGM early after T1D diagnosis, on metabolic control and QoL, comparing a group who started the use of the device within one month from the onset with another one who started at least one year later. Subjects and Methods: Patients who used isCGM within 1 month from T1D diagnosis were enrolled in group A; those who didn't have the device during the first year were considered as control group (group B). HbA1c and total daily insulin were evaluated at 3 (T1), 6 (T2) and 12 (T3) months post-baseline (T0, diabetes onset), QoL after 1 year. In group A, isCGM glucose metrics were also recorded. Results: 85 patients were enrolled in group A and 67 patients in group B. In group A isCGM was well accepted during follow up: no patient dropped out; percentage of time with active sensor was in mean > 87%; number of scans/day remained stable. QoL was higher in group A than in group B both in children-adolescents (p<0.0001) and in parents (p 0.003). Group A presented lower HbA1c during the first year after diagnosis (p<0.001), and this data correlated with glucose management indicator (GMI), time in range (TIR) and mean glucose. The honeymoon period lasted more in group A than in B (p 0.028). Furthermore, the mean hypoglycemia duration decreased during follow-up (p 0.001) in group A. Conclusions: Early use of isCGM, starting within the first month after diagnosis, improves metabolic control and QoL in pediatric patients with T1D.

53rd ESPE Meeting, Aug 28, 2014

Acta Diabetologica, Jan 28, 2022

Aim: To investigate the prevalence, risk factors, and impact of pelvic floor dysfunctions in fema... more Aim: To investigate the prevalence, risk factors, and impact of pelvic floor dysfunctions in female nurses. Design: A systematic review. Data Sources: Searches were conducted in the following five electronic databases: PubMed/Medline, LILACS, SCIELO, Cochrane Library, and CINAHL. There were no period or language limitations. Review Methods: Data extraction and synthesis were conducted and the appraisal of the quality of the studies was performed using the Joanna Briggs Institute critical appraisal tool checklist for prevalence data. Results: A total of 15 studies were included. The symptoms investigated were lower urinary tract symptoms, including urinary incontinence and its subtypes, sexual dysfunctions, constipation, faecal incontinence, and dual incontinence. Overall, prevalence ranged from 9.9% to 89.6%. Associated factors related to occupational roles were lifting heavy weights and poor bladder habits. Quality of life was significantly worse for nurses with pelvic floor disorders. Conclusion: Pelvic floor dysfunctions are very common among female nurses, considerably affecting their quality of life. Additional studies are needed to investigate the impact on work productivity, causal relationships with the occupation and the performance of prevention and treatment interventions directed toward this population.

Frontiers in Pediatrics, May 5, 2021

To explore the impact of real-time continuous glucose monitoring (rtCGMs) or intermittently scann... more To explore the impact of real-time continuous glucose monitoring (rtCGMs) or intermittently scanned/viewed CGM (isCGM) on psychological outcomes in children and caregivers, and to grade the level of evidence. Method: Systematic review of the literature from PubMed, Embase, Cochrane Library, Web of Science, CINAHL, Nursing reference center, Up to date, Google Scholar, and PsycINFO databases. The studies selected used validated questionnaires for investigating the psychological outcomes. We applied GRADE (Grading of Recommendations Assessment, Development and Evaluation) to rank the quality of a body of evidence. Results: A total of 192 studies were identified in the initial search and after the process of evaluation 25 studies were selected as appropriate to be included in this systematic review. We found in moderate quality studies that isCGM in adolescents can improve diabetes related distress, family conflicts, fear of hypoglycemia, and quality of life, while depression, anxiety, and quality of sleep have not yet been evaluated by validated questionnaires. In moderate-high quality studies, rtCGM technology does not impact on diabetes burden, diabetes specific family conflict, and depressive symptoms. The effect on fear of hypoglycemia, sleep quality, and anxiety is still debated and RCT studies powered to find significant results in psychological outcomes are lacking. RtCGM increases satisfaction and quality of life in parents and patients wearing rtCGM. Conclusion: these data present an interesting point to consider when families are deciding whether or not to start CGM use, choosing between rtCGM to reach a tighter metabolic control, or isCGM which allows greater benefits on psychological outcomes.

PubMed, Nov 4, 2020

Background: management of children with type 1 diabetes (T1DM) during physical activity includes ... more Background: management of children with type 1 diabetes (T1DM) during physical activity includes intensive blood glucose monitoring and proper insulin and nutritional adjustments in order to prevent hypoglycemia. Regarding the treatment of hypoglycemia during physical activity, different types of rapid acting carbohydrate (CHO) can be used and recommendations are still debated. Aim of the work: compare the response to three types of frequently used rapid acting CHO to correct hypoglycemia during prolonged aerobic exercise. Subjects and Methods: 21 subjects with T1DM, aged 12-16 years, agreed to be recruited in the study. All participants took part in a trekking camp for 5 days, with 70 Km itinerary. A "flash monitoring" device was put on every participant and insulin and nutritional adjustments were done according to a protocol. Subjects have been randomized into three different groups: group 1 had to correct hypoglycemia with 0.3g/Kg of a glucose preparation; group 2 used sugar fondant candies; group 3 used fruit juice. Results: no significant differences were highlighted among the three treatments in terms of time spent in hypoglycemia, rise in blood glucose levels and number of hypoglycemic events after correction of hypoglycemia. Conclusions: our results suggest that 0.3g pro Kg of rapidly acting CHO in the form of glucose, sugar fondant or orange juice, effectively resolve hypoglycemia in children during aerobic prolonged physical activity.

Healthcare, Jun 28, 2021

This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY

Diabetes Research and Clinical Practice, Sep 1, 2021

Aims In March and April 2020, at the start of the COVID-19 pandemic, our previous survey of Itali... more Aims In March and April 2020, at the start of the COVID-19 pandemic, our previous survey of Italian pediatric diabetes centers showed that 75% of telemedicine use was voluntary. We hypothesized that the COVID-19 pandemic has acted as a picklock to overcome barriers to telemedicine regulation, use, and reimbursement. Methods Between March 22nd and April 12th, 2021, the same survey administered in 2020 was sent to all 68 Italian pediatric diabetes centers belonging to the Italian Society for Pediatric Endocrinology and Diabetes (ISPED) to collect data on the demographic variables of respondents; information about the center; the use, codification, and reimbursement of telemedicine; and used tools. Descriptive data were evaluated to establish how the COVID-19 pandemic has changed telemedicine practice. Results Eighty-two percent of responder centers reported an increase in the use of telemedicine, with televisits by video calling implemented in over half of centers. There was a significant increase in the number of centers formally tracking telemedicine use and obtaining reimbursement from the national health service (42% vs. 29% and 62% vs. 32%; p < 0.001, respectively). No reimbursement was provided to centers not using televisits. Conclusions From a voluntary procedure with a lack of traceability, telemedicine has become a new structured reality that may help our pediatric patients beyond this pandemic.

Acta Diabetologica, Apr 9, 2022

Data about sleep quality and quantity are not available in patients with type 1 diabetes (T1D) us... more Data about sleep quality and quantity are not available in patients with type 1 diabetes (T1D) using intermittently scanned continuous glucose monitoring (isCGM). We questioned whether the isCGM with alarms could fragment sleep in patients and parents, compared to isCGM without alarms. A prospective, observational study including 47 child-adolescents with T1D who had experience with isCGM without alarms (Freestyle Libre 1–FSL1). They were asked to wear the isCGM with alarms (Freestyle Libre 2–FSL2) for 14 days. Patients enrolled and their caregiver (s), during a 14 day period with FSL1 and the following 14 days with FSL2, completed psychosocial and sleep-related questionnaires. Furthermore they wore an actigraph that was downloaded to a web platform and processed by the validated and certified algorithm “Dormi®.” By the switch to the alarmed FSL2 we found about a 5% increase in Time In Range (from 62.5 to 67.8%), a reduction in time spent in hypoglycemia, number of weekly hypoglycemic events, and coefficient of variation. We did not find significant differences in sleep parameters in patients and their parents; therefore, alarms did not worsen the duration and quality of sleep. A significant improvement in the Quality of Life was perceived by parents using FSL2. Introduction of alarms in isCGM systems gives, in the short term, an improvement in metabolic control in terms of time in range and reduction in hypoglycemia, without worsening duration and quality of sleep, measured by actigraphy, in children-adolescent and their parents.

Diabetes Research and Clinical Practice

Diabetes, Obesity and Metabolism

Diabetes Research and Clinical Practice

La diffusione della terapia insulinica sottocutanea continua con microinfusore (CSII) \ue8 in con... more La diffusione della terapia insulinica sottocutanea continua con microinfusore (CSII) \ue8 in continuo aumento nel mondo, grazie anche al miglioramento della tecnologia degli strumenti. Scopo di questo lavoro \ue8 stato quello di valutare lo stato attuale della CSII in Italia. A tal fine ai responsabili di 272 strutture diabetologiche che seguono pazienti in terapia con microinfusore \ue8 stato inviato un questionario che indagava aspetti clinici, tecnici e organizzativi della terapia con microinfusore. Duecentodiciassette strutture (79,8%) hanno partecipato all\u2019indagine. Dai dati raccolti \ue8 emerso che a fine aprile 2013 in tali strutture vi erano 10.152 pazienti in terapia con microinfusore, quasi tutti (98,2%) affetti da diabete di tipo 1, prevalentemente adulti (82,4%) e di sesso femminile (57%). La diffusione della CSII risultava molto disomogenea tra le diverse Regioni e anche tra le diverse strutture diabetologiche di una stessa Regione: solo il 59% delle strutture seguiva pi\uf9 di 20 pazienti ciascuna. Motivo principale per iniziare la CSII era la ricerca del buon controllo glicemico. Il drop-out (8,65% dei casi), avveniva soprattutto per problemi legati alla portabilit\ue0 della pompa o al mancato raggiungimento del target glicemico. La maggior parte dei pazienti (61%) utilizzava un microinfusore tradizionale, il 39% un microinfusore integrato (32%) o associato (7%) a un dispositivo per il monitoraggio in continuo della glicemia. Le funzioni avanzate del microinfusore venivano mediamente utilizzate solo dal 68% dei pazienti e il sensore era utilizzato mediamente solo per 12 giorni al mese. L\u201981% delle strutture garantiva una reperibilit\ue0 24 ore su 24. Solo nel 40% delle strutture per adulti e nel 50% di quelle pediatriche i pazienti venivano seguiti da un team completo. In conclusione, la CSII si sta sempre pi\uf9 diffondendo in Italia, sia tra i pazienti adulti sia tra quelli pediatrici. \uc8 auspicabile una maggiore uniformit\ue0 tra le diverse Regioni e un uso pi\uf9 adeguato della tecnologia stessa

Ketoacidosis is a potentially life-threatening complication in patients with type 1 diabetes mell... more Ketoacidosis is a potentially life-threatening complication in patients with type 1 diabetes mellitus (T1DM), particularly children. If diabetic ketoacidosis (DKA) is diagnosed late, the child risks cerebral edema, permanent neurological damage or even death. There have been only few studies of DKA in Italy. From January-May 2014 a nation-wide observational, retrospective study of DKA at diabetes onset was done by the Pediatric Diabetology Study Group (PDSG) of the Italian Society of Pediatric Endocrinology and Diabetes (ISPED), involving 76 Italian centers. DKA was defined using ISPAD criteria; 7457 new cases of T1DM were recruited from mainland Italy and the island of Sicily and 770 from Sardinia, in the period 2004-2013. On the mainland and in Sicily, DKA at diabetes onset was about 32.9% (95% CI 31.8-34.0%), and there was 6.6% (95% CI 6.02-7.20%) of the severe form. Mild and severe DKA risk was significantly higher in children aged 0-4 years; no significant temporal trend was found in the study period. Patients living in Sardinia or having a firstdegree relative with T1DM were at significantly lower risk of DKA at diabetes onset. In the ten-year study period three children died of DKA at onset and four suffered permanent neurological lesions. From November 2011-April 2012 the PDSG conducted a retrospective study based on a sample of 2025 patients with T1DM, aged 0-18 years, involving 29 national centers for pediatric diabetes. The incidence of DKA was 2.4% (IC 95% 1.8-3.1), with children older than ten years at significantly higher risk, probably due to shortages of insulin. Multiple analysis showed a higher risk of DKA in those using a rapid-acting insulin analog and in those with high HbA1c. Young mothers and low levels of education were also associated with DKA. In conclusion, although a wide network of specialized home pediatricians and pediatric diabetes centers is spread across the country, the incidence of DKA at diabetes onset is still high. Further social and health-system efforts are needed to boost awareness of this risk and to reduce damages and costs related to the complication

Italian Journal of Pediatrics, 2016

Cherubini and Study Group for Diabetes of ISPED Unfortunately, the original version of this artic... more Cherubini and Study Group for Diabetes of ISPED Unfortunately, the original version of this article [1] contained an error. The name of one of the authors from the Study Group for Diabetes of ISPED was included incorrectly and it read "A. Galero" instead of "A. Gaiero" in the Acknowledgements section. The correct Acknowledgements section has been included in full in this erratum.

Journal of Diabetes Research, 2016

We conducted a retrospective survey in pediatric centers belonging to the Italian Society for Ped... more We conducted a retrospective survey in pediatric centers belonging to the Italian Society for Pediatric Diabetology and Endocrinology. The following data were collected for all new-onset diabetes patients aged 0–18 years: DKA (pH < 7.30), severe DKA (pH < 7.1), DKA in preschool children, DKA treatment according to ISPAD protocol, type of rehydrating solution used, bicarbonates use, and amount of insulin infused. Records(n=2453)of children with newly diagnosed diabetes were collected from 68/77 centers (87%), 39 of which are tertiary referral centers, the majority of whom (n=1536, 89.4%) were diagnosed in the tertiary referral centers. DKA was observed in 38.5% and severe DKA in 10.3%. Considering preschool children, DKA was observed in 72%, and severe DKA in 16.7%. Cerebral edema following DKA treatment was observed in 5 (0.5%). DKA treatment according to ISPAD guidelines was adopted in 68% of the centers. In the first 2 hours, rehydration was started with normal saline in all...

International Journal of Molecular Sciences

No data are available on insulin clearance (ClI) trends during the pubertal transition. The aim o... more No data are available on insulin clearance (ClI) trends during the pubertal transition. The aim of this study was to investigate in 973 youths with obesity whether ClI in fasting and post-oral glucose challenge (OGTT) conditions varies at the pubertal transition in relation to the severity of obesity and the presence of steatosis liver disease (SLD). The severity of obesity was graded according to the Centers for Disease Control. SLD was graded as absent, mild and severe based on alanine amino transferase levels. ClI was defined as the molar ratio of fasting C-peptide to insulin and of the areas under the insulin to glucose curves during an OGTT. In total, 35% of participants were prepubertal, 72.6% had obesity class II, and 52.6% had mild SLD. Fasting ClI (nmol/pmol × 10−2) was significantly lower in pubertal [0.11 (0.08–0.14)] than in prepubertal individuals [0.12 (0.09–0.16)] and higher in class III [0.15 (0.11–0.16)] than in class I obesity [0.11 (0.09–0.14)]. OGTT ClI was highe...

54th Annual ESPE, Aug 28, 2014

Background: Several studies have examined the relationship between type 1 diabetes and bone mass,... more Background: Several studies have examined the relationship between type 1 diabetes and bone mass, which reported contradictory data on BMD, bone remodelling markers and bone quality. Nevertheless an incresead prevalence of osteopenia was observed among patients with duration of disease of O6 years. Objective and hypotheses: The aim of the study was to investigate the potential negative impact of type 1 diabetes on bone status in a group of children with type 1 diabetes, by evaluating bone geometry, quality and bone markers. Method: 82 children (47 males, 35 females), mean age 10.7G3.0 years, height SDS 0.05G0.94, BMI SDS K0.49G0.87 with a mean duration of type 1 diabetes of 4.4G2.9 years were studied. Bone geometry was evaluated on digitalized x-rays at the level of the 2nd metacarpal bone. The following parameters were investigated: outer diameter (D), inner diameter (d), cortical area (CA) and medullary area (MA), meanwhile bone quality was evaluated by ultrasound and expressed as amplitude dependent speed of sound (Ad-Sos) and bone transmission time (BTT). Data were converted to SDS and evaluated according to bone age. Bone markers (P1NP, CTX and BAP), sclerostin, Dkk-1, PTH and 25OHD were also assessed. Differences in bone geometry and quality were evaluated against zero, while the biochemical values of the patients were compared with a control group of 40 subjects of normal weight and height, which did not suffer of any chronic diseases. Results: D (K0.99G 1,03), d (K0.42G0.92), CA (K0.87G0.82) and MA (K0.46G 0.82) were all significantly smaller than in controls (P!0.01) while Ad-Sos (0.40G1.22) and BTT (0.05G0.92) were not significantly reduced. The bone markers were similar in children with type 1 diabetes and controls. When the patients were subdivided according to the HbA1c value (!7.5% and O7.5%) no differences where found except for a BAP (106.43G35.12 mg/l vs 84.99G 39.84 mg/l; P!0.01) which is a marker of bone formation. Conclusion: Type 1 diabetic children show a bone of reduced size but with conserved proportion and quality. Bone neoformation seems to be negatively affected by a suboptimal metabolic control.

Hormones, Apr 4, 2022

The aim was to verify in a pediatric population with Hashimoto’s thyroiditis whether there is a r... more The aim was to verify in a pediatric population with Hashimoto’s thyroiditis whether there is a relationship between antithyroid antibodies and inflammatory status on thyroid ultrasound and thyroid function. Subjects and methods. A total of 154 children and adolescents, aged 4 to 18 years, diagnosed with Hashimoto’s thyroiditis with normal body weight were followed up for 1 year. Patients with only antiperoxidase antibodies presented with higher TSH levels than subjects with only antithyroglobulin antibodies (p 0.027) but with similar FT4 levels and thyroid score. Prevalence of seronegative Hashimoto’s thyroiditis in this cohort was 12.3% (19/154). At diagnosis, the seronegative group presented with lower prevalence of overt hypothyroidism, symptoms of hypothyroidism, and thyroid score, meaning less severe thyroid involvement. In contrast, similar TSH and FT4 values were found at diagnosis and during follow-up in both the seronegative and seropositive groups. A comparison between patients with seronegative Hashimoto’s thyroiditis and an overweight/obese antibody-negative population, who presented superimposable altered parenchymal pattern on thyroid ultrasound without circulating antithyroid antibodies, presented similar clinical data. We report for the first time in the literature that seronegative Hashimoto’s thyroiditis in the pediatric age group has a less severe pattern. The seronegative group presents similar characteristics to those of overweight/obese children and adolescents with ultrasound changes, but, according to the established knowledge, the latter condition is reversible and does not need follow-up examinations.

Frontiers in Endocrinology, Jun 17, 2022

Background: Use of Continuous Glucose Monitoring (CGM) systems early in the course of diabetes ha... more Background: Use of Continuous Glucose Monitoring (CGM) systems early in the course of diabetes has the potential to help glycemic management and to improve quality of life (QoL). No previous research has examined these outcomes in children-adolescents with type 1 diabetes (T1D) who use intermittently scanned CGM (isCGM) starting within the first month after diagnosis. Aim: To evaluate the impact of isCGM early after T1D diagnosis, on metabolic control and QoL, comparing a group who started the use of the device within one month from the onset with another one who started at least one year later. Subjects and Methods: Patients who used isCGM within 1 month from T1D diagnosis were enrolled in group A; those who didn't have the device during the first year were considered as control group (group B). HbA1c and total daily insulin were evaluated at 3 (T1), 6 (T2) and 12 (T3) months post-baseline (T0, diabetes onset), QoL after 1 year. In group A, isCGM glucose metrics were also recorded. Results: 85 patients were enrolled in group A and 67 patients in group B. In group A isCGM was well accepted during follow up: no patient dropped out; percentage of time with active sensor was in mean > 87%; number of scans/day remained stable. QoL was higher in group A than in group B both in children-adolescents (p<0.0001) and in parents (p 0.003). Group A presented lower HbA1c during the first year after diagnosis (p<0.001), and this data correlated with glucose management indicator (GMI), time in range (TIR) and mean glucose. The honeymoon period lasted more in group A than in B (p 0.028). Furthermore, the mean hypoglycemia duration decreased during follow-up (p 0.001) in group A. Conclusions: Early use of isCGM, starting within the first month after diagnosis, improves metabolic control and QoL in pediatric patients with T1D.

53rd ESPE Meeting, Aug 28, 2014

Acta Diabetologica, Jan 28, 2022

Aim: To investigate the prevalence, risk factors, and impact of pelvic floor dysfunctions in fema... more Aim: To investigate the prevalence, risk factors, and impact of pelvic floor dysfunctions in female nurses. Design: A systematic review. Data Sources: Searches were conducted in the following five electronic databases: PubMed/Medline, LILACS, SCIELO, Cochrane Library, and CINAHL. There were no period or language limitations. Review Methods: Data extraction and synthesis were conducted and the appraisal of the quality of the studies was performed using the Joanna Briggs Institute critical appraisal tool checklist for prevalence data. Results: A total of 15 studies were included. The symptoms investigated were lower urinary tract symptoms, including urinary incontinence and its subtypes, sexual dysfunctions, constipation, faecal incontinence, and dual incontinence. Overall, prevalence ranged from 9.9% to 89.6%. Associated factors related to occupational roles were lifting heavy weights and poor bladder habits. Quality of life was significantly worse for nurses with pelvic floor disorders. Conclusion: Pelvic floor dysfunctions are very common among female nurses, considerably affecting their quality of life. Additional studies are needed to investigate the impact on work productivity, causal relationships with the occupation and the performance of prevention and treatment interventions directed toward this population.

Frontiers in Pediatrics, May 5, 2021

To explore the impact of real-time continuous glucose monitoring (rtCGMs) or intermittently scann... more To explore the impact of real-time continuous glucose monitoring (rtCGMs) or intermittently scanned/viewed CGM (isCGM) on psychological outcomes in children and caregivers, and to grade the level of evidence. Method: Systematic review of the literature from PubMed, Embase, Cochrane Library, Web of Science, CINAHL, Nursing reference center, Up to date, Google Scholar, and PsycINFO databases. The studies selected used validated questionnaires for investigating the psychological outcomes. We applied GRADE (Grading of Recommendations Assessment, Development and Evaluation) to rank the quality of a body of evidence. Results: A total of 192 studies were identified in the initial search and after the process of evaluation 25 studies were selected as appropriate to be included in this systematic review. We found in moderate quality studies that isCGM in adolescents can improve diabetes related distress, family conflicts, fear of hypoglycemia, and quality of life, while depression, anxiety, and quality of sleep have not yet been evaluated by validated questionnaires. In moderate-high quality studies, rtCGM technology does not impact on diabetes burden, diabetes specific family conflict, and depressive symptoms. The effect on fear of hypoglycemia, sleep quality, and anxiety is still debated and RCT studies powered to find significant results in psychological outcomes are lacking. RtCGM increases satisfaction and quality of life in parents and patients wearing rtCGM. Conclusion: these data present an interesting point to consider when families are deciding whether or not to start CGM use, choosing between rtCGM to reach a tighter metabolic control, or isCGM which allows greater benefits on psychological outcomes.

PubMed, Nov 4, 2020

Background: management of children with type 1 diabetes (T1DM) during physical activity includes ... more Background: management of children with type 1 diabetes (T1DM) during physical activity includes intensive blood glucose monitoring and proper insulin and nutritional adjustments in order to prevent hypoglycemia. Regarding the treatment of hypoglycemia during physical activity, different types of rapid acting carbohydrate (CHO) can be used and recommendations are still debated. Aim of the work: compare the response to three types of frequently used rapid acting CHO to correct hypoglycemia during prolonged aerobic exercise. Subjects and Methods: 21 subjects with T1DM, aged 12-16 years, agreed to be recruited in the study. All participants took part in a trekking camp for 5 days, with 70 Km itinerary. A "flash monitoring" device was put on every participant and insulin and nutritional adjustments were done according to a protocol. Subjects have been randomized into three different groups: group 1 had to correct hypoglycemia with 0.3g/Kg of a glucose preparation; group 2 used sugar fondant candies; group 3 used fruit juice. Results: no significant differences were highlighted among the three treatments in terms of time spent in hypoglycemia, rise in blood glucose levels and number of hypoglycemic events after correction of hypoglycemia. Conclusions: our results suggest that 0.3g pro Kg of rapidly acting CHO in the form of glucose, sugar fondant or orange juice, effectively resolve hypoglycemia in children during aerobic prolonged physical activity.

Healthcare, Jun 28, 2021

This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY

Diabetes Research and Clinical Practice, Sep 1, 2021

Aims In March and April 2020, at the start of the COVID-19 pandemic, our previous survey of Itali... more Aims In March and April 2020, at the start of the COVID-19 pandemic, our previous survey of Italian pediatric diabetes centers showed that 75% of telemedicine use was voluntary. We hypothesized that the COVID-19 pandemic has acted as a picklock to overcome barriers to telemedicine regulation, use, and reimbursement. Methods Between March 22nd and April 12th, 2021, the same survey administered in 2020 was sent to all 68 Italian pediatric diabetes centers belonging to the Italian Society for Pediatric Endocrinology and Diabetes (ISPED) to collect data on the demographic variables of respondents; information about the center; the use, codification, and reimbursement of telemedicine; and used tools. Descriptive data were evaluated to establish how the COVID-19 pandemic has changed telemedicine practice. Results Eighty-two percent of responder centers reported an increase in the use of telemedicine, with televisits by video calling implemented in over half of centers. There was a significant increase in the number of centers formally tracking telemedicine use and obtaining reimbursement from the national health service (42% vs. 29% and 62% vs. 32%; p < 0.001, respectively). No reimbursement was provided to centers not using televisits. Conclusions From a voluntary procedure with a lack of traceability, telemedicine has become a new structured reality that may help our pediatric patients beyond this pandemic.

Acta Diabetologica, Apr 9, 2022

Data about sleep quality and quantity are not available in patients with type 1 diabetes (T1D) us... more Data about sleep quality and quantity are not available in patients with type 1 diabetes (T1D) using intermittently scanned continuous glucose monitoring (isCGM). We questioned whether the isCGM with alarms could fragment sleep in patients and parents, compared to isCGM without alarms. A prospective, observational study including 47 child-adolescents with T1D who had experience with isCGM without alarms (Freestyle Libre 1–FSL1). They were asked to wear the isCGM with alarms (Freestyle Libre 2–FSL2) for 14 days. Patients enrolled and their caregiver (s), during a 14 day period with FSL1 and the following 14 days with FSL2, completed psychosocial and sleep-related questionnaires. Furthermore they wore an actigraph that was downloaded to a web platform and processed by the validated and certified algorithm “Dormi®.” By the switch to the alarmed FSL2 we found about a 5% increase in Time In Range (from 62.5 to 67.8%), a reduction in time spent in hypoglycemia, number of weekly hypoglycemic events, and coefficient of variation. We did not find significant differences in sleep parameters in patients and their parents; therefore, alarms did not worsen the duration and quality of sleep. A significant improvement in the Quality of Life was perceived by parents using FSL2. Introduction of alarms in isCGM systems gives, in the short term, an improvement in metabolic control in terms of time in range and reduction in hypoglycemia, without worsening duration and quality of sleep, measured by actigraphy, in children-adolescent and their parents.

Diabetes Research and Clinical Practice

Diabetes, Obesity and Metabolism

Diabetes Research and Clinical Practice

La diffusione della terapia insulinica sottocutanea continua con microinfusore (CSII) \ue8 in con... more La diffusione della terapia insulinica sottocutanea continua con microinfusore (CSII) \ue8 in continuo aumento nel mondo, grazie anche al miglioramento della tecnologia degli strumenti. Scopo di questo lavoro \ue8 stato quello di valutare lo stato attuale della CSII in Italia. A tal fine ai responsabili di 272 strutture diabetologiche che seguono pazienti in terapia con microinfusore \ue8 stato inviato un questionario che indagava aspetti clinici, tecnici e organizzativi della terapia con microinfusore. Duecentodiciassette strutture (79,8%) hanno partecipato all\u2019indagine. Dai dati raccolti \ue8 emerso che a fine aprile 2013 in tali strutture vi erano 10.152 pazienti in terapia con microinfusore, quasi tutti (98,2%) affetti da diabete di tipo 1, prevalentemente adulti (82,4%) e di sesso femminile (57%). La diffusione della CSII risultava molto disomogenea tra le diverse Regioni e anche tra le diverse strutture diabetologiche di una stessa Regione: solo il 59% delle strutture seguiva pi\uf9 di 20 pazienti ciascuna. Motivo principale per iniziare la CSII era la ricerca del buon controllo glicemico. Il drop-out (8,65% dei casi), avveniva soprattutto per problemi legati alla portabilit\ue0 della pompa o al mancato raggiungimento del target glicemico. La maggior parte dei pazienti (61%) utilizzava un microinfusore tradizionale, il 39% un microinfusore integrato (32%) o associato (7%) a un dispositivo per il monitoraggio in continuo della glicemia. Le funzioni avanzate del microinfusore venivano mediamente utilizzate solo dal 68% dei pazienti e il sensore era utilizzato mediamente solo per 12 giorni al mese. L\u201981% delle strutture garantiva una reperibilit\ue0 24 ore su 24. Solo nel 40% delle strutture per adulti e nel 50% di quelle pediatriche i pazienti venivano seguiti da un team completo. In conclusione, la CSII si sta sempre pi\uf9 diffondendo in Italia, sia tra i pazienti adulti sia tra quelli pediatrici. \uc8 auspicabile una maggiore uniformit\ue0 tra le diverse Regioni e un uso pi\uf9 adeguato della tecnologia stessa

Ketoacidosis is a potentially life-threatening complication in patients with type 1 diabetes mell... more Ketoacidosis is a potentially life-threatening complication in patients with type 1 diabetes mellitus (T1DM), particularly children. If diabetic ketoacidosis (DKA) is diagnosed late, the child risks cerebral edema, permanent neurological damage or even death. There have been only few studies of DKA in Italy. From January-May 2014 a nation-wide observational, retrospective study of DKA at diabetes onset was done by the Pediatric Diabetology Study Group (PDSG) of the Italian Society of Pediatric Endocrinology and Diabetes (ISPED), involving 76 Italian centers. DKA was defined using ISPAD criteria; 7457 new cases of T1DM were recruited from mainland Italy and the island of Sicily and 770 from Sardinia, in the period 2004-2013. On the mainland and in Sicily, DKA at diabetes onset was about 32.9% (95% CI 31.8-34.0%), and there was 6.6% (95% CI 6.02-7.20%) of the severe form. Mild and severe DKA risk was significantly higher in children aged 0-4 years; no significant temporal trend was found in the study period. Patients living in Sardinia or having a firstdegree relative with T1DM were at significantly lower risk of DKA at diabetes onset. In the ten-year study period three children died of DKA at onset and four suffered permanent neurological lesions. From November 2011-April 2012 the PDSG conducted a retrospective study based on a sample of 2025 patients with T1DM, aged 0-18 years, involving 29 national centers for pediatric diabetes. The incidence of DKA was 2.4% (IC 95% 1.8-3.1), with children older than ten years at significantly higher risk, probably due to shortages of insulin. Multiple analysis showed a higher risk of DKA in those using a rapid-acting insulin analog and in those with high HbA1c. Young mothers and low levels of education were also associated with DKA. In conclusion, although a wide network of specialized home pediatricians and pediatric diabetes centers is spread across the country, the incidence of DKA at diabetes onset is still high. Further social and health-system efforts are needed to boost awareness of this risk and to reduce damages and costs related to the complication

Italian Journal of Pediatrics, 2016

Cherubini and Study Group for Diabetes of ISPED Unfortunately, the original version of this artic... more Cherubini and Study Group for Diabetes of ISPED Unfortunately, the original version of this article [1] contained an error. The name of one of the authors from the Study Group for Diabetes of ISPED was included incorrectly and it read "A. Galero" instead of "A. Gaiero" in the Acknowledgements section. The correct Acknowledgements section has been included in full in this erratum.

Journal of Diabetes Research, 2016

We conducted a retrospective survey in pediatric centers belonging to the Italian Society for Ped... more We conducted a retrospective survey in pediatric centers belonging to the Italian Society for Pediatric Diabetology and Endocrinology. The following data were collected for all new-onset diabetes patients aged 0–18 years: DKA (pH < 7.30), severe DKA (pH < 7.1), DKA in preschool children, DKA treatment according to ISPAD protocol, type of rehydrating solution used, bicarbonates use, and amount of insulin infused. Records(n=2453)of children with newly diagnosed diabetes were collected from 68/77 centers (87%), 39 of which are tertiary referral centers, the majority of whom (n=1536, 89.4%) were diagnosed in the tertiary referral centers. DKA was observed in 38.5% and severe DKA in 10.3%. Considering preschool children, DKA was observed in 72%, and severe DKA in 16.7%. Cerebral edema following DKA treatment was observed in 5 (0.5%). DKA treatment according to ISPAD guidelines was adopted in 68% of the centers. In the first 2 hours, rehydration was started with normal saline in all...