Glucose Control Research Articles

Optimal Frequency of Interrupting Prolonged Sitting for Cardiometabolic Health: A Systematic Review and Meta-Analysis of Randomized Crossover Trials.

Increasing evidence highlights the efficacy of interruptions in prolonged sitting (i.e., activity/sedentary breaks) for improving cardiometabolic health, but precise conclusions and recommendations regarding the optimal interruption frequency remain poorly defined. This systematic review and meta-analysis aimed to directly compare the effect of different frequencies of interrupting prolonged sitting on cardiometabolic health and to determine potential moderators. Randomized crossover trials with at least two frequency interruptions compared to a prolonged sitting condition were identified via systematic review. We compared the acute effects of high-frequency (≤ 30 min per bout, HF) versus low-frequency (> 30 min per bout, LF) interruption protocols on various cardiometabolic health outcomes via three-level meta-analysis with pooled effects evaluated within a random-effects model and exploration of potential sources of heterogeneity through subgroup analyses. The quality of evidence was assessed using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. Thirteen studies with 211 participants (24-66 years, 41% female) were included. When comparing HF to LF condition, the HF had a significantly greater reduction in glucose (9 studies [n = 740]; Hedge's g = -0.30, 95% CI [-0.57, -0.03], p = 0.03; I2-level 3 = 42%, PI [-1.01, 0.41]). However, there was no difference in insulin (4 studies [n = 304]; Hedge's g = -0.22, 95% CI [-0.73, 0.29], p = 0.35; I2-level 3 = 52%, PI [-1.18, 0.74]), triglyceride (3 studies [n = 484]; Hedge's g = 0.11, 95% CI [-0.10, 0.30], p = 0.29; I2-level 3 = 0%, PI [-0.10, 0.30]), blood pressure (5 studies [n = 352]; Hedge's g = -0.06, 95% CI [-0.41, 0.28], p = 0.69; I2-level 3 = 35%, PI [-0.81, 0.62]), and superficial femoral flow-mediated dilation (3 studies [n = 98]; Hedge's g = -0.42, 95% CI [-2.43, 1.60], p = 0.47; I2-level 3 = 78%, PI [-4.09, 3.25]) between the two conditions. The quality of evidence was low GRADE for all outcomes. The present study suggests that a higher sedentary interruption frequency might be more efficacious than a lower frequency/higher duration protocol for reducing glucose levels. Based on these findings, interrupting sedentary time at least, every 30 min may be an ideal strategy to improve glucose control.

Comparing Postprandial Glycemic Control using Fiasp vs. Insulin Aspart in Hospitalized Patients with Type 2 Diabetes

Hyperglycemia in hospitalized patients is associated with increased morbidity and mortality. Basal-bolus insulin therapy is the treatment of choice for most patients. The efficacy of an ultrarapid vs. rapid-acting insulin in hospitalized patients with diabetes has not been evaluated. We assessed non-inferiority in efficacy and safety of Fiasp vs. aspart (Novolog) as part of a basal-bolus insulin regimen in non-critically ill patients with type 2 diabetes in a safety-net hospital. This prospective, open-label, randomized trial included 137 patients with diabetes admitted to a non-ICU setting. Subjects were treated with glargine at bedtime and either Fiasp or Novolog for prandial and correction insulin. Subjects were enrolled for a minimum of 4 or maximum of 6 meal boluses. Capillary blood glucose was used for insulin adjustment and a blinded Dexcom G6 Pro captured data for study analysis. The primary endpoint was time spent in sensor glucose range 100-180 mg/dL in the 4-hour postprandial period (assessed among 106 participants with ≥ 4 meals with a 4-hour postprandial period). Time spent in hypoglycemic ranges (<70, <54, <40 mg/dL) was assessed for safety. Four-hour postprandial time in range 100-180 mg/dL was 45% in the Fiasp group vs. 36% in the Novolog group (p=0.012; meeting prespecified non-inferiority criteria). Other glycemic metrics were similar between groups with no difference in time spent in hypoglycemic ranges. Fiasp provides non-inferior postprandial glucose control in hospitalized patients with type 2 diabetes when compared to Novolog with no increase in rates of hypoglycemia.

Double-blind Randomized placebo-controlled Trials on controlling blood glucose level using the extract from &lt;i&gt;Opuntia ficus-indica&lt;/i&gt; var. saboten

Objectives: The aim of this study was to evaluate the effects of Opuntia ficus-indica var. saboten extract on blood glucose regulation in both healthy individuals and those with impaired fasting glucose (IFG). Additionally, the study assessed the safety of &lt;i&gt;Opuntia&lt;/i&gt; extract regarding liver and kidney function over a 12-week period.Methods: A double-blind, randomized, placebo-controlled clinical trial was conducted with 85 participants, including 47 healthy individuals and 38 individuals with impaired fasting glucose (IFG) or impaired glucose tolerance (IFG). Participants were randomly assigned to receive either Opuntia extract or a placebo for 12 weeks. Blood glucose control was evaluated using fasting blood glucose (FBS), oral glucose tolerance tests (OGTT), HbA1c, insulin, and C-peptide levels. Safety assessments included liver function tests (AST, ALT, &lt;i&gt;γ&lt;/i&gt;-GTP, ALP) and kidney function tests (BUN, creatinine). Data were analyzed using independent and paired t-tests, with a significance level of p&lt;0.05.Results: A total of 85 participants were initially enrolled, and after excluding 13 participants due to dropout, consent withdrawal, or protocol violations, the final statistical analysis was conducted with 72 participants. In the IFG group, Opuntia extract significantly reduced fasting blood glucose levels compared to the placebo group (p=0.010). Additionally, Opuntia extract reduced postprandial blood glucose levels at 120 minutes during the OGTT in healthy participants (p=0.047). No significant changes were observed in HbA1c, insulin, or C-peptide levels. Importantly, no adverse effects on liver or kidney function were detected in either group during the 12-week intervention.Conclusions: The administration of &lt;i&gt;Opuntia ficus-indica var. saboten&lt;/i&gt; extract for 12 weeks demonstrated significant blood glucose-lowering effects in individuals with impaired glucose tolerance, without causing any liver or kidney toxicity. These findings suggest that &lt;i&gt;Opuntia&lt;/i&gt; extract may be a safe and effective natural option for blood glucose regulation, particularly in pre-diabetic individuals. Further large-scale studies are recommended to confirm these results and explore its potential clinical applications.

Shortcomings in the Evaluation of Blood Glucose Forecasting.

Recent years have seen an increase in machine learning (ML)-based blood glucose (BG) forecasting models, with a growing emphasis on potential application to hybrid or closed-loop predictive glucose controllers. However, current approaches focus on evaluating the accuracy of these models using benchmark data generated under the behavior policy, which may differ significantly from the data the model may encounter in a control setting. This study challenges the efficacy of such evaluation approaches, demonstrating that they can fail to accurately capture an ML-based model's true performance in closed-loop control settings. Forecast error measured using current evaluation approaches was compared to the control performance of two forecasters-a machine learning-based model (LSTM) and a rule-based model (Loop)-in silico when the forecasters were utilized with a model-based controller in a hybrid closed-loop setting. Under current evaluation standards, LSTM achieves a significantly lower (better) forecast error than Loop with a root mean squared error (RMSE) of 11.57 ±0.05 mg/dL vs. 18.46 ±0.07 mg/dL at the 30-minute prediction horizon. Yet in a control setting, LSTM led to significantly worse control performance with only 77.14% (IQR 66.57-84.03) time-in-range compared to 86.20% (IQR 78.28-91.21) for Loop. Prevailing evaluation methods can fail to accurately capture the forecaster's performance when utilized in closed-loop settings. Our findings underscore the limitations of current evaluation standards and the need for alternative evaluation metrics and training strategies when developing BG forecasters for closed-loop control systems.

Comprehensive Mini Review Of Pediatric Sleep Disorders: Types, Impact On Health, And Current Management Strategies

Abstract Aim: This mini review explores the health implications of sleep disorders in children and examines current treatment approaches. Materials and Methods: A comprehensive analysis of recent literature from PubMed and Google Scholar, focusing on studies published between 2019 and 2024, was conducted to assess the types of sleep disorders in children, their impact on health, and effective management strategies. Results: The review details the significant impact of sleep disorders on children's physical, mental, and emotional health, highlighting issues such as impaired glucose control, inflammation, obesity, behavioral problems, and emotional dysregulation. Effective treatment methods and management strategies include sleep hygiene, behavioral therapies, and innovative interventions like bright light therapy combined with cognitive-behavioral therapy. Conclusion: Early detection and comprehensive management of sleep disorders in children are crucial to improving overall child health and well-being. Keywords: Sleep Disorders, Child Health, Sleep Hygiene, Treatment, Prevention

The Effect of Nursing Intervention Application in Patients with Diabetes Mellitus and Urinary Tract Infection

Objective: To analyze the effect of using a comprehensive nursing intervention model for patients with diabetes mellitus and urinary tract infections. Methods: 60 patients with diabetes mellitus combined with urinary tract infection who were admitted to the hospital from November 2021 to November 2023 were randomly divided into the observation group and the control group, and were treated with conventional nursing interventions and comprehensive nursing interventions respectively. The nursing status of the two groups was compared and analyzed. Results: After the intervention, the observation group showed lower levels of fasting blood glucose and other indicators, and lower anxiety and depression scores, P &lt; 0.05. After the intervention, the observation group’s blood creatinine and other biochemical indicators improved significantly, P &lt; 0.05. Conclusion: For the treatment of patients with both diabetes mellitus and urinary tract infections, nursing staff should pay attention to the development of nursing interventions to enhance the level of patients’ glucose control, improve the patients’ bad moods, and improve patients’ therapeutic efficacy.

Critical care nutrition: a Bayesian re-analysis of trial data.

Nutritional support and optimal glucose control are key components of care during critical illness, yet evidence surrounding their use remains conflicting, making translation into clinical practice challenging. This review explores Bayesian methods to enhance the interpretation of frequentist critical care trials, particularly for interventions with inconclusive outcomes. Bayesian re-analysis frameworks may clarify conflicting evidence in critical care, thus enhancing interpretability and supporting clinical decision-making. This review focuses on the Bayesian re-analysis of three recent trials with indeterminate results for mortality - NUTRIREA-3, EFFORT Protein, and TGC-Fast - that examined the effects of enteral nutrition and glucose control strategies. We re-analyzed the mortality outcomes of these trials within a Bayesian framework, contrasting our findings with the original trial results to illustrate how Bayesian methods can enhance the clinical applicability of trial outcomes. Although Bayesian and frequentist analyses generally agree on the direction and magnitude of effect, Bayesian methods offer the advantage of providing posterior probabilities of benefit and harm, thus identifying promising and potentially harmful interventions. This review underscores the value of Bayesian analysis in re-evaluating clinical trial data and guiding clinical practice.

Tight and stable glucose control is associated with better prognosis in patients hospitalized for Covid-19 and pneumonia.

To investigate possible associations of glucose patterns with outcomes of Corona Virus Disease 19 (COVID-19) using continuous glucose monitoring (CGM) in 43 patients hospitalized for COVID-19 mild-to-moderate pneumonia, regardless of diabetes. Prospective observational study conducted during two pandemic waves in 2020-2021. Glucose sensor metrics of 7-day recording were obtained from blinded CGM. Respiratory function was evaluated as arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2) ratio (PaO2:FiO2). PaO2:FiO2 ratio was positively correlated with time in tight range (TITR) 70-140 (r = 0.49, p < 0.001) and time in range (TIR) 70-180 (r = 0.32, p < 0.05), and negatively correlated with average glucose (r =- 0.31, p < 0.05), coefficient of glucose variation (CV) (r =- 0.47, p < 0.01) and time above range (TAR) > 140 (r =- 0.49, p < 0.001). No relations were observed with HbA1c. Multivariate regression analysis showed that normal respiratory function at time of CGM removal correlated positively with TITR 70-140mg/dL (p < 0.01), negatively with CV and TAR > 140mg/dL (both p < 0.05) and not with TIR 70-180 and average glucose. Lower glucose variability and optimal glucose control, expressed as CV and TITR, are CGM metrics predictive of a better prognosis in COVID-19 patients with pneumonia.

Design, fabrication, and evaluation of antimicrobial sponge microneedles for the transdermal delivery of insulin

Transdermal drug delivery systems hold promise, but their effectiveness is often constrained by the skin’s barrier. Microneedles (MNs) improve drug permeability by creating micro-channels in the skin, yet they continue to face challenges such as infection risks and safety concerns. To overcome these challenges, a novel antimicrobial sponge MNs (ASMNs@PVP-INS) modified with polyvinylpyrrolidone (PVP) for insulin (INS) delivery was designed. Mechanical testing demonstrated that these MNs possess excellent mechanical strength, capable of withstanding at least 0.11 N per needle without rupture. In vitro drug penetration tests revealed that the MNs consistently released over 75 % of INS within a 6 h. In an animal model, ASMNs@PVP-INS reduced initial blood glucose levels from 22.4 to 5.72 mmol/L, effectively maintaining glucose control for more than 6 h without inducing hypoglycemia. Additionally, agar diffusion assays indicated that INS loading did not compromise the antimicrobial properties of antimicrobial sponge MNs (ASMNs). Skin irritation tests showed that ASMNs@PVP-INS exhibited mild irritation (PII < 0.6), with skin damage fully recovering within 8 h. Safety assessments indicated no significant toxicity to mice, with biochemical markers remaining within normal ranges, thereby confirming their good biocompatibility. In conclusion, ASMNs@PVP-INS hold promise as a novel drug delivery vehicle.

The Gut Microbiome's Influence on Incretins and Impact on Blood Glucose Control.

Obesity and type 2 diabetes mellitus (T2DM) have been increasing in prevalence, causing complications and strain on our healthcare systems. Notably, gut dysbiosis is implicated as a contributing factor in obesity, T2DM, and chronic inflammatory diseases. A pharmacology exists which modulates the incretin pathway to improve glucose control; this has proven to be beneficial in patients with obesity and T2DM. However, it is unclear how the gut microbiome may regulate insulin resistance, glucose control, and metabolic health. In this narrative review, we aim to discuss how the gut microbiome can modulate incretin pathways and related mechanisms to control glucose. To investigate this, Google Scholar and PubMed databases were searched using key terms and phrases related to the microbiome and its effects on insulin and glucose control. Emerging research has shown that several bacteria, such as Akkermansia and MN-Gup, have GLP-1-agonistic properties capable of reducing hyperglycemia. While more human research is needed to prove clinical benefit and identify long-term implications on health, the usage of pre-, pro-, and postbiotics has the potential to improve glucose control.

Correlation Between Prognostic Nutritional Index, Glasgow Prognostic Score, and Different Obesity-Related Indices in People with Diabetes or Prediabetes.

The prognostic nutritional index (PNI) and Glasgow Prognostic Score (GPS) are associated with patients' nutritional and immune statuses. One important factor in the pathophysiology of type 2 diabetes mellitus (T2DM) is inflammation. Being present in insulin-target tissues, chronic tissue inflammation has become recognized as a crucial aspect of obesity and type 2 diabetes. This study aimed to compare the PNI and GPS levels of the subjects with T2DM to those of prediabetes (preDM) individuals. Furthermore, the goal was to investigate how these inflammatory markers relate to different types of obesity and whether the combination of PNI, GPS, and obesity-related indices was associated with any particular prognostic variables. In this study, we enrolled one-hundred patients with newly diagnosed T2DM and one-hundred patients with preDM. Four findings emerged from this observational study. As a first observation, 28% of patients with preDM and 15% of patients with T2DM had a normal weight, while up to 43% of patients with preDM and 60% of patients with T2DM were obese. The second important observation was that the PNI of the T2DM patients was significantly lower than the PNI of the patients with preDM (p < 0.0001). The PNI showed that patients with T2DM had a moderate-to-severe malnutrition status (median value of 38.00). Patients with preDM had a mild-to-moderate malnutrition status (median value of 61.00) at diagnosis. Third, observed in the current study, preDM patients with PNI < 61.00 and T2DM patients with a PNI < 38.00 were associated with significantly higher median values of the waist-to-height ratio (WHtR) (p = 0.041, and p = 0.034, respectively) and body mass index (BMI) (p = 0.016, and p = 0.041, respectively). Fourth, this study also revealed, in the T2DM group, a moderate and statistically significant negative correlation between PNI and weight (rho = -0.322, p = 0.035), waist circumference (WC) (rho = -0.308, p = 0.042), hip circumference (HC) (rho = -0.338, p = 0.039), WHtR (rho = -0.341, p = 0.022), body adiposity index (BAI) (rho = -0.312, p = 0.032), and fasting plasma glucose (FPG) (rho = -0.318, p = 0.029). Additionally, the PNI values expressed a weak negative correlation with BMI (rho = -0.279, p = 0.015), and glycated hemoglobin A1c (HbA1c) (rho = -0.245, p = 0.025). The PNI levels exhibited a single positive correlation, weak but statistically significant, with estimated glomerular filtration rate (eGFR-CKD-EPI) values (rho = 0.263, p = 0.018). The findings of this study regarding the correlations between PNI, GPS, and different obesity-related indices in people with diabetes or prediabetes suggest that these indices, which assess nutritional and inflammatory status, can be used as independent predictor factors associated with the four pillars of DM management (glucose, blood pressure, lipids, and weight control) recommended by the American Diabetes Association (ADA).

Preoperative Carbohydrate Loading in Pediatric Surgery: A Scoping Review of Current Clinical Trials

Abstract Introduction Preoperative carbohydrate loading (PCL), part of Enhanced Recovery After Surgery (ERAS) protocols, involves giving carbohydrate-rich liquids before surgery instead of traditional fasting. It improves glucose control, reduces insulin resistance, and enhances patient comfort. Methods A comprehensive scoping review was conducted using databases such as PubMed, CINAHL, EMBASE, Cochrane Library, Scopus, and Web of Science, focusing on studies from 2017 to 2024. Primary, English-language clinical trial involving pediatric patients were included without restrictions on surgical procedure, or outcomes. Data extraction was focused on sample sizes, PCL types, and perioperative outcomes. Results The scoping review examined 10 studies on PCL in pediatric surgery, covering various procedures with sample sizes ranging from 18 to 1200 participants. Most studies indicated metabolic benefits, with 7 out of 11 showing stabilized blood glucose and reduced hypoglycemia risk. Additionally, 5 studies associated PCL with reduced preoperative anxiety, agitation, and discomfort, including thirst and hunger. For stomach content, 5 studies showed PCL reduced gastric residual volume and improved pH. Postoperative findings were mixed: 4 studies found no significant difference in nausea and vomiting, while 2 suggested benefits. Length of hospital stay from 3 studies showed no clinical difference results. Conclusions PCL in pediatric surgery shows potential to stabilize blood glucose, reduce metabolic risks, and improve recovery. However, the evidence regarding outcomes such as length of hospital stay and postoperative complications remains inconsistent, indicating the need for further investigation.

Analysis of the Prognostic Impact of Heart Rate Deceleration Capacity on Type 2 Diabetes Mellitus with Ventricular Premature Contractions

At present, one of the greatest life-threatening risks for patients with type 2 diabetes is cardiovascular complications. According to relevant research, approximately 70% to 80% of these patients die due to cardiovascular disease. Compared to non-diabetic individuals, diabetic patients face a two- to four-fold higher risk of developing cardiovascular and cerebrovascular diseases, with vascular complications resulting in an average life expectancy reduction of about 12 years. Increasing evidence indicates that cardiovascular-related indicators become abnormal as early as the initial stages of type 2 diabetes. During this period, the likelihood of adverse cardiovascular events rises, and cardiac autonomic dysfunction (CAD) begins, disrupting the balance between the parasympathetic and sympathetic nervous systems and thereby increasing cardiovascular disease risk. Cardiac autonomic dysfunction is one of many severe complications, and ventricular premature contractions are common arrhythmias in patients with type 2 diabetes, often seen as key indicators of declining cardiac function. Continuous heart rate deceleration, observed as deceleration runs (DRs) in Holter ECGs, manifests as a gradual prolongation of consecutive RR intervals, an indicator useful in assessing cardiac autonomic neuropathy. Persistent hyperglycemia or pre-diabetic states are associated with coronary artery disease (CAD), and strict blood glucose control helps slow the progression of microvascular complications. HRV monitoring is an effective method for evaluating early-stage cardiovascular autonomic neuropathy (CAN), providing a quantitative assessment of autonomic function and aiding in diagnosing other vascular complications.

Trends and Motivations in Dietary Supplement Use Among People with Diabetes: A Population-Based Analysis Using National Health and Nutrition Examination Survey Data from the 2009-2020 Period.

Dietary supplements have gained attention among people with diabetes as an alternative and complementary treatment, yet there is a limited understanding of supplement use and the motivations behind it. Data from the National Health and Nutrition Examination Survey (NHANES) from the 2009-2020 period were analyzed, including data on 5784 people with diabetes aged 20 years or older. Dietary supplement use was self-reported. Trends in supplement use were examined across three periods: 2009-2012, 2013-2016, and 2017-2020. Statistical analyses were conducted while considering NHANES's complex survey design to provide nationally representative estimates for the general noninstitutionalized population of the United States. A total of 61.72% of individuals reported using dietary supplements with a notable increase over time. Supplement users were generally older, more likely to be female, better educated, and had superior blood glucose control with lower smoking rates compared to non-users. Common supplements included multivitamins, multimineral supplements, vitamin D, calcium, zinc, vitamin C, and fish oil. Only 44.58% of individuals used dietary supplements based on medical advice, with the rest opting for self-directed usage. The primary specific health reasons for supplement use were to improve bone health and heart health and enhance the immune system. Dietary supplement use is prevalent among people with diabetes, and most diabetic supplement use is self-directed, which reflects a growing trend toward complementary therapies. Healthcare providers are encouraged to inquire about patients' use of supplements and offer appropriate guidance as an integral component of comprehensive diabetes management.

Effectiveness of glucagon-like peptide-1 receptor agonists for reduction of body mass index and blood glucose control in patients with type 2 diabetes mellitus and obesity: A retrospective cohort study and difference-in-difference analysis

ObjectiveThis study aimed to evaluate the effectiveness of glucagon-like peptide-1 receptor agonists (GLP-1RA) in reducing body mass index (BMI) and blood glucose levels in individuals with type 2 diabetes mellitus...

Glucose Control During Labour and Delivery in Type 1 Diabetes - An Update on Current Evidence.

To provide an update on diabetes management during labour and delivery in women with type 1 diabetes with focus on appropriate insulin administration, carbohydrate supply and use of diabetes technology to support safe delivery and neonatal well-being. During active labour and elective cesarean section capillary blood glucose monitoring or continuous glucose monitoring at least hourly is recommended. Infusion with isotonic (5%) glucose can be given with adjustable infusion rate to address maternal carbohydrate requirements and to prevent maternal hypoglycemia. Subcutaneous insulin administration with multiple injections or insulin pump therapy is considered at least as safe and efficient as intravenous administration to obtain tight glycemic targets. Automated insulin delivery via insulin pump can be continued during labour and delivery. Diabetes management during labour and delivery involves intensive glucose monitoring, adequate insulin administration and carbohydrate administration to support safe delivery and neonatal well-being.

Enhancing the Impact of Individualized Nutrition Therapy with Real-Time Continuous Glucose Monitoring Feedback in Overweight and Obese Individuals with Prediabetes.

prediabetes is a significant risk factor for the development of type 2 diabetes, cardiovascular diseases, chronic kidney disease, and other complications. Early diagnosis of prediabetes, coupled with education on lifestyle changes that support blood glucose management, are crucial for the prevention or delay of type 2 diabetes and related complications. This study aimed to evaluate the impact of incorporating real-time feedback from continuous glucose monitoring (CGM) into individualized nutrition therapy (INT) on blood glucose control in individuals with prediabetes who are overweight or obese. participants (mean age ± SD: 55 ± 6 years; BMI: 31.1 ± 4.1 kg/m²) were randomly assigned to either the treatment group (n = 15) or the control group (n = 15). Both groups received INT and CGM, but the control group was blinded to the CGM data until the end of this study. Participants were followed for 30 days and visited the lab every 10 days for CGM replacement, study measurements, and dietary consultations. the treatment group showed a significant increase in the percentage of time spent in the target blood glucose range (p = 0.02) and a significant decrease in the mean blood glucose concentration (p < 0.05), glucose management indicator (p = 0.02), percent coefficient of variation for blood glucose (p = 0.01), and percent time spent in the high or very high blood glucose ranges (p = 0.04). These changes were not statistically significant for the control group. adding CGM feedback to INT resulted in better management of blood glucose levels in overweight or obese individuals with prediabetes.

Four New Patient-Reported Outcome Measures Examining Health-Seeking Behavior in Persons With Type 2 Diabetes Mellitus (REDD-CAT): Instrument Development Study.

The management of type 2 diabetes mellitus (T2DM) includes mastery of complex care activities, self-management skills, and routine health care encounters to optimize glucose control and achieve good health. Given the lifelong course of T2DM, patients are faced with navigating complex medical and disease-specific information. This health-seeking behavior is a driver of health disparities and is associated with hospitalization and readmission. Given that health-seeking behavior is a potentially intervenable social determinant of health, a better understanding of how people navigate these complex systems is warranted. To address this need, we aimed to develop new patient-reported outcome (PRO) measures that evaluate health-seeking behavior in persons with T2DM. These new PROs were designed to be included in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system, which includes several other PROs that capture the importance of social determinants of health. Overall, 225 participants with T2DM completed 56 self-report items that examined health-seeking behaviors. Classical Test Theory and Item Response Theory were used for measurement development. Exploratory factor analysis (EFA; criterion ratio of eigenvalue 1 to eigenvalue 2 being >4; variance for eigenvalue 1 ≥40%) and confirmatory factor analysis (CFA; criterion 1-factor CFA loading <.50; 1-factor CFA residual correlation >.20; comparative fit index ≥0.90; Tucker-Lewis index ≥0.90; root mean square error of approximation <0.15) were used to determine unidimensional sets of items. Items with sparse responses, low-adjusted total score correlations, nonmonotonicity, low factor loading, and high residual correlations of high error modification indices were candidates for exclusion. A constrained graded response model was used to examine item misfit, and differential item functioning was examined to identify item bias. Cronbach α was used to examine internal consistency reliability for the new PROs (criterion ≥0.70), and floor and ceiling effects were examined (criterion ≤20%). Four unidimensional sets of items were supported by EFA (all EFA eigenvalue ratios >4; variance for eigenvalue 1=41.4%-67.3%) and CFA (fit statistics all exceeded criterion values). This included (1) "Health-Seeking Behavior: PCP-Specific" (6 items); (2) "Health-Seeking Behavior: General Beliefs" (13 items); (3) "Health-Seeking Behavior: Family or Friends-Specific" (5 items); and (4) "Health-Seeking Behavior: Internet-Specific" (4 items). All items were devoid of differential item functioning for age, sex, education, or socioeconomic status factors. "Health-Seeking Behavior: General Beliefs" was developed to include both a computer adaptive test and a 6-item short form version; all other PROs were developed as static short forms. The psychometric reliability of these new PROs was supported; internal consistency ranged from acceptable to excellent (Cronbach α=.78-.91), and measures were free of significant floor or ceiling effects (floor effects range: 0%-8.9%; ceiling effects range: 0%-8.4%). The new REDD-CAT Health-Seeking Behavior PROs provide reliable assessments of health-seeking behaviors among those with T2DM.

Adaptation of The Diabetes Distress Scale on a Russian-speaking sample of patients with type 1 and type 2 diabetes mellitus

BACKGROUND: Diabetes distress (DD) is the negative emotional or affective experience resulting from living with diabetes. DD is a negative predictor of blood glucose control and quality of life, and may lead to decreased adherence to treatment. To diagnose DD, questionnaires are used to screen the emotional state and psychosocial aspects. In the study, linguistic, cultural adaptation and assessment of the psychometric properties of the Russian version of the questionnaire “The Diabetes Distress Scale” were conducted among patients suffering from T1DM and T2DM.Patients with diabetes mellitus (DM) have diabetic distress as one of the most common mental disorders along with depression. Depression and diabetic distress increase the risk of death in diabetes, negatively affect treatment adherence and self-monitoring of glycemia. Identification of these conditions among patients with T1DM and T2DM can contribute to their timely correction.AIM: To carry out linguistic and cultural adaptation of the questionnaire “The Diabetes Distress Scale” and evaluate the psychometric properties of the Russian version of the DDS questionnaire on a Russian-speaking sample of patients with T1DM and T2DM.MATERIALS AND METHODS: A study was conducted on a sample of 198 patients with T1DM and T2DM; data was collected on the use of the Russian version was collected DDS scales, as well as the EQ-5D-5L (European Quality of Life Questionnaire), SPANE (Positive and Negative Experiences Scale) and HADS (Hospital Anxiety and Depression Scale) scales. The last three scales were used to assess the convergent validity of the adapted questionnaire. Reliability of the DDS questionnaire was assessed using Cronbach’s α coefficient of internal consistency and participant retest after 1–4 months.RESULTS: The factor structure of The Diabetes Distress Scale questionnaire is fully reproduced when all 17 questions are included (measurement model fit indicators: CFI=0.981, RMSEA=0.055, TLI=0.967). The internal consistency of the subscales (α ϵ [0.836; 0.874]) and the questionnaire as a whole (α=0.948) is assessed as high. Significant correlations of the adapted methodology and its subscales with the scales of the EQ-5D-5L, SPANE, HADS questionnaires were obtained, the closest connections (Rho ϵ [0.370; 0.437], p&lt;0.01), which indicates good external validity of the adapted methodology.CONCLUSION: The Russian version of the DDS questionnaire has good psychometric properties. It is a valid and reliable tool for assessing diabetes distress among patients with T1DM and T2DM and can be recommended for use in clinical practice for timely diagnosing depression and DD.

Simplified meal announcement study (SMASH) using hybrid closed-loop insulin delivery in youth and young adults with type 1 diabetes: a randomised controlled two-centre crossover trial

Aims/hypothesisThe majority of hybrid closed-loop systems still require carbohydrate counting (CC) but the evidence for its justification remains limited. Here, we evaluated glucose control with simplified meal announcement (SMA) vs CC in youth and young adults with type 1 diabetes using the mylife CamAPS FX system.MethodsWe conducted a two-centre, randomised crossover, non-inferiority trial in two University Hospitals in Switzerland in 46 participants (aged 12–20 years) with type 1 diabetes using multiple daily injections (n=35), sensor-augmented pump (n=4) or hybrid closed-loop (n=7) therapy before enrolment. Participants underwent two 3 month periods with the mylife CamAPS FX system (YpsoPump, Dexcom G6) to compare SMA (individualised carbohydrate meal sizes) with CC, in a randomly assigned order using computer-generated sequences. The primary endpoint was the proportion of time glucose was in target range (3.9–10.0 mmol/l) with a non-inferiority margin of 5 percentage points. Secondary endpoints were other sensor glucose and insulin metrics, usability and safety endpoints.ResultsForty-three participants (18 women and girls) completed the trial. In the intention-to-treat analysis, time in range (mean±SD) was 69.9±12.4% with SMA and 70.7±13.0% with CC (estimated mean difference −0.6 percentage points [95% CI −2.4, 1.1], demonstrating non-inferiority). Time <3.9 mmol/l (median [IQR] 1.8 [1.2–2.2]% vs 1.9 [1.6–2.5]%) and >10.0 mmol/l (28.2±12.6% vs 27.2±13.4%) was similar between periods. Total daily insulin dose was higher with SMA (54.0±14.7 U vs 51.7±12.1 U, p=0.037). Three participants experienced serious adverse events, none of which were intervention-related.Conclusions/interpretationGlucose control using the CamAPS FX algorithm with SMA was non-inferior to its use with CC in youth and young adults with type 1 diabetes.Trial registrationClinicalTrials.gov NCT05481034.FundingThe study was supported by the Swiss Diabetes Foundation and by a YTCR grant from the Bangerter-Rhyner Foundation and the Swiss Academy of Medical Sciences. Dexcom and Ypsomed provided product support.Graphical