Glycaemic control metrics and metabolic dysfunction-associated steatotic liver disease in children and adolescents with type 1 diabetes.

AIM: The aim was to examine the prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD), a risk factor for atherosclerotic cardiovascular disease, and its association with glycaemic control metrics in children and adolescents with type 1 diabetes (T1D). MATERIALS AND METHODS: We enrolled 244 children and adolescents with T1D (115 girls, mean age: 16.2 ± 3.2 years). The diagnosis of MASLD was defined by the presence of hepatic steatosis on ultrasonography in combination with at least one of five common cardiometabolic risk factors. Metrics of short-term and long-term glycaemic control, blood pressure, lipids, anthropometric characteristics and three genetic variants strongly related to MASLD susceptibility (rs738409 [patatin-like phospholipase domain-containing 3], rs58542926 [transmembrane 6 superfamily member 2] and rs1260326 [glucokinase regulator]) were assessed. Characteristics of these subjects with and without MASLD were compared using the unpaired Student t test, Mann-Whitney test or χ2 test as appropriate. Logistic regression analyses were performed to determine the main independent predictors of MASLD. RESULTS: The prevalence of MASLD was 27.5% in children and adolescents with T1D. Blood pressure, total cholesterol, low-density lipoprotein (LDL) cholesterol, non-high-density lipoprotein cholesterol, HbA1c and time above range (TAR) were significantly higher in subjects with MASLD than in those without MASLD. Mean HbA1c values from diabetes onset (adjusted odds ratio [OR]: 1.703, 95% confidence interval [CI]: 1.040-2.787, p = 0.034), TAR (adjusted OR: 1.028, 95% CI: 1.009-1.047, p = 0.006) and plasma LDL cholesterol (adjusted OR: 1.045, 95% CI: 1.013-1.078, p = 0.004) were independently associated with the presence of MASLD. CONCLUSIONS: MASLD is a common condition in children and adolescents with T1D. The mean HbA1c values from diabetes onset, TAR and LDL cholesterol levels were the independent predictors of MASLD.

Future acceptance of automated insulin delivery systems in youths with type 1 diabetes: validation of the Italian artificial pancreas-acceptance measure.

AIM: The purpose of this study was to develop a questionnaire to examine the future acceptance of Automatic insulin delivery systems (AIDs), their perceived usefulness, ease of use, and trust in the device in subjects with type 1 diabetes (T1D). METHODS: A questionnaire in Italian, based on the Technology Acceptance Model, was developed to examine intention to use AIDs, considered as a measure of future acceptance, and its determinants to use the system. A total of 43 questions for children and 46 for parents were included, and a 5-point Likert scale was used. RESULTS: 239 subjects with T1D using multiple daily injections (MDI) or sensor-augmented pump (SAP) and their parents completed the questionnaire. The completion rate was excellent, with almost 100% of items answered. The overall Cronbach's coefficient for children and adolescents was 0.92 and 0.93 for parents, indicating excellent internal consistency in both groups. Parent-youth agreement was 0.699 (95% confidence interval: 0.689-0.709), indicating a good agreement between the two evaluations. Factor analysis identified measurement factors for the "artificial pancreas (AP)-acceptance labeled benefits and hassles of AIDs, and the internal consistency of the total scale was alpha = 0.94 for subjects with T1D and 0.95 for parents. The level of AP acceptance was more than neutral: 3.91 ± 0.47 and 3.99 ± 0.43 (p = 0.07) for youths and parents, respectively (possible score range 1 to 5, neutral score is 3.0). Parents reported higher scores in the benefit items than children-adolescents (p = 0.04). CONCLUSIONS: We developed a new questionnaire based on the items available in the literature, and we demonstrated that the "AP-acceptance" reveals a meaningful factor structure, good internal reliability, and agreement between parent-young people evaluations. This measure could be a valuable resource for clinicians and researchers to assess AP acceptance in pediatric patients with T1D and their parents. This patient profiling approach could help to enroll candidates for AIDs with proper expectations and who most likely will benefit from the system.

Safety and Psychological Outcomes of Tandem t:Slim X2 Insulin Pump with Control-IQ Technology in Children, Adolescents, and Young Adults with Type 1 Diabetes: A Systematic Review.

The Tandem t:slim X2 insulin pump is a second-generation automated insulin delivery system with Control-IQ technology. It consists of an X2 insulin pump, an integrated Dexcom sensor, and an embedded 'Control-IQ' algorithm, which predicts glucose levels 30 min in the future, adapting the programmed basal insulin rates to get glucose levels between 112.5 and 160 mg/dl (8.9 mmol/l). The system delivers automatic correction boluses of insulin when glucose levels are predicted to rise > 180 mg/dl (10 mmol/l). It has been commercially available since 2016. We reviewed the current evidence about the psychological, safety, and exercise-related outcomes of this device in children, adolescents, and young adults living with type 1 diabetes. We screened 552 papers, but only 21 manuscripts were included in this review. Fear of hypoglycemia is significantly reduced in young people with diabetes and their parents. Interestingly, diabetes-related distress is decreased; thus, the system is well accepted by the users. The sleeping quality of subjects living with diabetes and their caregivers is improved to a lesser extent as well. Despite the small number of data, this system is associated with a low rate of exercise-related hypoglycemia. Finally, evidence from the literature shows that this system is safe and effective in improving psychological personal outcomes. Even if further steps toward the fully closed loop are still mandatory, this second-generation automated insulin delivery system reduces the burden of diabetes. It properly addresses most psychological issues in children, adolescents, and young adults with type 1 diabetes mellitus; thus, it appears to be well accepted.

Maintaining a gluten-free diet is associated with quality of life in youths with type 1 diabetes and celiac disease.

AIM: Conflicting findings have been reported on whether in youths, the double diagnosis of type 1 diabetes (T1D) and celiac disease (CD) substantially impacts quality of life QoL, compared to subjects with T1D only. METHODS: In this study, 86 youths with double diagnosis and their parents were compared to 167 subjects with T1D only. QoL was assessed through the KINDL questionnaire. Anti-tissue transglutaminase antibodies and dietary interviews evaluated the degree of maintaining a gluten-free diet (GFD). RESULTS: We found that having CD in addition to T1D has little effect on overall QoL. However, analysis of the degree of maintaining GFD revealed significantly lower total QoL scores in groups with T1D + CD not strictly maintaining GFD compared to T1D only (p = 0.0014). The multivariable linear regression model confirmed the importance of maintaining GFD on QoL in subjects (p = 0.0066) and parents (p = 0.023). CONCLUSION: The coexistence of T1D and CD and the adoption of a GFD resulted in poor QoL levels, as in youth as in their parents, when difficulties implementing the GFD are present. Psychological support should consider the importance of maintaining GFD not only to prevent potential complications in the future but also to improve actual QoL in different subdomains.

Sustained Effectiveness of an Advanced Hybrid Closed-Loop System in a Cohort of Children and Adolescents With Type 1 Diabetes: A 1-Year Real-World Study.

OBJECTIVE: To investigate glucose metrics and identify potential predictors of the achievement of glycemic outcomes in children and adolescents during their first 12 months of MiniMed 780G use. RESEARCH DESIGN AND METHODS: This multicenter, longitudinal, real-world study recruited 368 children and adolescents with type 1 diabetes (T1D) starting SmartGuard technology between June 2020 and June 2022. Ambulatory glucose profile data were collected during a 15-day run-in period (baseline), 2 weeks after automatic mode activation, and every 3 months. The influence of covariates on glycemic outcomes after 1 year of MiniMed 780G use was assessed. RESULTS: After 15 days of automatic mode use, all glucose metrics improved compared with baseline (P < 0.001), except for time below range (P = 0.113) and coefficient of variation (P = 0.330). After 1 year, time in range (TIR) remained significantly higher than at baseline (75.3% vs. 62.8%, P < 0.001). The mean glycated hemoglobin (HbA1c) over the study duration was lower than the previous year (6.9 ± 0.6% vs. 7.4 ± 0.9%, P < 0.001). Time spent in tight range (70-140 mg/dL) was 51.1%, and the glycemia risk index was 27.6. Higher TIR levels were associated with a reduced number of automatic correction boluses (P < 0.001), fewer SmartGuard exits (P = 0.021), and longer time in automatic mode (P = 0.030). Individuals with baseline HbA1c >8% showed more relevant improvement in TIR levels (from 54.3% to 72.3%). CONCLUSIONS: Our study highlights the sustained effectiveness of MiniMed 780G among youth with T1D. Findings suggest that even children and adolescents with low therapeutic engagement may benefit from SmartGuard technology.

The role of sex on the prevalence of cardiovascular risk factors in children and adolescents with Type 1 diabetes: The SWEET international database.

OBJECTIVE: To assess the prevalence of cardiovascular risk factors (CVRFs) in children and adolescents with type 1 diabetes (T1D) in the International SWEET registry and the possible role of clinical variables in modifying the risk of having single or multiple CVRFs. STUDY DESIGN: The study is a cross-sectional study. Cut-off points for CVRFs were fixed according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines and WHO parameters: LDL cholesterol (LDL-C) > 100 mg/dL; Systolic Blood Pressure (BP-SDS) > 90th percentile for sex, age, and height; BMI-SDS > 2SD for sex and age. Logistic regression models were applied to evaluate variables associated with at least 1 or 2 CVRFs among registry children and adolescents. RESULTS: 29,649 individuals with T1D (6-18 years, T1D ≥ 2 years) participating in the SWEET prospective multicenter diabetes registry were included. In the cohort, 41 % had one or more CVRFs, and 10 % had two or more CVRFs. Thirty-five percent of enrolled individuals had LDL-C > 100 mg/dL, 26 % had BMI-SDS > 2SD, and 17 % had Systolic BP-SDS > 90th percentile. Females had higher frequency than males of having 1 or 2 CVRFs (45.1 % vs 37.4 %, 11.8 % vs 7.8 %; p < 0.001). Multivariable logistic regression models showed that sex (female), HbA1c category (>7.0 %), and age (>10 years) were associated with a higher chance of having at least 1 or 2 CVRFs (p < 0.001). CONCLUSIONS: In children and adolescents with T1D, female sex, in addition to HbA1c above 7 %, and older age (>10 years) was associated with a higher risk of having at least a CVRF (LDL-C, BMI-SDS, BP) according to internationally defined cut-offs.

Glucometrics and device satisfaction in children and adolescents with type 1 diabetes using different treatment modalities: A multicenter real-world observational study.

AIMS: To analyze metabolic outcomes, diabetes impact and device satisfaction in children and adolescents with type 1 diabetes in Italy who used different treatment modalities for diabetes care in a real-life context. METHODS: In this multicenter, nationwide, cross-sectional study, 1464 participants were enrolled at a routine visit. The following treatment modalities were considered MDI + SMBG; MDI + CGM; Sensor Augmented Pump Therapy; predictive management of low glucose; Hybrid Closed Loop (HCL); Advanced Hybrid Closed Loop (AHCL). Health related quality of life was evaluated by the Italian version of the Diabetes Impact and Device Satisfaction Scale (DIDS) questionnaire. RESULTS: Patients treated with AID systems were more likely to have HbA1c ≤ 6.5 %, higher percentage of time with glucose levels between 70 and 180 mg/dL, lower percentage of time with glucose levels above 180 mg/dL, higher device satisfaction, and reduced impact of diabetes. All the therapeutic modalities with respect to MDI + CGM, except for MDI + SMBG, contributed to increase the device satisfaction. HCL and AHCL respect to MDI + CGM were associated with lower diabetes impact. CONCLUSION: Real-life use of automated insulin delivery systems is associated with reduced type 1 diabetes impact, increased device satisfaction, and achievement of glycemic goals.

Satisfaction with continuous glucose monitoring is associated with quality of life in young people with type 1 diabetes regardless of metabolic control and treatment type.

AIMS: While continuous glucose monitoring (CGM) and associated technologies have positive effects on metabolic control in young people with type 1 diabetes (T1D), less is known about their impact on quality of life (QoL). Here, we quantified CGM satisfaction and QoL in young people with T1D and their parents/caregivers to establish (i) the relationship between QoL and CGM satisfaction and (ii) the impact of the treatment regimen on QoL. METHODS: This was a cross-sectional study of children and adolescents with T1D on different treatment regimens (multiple daily injections, sensor-augmented pumps and automated insulin delivery). QoL was assessed with the KINDL instrument, and CGM satisfaction with the CGM-SAT questionnaire was evaluated in both youths with T1D and their parents. RESULTS: Two hundred and ten consecutively enrolled youths with T1D completed the KINDL and CGM-SAT questionnaires. The mean total KINDL score was greater than neutral in both subjects with T1D (3.99 ± 0.47) and parents (4.06 ± 0.40), and lower overall CGM-SAT scores (i.e., higher satisfaction) were significantly associated with higher QoL in all six KINDL subscales (p < 0.05). There were no differences in KINDL scores according to delivery technology or when participants were grouped according to optimal and sub-optimal glucose control. CONCLUSIONS: Higher satisfaction with recent CGMs was associated with better QoL in all dimensions. QoL was independent of both the insulin delivery technology and glycaemic control. CGM must be further disseminated. Attention on perceived satisfaction with CGM should be incorporated with the clinical practice to improve the well-being of children and adolescents with T1D and their families.

Short-Term Weight Gain after Tonsillectomy Does Not Lead to Overweight: A Systematic Review.

Different studies and systematic reviews have reported weight increase after tonsillectomy. However, the odds of a child being overweight or obese after tonsillectomy were no different than before surgery, according to a few studies. This systematic review aims to analyze the impact of adenotonsillectomy (TA) on weight gain and identify subgroups of children and adolescents at risk of experiencing weight gain. A systematic search included studies published in the last ten years. The PICO framework was used in the selection process, and evidence was assessed using the GRADE system. A total of 26 studies were included, and moderate-high level quality ones showed that children who underwent TA could present an increase in BMI z-score. However, this weight gain was significant in individuals younger than six years old and was considered catch-up growth in underweight subjects at baseline. In contrast, for normal-weight or overweight individuals, TA did not lead to overweight per se. At the same time, diet changes and overfeeding did not have a leading role in weight gain. In conclusion, TA may not be an independent risk factor for unfavorable weight gain in children; however, individuals who were underweight pre-operatively or younger than six years reported more weight gain after TA than expected.

Glucose sensor with predictive alarm for hypoglycaemia: Improved glycaemic control in adolescents with type 1 diabetes.

AIM: Hypoglycaemic events are linked to microvascular and macrovascular complications in people with type 1 diabetes. We aimed to evaluate the efficacy of glucose sensor [real-time continuous glucose monitoring (RT-CGM)] with predictive alarm (PA) in reducing the time spent below the range (%TBR <70 mg/dl) in a group of adolescents with type 1 diabetes (AwD). MATERIALS AND METHODS: This was a crossover, monocentric and randomized study. RT-CGM was set with Alarm on Threshold (AoT) at 70 mg/dl) or PA for hypoglycaemia (20 m before threshold). Twenty AwD were enrolled and randomized to either a PA/AoT or AoT/PA treatment sequence, in a 1:1 ratio. The two groups (PA vs. AoT) were compared using two-way repeated measures ANOVA taking account of the carryover effect. RESULTS: AwD using PA for hypoglycaemia spent less time in severe hypoglycaemia (%TBR2 <54 mg/dl; 0.32 ± 0.31 vs. 0.91 ± 0.90; p < .02) and hypoglycaemia (%TBR <70 mg/dl; 1.68 ± 1.06 vs. 2.90 ± 2.05; p < .02), with better glycaemia risk index (51.3 ± 11.0 vs. 61.5 ± 12.6; p ≤ .01). CONCLUSION: The use of RT-CGM with PA for hypoglycaemia technology in AwD using multiple daily insulin injection treatment could significantly reduce the risk of having hypoglycaemic events resulting in an improved quality of glucose control. CLINICAL TRIAL REGISTRATION NUMBER: NCT05574023.

Aiming for the Best Glycemic Control Beyond Time in Range: Time in Tight Range as a New Continuous Glucose Monitoring Metric in Children and Adolescents with Type 1 Diabetes Using Different Treatment Modalities.

Introduction: To evaluate time in tight range (TITR) 70-140 mg/dL (3.9-7.8 mmol/L), its correlation with standard continuous glucose monitoring (CGM) metrics and the clinical variables that possibly have a substantial impact on its value, in a large cohort of pediatric subjects using different treatment strategies. Materials and Methods: A total of 854 children and adolescents with type 1 diabetes were consecutively recruited in this real world, dual center, cross-sectional study. Participants were categorized into four treatment groups (multiple daily injections [MDI] + real-time CGM, MDI + intermittently scanned CGM, sensor augmented pump, and hybrid closed loop [HCL]). Demographical and clinical data, including CGM data, were collected and analyzed. Results: The overall study population exhibited an average TITR of 36.4% ± 12.8%. HCL users showed higher TITR levels compared to the other treatment groups (P < 0.001). A time in range (TIR) cut-off value of 71.9% identified subjects achieving a TITR ≥50% (area under curve [AUC] 0.98; 95% confidence interval 0.97-0.99, P < 0.001), and a strong positive correlation between these two metrics was observed (r = 0.95, P < 0.001). An increase in TIR of 1% was associated with 1.84 (R2 Nagelkerke = 0.35, P < 0.001) increased likelihood of achieving TITR ≥50%. Use of HCL systems (B = 7.78; P < 0.001), disease duration (B = -0.26, P = 0.006), coefficient of variation (B = -0.30, P = 0.004), and glycated hemoglobin (B = -8.82; P < 0.001) emerged as significant predictors of TITR levels. Conclusions: Our study highlights that most children and adolescents with type 1 diabetes present TITR levels below 50%, except those using HCL. Tailored interventions and strategies should be implemented to increase TITR.

Maintaining the gluten-free diet: The key to improve glycemic metrics in youths with type 1 diabetes and celiac disease.

AIMS: Gluten-free diets (GFD) were considered as high glycemic index and/or high content of saturated fats; this could affect keeping good metabolic control in individuals with both type 1 diabetes (T1D) and celiac disease (CD). Our objective was to analyze time in range and other continuous glucose monitoring (CGM) metrics with real-time CGM systems, in youths with T1D and CD, compared to those with T1D only. METHODS: An observational case-control study, comparing youths aged 8-18 years with T1D and CD, with people with T1D only was performed. The degree of maintaining GFD was assessed through anti-tissue transglutaminase antibodies and dietary interview, and maintaining Mediterranean diet through the KIDMED questionnaire. RESULTS: 86 youths with T1D and CD, 167 controls with T1D only, were included in the study and the two groups reported similar real-time CGM metrics. Among the first group, 29 % were not completely maintaining GFD and compared to people with T1D only they showed higher hyperglycemia rates (% time above range: 38.72 ± 20.94 vs 34.34 ± 20.94; P = 0.039). CONCLUSIONS: Individuals with T1D and CD who maintain GFD presented similar glucose metrics compared to youths with T1D only. Individuals not strictly maintaining GFD presented higher hyperglycemia rates.

Glycemic variability and Time in range are associated with the risk of overweight and high LDL-cholesterol in children and youths with Type 1 Diabetes.

INTRODUCTION: Reducing cardiovascular risk factors (CVRFs) exposure in children and youths with type 1 diabetes (T1D) is critical for cardiovascular diseases (CVD) prevention. Long-term exposure to hyperglycaemia, measured by HbA1c, had been recognized as the main factor affecting CVRFs profile. To date, the possible association between short-term glycaemic control and variability measured by continuous glucose monitoring (CGM) metrics and CVRFs has not been explored. The aim of this study was to test the hypothesis that CGM metrics independently contribute to CVRFs exposure in children and youths with T1D. METHOD: BMI, blood pressure (BP), lipid profile, and CGM data of 895 children and youths with T1D were analysed. Binary multivariable logistic regression analyses were performed to test independent associations between CVRFs (BMI percentile>85th, LDL-c>100 mg/dL, BP>90th percentile) and CGM metrics according to sex and adjusting for confounding factors. RESULTS: In both sexes, metrics of hypoglycaemia and glycaemic variability (coefficient of variation [%CV]) positively correlated with BMI percentile. LDL-c positively correlated with mean glucose and metrics of hyperglycaemia. A negative correlation was found between LDL-c and time in range (TIR). No significant correlations were found between CGM metrics and BP percentiles. In both sexes, TIR<70% was significantly associated with LDL-c>100 mg/dL (OR 3.2 in males, 2.1 in females). In females, CV>36% was significantly associated with overweight (OR 2.1). CONCLUSIONS: CGM metrics of glycaemic control and variability were significantly associated with the risk of overweight in females and high LDL-c in both sexes.

Satisfaction with continuous glucose monitoring is positively correlated with time in range in children with type 1 diabetes.

AIMS: Continuous glucose monitoring (CGM) can improve glucometrics in children with type 1 diabetes (T1D), and its efficacy is positively related to glucose sensor use for at least 60% of the time. We therefore investigated the relationship between CGM satisfaction as assessed by a robust questionnaire and glucose control in pediatric T1D patients. METHODS: This was a cross-sectional study of children and adolescents with T1D using CGM. The CGM Satisfaction (CGM-SAT) questionnaire was administered to patients and demographic, clinical, and glucometrics data were recorded. RESULTS: Two hundred and ten consecutively enrolled patients attending 14 Italian pediatric diabetes clinics completed the CGM-SAT questionnaire. CGM-SAT scores were not associated with age, gender, annual HbA1c, % of time with an active sensor, time above range (TAR), time below range (TBR), and coefficient of variation (CV). However, CGM satisfaction was positively correlated with time in range (TIR, p < 0.05) and negatively correlated with glycemia risk index (GRI, p < 0.05). CONCLUSIONS: CGM seems to have a positive effect on glucose control in patients with T1D. CGM satisfaction is therefore an important patient-reported outcome to assess and it is associated with increased TIR and reduced GRI.

Measures of Patient-Reported Expectations, Acceptance, and Satisfaction Using Automated Insulin Delivery Systems: A Review.

In people with type 1 diabetes, Automated Insulin Delivery (AID) systems adjust insulin delivery in response to sensor glucose data and consist of three components: an insulin pump, a continuous glucose sensor, and an algorithm that determines insulin delivery. To date, all the available AID systems require users to announce carbohydrate intake and deliver meal boluses, as well as respond to system alarms. The use of AID devices both initially and over time may be influenced by a variety of psychological factors. Analysis of patient-related outcomes should be taken into account, while recruiting applicants for the systems who are motivated and have realistic expectations in order to prevent AID dropout. We report an up-to-date summary of the available measures and semi-structured interview content to assess AID expectations, acceptance, and satisfaction using the AID systems. In conclusion, we suggest, before and after starting using AID systems, performing a specific evaluation of the related psychological implications, using validated measures and semi-structured interviews, that allows diabetes care providers to tailor their education approach to the factors that concern the patient at that time; they can teach problem-solving skills and other behavioral strategies to support sustained use of the AID system.

Family and Community Nurses as a Resource for the Inclusion of Youths with Type 1 Diabetes at School.

School nurses can facilitate the inclusion of students with type 1 diabetes (T1D) at school; this model has been widespread in some countries but not in Italy, which is due to the insufficient number of school nurses that are able to provide medical attention at all times. The National Recovery and Resilience Plan (PNRR) devised a series of aids and support for the reorganization of the Italian National Health System (NHS) through the creation of community houses in addition to family and community nurses (FCNs), who will operate in these structures to promote the integration of the various professional figures and community services. In this study, starting with the needs and suggestions of teachers (No. 79) and parents (No. 48) collected using a survey, we developed a new model for the inclusion of students at school where FCNs who have experience in pediatric T1D have the role of an educator, coordinator, and facilitator' they cannot be on site and available all the time during school hours, so they must make many efforts to improve the school staff's knowledge, intervene to offer training when requested, and solve new emerging problems.