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Purpose: In recent years there has been a noticeable increase in the use of advanced hybrid closed-loop systems (AHCLs) for managing type 1 diabetes (T1D) among youth. However, there is a lack of comparison between the open-source automated insulin delivery (AID) system and the MiniMed™ 780 G system (780 G)., Methods: In this multi-center study, we retrospectively compared selected glycemic ranges of 26 individuals who used open-source AID and 20 individuals who used 780 G (age 11.3 years [IQR 9.3, 12.9] and 13.4 years [IQR 10.9, 16.5], respectively, p = 0.069) from system initiation to the most recent visit., Results: At baseline, the median HbA1c was significantly lower and the time below range (TBR) <54mg/dL was significantly higher in the open-source AID group compared to the 780 G group (6.8% [IQR 6.4, 7.1] vs. 7.4% [IQR 6.9, 8.6], p = 0.006 and (1.0% [IQR 0.5, 2.8] vs. 0.0% [0.0, 1.0], p = 0.014), respectively; the median time in range (TIR 70-180mg/dL ) was similar (p = 0.068). After a median duration of 10.9 months on AHCLs the reduction of HbA1c was similar ( ~ 0.3%). The time spent in the hypoglycemic ranges was longer among users of the open-source AID compared to 780 G (TBR 54-70mg/dL 4.2% [IQR 2.6, 7.3] vs. 2.0% [1.0, 4.0], p = 0.005) and TBR <54mg/dL 1.1% [IQR 0.4, 2.3] vs. 0.0 [0.0, 1.0], p = 0.001)., Conclusions: Both AHCLs similarly improved HbA1c and TIR 70-180mg/dL . The open-source AID youth had better glycemic control but spent longer time in the hypoglycemic range. These findings must be considered when choosing the use of AHCL technologies., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Aims: Achieving good glycemic control is a major challenge for adolescents with type 1 diabetes (TID). The introduction of the MiniMed 780G system, an advanced hybrid closed-loop (AHCL) that enables an automatic correction of insulin, gave hope for improved glycemic outcomes in adolescents. We assessed specific characteristics associated with glycemic measures in youth with T1D switching to Minimed 780G. Methods: This retrospective observational real-life multicenter study from the AWeSoMe Group assessed continuous glucose monitoring (CGM) metrics of 22 patients (59% females, median age 13.9 interquartile range [IQR 11,18] years), from a high socioeconomic background. CGM metrics were recorded for 2-week periods before AHCL, after 1, 3, 6 months, and at the end of follow-up (median 10.9 [IQR 5.4, 17.4] months). Delta-variables (Δ) were calculated as the difference between the end of follow-up and baseline. Results: Time in range (TIR) 70-180mg/dL increased from 65% [52, 72] to 75% [63, 80], P  = 0.008, from baseline to end of follow-up. Time above range >180mg/dL decreased from 28% [20, 46] to 22% [14, 35], P  = 0.047. Advanced pubertal stage was correlated with less improvement in ΔTAR >180mg/dL , r  = 0.47, P  = 0.05, and less CGM usage r  = -0.57, P  = 0.05. A longer disease duration was associated with less improvement in ΔTAR 180-250mg/dL , r  = 0.48, P  = 0.05. Lower pump site change frequency was associated with higher glucose management indicator, r  = 0.5, P  = 0.03, and lower TIR 70-180mg/dL r  = -0.52, P  = 0.08. Conclusion: The use of AHCL enabled improvements in TIR 70-180mg/dL in youth with T1D. More advanced pubertal stages, longer disease duration, and less compliance were associated with less improvement, stressing the need for continuous support, and re-education in this age group.

Aims: Billions of people have been under lockdown in an attempt to prevent COVID-19 spread. Lifestyle changes during lockdown could lead to deterioration of glycemic control in type 1 diabetes (T1D). We aimed to assess the impact of COVID-19 lockdown on the glycemic control of pediatric patients with T1D., Methods: This observational real-life study from the AWeSoMe Group assessed continuous glucose monitoring (CGM) metrics of 102 T1D patients (52.9% males, mean age 11.2 ± 3.8 years, mean diabetes duration 4.2 ± 3.8 years) who used  Dexcom G5. The data were accessed without any interface between patients, caregivers, and the diabetes team. Study variables from CGM metrics were: mean glucose level, time-in-range (TIR, 70-180 mg/dL; 3.9-10 mmol/L), hypoglycemia (< 54 mg/dL; < 3 mmol/L), hyperglycemia (> 250 mg/dL; > 13.3 mmol/L), coefficient of variation (CV), and time CGM active before and during lockdown. Delta-variable = lockdown variable minus before-lockdown variable., Results: The mean TIR was 60.9 ± 14.3% before lockdown, with no significant change during lockdown (delta-TIR was 0.9 ± 7.9%). TIR during lockdown was significantly correlated with TIR before lockdown (r = 0.855, P < 0.001). Patients with improved TIR (delta-TIR > 3%) were significantly older than patients with stable or worse TIR (P = 0.028). Children aged < 10 years had a significantly higher CV before lockdown and during lockdown than children aged ≥ 10 years (P = 0.02 and P = 0.005, respectively). Among children aged < 10 years, a multiple linear regression model revealed associations of age and lower socioeconomic cluster with delta-TIR (F = 4.416, P = 0.019) and with delta-mean glucose (F = 4.459, P = 0.018)., Conclusions: CGM metrics in pediatric patients with T1D were relatively stable during a nationwide lockdown. Intervention plans should focus on younger patients with lower socioeconomic position.

Aims/hypothesis: Maternal type 2 diabetes during pregnancy and gestational diabetes are associated with childhood adiposity; however, associations of lower maternal glucose levels during pregnancy with childhood adiposity, independent of maternal BMI, remain less clear. The objective was to examine associations of maternal glucose levels during pregnancy with childhood adiposity in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) cohort., Methods: The HAPO Study was an observational epidemiological international multi-ethnic investigation that established strong associations of glucose levels during pregnancy with multiple adverse perinatal outcomes. The HAPO Follow-up Study (HAPO FUS) included 4832 children from ten HAPO centres whose mothers had a 75 g OGTT at ~28 weeks gestation 10-14 years earlier, with glucose values blinded to participants and clinical caregivers. The primary outcome was child adiposity, including: (1) being overweight/obese according to sex- and age-specific cut-offs based on the International Obesity Task Force (IOTF) criteria; (2) IOTF-defined obesity only; and (3) measurements >85th percentile for sum of skinfolds, waist circumference and per cent body fat. Primary predictors were maternal OGTT and HbA 1c values during pregnancy., Results: Fully adjusted models that included maternal BMI at pregnancy OGTT indicated positive associations between maternal glucose predictors and child adiposity outcomes. For one SD difference in pregnancy glucose and HbA 1c measures, ORs for each child adiposity outcome were in the range of 1.05-1.16 for maternal fasting glucose, 1.11-1.19 for 1 h glucose, 1.09-1.21 for 2 h glucose and 1.12-1.21 for HbA 1c . Associations were significant, except for associations of maternal fasting glucose with offspring being overweight/obese or having waist circumference >85th percentile. Linearity was confirmed in all adjusted models. Exploratory sex-specific analyses indicated generally consistent associations for boys and girls., Conclusions/interpretation: Exposure to higher levels of glucose in utero is independently associated with childhood adiposity, including being overweight/obese, obesity, skinfold thickness, per cent body fat and waist circumference. Glucose levels less than those diagnostic of diabetes are associated with greater childhood adiposity; this may have implications for long-term metabolic health.

Objective: This study examined associations of maternal glycemia during pregnancy with childhood glucose outcomes in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) cohort., Research Design and Methods: HAPO was an observational international investigation that established associations of maternal glucose with adverse perinatal outcomes. The HAPO Follow-up Study included 4,832 children ages 10-14 years whose mothers had a 75-g oral glucose tolerance test (OGTT) at ∼28 weeks of gestation. Of these, 4,160 children were evaluated for glucose outcomes. Primary outcomes were child impaired glucose tolerance (IGT) and impaired fasting glucose (IFG). Additional outcomes were glucose-related measures using plasma glucose (PG), A1C, and C-peptide from the child OGTT., Results: Maternal fasting plasma glucose (FPG) was positively associated with child FPG and A1C; maternal 1-h and 2-h PG were positively associated with child fasting, 30 min, 1-h, and 2-h PG, and A1C. Maternal FPG, 1-h, and 2-h PG were inversely associated with insulin sensitivity, whereas 1-h and 2-h PG were inversely associated with disposition index. Maternal FPG, but not 1-h or 2-h PG, was associated with child IFG, and maternal 1-h and 2-h PG, but not FPG, were associated with child IGT. All associations were independent of maternal and child BMI. Across increasing categories of maternal glucose, frequencies of child IFG and IGT, and timed PG measures and A1C were higher, whereas insulin sensitivity and disposition index decreased., Conclusions: Across the maternal glucose spectrum, exposure to higher levels in utero is significantly associated with childhood glucose and insulin resistance independent of maternal and childhood BMI and family history of diabetes., (© 2019 by the American Diabetes Association.)

Aims: Frequent glucose testing is required for optimal management of type 1 diabetes (T1D). Limited data are available regarding real-world experience of the novel technology for monitoring by continuous interstitial fluid glucose (IFG), using flash glucose-sensing technology (FSL-CGM). We aimed to assess the effect of FSL-CGM in a real-life clinical setting on glycemic control parameters, compliance, and adverse events among pediatric and young adult T1D patients., Methods: This observational multi-center study assessed FSL-CGM use (6-12 months) in T1D patients (mean ± SD age 13.4 ± 4.9 years) who purchased the device out-of-pocket. Outcome measures included HbA1c, mean IFG levels, CGM metrics [time in hypoglycemia (< 54 mg/dL; < 3 mmol/L), in target range (70-180 mg/dL; 3.9-10 mmol/L), and in hyperglycemia > 240 mg/dL; > 13.3 mmol/L)], frequency of self-monitoring of blood glucose, acute complications, skin reactions, and reasons for initiation/discontinuation., Results: Among patients with regular use of the FSL-CGM (n = 59), mean HbA1c decreased from 8.86 ± 0.23 to 8.05 ± 0.2% (73.3-64.5 mmol/mol) in 3 months (p = 0.0001) and plateaued thereafter. A clinically significant reduction in HbA1c (defined as a decrease of ≥ 0.5%) was associated with shorter diabetes duration. Of 71 patients who initiated use of the FSL-CGM, 12 (16.9%) discontinued during the study period. No statistically significant changes were found after FSL-CGM use, in mean and standard deviation IFG levels, and in time of glucose levels in target, hypoglycemia, and hyperglycemia ranges. One patient with hypoglycemia unawareness was found dead-in-bed while using FSL-CGM., Conclusions: Real-life observational data in a self-selected young T1D population demonstrated a significant and sustained reduction in HbA1c with FSL-CGM in one-third of the participants. Surveillance of glucose monitoring should be individualized, especially for patients with hypoglycemia unawareness.

Aims: The transition of emerging adults with type 1 diabetes (T1D) from pediatric diabetes clinics to adult clinics between 18 and 21 years of age could result in decreased clinic attendance and thus worsen glycemic control. Our institutional policy offering surveillance till age 30 enabled us to evaluate clinic attendance without the confounding effect of transition. Our aim was to determine the association between glycemic control (HbA1c) and attendance rate., Methods: The medical records of 261 (54% males) young adult T1D patients (median age 22.9 years) were reviewed. Patients were stratified according to the attainment/nonattainment of glycemic targets (HbA1c ≤ 7% versus HbA1c > 7% (53 mmol/mol)). The attendance rate was calculated as the number of clinic visits/number of scheduled appointments., Results: Median annual number of scheduled visits was 3 (3, 4); attendance rate was 75% (53.6%, 100%). Seventy-four (28.4%) patients attained glycemic targets (median HbA1c 6.5% (48 mmol/mol) (6.3%, 6.8% (45.51 mmol/mol)); 187 (71.6%) patients had a median HbA1c of 7.8% (62 mmol/mol) (7.4%, 8.4% (57.68 mmol/mol)). The attainment of the treatment target was more prevalent in older patients ( P = 0.006), in male patients ( P = 0.007), and in patients with higher education ( P = 0.017). Higher attendance rate ( β (2.483), P < 0.001) and male gender ( β (0.746), P = 0.015) were associated with better metabolic control., Conclusions: In emerging adults with T1D during the ongoing stable phase of diabetes management, higher attendance rate, rather than absolute number of clinic visits, was associated with the attainment of glycemic targets.

The aim of this study is to assess the impact of the internet-based upload blood glucose monitoring and therapy management system (Carelink(®)) in patients with type 1 diabetes. Diabetic patients treated with pump infusion for ≥3 months were prospectively randomized to use the CareLink(®) with (4 months) and without (4 months) diabetes-team initiated contact (n = 36, intervention group) or to continue standard care for 4 months and then transfer to the CareLink(®) without diabetes-team initiated contact (n = 34, control group). In the first 4 months, treatment was adjusted monthly by the same team in both groups. Main outcome measures were HbA1c level and scores on the Diabetes Treatment Satisfaction and Diabetes Quality of Life Questionnaires. Patients who submitted <3 times during each 4-month segment were considered noncompliant. Mean patient age was 14.02 ± 5.33 years; mean diabetes duration, 6.4 ± 4.7 years; median duration of pump treatment, 2.5 years. After 4 months, mean HbA1c level decreased from 8.75 ± 0.84 to 8.45 ± 0.90% in the intervention group (p = 0.013) and from 8.65 ± 0.57 to 8.37 ± 0.73% in the control group (p = 0.054). Within the intervention group, the difference in the change in HbA1c levels between compliant and noncompliant patients was significant (8.17 ± 0.81 vs. 8.99 ± 0.85%, p = 0.017). Only in the compliant subgroup was the decrease from baseline significant (p = 0.006). Similar findings were noted in the control group at 8 months (p < 0.05 and p = 0.018, respectively). There were no significant changes in questionnaire scores at 4 or 8 months in either group. Use of the CareLink(®) system is associated with significantly improved glycemic control in compliant patients, with no apparent effect on patient satisfaction or quality of life.

Background: Continuous subcutaneous insulin infusion (CSII) mimics physiologic insulin release better than multiple daily injection (MDI) therapy and allows for greater flexibility in food intake and physical activity. Given these benefits, it raises the question "Is it required to wait to offer CSII to patients with type 1 diabetes (T1D) only after MDI therapy has failed"? This study sought to determine if starting CSII in patients with T1D within 1 year of diagnosis results in better long-term glycemic control than starting it later., Methods: This retrospective observational study was conducted in a tertiary-care medical center. The charts of 488 patients with T1D (273 females) 2.6-39 years old (mean, 19.9 ± 7.7 years) who started CSII in 1998-2008 and used it for at least 1 year were reviewed for background, disease-related, and treatment-related variables. Study end points were glycosylated hemoglobin (HbA1c) level, rate of severe hypoglycemia, and diabetic ketoacidosis events during CSII use. Findings were compared between patients who started CSII within 1 year of diagnosis (Group 1, n=93) or later (Group 2, n=395)., Results: Compared with Group 2, Group 1 patients were characterized by a significantly younger age at CSII initiation (10.7±5.7 vs. 16.4±7.0 years, P<0.001), more frequent blood glucose monitoring (5.4 ± 1.8 vs. 3.9 ± 1.5 times per day, P<0.001), and shorter total duration of diabetes (4.3 ± 2.1 vs. 11.9 ± 6.4 years, P<0.001) and of CSII therapy (3.6 ± 2.1 vs. 4.7 ± 2.5 years, P<0.001). There were no significant between-group differences in patient gender or ethnicity, indications for initiating CSII, mean HbA1c level, attainment of target HbA1c, or rates of severe hypoglycemia or ketoacidosis events after CSII initiation., Conclusions: Starting pump therapy at an early disease stage has no added benefit for glycemic control over time than starting later. The timing of CSII initiation should be tailored to the individual patient by the diabetes care team.

Background: Genetic susceptibility and lifestyle are associated with glycemic control and diabetic complications in type 1 diabetes (T1D)., Objectives: To investigate metabolic control and occurrence of acute and microvascular complications among familial and sporadic T1D patients., Patients and Methods: Retrieved from our institutional registry of new T1D cases for the years 1979-2008 were 226 familial patients belonging to 121 families (58 parent-offspring, 63 sib-pairs) and 226 sporadic cases matched for age, gender, and year of diagnosis. Extracted from medical files were clinical course and therapeutic regimen., Results: Mean age at diagnosis of diabetes of the cohort was 10.8 ± 5.7 years. Throughout follow-up (11.1 ± 8.7 years) mean HbA1c values were significantly higher in familial than in sporadic cases (8.18%± 1.15% vs. 7.85%± 1.15%, p=0.005). Diabetic ketoacidosis (DKA) rates were higher in familial than sporadic cases (2.8 vs. 1.9 events per 100 patient-years; incidence rate ratio (IRR)=1.5, 95% CI [1.03, 2.22, p=0.03]). Severe hypoglycemia events per 100 patient-years were comparable in familial and sporadic groups (3.7 vs. 4.0 events); sib-pairs had higher rates than parent-offspring (4.8 vs. 2.4 events; (IRR)=2, 95% CI [1.03, 3.25, p=0.03]). The percentage of patients with microvascular complications was similar in the familial (21.7%) and sporadic (26.7%) groups. In both familial and sporadic cases the most significant predictor for metabolic control and microvascular complications was diabetes duration; a higher mean HbA1c level was the predictor for DKA events., Conclusions: The worse metabolic control and increased rate of DKA in familial T1D patients as compared to those in the sporadic T1D patients warrant intensified surveillance in this population., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Aims: This study evaluated treatment satisfaction, comfort, and function using the wireless OmniPod™ Insulin Management System (Insulet Corp., Bedford, MA) compared with conventional (infusion set) insulin pumps in young adults with type 1 diabetes., Research Design and Methods: Twenty-nine patients (age, 24.0 ± 5.1 years; diabetes duration, 12.1 ± 5.7 years; insulin pump duration, 6.4 ± 3.1 years; glycated hemoglobin [HbA1c], 8.6 ± 0.7%) participated in a randomized, two-arm open crossover study comparing two consecutive 12-week periods of continuous subcutaneous insulin infusion (CSII): one period using the OmniPod system and the other period using conventional CSII. The main outcome measures were treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), user evaluation (OmniPod System User Evaluation Questionnaire), and HbA1c levels., Results: Treatment satisfaction at baseline was high, with a mean score of 28.6±4.6 (maximal score, 36) and no significant difference between the two randomized groups. Upon completion of the study period 43% "would switch to OmniPod," 36% were "undecided," and 21% "would not switch pumps." Seventy-six percent preferred the OmniPod automated cannula insertion system, and 56% reported that OmniPod fit better into their lifestyle than conventional CSII. HbA1c levels significantly decreased with both OmniPod and conventional CSII (7.9 ± 0.9% vs. 8.8 ± 0.7% and 8.2 ± 0.9% vs. 8.5 ± 0.5%, respectively; P<0.001 for both groups) after completion of the first treatment arm. The decrease in HbA1c was more marked in the OmniPod group (P=0.044), without additional improvement at the end of the study in either group., Conclusions: The OmniPod system was well received by young adults with type 1 diabetes experienced with conventional CSII.