Neutrophil-to-Lymphocyte Ratio as a Potential Biomarker to Managing Type 2 Diabetes Mellitus and Predicting Disease Progression.

Introduction Diabetes is a chronic disease that causes dysregulation of blood glucose. Type 2 diabetes mellitus (T2DM) could result in long-term inflammatory conditions that affect different organs of the body. Despite the availability of diagnostic markers like glycated hemoglobin (HbA1c) for T2DM, it is essential to find an appropriate marker that could predict long-term complications. This study evaluates the potential role of neutrophil-to-lymphocyte ratio (NLR) in predicting disease progression and treatment responses.  Methods This case-control study was carried out among 160 T2DM patients and 132 non-diabetic persons. Blood samples were collected from each participant and were processed for hemoglobin, HbA1c, iron, ferritin, and complete blood picture (NLR).  Results The study showed that there was a significant variation in the serum levels of ferritin (264.8±611.6 ng/ml versus 168.3±364.7 ng/ml, p=0.392), iron (4.095±8.851 mcg/dl versus 55.20±37.62 mcg/dl, p=0.0111), and HbA1c (8.169±1.635% versus 5.668±0.5260% p<0.0001) among T2DM patients compared to non-diabetic persons. The NLR values (4.189±4.154 versus 4.095±8.851, p=0.009) among patients with T2DM significantly varied with that of non-diabetic persons. A significant negative correlation was noticed between the serum levels of iron and NLR (r=-0.17, p=0.014) and a positive correlation was noticed between HbA1c and NLR (r=0.19, p=0.014). The serum levels of iron revealed a significant positive correlation with the serum levels of ferritin (r=0.24, p=0.002) and hemoglobin percentage (r=0.41, p=0.008). HbA1c revealed a significant positive correlation with NLR (r=0.19, p=0.014). Additionally, a significant negative correlation was observed between iron with NLR (r=-0.17, p=0.029) and hemoglobin percentage with NLR (r=-0.30, p=0.005). However, no such correlation was demonstrated among non-diabetic persons. With an accuracy of 89.85% and high sensitivity and specificity, NLR showed diagnostic accuracy like HbA1c.  Conclusions NLR demonstrated equivalent efficacy to HbA1c in predicting glycemic control. Since diabetes affects different organs of the body, evaluating NLR probably predicts inflammation. Therefore, NLR could be useful in the management of T2DM and in predicting long-term complications.

Risk of Thyroid Cancer in People With Type 1 Diabetes by Autoimmune Thyroid Diseases and Tumor Histology.

Context: Thyroid cancer is the most common endocrine cancer, but little is known about it in type 1 diabetes (T1D) and its potential association with autoimmune diseases. Objective: This study aims to assess the risk of thyroid cancer in adults with long-term T1D compared to individuals without diabetes and the proposed association of thyroid autoimmune diseases with thyroid cancer. Methods: The study included 4758 individuals with T1D participating in the Finnish Diabetic Nephropathy Study and 12 710 controls. Thyroid cancers were obtained from the Finnish Care Registers for Health Care. Results: 27 (0.57%) individuals with T1D had thyroid cancer compared to 27 (0.21%) in the controls (standardized incidence ratio 2.43; 95% confidence interval 1.59-3.56). The absolute increase in incidence was modest, with a 0.36%-unit rise. This translates to 17 additional cases among 4710 individuals with T1D. Cancer type was papillary in 81.5% of individuals with T1D and 88.9% of the controls; the rest were follicular. In T1D the distribution of hypothyreosis was similar between those with (n = 5, 18.5%) and without (18.1%) cancer, but hyperthyreosis was diagnosed more often with thyroid cancer (n = 3, 11.1%) than without (2.3%, P = .003). None of the thyroid cancers were invasive or had metastatic characteristics. Conclusion: Although there is an excess risk of thyroid cancer, it is only marginally increased (0.36%-unit) in individuals with T1D compared to control individuals and was not associated with increased morbidity or mortality. An overdiagnosis effect due to regular health care contacts is the most likely explanation for the higher risk.

Blood glucose monitoring devices for type 1 diabetes: a journey from the food and drug administration approval to market availability.

Blood glucose monitoring constitutes a pivotal element in the clinical management of Type 1 diabetes (T1D), a globally escalating metabolic disorder. Continuous glucose monitoring (CGM) devices have demonstrated efficacy in optimizing glycemic control, mitigating adverse health outcomes, and augmenting the overall quality of life for individuals afflicted with T1D. Recent progress in the field encompasses the refinement of electrochemical sensors, which enhances the effectiveness of blood glucose monitoring. This progress empowers patients to assume greater control over their health, alleviating the burdens associated with their condition, and contributing to the overall alleviation of the healthcare system. The introduction of novel medical devices, whether derived from existing prototypes or originating as innovative creations, necessitates adherence to a rigorous approval process regulated by the Food and Drug Administration (FDA). Diverse device classifications, stratified by their associated risks, dictate distinct approval pathways, each characterized by varying timelines. This review underscores recent advancements in blood glucose monitoring devices primarily based on electrochemical sensors and elucidates their regulatory journey towards FDA approval. The advent of innovative, non-invasive blood glucose monitoring devices holds promise for maintaining stringent glycemic control, thereby preventing T1D-associated comorbidities, and extending the life expectancy of affected individuals.

Telemedicine care coordination and visit frequency in pediatric patients with type 1 diabetes in Oregon.

Introduction: Children with type 1 diabetes require close monitoring with visits every 3-4 months. COVID-19-induced telemedicine expansion may alleviate the challenge of high visit frequency that children with type 1 diabetes face. However, telemedicine's impact on access to care may be limited if patients lack adequate support for telemedicine. The purpose of this study was to evaluate the impact of telemedicine care coordination services on visit frequency in an urban medical center without care coordination services versus a rural outreach program with established care coordination services serviced by the same providers. Methods: We evaluated EHR data from 790 children receiving care between July 2018 and December 2021 at a single academic center in Oregon. We estimated differences in likelihood of adequately timed monitoring care over time by patient care coordination services status using Generalized Estimating Equations. Results: Just prior to telemedicine expansion, patients receiving care coordination services were 25.6 % less likely to receive adequately timed monitoring care (95 % CI: 51.6 %, 114 %). Following telemedicine expansion, likelihood of adequately timed monitoring care increased from 28.8 % to 58.2 % among those receiving care coordination services and decreased from 38.7 % to 22.0 % among those not receiving care coordination services; increases in adequately timed monitoring care were 3.55 times greater in patients receiving care coordination services relative to those not (95 % CI: 2.10, 6.01). Discussion: For pediatric patients with type 1 diabetes, telemedicine care coordination may be an important factor for increasing visit adherence and may increase the number of patients meeting goal visit frequency beyond levels seen prior to widespread telemedicine availability.

Brain functional and structural changes in diabetic children. How can intellectual development be optimized in type 1 diabetes?

The neuropsychological functioning of people with type 1 diabetes (T1D) is of key importance to the effectiveness of the therapy, which, in its complexity, requires a great deal of knowledge, attention, and commitment. Intellectual limitations make it difficult to achieve the optimal metabolic balance, and a lack of this alignment can contribute to the further deterioration of cognitive functions. The aim of this study was to provide a narrative review of the current state of knowledge regarding the influence of diabetes on brain structure and functions during childhood and also to present possible actions to optimize intellectual development in children with T1D. Scopus, PubMed, and Web of Science databases were searched for relevant literature using selected keywords. The results were summarized using a narrative synthesis. Disturbances in glucose metabolism during childhood may have a lasting negative effect on the development of the brain and related cognitive functions. To optimize intellectual development in children with diabetes, it is essential to prevent disorders of the central nervous system by maintaining peri-normal glycemic levels. Based on the performed literature review, it seems necessary to take additional actions, including repeated neuropsychological evaluation with early detection of any cognitive dysfunctions, followed by the development of individual management strategies and the training of appropriate skills, together with complex, multidirectional environmental support.

Intellectual development in children with type 1 diabetes Disturbances in glucose metabolism during childhood may have a lasting negative effect on the development of the brain and related cognitive functions. To optimize intellectual development in children with type 1 diabetes, it is essential to prevent disorders of the central nervous system by maintaining close to normal glycemic levels. Based on the performed literature review, it seems necessary to take additional actions, including repeated neuropsychological evaluation with early detection of cognitive dysfunctions, followed by the development of individual management strategies, and the training of appropriate skills, together with complex, multidirectional environmental support.

Risk factors associated with cognitive performance and cognitive impairment in older adults with type 1 diabetes: Data from the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) study.

BACKGROUND: Adults with type 1 diabetes (T1D) are considered at increased risk for cognitive impairment and accelerated brain aging. However, longitudinal data on cognitive impairment and dementia in this population are scarce. OBJECTIVE: To identify risk factors associated with cognitive performance and cognitive impairment in a longitudinal sample of older adults with T1D. METHODS: We analyzed data collected as part of the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) Study, in which 22 endocrinology practices participated. Randomized participants with T1D ≥60 years of age who completed at least one cognitive assessment were included in this study (n = 203). Cognitive impairment was classified using published recommendations. RESULTS: Older age, male sex, non-private health insurance, worse daily functioning, diagnosis of neuropathy, and longer duration of diabetes were associated with worse cognitive performance, but not cognitive impairment. 49 % and 39 % of the sample met criteria for cognitive impairment at baseline and 52 weeks respectively. Of the participants that had data at both time points, 10 % were normal at baseline and impaired at 52 weeks and 22 % of participants (44 % of those classified with cognitive impairment at baseline) reverted to normal over 52 weeks. CONCLUSION: This study indicated that several demographic and clinical characteristics are associated with worse cognitive performance in older adults with T1D, but there were no associations between these characteristics and cognitive impairment defined by NIH Toolbox cognitive impairment criteria. Caution is warranted when assessing cognition in older adults with T1D, as a large percentage of those identified as having cognitive impairment at baseline reverted to normal after 52 weeks. There is need for future studies on the interrelationship of cognition and aging to better understand the effects of T1D on cognitive health, to improve clinical monitoring and help mitigate the risk of dementia in this population.

Comparative Effectiveness of Hybrid Closed-Loop Automated Insulin Delivery Systems Among Patients with Type 1 Diabetes.

BACKGROUND: Clinical trials have demonstrated the efficacy and safety of hybrid closed-loop (HCL) systems, yet few studies have compared outcomes in the real-world setting. METHOD: This retrospective study analyzed patients from an academic endocrinology practice between January 1, 2018, and November 18, 2022. The inclusion criteria were diagnosis code for type I diabetes (T1D), >18 years of age, new to any HCL system [Medtronic 670G/770G (MT), Tandem Control IQ (CIQ), or Omnipod 5 (OP5)], and availability of a pump download within three months. The outcomes included %time in range (TIR) of 70 to 180 mg/dL, %time below range (TBR) <70 mg/dL at 90 days, and HbA1c for 91 to 180 days. RESULT: Of the 176 participants, 47 were MT, 74 CIQ, and 55 OP5. Median (25%, 75%) change in HbA1c was -0.1 (-0.8, 0.3), -0.6 (-1.1, -0.15), and -0.55 (-0.98, 0)% for MT, CIQ, and OP5, respectively, (P = .04). TIR was 70 (57, 76), 67 (59, 75), and 68 (60, 76)% (P = .95) at 90 days while TBR was 2 (1, 3), 1 (0, 2), and 1 (0, 1)%, respectively, (P = .002). The %time in automated delivery was associated with TIR and change in HbA1c. After controlling other factors including %time in automated delivery, HCL type was not an independent predictor of change in HbA1c nor TIR but remained a significant predictor of TBR. CONCLUSION: There were significant reductions in HbA1c in CIQ and OP5. TIR was similar across pumps, but TBR was highest with MT. The %time in automated delivery likely explains differences in change in HbA1c but not TBR between HCL systems.

Supplementation of High-Strength Oral Probiotics Improves Immune Regulation and Preserves Beta Cells among Children with New-Onset Type 1 Diabetes Mellitus: A Randomised, Double-Blind Placebo Control Trial.

OBJECTIVES: To investigate the mechanism of glycemic control in children with type 1 diabetes (T1D) following high-strength probiotics supplementation by assessing immune-regulatory markers. METHODS: In this single-centre randomised double-blinded placebo-controlled study, children with new-onset T1D on regular insulin therapy were randomised into probiotic or placebo groups with 30 children each. The probiotics group received oral powder of Vivomixx®, and the placebo group received corn starch for six months. The primary outcome parameters included induced T regulatory cells (i-Tregs) percentage, insulin autoantibodies (IAA), insulinoma associated 2 autoantibodies (IA2), glutamic acid decarboxylase autoantibodies (GAD 65) and plasma interleukin-10 (IL-10) levels. The secondary outcome variables were changes in plasma C-peptide levels and glycemic control parameters. RESULTS: Twenty-three children in the placebo group and 27 in the probiotic group completed the study. There was a significant increase in the percentage of iTregs (3.40 in the probiotic vs. 2.46 in the placebo group; p = 0.034). Median glycated hemoglobin (HbA1c) levels significantly decreased from 68 mmol/mol (8.35%) in the placebo group to 60 mmol/mol (7.55%) in the probiotic group (p = 0.017). Median C-peptide levels were significantly higher in probiotics (0.72 ng/ml) vs. placebo group (0.11 ng/ml) (p = 0.036). The plasma IL-10 levels significantly increased in the probiotic group after six months of treatment (p = 0.002). CONCLUSIONS: The high-strength probiotics improved the immunoregulatory milieu, thereby preserving the beta-cell function and better glycemic control.

Short, frequent, light-intensity walking activity improves postprandial vascular-inflammatory biomarkers in people with type 1 diabetes: The SIT-LESS randomized controlled trial.

AIM: To examine the effect of interrupting prolonged sitting with short, frequent, light-intensity activity on postprandial cardiovascular markers in people with type 1 diabetes (T1D). MATERIALS AND METHODS: In a randomized crossover trial, 32 adults with T1D (mean ± SD age 28 ± 5 years, glycated haemoglobin 67.9 ± 12.6 mmol/mol, 17 women) completed two 7-h laboratory visits separated by >7 days. Participants either remained seated for 7 h (SIT) or interrupted sitting with 3-min bouts of self-paced walking at 30-min intervals commencing 1 h after each meal (SIT-LESS). Physical activity, insulin regimen, experimental start times, and meal consumption were standardized during each arm. Plasma levels of interleukin (IL)-1ß, tumour necrosis factor (TNF)-α, plasminogen activator inhibitor (PAI)-1 and fibrinogen were sampled at baseline, 3.5 and 7 h, and assessed for within- and between-group effects using a repeated measures ANOVA. The estimated glucose disposal rate was used to determine the insulin resistance status. RESULTS: Vascular-inflammatory parameters were comparable between SIT and SIT-LESS at baseline (p > .05). TNF-α, IL-1ß, PAI-1 and fibrinogen increased over time under SIT, whereas these rises were attenuated under SIT-LESS (p < .001). Specifically, over the 7 h under SIT, postprandial increases were detected in TNF-α, IL-1ß, PAI-1 and fibrinogen (+67%, +49%, +49% and +62%, respectively; p < .001 for all). Conversely, the SIT-LESS group showed no change in IL-1ß (-9%; p > .50), whereas reductions were observed in TNF-α, PAI-1 and fibrinogen (-22%, -42% and -44%, respectively; p < .001 for all). The intervention showed enhanced effects in insulin-resistant individuals with T1D. CONCLUSIONS: Interrupting prolonged sitting with light-intensity activity ameliorates postprandial increases in vascular-inflammatory markers in T1D. TRIAL REGISTRATION: The trial was prospectively registered (ISRCTN13641847).

Prevalence of Metabolic Syndrome and Its Risk Factors Influence on Microvascular Complications in Patients With Type 1 and Type 2 Diabetes Mellitus.

BACKGROUND: Diabetes mellitus (DM) long-term macrovascular and microvascular complications pose significant health risks and increase mortality. In DM patients, metabolic syndrome (MetSy) either precedes or coexists with the condition. Central obesity, poor glycemic control, hypertension, elevated triglycerides (TG), and low high-density lipoproteins (HDL-C) are the components of MetSy. The purpose of this study is to investigate related diabetic microvascular complications in type 1 DM (T1DM) by comparing them with type 2 DM (T2DM), determine potential risk factors, and estimate prevalence based on the diagnosis of MetSy. METHODOLOGY: This study included 160 T1DM and 160 T2DM patients, totaling 320 DM patients. It was carried out from April 20, 2022, to September 31, 2023, at the Sheikh Zayed Hospital, Rahim Yar Khan, in the Outdoor Diabetic Clinic and Medicine Department. A unique questionnaire was utilized to gather socio-demographic, general, clinical, and laboratory data for the MetSy criteria set forth by the International Diabetes Federation (IDF). The blood pressure, BMI, and waist circumference (WC) were measured, while venous fasting blood was used to assess biochemical markers such as HDL-C, TG, and fasting blood sugar. The microvascular diabetes complications were identified using abdominal ultrasound, fundus ophthalmoscopy, and routine laboratory tests. We quantified and analyzed these variables individually for T1DM and T2DM patients with or without MetSy and compared them in the presence or absence of diabetes microvascular complications. RESULTS: MetSy prevalence was 25.62% (41, n=160) for T1DM and 60.62% (97, n=160) for T2DM, totaling 43.12%. Among T1DM patients with MetSy, the majority were married males, aged 36-49 years, with a BMI of 26.69±2.20 kg/m2 and a WC of 85.12±4.23, and 67.5% (108) patients had diabetes microvascular complications. Comparatively, in T2DM with MetSy, the majority were married females aged 50-59 years with a BMI of 29.79 ± 4.65 kg/m² and a large WC of 93.43±4.49, and 75% (123) patients had diabetes microvascular complications. Overall, this study noted significant p-values for hypertension, elevated TG, low HDL-c, high WC, obesity, female gender in T2DM, and above 36 years of age in both groups with MetSy. Diabetic retinopathy (DR) at 32.4% (p<0.001) was the most prevalent T1DM microvascular complication, followed by nephropathy (30.6%), neuropathy (DN) at 28.1%, and gastroparesis (DG) at 22.3%. Whereas in T2DM, the prevalence of DN was 36.3% (p<0.001), followed by DKD (29.3%), DG (28.9%), and DR (24.9%). CONCLUSION: Nearly a quarter of T1DM patients had MetSy, with increasing percentages of overweight and obese patients who are more likely to have DR, DKD, or DN. MetSy affects two-thirds of T2DM patients, with married obese females aged 50-59 being more susceptible than males, who are more likely to suffer DN, DKD, or DG. Risk factors that contribute to the MetSy burden in T1DM and T2DM include hypertension, poor glycemic management, low HDL-C, high TG, and a higher BMI or WC. Increasing age, female gender in T2DM, longer diabetes duration, and co-morbid hypertension were independent predictors of microvascular complications. DR, DN, DKD, and gastroparesis are the most prevalent diabetic microvascular sequelae. The clinical management of diabetic patients with healthy lifestyle adaptations, good glycemic control, antihypertensives, and statins will contribute greatly to MetSy prevention.

Incidence of menstrual cycle abnormalities and polycystic ovary syndrome in female Japanese patients with type 1 diabetes mellitus. The role of androgens.

Type 1 diabetes mellitus (T1DM) adversely affects gonadal function. This study aimed to define the characteristics and factors associated with menstrual cycle abnormalities and polycystic ovary syndrome (PCOS) in Japanese patients with T1DM. Our study enrolled 157 patients, including 55 with oligomenorrhea (prolonged menstrual cycle) and 102 without oligomenorrhea. LH/FSH ratio (p = 0.04) and total testosterone levels (p = 0.03) were significantly higher in the oligomenorrhea group than in the non-oligomenorrhea group. No significant differences were found between the two groups regarding age at menarche, age at T1DM diagnosis, treatment, glycated hemoglobin, or total daily insulin dose. Of the 55 patients in the oligomenorrhea group, 27 were diagnosed with PCOS based on the Rotterdam criteria. We concluded that female patients with T1DM, as well as abnormal menstrual cycles and hyperandrogenism, may suffer from undiagnosed PCOS and should be referred to a gynecologist for full assessment, diagnosis, and treatment.

Household food insecurity and associations with hemoglobin A1c and acute diabetes-related complications in youth and young adults with type 1 diabetes: The SEARCH for diabetes in youth study.

AIMS: To examine, among youth and young adults (YYA) with type 1 diabetes (T1D), the association of household food insecurity (HFI) with: 1) HbA1c and 2) episodes of diabetic ketoacidosis (DKA) and severe hypoglycemia. METHODS: HFI was assessed using the U.S. Household Food Security Survey Module in SEARCH for Diabetes in Youth participants with T1D between 2016 and 2019. Linear and logistic regression models adjusted for age, diabetes duration, sex, race, ethnicity, clinic site, parent/participant education, household income, health insurance, and diabetes technology use. RESULTS: Of 1830 participants (mean age 20.8 ±â€¯5.0 years, 70.0 % non-Hispanic White), HbA1c was collected for 1060 individuals (mean HbA1c 9.2 % ± 2.0 %). The prevalence of HFI was 16.4 %. In the past 12 months, 18.2 % and 9.9 % reported an episode of DKA or severe hypoglycemia, respectively. Compared to participants who were food secure, HFI was associated with a 0.33 % (95 % CI 0.003, 0.657) higher HbA1c level. Those with HFI had 1.58 (95 % CI 1.13, 2.21) times the adjusted odds of an episode of DKA and 1.53 (95 % CI 0.99, 2.37) times the adjusted odds of an episode of severe hypoglycemia as those without HFI. CONCLUSIONS: HFI is associated with higher HbA1c levels and increased odds of DKA in YYA with T1D.

Pressure pain sensitivity: A new stress measure in children and adolescents with type 1 diabetes?

Type 1 diabetes (T1D) is associated with general- and diabetes-specific stress which has multiple adverse effects. Hence measuring stress is of great importance. An algometer measuring pressure pain sensitivity (PPS) has been shown to correlate to certain stress measures in adults. However, it has never been investigated in children and adolescents. The aim of our study was to examine associations between PPS and glycated hemoglobin (HbA1c), salivary cortisol and two questionnaires as well as to identify whether the algometer can be used as a clinical tool among children and adolescents with T1D. Eighty-three participants aged 6-18 years and diagnosed with T1D were included in this study with data from two study visits. Salivary cortisol, PPS and questionnaires were collected, measured, and answered on site. HbA1c was collected from medical files. We found correlations between PPS and HbA1c (rho = 0.35, P = 0.046), cortisol (rho = -0.25, P = 0.02) and Perceived Stress Scale (rho = -0.44, P = 0.02) in different subgroups based on age. Males scored higher in PPS than females (P < 0.001). We found PPS to be correlated to HbA1c but otherwise inconsistent in results. High PPS values indicated either measurement difficulties or hypersensibility towards pain.

Modulatory effect of interleukin-2 loaded chitosan nano sphere on regulatory T cell activity in streptozotocin-induced diabetic mice.

OBJECTIVE: The current study aimed to assess the modulating effect of IL-2 encapsulated chitosan-nanoparticles (CSNPs) on the function of Treg cells through induction of type 1 diabetes (T1D). Treg cell function was monitored by the forkhead box P3 (FoxP3) and transforming growth factor beta (TGFß) levels, correlating them with blood glucose and serum insulin levels. MATERIALS AND METHODS: In this case-control study, a low dose of IL-2 (free and chitosan-loaded) was injected into a diabetic mice group. The levels of FoxP3 and TGF-ß 1 were assessed using Enzyme-Linked Immunosorbent Assay. In addition, blood glucose and serum insulin levels were determined. RESULTS: The mean glucose level decreased significantly after free rIL-2 or rIL-2 / CSNPs treatment. Meanwhile, the mean serum insulin level was significantly increased after treatment with free rIL-2 or rIL-2/CSNPs. The mean levels of FoxP3 and TGFß 1 were significantly increased with either free rIL-2 or rIL-2/CSNPs compared to the T1D untreated group (P < 0.001). In the treated mice group receiving free CSNPs, there was a significant negative correlation between glucose and insulin levels. Moreover, FoxP3 & TGFß 1 levels had a significant positive correlation. In treated mice groups with free rIL-2 and IL-2 CSNPs, there was a significant positive correlation between FoxP3 and glucose levels. A significant negative correlation was found after conducting a correlation between insulin level and FoxP3 in the T1D/ rIL-2 / CSNPs group. CONCLUSIONS: Low-dose IL-2 selectively modulates FoxP3 + Tregs, and TGFß 1 increases their levels. These results demonstrated that IL-2-free and chitosan-loaded nanoparticles can be therapeutic agents in T1D.

Automated Insulin Delivery in Adults With Type 1 Diabetes and Suboptimal HbA1c During Prior Use of Insulin Pump and Continuous Glucose Monitoring: A Randomized Controlled Trial.

BACKGROUND: Automated insulin delivery (AID) systems offer promise in improving glycemic outcomes for individuals with type 1 diabetes. However, data on those who struggle with suboptimal glycemic levels despite insulin pump and continuous glucose monitoring (CGM) are limited. We conducted a randomized controlled trial to assess the effects of an AID system in this population. METHODS: Participants with hemoglobin A1c (HbA1c) ≥ 58 mmol/mol (7.5%) were allocated 1:1 to 14 weeks of treatment with the MiniMed 780G system (AID) or continuation of usual care (UC). The primary endpoint was change in time in range (TIR: 3·9-10·0 mmol/L) from baseline to week 14. After this trial period, the UC group switched to AID treatment while the AID group continued using the system. Both groups were monitored for a total of 28 weeks. RESULTS: Forty adults (mean ± SD: age 52 ± 11 years, HbA1c 67 ± 7 mmol/mol [8.3% ± 0.6%], diabetes duration 29 ±13 years) were included. After 14 weeks, TIR increased by 18.7% (95% confidence interval [CI] = 14.5, 22.9%) in the AID group and remained unchanged in the UC group (P < .0001). Hemoglobin A1c decreased by 10.0 mmol/mol (95% CI = 7.0, 13.0 mmol/mol) (0.9% [95% CI = 0.6%, 1.2%]) in the AID group but remained unchanged in the UC group (P < .0001). The glycemic benefits of AID treatment were reproduced after the 14-week extension phase. There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the study. CONCLUSIONS: For adults with type 1 diabetes not meeting glycemic targets despite use of insulin pump and CGM, transitioning to an AID system confers considerable glycemic benefits.

Safety and efficacy of teplizumab in the treatment of type 1 diabetes mellitus: An updated systematic review and meta-analysis of randomized controlled trials.

AIM: To provide updated efficacy and safety information for teplizumab in the treatment of Stage 3 type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: The PubMed, Embase and Cochrane databases were searched for randomized controlled trials (RCTs) comparing teplizumab to placebo for T1DM that reported any of the following outcomes: (1) C-peptide area under the curve (AUC); (2) glycated haemoglobin (HbA1c) levels; (3) insulin requirements; and (4) adverse events. Heterogeneity was examined with I2 statistics. p values <0.05 were taken to indicate statistical significance. The continuous endpoints were compared through the pooled mean difference (MD) and binary endpoints were assessed using risk ratios, both with 95% confidence intervals (CIs). Statistical analyses were performed using Review Manager Web software. RESULTS: Eight RCTs with 1052 patients (754 receiving teplizumab) were included. Teplizumab significantly increased the AUC of C-peptide levels at 6 (MD 0.10 nmol/L, 95% CI 0.05, 0.16), 12 (MD 0.13 nmol/L, 95% CI 0.06, 0.20), 18 (MD 0.18 nmol/L, 95% CI 0.09, 0.27) and 24 months (MD 0.16 nmol/L, 95% CI 0.02, 0.31), significantly reduced HbA1c levels at 6 (MD -0.57%, 95% CI -1.07, -0.08) and 12 months (MD -0.31%, 95% CI -0.59, -0.02), and significantly reduced insulin requirements at 6 (MD -0.12 U/kg, 95% CI -0.16, -0.08), 12 (MD -0.11 U/kg, 95% CI -0.15, -0.07), 18 (MD -0.17 U/kg, 95% CI -0.26, -0.09) and 24 months (MD -0.11 U/kg, 95% CI -0.22, -0.01). CONCLUSION: Teplizumab increases AUC of C-peptide levels and decreases HbA1c levels and insulin use, without raising serious adverse event risk.

Simplified integration of optimal self-management behaviors is associated with improved HbA1c in patients with type 1 diabetes.

PURPOSE: Living with type 1 diabetes requires burdensome and complex daily diabetes self-management behaviors. This study aimed to determine the association between integrated behavior performance and HbA1c, while identifying the behavior with the most significant impact on HbA1c. METHODS: A simple and feasible questionnaire was used to collect diabetes self-management behavior in patients with type 1 diabetes (n = 904). We assessed six dimensions of behavior performance: continuous glucose monitor (CGM) usage, frequent glucose testing, insulin pump usage, carbohydrate counting application, adjustment of insulin doses, and usage of apps for diabetes management. We evaluated the association between these behaviors and HbA1c. RESULTS: In total, 21.3% of patients performed none of the allotted behavior, while 28.5% of patients had a total behavior score of 3 or more. 63.6% of patients with a behavior score ≥ 3 achieved HbA1c goal, contrasting with only 30.4% of patients with a behavior score of 0-1. There was a mean 0.54% ± 0.05% decrease in HbA1c for each 1-unit increase in total behavior score after adjustment for age, family education and diabetes duration. Each behavior was independently correlated with a lower HbA1c level, with CGM having the most significant effect on HbA1c levels. CONCLUSIONS: Six optimal self-management behaviors, especially CGM usage, were associated with improved glycemic control, emphasizing the feasibility of implementing a simplified version of DSMES in the routine clinical care. REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT03610984.