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Aims: To assess the effectiveness of the intermittent-scanned continuous glucose monitoring (isCGM) system in preventing severe hypoglycemic episodes and in improving glucose parameters and quality of life., Methods: Four hundred T1D individuals were enrolled in a prospective real-word study with an intermittently scanned continuous glucose monitoring device during the 12-months follow-up. The primary endpoint was the incidence of severe hypoglycemic events., Results: 82% of subjects were naïve to the use of the device (group A) and 18% were already wearing the system (group B). The cumulative incidence of severe hypoglycemia (SH) at 12 months was 12.06 per 100 person-year (95% CI: 8.35-16.85) in group A and 10.14 (95% CI: 4.08-20.90) in group B without inter-group differences. In group A there was a significant decrease in SH at 12 months compared to 3 months period (p = 0.005). Time in glucose range significantly increased in both groups accompanied with a significant decrease in glucose variability. HbA1c showed a progressive significant time-dependent decrease in group A. The use of the device significantly improved the perceived quality of life., Conclusion: This study confirmed the effectiveness of the isCGM in reducing hypoglycemic risk without glucose deterioration, with potential benefits on adverse outcomes in T1D individuals., Trial Registration: ClinicalTrials.gov registration no. NCT04060732., (© 2024. The Author(s).)

Aims: The present study assessed the transitioning process of young adults with type 1 diabetes mellitus (T1D) in Italy., Materials and Methods: We asked Pediatric Diabetes Centers (PDC) and Adult Diabetes Centers (CAD) to fill in a web-based survey on the current state of services, the number of transitioning adolescents with T1D within the last year, observations on limitations, and future directions., Results: 93 centers (46 PDCs, 47 CADs) joined the study. The total number of subjects with T1D being followed by a PDC was 16,261 (13,779 minors and 2483 young adults), while CADs had 25,500 patients. The survey showed an uneven situation. Only some services had a dedicated diabetes team (78% of PDCs, 64% of CADs). 72% of PDCs and 58% of CADs reported a protocol dedicated to transition. The median age for transition was 19 (range 16-25 years); the time required for preparing transition, indicated by both PDCs and CADs, was 5.5 months. A high percentage of CADs (80%) confirmed receiving sufficient clinical information, mainly through paper or computerized reports. The transition process is hampered by a lack of resources, logistical facilities, and communication between services. While some services have a protocol, monitoring of results is only carried out in a few cases. Most specialists expressed the need to enhance integration and continuity of treatment., Conclusions: The current situation could be improved. Applying standard guidelines, taking into consideration both clinicians' and patients' necessities, would lead to a more successful transition process., (© 2024. Springer-Verlag Italia S.r.l., part of Springer Nature.)

Aims: Depression in type 2 diabetes may heavily affect the course of the disease. In this study, we investigated, among new cases with type 2 diabetes, the incidence and clinical predictors of depression and determined the extent to which depression constitutes a risk factor for acute and long-term diabetes complications and mortality., Methods: In this population-based retrospective cohort study, incident cases of type 2 diabetes without a prior history of depression were identified from the administrative databases of the Emilia-Romagna Region, Italy, between 2008 and 2017 and followed up until 2020. Logistic regression models were used to identify the predictors of depression. Cox regression models were used to estimate the risk of acute complications over three years, and the risk of long-term complications and mortality over ten years., Results: Incident cases with type 2 diabetes were 30,815, of whom 5146 (16.7%) developed depression. The predictors of depression onset were as follows: female sex, age > 65 years, living in rural areas and comorbid diseases. Depression in type 2 diabetes was associated with a 2.3-fold risk of developing acute complications, 1.6-fold risk of developing long-term complications and 2.8-fold mortality risk., Conclusions: Our findings highlight that depression is associated with an increased risk for complications in type 2 diabetes and mortality and should not be neglected. Therefore, it is important to promote screening activities and introduce targeted and personalized treatment for depression in order to reduce the risk of poor short- and long-term outcomes of diabetes., (© 2021. The Author(s).)

Aims: To assess use of self-monitoring of blood glucose (SMBG) in type 2 diabetes (T2DM) in the context of a continuous quality improvement initiative (AMD Annals)., Methods: 14 quality-of-care indicators were developed, including frequency of SMBG, fasting blood glucose (FBG), and post-prandial glucose (PPG) levels, and hypoglycemia and hyperglycemia episodes. Clinical data and SMBG values downloaded from any glucose meter were obtained from electronic medical records. The most frequently used glucose-lowering treatment regimens were identified and the indicators were assessed separately by regimen., Results: Overall, 21 Italian centers and 13,331 patients (accounting for 35,657 HbA1c tests and 8.44 million SMBG values collected during 2014 and 2015) were included in the analysis; 11 therapeutic regimens were selected. Patients in regimens not including insulin performed 15-23 measurements per patient-month, those treated with basal insulin 32.1 tests/patient-month, and those treated with basal and short-acting insulin 53-58 tests/patient-month. In all treatment regimens, PPG measurements represented a minority of all tests; pre-breakfast measurements accounted for about 50% of all FBG values. Mean FBG levels exceeded 130 mg/dl in 49.3-88.3% of the cases in the different treatment regimens, while PPG levels were over 140 mg/dl in 46.7-81.0%. From 5.7 to 32.7%, patients in the different regimens had at least one episode of hypoglycemia (< 70 mg/dl), while from 3.7 to 47.7% had at least one episode of hyperglycemia (> 300 mg/dl)., Conclusions: SMBG is underutilized in patients with T2DM treated or not with insulin. In all treatment groups, PPG is seldom investigated. Poor metabolic control and rates of hyper- and hypoglycemia deserve consideration in all treatment groups.

Aim: To describe characteristics relevant in case of an unplanned pregnancy for T1D or T2D women of childbearing age., Methods: We analyzed the 2011 AMD-Annals dataset, compiling information from 300 clinics (28,840 T1D patients and 532,651 T2D patients). A risk score of unfavorable conditions for pregnancy included HbA1c > 8.0%; BMI ≥ 35; systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg; microalbuminuria/proteinuria; use of statins, ACE inhibitors, ARB; use of diabetes drugs other than metformin/insulin., Results: The proportion of T2D cases increased from 30.8% (95% CI 29.9-32.4) at age 18-30 years to 67.5% (66.6-68.5) at age 36-45 years. The proportion of women with HbA1c < 7.0% was 20.4% (20.0-20.8) in T1D and 43.4% (42.8-43.9) in T2D women. Furthermore, 47.6% (47.0-48.3) of T1D women and 34.5% (33.9-35.0) of T2D women had HbA1c ≥ 8.0%. The prevalence of obesity (BMI ≥ 30) was sevenfold higher among T2D than T1D women [49.9% (49.4-50.5) and 7.4% (7.2-7.5), respectively]. T2D women were more likely to have hypertension or microalbuminuria than T1D women. Almost half of the T2D women were taking drugs not approved during pregnancy. At least one unfavorable condition for starting a pregnancy was present in 51% of T1D women of childbearing age and in 66.7% of T2D women., Conclusions: Women with either T1D or T2D of childbearing age in Italy were far from the ideal medical condition for conception. Our data strongly support the need for counseling all women with diabetes about pregnancy planning.

Aims: To compare iBGStar™ + DMApp (experimental meter + telemedicine system) (iBGStar) with a traditional glucose meter (Control) in type 1 diabetes adolescents/young adults., Methods: i-NewTrend was a multicenter, open-label, randomized trial involving subjects aged 14-24 years, on basal-bolus insulin, HbA1c ≥ 8.0%, and poorly compliant with SMBG (i.e., <30% of the recommended frequency). Primary end points were change in HbA1c and achievement of compliance with SMBG (≥30% of the recommended frequency) after 6 months. Quality of life was also evaluated. A post-trial observational phase was conducted, where both groups used the experimental device., Results: Of 182 randomized patients (51.1% male; age 17.7 ± 3.0 years; diabetes duration 8.8 ± 4.7 years; HbA1c levels 10.0% ± 1.4), 92 were allocated to iBGStar and 90 to Control; 6.5% in iBGStar and 8.9% in Control dropped-out. After 6 months, HbA1c changes (±SE) were -0.44% ± 0.13 in iBGStar and -0.32% ± 0.13 in Control (p = 0.51). In the post-trial phase, HbA1c changes from 6 months (±SE) were -0.07% ± 0.14 in iBGStar and -0.31% ± 0.14 in Control (p = 0.24). Compliance end point was reached by 53.6% in iBGStar and 55.0% in Control (p = 0.86). Mean daily SMBG measurements increased from 1.1 to 2.3 in both groups without worsening quality of life. Compliant subjects showed a greater reduction in HbA1c levels (-0.60% ± 0.23 in iBGStar; -0.41% ± 0.21 in Control; p = 0.31). Within iBGStar group, telemedicine users (38.0%) reduced HbA1c by -0.58 ± 0.18., Conclusions: iBGStar was not superior to the traditional meter. Irrespective of the strategy, increasing from 1 to 2 SMBG tests/day was associated with HbA1c reduction in both groups, without pharmacologic interventions. Identifying new technologies effective and acceptable to patients is an option to improve adherence to diabetes care., Trial Registration: The trial was registered at ClinicalTrials.gov (registration number NCT02073188).

Objective: Quality of care monitoring is a key strategy for health policy. In Italy, the AMD Annals continuous monitoring and quality improvement initiative has been in place since 2006. Results after 8 years are now available., Research Design and Methods: Quality of diabetes care indicators during the years 2004-2011 were extracted from electronic medical records of 300 diabetes clinics. From 200,000 to 500,000 patients with type 2 diabetes were analyzed per year. Six process indicators, eight intermediate outcome indicators, seven indicators of treatment intensity/appropriateness, and a quality of care summary score (Q score) were evaluated. Previous studies documented that the risk of developing a new cardiovascular event was 80 % higher in patients with a Q score <15 and 20 % higher in those with a score between 15 and 25, as compared to those with a score >25., Results: The proportion of patients with HbA1c ≤7 %, LDL cholesterol <100 mg/dl, and blood pressure ≥140/90 mmHg increased by 4.8, 21.9, and 10.0 %, respectively. Process and treatment intensity/appropriateness indicators consistently improved. The proportion of patients with a Q score <15 decreased from 13.5 to 6.5 %, while those with a Q score >25 increased from 22.9 to 38.5 %., Conclusions: AMD Annals document the progress in quality of diabetes care. Longitudinal improvements in Q score can translate into less cardiovascular events, with evident clinical and economic implications. AMD Annals represent a physician-led effort not requiring allocation of extra-economic resources, which is easy to implement and deeply rooted in routine clinical practice. They are a potential case model for other healthcare systems.