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AIM: There is a bidirectional relationship between glucose control of and sleep quality and timing in type 1 diabetes (T1D). The aim was to investigate the sleep quality and the glucose metrics in people with T1D at the seasonal clock adjustment. METHODS: This observational study retrospectively compared the continuous glucose monitoring (CGM) derived metrics and sleep quality observed before (Time 0) and after (Time 1) transition in autumn and before (Time 2) and after (Time 3) transition in spring. We included adults with T1D, treated with CGM systems, who completed the Pittsburgh Sleep Quality Index questionnaire. The main outcome measure was the change in glucose monitoring indicator (GMI), time in range (TIR), time above range (TAR) and time below range. RESULTS: Sixty-two participants showed no changes in sleep quality at time transitions. GMI values increased during both time transitions and the percentage of TIR decreased from Time 0 to Time 1 and from Time 2 to Time 3. The percentage of level 2 TAR increased during the observation. CONCLUSIONS: At similar level of sleep quality, adults with T1D underwent the worsening of most of CGM-derived glucose control metrics during the transition time.

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AIM: To determine the incidence and presenting features of type 1 diabetes mellitus and diabetic ketoacidosis in a paediatric population serviced by a regional health service in Queensland, Australia. METHODS: All patients less than 16 years old diagnosed with type 1 diabetes mellitus between 01 January 2015 and 31 December 2021 were included in this retrospective, observational study. The electronic medical records of each patient were reviewed to collect data on demographics, presentation and ongoing diabetes care. RESULTS: Sixty-four paediatric patients were diagnosed with type 1 diabetes mellitus during the study period, giving an incidence of 25 cases per 100 000 person years. Half the patients presented with diabetic ketoacidosis, with 14 (22% of the total cohort) presenting in severe diabetic ketoacidosis. There was no significant increase in the incidence of type 1 diabetes mellitus or proportion of patients with diabetic ketoacidosis across the years of the study. Patients that had a delayed diagnosis had an increased likelihood of presenting with severe diabetic ketoacidosis. CONCLUSION: Incidence of type 1 diabetes mellitus in the paediatric population in this regional centre in Queensland, Australia, is similar to national data. High proportions of patients presenting with diabetic ketoacidosis and severe diabetic ketoacidosis were identified in the study population, with delayed diagnosis, a risk factor for severe diabetic ketoacidosis.

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It is oftentimes the case in studies of disease progression that subjects can move into one of several disease states of interest. Multistate models are an indispensable tool to analyze data from such studies. The Environmental Determinants of Diabetes in the Young (TEDDY) is an observational study of at-risk children from birth to onset of type-1 diabetes (T1D) up through the age of 15. A joint model for simultaneous inference of multistate and multivariate nonparametric longitudinal data is proposed to analyze data and answer the research questions brought up in the study. The proposed method allows us to make statistical inferences, test hypotheses, and make predictions about future state occupation in the TEDDY study. The performance of the proposed method is evaluated by simulation studies. The proposed method is applied to the motivating example to demonstrate the capabilities of the method.

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The collapse of immune homeostasis induces type 1 diabetes (T1D). In T1D, uncontrolled immune attacks against islet ß cells reduce insulin secretion, resulting in hyperglycaemia and various complications. Type 1 regulatory (Tr1) cell therapy is a promising approach for the treatment of T1D. Tr1 cells are a subset of regulatory T (Treg) cells that are characterised by high interleukin-10 secretion and forkhead box protein P3 non-expression. Tr1 cells are reduced and have impaired function in patients with T1D. Immunotherapy is used to treat various diseases, and Treg cells have been applied to treat T1D in animal models and clinical trials. However, the safety and efficacy of Tr1 cells in treating diabetes and other diseases remain unclear. In this review, we aim to investigate the identification and biological function of Tr1 cells and related studies on immune diseases; additionally, we discuss the feasibility, limitations, and possible solutions of Tr1 cell therapy in T1D. This review shows that T1D is caused by an immune imbalance where defective Tr1 cells fail to control effector T cells, leading to the destruction of islet ß cells. However, Tr1 cell therapy is safe and effective for other immune diseases, suggesting its potential for treating T1D.

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Background: Co-occurrence of inflammatory bowel disease (IBD) and type 1 diabetes (T1D) has been linked to poor clinical outcomes, but evidence on their bidirectional associations remain scarce. This study aims to investigate their bidirectional associations. Methods: A nationwide matched cohort and case-control study with IBD patients identified between 1987 and 2017. The cohort study included 20,314 IBD patients (≤28 years; Crohn's disease [CD, n = 7277], ulcerative colitis [UC, n = 10,112], and IBD-unclassified [IBD-U, n = 2925]) and 99,200 individually matched reference individuals, with a follow-up until December 2021. The case-control study enrolled 87,001 IBD patients (no age restriction) and 431,054 matched controls. We estimated adjusted hazard ratio (aHR) of incident T1D in the cohort study with flexible parametric survival model and adjusted odds ratio (aOR) of having a prior T1D in the case-control study with conditional logistic regression model, with 95% confidence intervals (CI). Findings: During a median follow-up of 14 years, 116 IBD patients and 353 reference individuals developed T1D. Patients with IBD had a higher hazard of developing T1D (aHR = 1.58 [95% CI = 1.27-1.95]). The hazard was increased in UC (aHR = 2.02 [1.51-2.70]) but not in CD or IBD-U. In the case-control study, a total of 1018 (1.2%) IBD patients and 3496 (0.8%) controls had been previously diagnosed with T1D. IBD patients had higher odds of having prior T1D (aOR = 1.36 [1.26-1.46]). Such positive association was observed in all IBD subtypes. The sibling comparison analyses showed similar associations between IBD and T1D (aHR = 1.44 [0.97-2.15] and aOR = 1.32 [1.18-1.49]). Interpretation: Patients with IBD had a moderately increased hazard of developing T1D and higher odds of having prior T1D. Their bidirectional associations may be partially independent of shared familial factors. Funding: European Crohn's and Colitis Organisation, Stiftelsen Professor Nanna Svartz Fond, SSMF (project#: PG-23-0315-H-02), Ruth and Richard Julin Foundation; and FORTE (project#: 2016-00424).

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Type 1 diabetes is rising in the pediatric population, affecting approximately 1.2 million children and adolescents globally. Its complex pathogenesis involves the interaction between genetic predisposition and environmental factors, leading to T cell-mediated destruction of insulin-producing pancreatic beta-cells. This destruction results in insulin insufficiency and hyperglycemia. Hence, managing type 1 diabetes requires a comprehensive approach that includes various aspects such as blood glucose monitoring, insulin therapy, carbohydrate counting, caloric intake monitoring, considering family habits and food preferences, planning daily schedules, and incorporating physical activity. Children with type 1 diabetes encounter age-specific challenges in disease management that may exacerbate the risk of metabolic complications and adverse health outcomes. These risk factors may be neurological, physiological, behavioral, psychological, or social, complicate management and necessitate tailored approaches for effective care. Regardless of the age group, primary caregivers have a high responsibility to maintain optimal glycemic control, including monitoring diet, daily activity, and administering insulin. By reviewing research on the challenges faced by pediatric patients with type 1 diabetes, we summarized key insights aimed at developing targeted interventions and support systems that enhance diabetes management and improve health outcomes in this vulnerable population.

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Type 1 diabetes mellitus (T1D) is associated with cognitive impairments in humans. A well-established animal model of T1D is induced through the administration of streptozotocin (STZ), a glucose analog that induces pancreatic ß-cell death, resulting in hyperglycemia and cognitive impairment linked to neuroinflammation and oxidative stress. Tumor necrosis factor (TNF)-α, a key inflammatory mediator, is elevated in the central nervous system (CNS) of diabetic animals. In this study, we utilized TNFR1 knockout mice to investigate the role of TNFR1 signaling in short-term T1D-related cognitive impairment. Our findings showed that diabetic animals did not develop cognitive damage within the first 2 weeks of T1D but exhibited reduced exploration in all behavioral tests. Our findings suggest that this reduction in exploration was attributable to motor impairment, as there was no reduction in motivated novelty-seeking behavior. Additionally, deletion of TNFR1 signaling attenuated gait speed impairment in diabetic mice, but did not affect other motor-related or exploratory behaviors.

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BACKGROUND: Type-1 diabetes mellitus (T1DM) is one of the most dreaded chronic diseases, especially in children or youth. To help patients and their families effectively manage their disease, structured therapeutic patient education (TPE) is essential. MATERIALS AND METHOD: The purpose of this non-randomized before and after controlled study was to assess TPE program effects. In total, 200 T1DM children and adolescents, aged 8-18 years, selected from two pediatric departments, were equally assigned to the intervention and control groups. The primary endpoints were differences between groups at 3 months follow-up in measured HbA1c and health-related quality of life (QoL) assessed by a validated questionnaire. RESULTS: At 3 months follow-up of a TPE intervention for T1DM children and adolescents, although there was no significant change in HbA1c for both groups, a significant improvement was observed in the maximum pre- and postprandial blood glucose levels (r: ~0.3; variation rates: -10,47% and -3,85%, respectively) in the intervention group, whereas there was a significant increase in the maximum and minimum of preprandial blood glucose levels in the control group (r: ~0.3, variation rates: 14.29% and 25%, respectively). Global and dimensional QoL mean scores variation rates showed a significant difference between groups, with an improvement in the intervention group (r ≥ 0.7, Cohen's > 0.8) and a decrease in the control group (r ≥ 0.7). CONCLUSION: These results support the hypotheses of difference between the study groups in favor of better glycemic control and QoL for the intervention group.

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The Canary Islands inhabitants, a recently admixed population with significant North African genetic influence, has the highest incidence of childhood-onset type 1 diabetes (T1D) in Spain and one of the highest in Europe. HLA accounts for half of the genetic risk of T1D. AIMS: To characterize the classical HLA-DRB1 and HLA-DQB1 alleles in children from Gran Canaria with and without T1D. METHODS: We analyzed classic HLA-DRB1 and HLA-DQB1 alleles in childhood-onset T1D patients (n = 309) and control children without T1D (n = 222) from the island of Gran Canaria. We also analyzed the presence or absence of aspartic acid at position 57 in the HLA-DQB1 gene and arginine at position 52 in the HLA-DQA1 gene. Genotyping of classical HLA-DQB1 and HLA-DRB1 alleles was performed at two-digit resolution using Luminex technology. The chi-square test (or Fisher's exact test) and odds ratio (OR) were computed to assess differences in allele and genotype frequencies between patients and controls. Logistic regression analysis was also used. RESULTS: Mean age at diagnosis of T1D was 7.4 ± 3.6 years (46% female). Mean age of the controls was 7.6 ± 1.1 years (55% female). DRB1*03 (OR = 4.2; p = 2.13-13), DRB1*04 (OR = 6.6; p ≤ 2.00-16), DRB1* 07 (OR = 0.37; p = 9.73-06), DRB1*11 (OR = 0.17; p = 6.72-09), DRB1*12, DRB1*13 (OR = 0.38; p = 1.21-05), DRB1*14 (OR = 0.0; p = 0.0024), DRB1*15 (OR = 0.13; p = 7.78-07) and DRB1*16 (OR = 0.21; p = 0.003) exhibited significant differences in frequency between groups. Among the DQB1* alleles, DQB1*02 (OR: 2.3; p = 5.13-06), DQB1*03 (OR = 1.7; p = 1.89-03), DQB1*05 (OR = 0.64; p = 0.027) and DQB1*06 (OR = 0.19; p = 6.25-14) exhibited significant differences. A total of 58% of the studied HLA-DQB1 genes in our control population lacked aspartic acid at position 57. CONCLUSIONS: In this population, the overall distributions of the HLA-DRB1 and HLA-DQB1 alleles are similar to those in other European populations. However, the frequency of the non-Asp-57 HLA-DQB1 molecules is greater than that in other populations with a lower incidence of T1D. Based on genetic, historical and epidemiological data, we propose that a common genetic background might help explain the elevated pediatric T1D incidence in the Canary Islands, North-Africa and middle eastern countries.

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BACKGROUND: Type 1 diabetes mellitus (T1D) is an autoimmune disease caused by destruction of pancreatic islet beta-cells. There is significant residual beta-cell function, measured through circulating C-peptide, present at the time of T1D diagnosis but this subsequently decreases with time. Higher residual beta-cell function at diagnosis associates with better glycaemic control and less glucose variability, and later in the disease course with less hypoglycaemia, lower glucose variability and fewer microvascular complications. There is therefore value in preserving residual beta cell function in new onset T1D Immunotherapeutic agents can protect residual beta-cell function in type 1 diabetes. However, clinical trials of such agents, whilst demonstrating C-peptide preservation in short term studies, have yet to be taken forward into routine clinical care due to concerns around safety and long-term efficacy. Here we report the case of a gentleman with newly diagnosed T1D whose glycaemic control and insulin requirement improved whilst on a five year infusion programme of infliximab, a monoclonal antibody against TNF-alpha, for colitis. CASE PRESENTATION: A 52-year-old White Caucasian man was diagnosed with T1D in August 2018. Glucose was 25.6 mmol/L, HbA1c was 98mmol/mol and GAD antibodies were strongly positive. HbA1c marginally improved to 91mmol/mol following initiation of insulin detemir 5 units at night and 1:10 g of insulin aspart (November 2018). In June 2019, he developed rectal bleeding and abdominal pain. Following colonoscopy, he was diagnosed with "indeterminate colitis" and commenced on 6-weekly infusions of 400-450 mg infliximab. Thus far, he has received 32 doses and achieved colitis remission. Following infliximab initiation there was increased frequency of mild-moderate hypoglycaemia and he was gradually weaned off and discontinued detemir in June 2020. Since then, HbA1c improved from 57mmol/mol in August 2019 to 52mmol/mol in April 2022, remaining stable at 51mmol/mol. His most recent HbA1c is 54mmol/mol in February 2024. His c-peptide was 550pmol/L in October 2022 and 442pmol/L in February 2024, suggesting well-preserved beta-cell function almost 6 years post-diagnosis. CONCLUSIONS: Our patient's improvement in glycaemic control can be explained by immunomodulation and C peptide preservation from infliximab. With the growing focus on type 1 diabetes disease modulation and working towards an 'insulin free T1D', our findings strengthen the evidence base for the repurposing of and long-term treatment with anti-TNF-α agents to preserve beta-cell function in new onset T1D.

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BACKGROUND: The prevalence of type 1 diabetes (T1D) is increasing worldwide, with a much higher proportion of adult patients. However, achieving stable glycemic control is difficult in these patients. OBJECTIVE: After periodic implementation of structured education for patients with T1D through the Home and Self-Care Program, a pilot home health care project promoted by the Korean government, we evaluated the program's effects on glycemic control. METHODS: This study was conducted from April 2020 to March 2023. We analyzed 119 participants with T1D aged >15 years. Nursing and nutrition education were provided separately up to 4 times per year, with physician consultation up to 6 times per year. A distinguishing feature of this study compared with previous ones was the provision of remote support using a general-purpose smartphone communication app offered up to 12 times annually on an as-needed basis to enhance the continuity of in-person education effects. Patients were followed up on at average intervals of 3 months for up to 24 months. The primary end point was the mean difference in glycated hemoglobin (HbA1c) at each follow-up visit from baseline. For continuous glucose monitoring (CGM) users, CGM metrics were also evaluated. RESULTS: The mean HbA1c level of study participants was 8.6% at baseline (mean duration of T1D 10.02, SD 16.10 y). The HbA1c level reduction in participants who received at least 1 structured educational session went from 1.63% (SD 2.03%; P<.001; adjustment model=1.69%, 95% CI 1.24%-2.13% at the first follow-up visit) to 1.23% (SD 1.31%; P=.01; adjustment model=1.28%, 95% CI 0.78%-1.79% at the eighth follow-up visit). In the adjustment model, the actual mean HbA1c values were maintained between a minimum of 7.33% (95% CI 7.20%-7.46% at the first follow-up visit) and a maximum of 7.62% (95% CI 7.41%-7.82% at the sixth follow-up visit). Among CGM users, after at least 1 session, the mean time in the target range was maintained between 61.59% (adjusted model, 95% CI 58.14%-65.03% at the second follow-up visit) and 54.7% (95% CI 50.92%-58.48% at the eighth follow-up visit), consistently staying above 54.7% (corresponding to an HbA1c level of <7.6%). The mean time below the target range (TBR) also gradually improved to the recommended range (≤4% for TBR of <70 mg/dL and ≤1% for TBR of <54 mg/dL). CONCLUSIONS: The Home and Self-Care Program protocol for glycemic control in patients with T1D is effective, producing significant improvement immediately and long-term maintenance effects, including on CGM indexes.

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Childhood-onset type 1 diabetes (T1D) is associated with substantial psychiatric morbidity in later life, but it remains unknown whether these associations are due to common underlying biological mechanisms or the impacts of living with the condition and its treatment. Here, using Czech national register data, we identified children with T1D aged ≤14 years between 1994 and 2007 and estimated the risk of psychiatric disorders up to 24 years later. We found that children diagnosed with T1D had an elevated risk of developing substance use, mood, anxiety and personality disorders, and behavioral syndromes. Conversely, we found that children with T1D had a lower risk of developing psychotic disorders. In Mendelian randomization analysis, we found an association with schizophrenia, which, however, did not persist following multiple testing adjustment. The combined observational and Mendelian randomization evidence suggests that T1D diagnosis in childhood predisposes to far-reaching, extensive psychiatric morbidity, which is unlikely to be explicable by common underlying biological mechanisms. The findings of this study highlight that monitoring and addressing the mental health needs of children with T1D is imperative, whereas glucose dysregulation and/or inflammation implicated in schizophrenia pathogenesis warrants future research.

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OBJECTIVE: Diabetic kidney disease (DKD) is influenced by multiple factors, yet its precise progression mechanisms remain largely unclear. This study aimed to create a clinical risk-scoring system based on genetic polymorphisms in the AFF3, CARS, CERS2, ERBB4, GLRA3, RAET1L, TMPO, and ZMIZ1 genes. METHODS: The study included a DKD group diagnosed with diabetic kidney disease before age 18 and a WDC group matched by age, gender, and age at diabetes diagnosis. Genetic data and clinical data from diabetes diagnosis to moderately increased albuminuria (MIA) detection were compared between the groups. RESULTS: Among 43 DKD cases, 22 were girls and 21 were boys. At MIA diagnosis, mean body weight SDS was -0.24 ± 0.94, height SDS was 0.34 ± 1.15, and BMI SDS was -0.26 ± 0.94. Systolic blood pressure was at the 72nd percentile (2-99), and diastolic blood pressure was at the 74th percentile (33-99). Significant differences in rs267734, rs267738, and rs942263 polymorphisms were found between DKD and non-complication diabetic groups (13[30.2 %] vs 5[11.6 %], p = 0.034; 14[32.6 %] vs 5[11.6 %], p = 0.019; 26[60.5 %] vs 40[93 %], p < 0.001). CONCLUSION: Several factors were identified as significant in DKD onset, including low follow-up weight SDS, elevated diastolic blood pressure, presence of rs267734, and absence of rs942263 polymorphisms. The model demonstrated a specificity of 81.4 % and a sensitivity of 74.4 %.

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AIMS: To examine the association of daily PA levels and sedentary behaviour with body composition, estimated insulin sensitivity, and arterial stiffness in adults with type 1 diabetes (T1D). METHODS: Cross-sectional study in adults with T1D (n = 54). PA levels (daily steps, and time in moderate-to-vigorous intensity PA (MVPA)) and sedentary behaviour were measured using accelerometry for 7 days (McRoberts® DynaPort MoveMonitor). Cardiopulmonary exercise test for VO2max. Anthropometrics were collected, and body composition (total and % of fat mass (FMtot, FM%), total and % of lean mass (LMtot, LM%), and estimated visceral adipose tissue (VAT)) volume was assessed with dual energy X-ray-absorptiometry (DXA). Estimates of insulin sensitivity were determined (estimated glucose disposal rate (eGDR) and total daily insulin dose). Arterial stiffness was assessed with carotid-femoral pulse wave velocity (cf-PWV (m/s); SphygmoCor®). RESULTS: Lower 10-years HbA1c associated moderately with all PA measures. Favourable moderate associations were also found between PA measures and BMI, waist, VAT but not FM and LM. PA measures were favourably associated with a lower total daily insulin dose and higher eGDR. All PA parameters associated moderately with cf-PWV however not independent from traditional risk factors. VO2max inversely associated with cf-PWV independent of age, T1D duration and 24-hour mean blood pressure. CONCLUSIONS: Higher levels of PA, lower sedentary behaviour and greater exercise capacity are favourably associated with long-term glycaemic control, body composition, insulin dosage, estimated insulin sensitivity and arterial stiffness in adults with T1D. Therefore, regular PA and limiting sedentary time should be encouraged to improve metabolic and cardiovascular health in this population. Future longitudinal studies should explore mutual interactions and synergistic effects of PA on these outcomes.

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AIMS: We investigated whether a short period of tightly controlled low-carbohydrate diet (LCD) leads to higher time in range without increasing the associated risks in children and young people with diabetes (CYPwD). METHODS: Thirty-five (CYPwD) were recruited into this randomized controlled cross-over study (20 female; 20 CSII; age 14.5 ± 2.9 years; HbA1c 48.9 ± 9.4 mmol/mol). The interventions were five and five weeks of ready-made food box deliveries of isocaloric diets in random order: either LCD (94.5 ± 4.7 g/day) or recommended carbohydrate diet (RCD) (191 ± 19.2 g/day). The outcomes were continuous glucose monitoring parameters, anthropometric, laboratory and quality of life (QoL) data. RESULTS: Time in range was significantly higher in the LCD than in the RCD period (77.1 % vs. 73.8 %, P=0.008). Times in hyperglycemia and average glycaemia were significantly lower in the LCD. There was no difference between the diets in time in hypoglycemia or glycemic variability. The subjects' body weight and BMI were significantly lower during the LCD. There was no significant difference in the LDL-cholesterol levels. No significant differences were observed in the self-assessed QoL. CONCLUSIONS: Short-term LCD led to an improvement of glycemic parameters without increasing time in hypoglycemia, disturbing the lipid profile or negatively affecting the quality of life of CYPwD.

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BACKGROUND: Collaboration between parents and school nurses is important for effective healthcare in schools. This study focuses on the competency of school nurses, which encompasses their knowledge and self-efficacy in diabetes care, and investigates how these factors, along with workload, influence healthcare partnerships in schools. However, it is unknown whether school nurses' knowledge and self-efficacy about diabetes care, as well as their workload, affect school healthcare partnerships concerning children with type 1 diabetes. AIM: This study aimed to investigate the impact of school nurses' self-efficacy, knowledge, attitude, and role overload on healthcare partnerships with parents of children with type 1 diabetes in schools. DESIGN: A cross-sectional, descriptive design. SETTING AND PARTICIPANTS: Between December 2023 and January 2024 in South Korea, 142 elementary- and middle-school nurses participated in this study. METHODS: School healthcare partnership, self-efficacy in diabetes education, knowledge of and attitude toward school healthcare for type 1 diabetes, and the role-overload scale were utilized in the analysis. Data were analyzed using multiple regression. RESULTS: Knowledge of school healthcare (ß = 0.34, p < .001) and attitude toward it (ß = 0.29 p = .001) for type 1 diabetes, as well as the grade level of the current employing school (ß = -0.15, p = .039) were predictors of school healthcare partnerships. These three variables explained 30.3 % of the total variance in school healthcare partnerships (F = 21.44, p < .001). CONCLUSIONS: Knowledge of school healthcare and attitudes toward it for type 1 diabetes were identified as factors in school nurses' school healthcare partnerships. Therefore, interventions to strengthen school nurses' competencies should be developed to improve school healthcare partnerships.

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BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare but life-threatening skin lesion triggered by hypersensitive drug reaction. They are characterized by extensive epidermal necrosis and skin exfoliation. Fulminant type 1 diabetes mellitus (FT1DM) is featured by a rapid-onset of hyperglycemia with ketoacidosis due to severely destroyed ß-cell function. Fulminant type 1 diabetes mellitus as a sequela of SJS/TEN has rarely been reported. CASE PRESENTATION: We present a 73-year-old female patient who developed SJS/TEN skin allergic reaction after taking carbamazepine and phenytoin for 35 days. Then, hyperglycemia and diabetic ketoacidosis occurred 20 days after discontinuation of antiepileptic drugs. A very low serum C-peptide level (8.79 pmol/l) and a near-normal glycosylated hemoglobin level met the diagnostic criteria for fulminant T1DM. Intravenous immunoglobulin (IVIG) and insulin were promptly administered, and the patient recovered finally. CONCLUSIONS: This rare case indicates that monitoring blood glucose is necessary in SJS/TEN drug reaction, and comprehensive therapy with rehydration, insulin, antibiotics, and IVIG may improve the prognosis.

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AIMS: This study aimed to investigate whether the response to adding metformin to insulin in young adults with type 1 diabetes (T1D) differs according to weight phenotype and insulin sensitivity index. METHODS: A prospective pilot study was conducted over 26 weeks in which insulin plus metformin (2 g/day) was administered to 35 individuals, ranging from normal weight (NW) to overweight (OW) to obese (OB) T1D individuals, to correlate insulin sensitivity indices and other clinical variables. RESULTS: At the end of the follow-up period, all groups showed an increase in the eGDR (NW: 7.37 vs 8.16, p = 0.002; OW: 7.28 vs 8.24, p < 0.001; OB: 6.33 vs 7.52 p < 0.001). KITT and SEARCH SCORE improved only in the OB group (2.15 vs 3.14, p < 0.001 and 5.26 vs 5.72, p = 0.007, respectively). Furthermore, HbA1c and BMI were significantly greater in the OB group (- 0.62%, p < 0.001; - 1.12 kg/m2, p = 0.031, respectively). Regression analysis revealed that the serum levels of triglycerides and uric acid were significantly (0.059, p = 0.013; 0.076, p = 0.001) associated with insulin sensitivity indices. CONCLUSIONS: The study showed that eGDR improved independently of basal weight after metformin treatment. However, the KITT and SEARCH indices improved only in the obese group. Triglycerides and uric acid are associated with insulin sensitivity indices. These results highlight the heterogeneity of the mechanisms underlying insulin resistance and its response to metformin in individuals with T1D.

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Aim: There is an ongoing search for novel biomarkers of diabetes. We conducted a systematic review and meta-analysis of the serum concentrations of ischemia-modified albumin (IMA), a candidate biomarker of oxidative stress, acidosis, and ischemia, in patients with pre-diabetes, different types of diabetes mellitus (type 1, T1DM, type 2, T2DM, and gestational, GDM), and healthy controls. Methods: We searched for case-control studies published in PubMed, Web of Science, and Scopus from inception to December 31, 2023. The risk of bias and the certainty of evidence were assessed using the Joanna Briggs Institute Critical Appraisal Checklist and GRADE, respectively. Results: In 29 studies, T2DM patients had significantly higher IMA concentrations when compared to controls (standard mean difference, SMD = 1.83, 95 % CI 1.46 to 2.21, p˂0.001; I2 = 95.7 %, p < 0.001; low certainty of evidence). Significant associations were observed between the SMD and glycated hemoglobin (p = 0.007), creatinine (p = 0.003), triglycerides (p = 0.029), and the presence of diabetes complications (p = 0.003). Similar trends, albeit in a smaller number of studies, were observed in T1DM (two studies; SMD = 1.59, 95 % CI -0.09 to 3.26, p˂0.063; I2 = 95.8 %, p < 0.001), GDM (three studies; SMD = 3.41, 95 % CI 1.14 to 5.67, p = 0.003; I2 = 97.0 %, p < 0.001) and pre-diabetes (three studies; SMD = 15.25, 95 % CI 9.86 to 20.65, p˂0.001; I2 = 99.3 %, p < 0.001). Conclusion: Our study suggests that IMA is a promising biomarker for determining the presence of oxidative stress, acidosis, and ischemia in pre-diabetes and T1DM, T2DM, and GDM. However, the utility of measuring circulating IMA warrants confirmation in prospective studies investigating clinical endpoints in pre-diabetes and in different types of diabetes (PROSPERO registration number: CRD42024504690).