A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting.

OBJECTIVE: Advanced hybrid closed-loop systems (AHCL) have been shown to improve glycemic control and patient-reported outcomes in type 1 diabetes. The aim was to analyze the outcomes of two commercially available AHCL in real life. RESEARCH DESIGN AND METHODS: A prospective study was performed, including adolescents and adults with type 1 diabetes, AHCL naïve, from 14 centers, who initiated the use of MM780G with SmartGuard or Tandem t:slimX2 with Control-IQ. Baseline and 3-month evaluations were performed, assessing HbA1c, time in different glycemic ranges, and patient-reported outcomes. The primary outcome was the between-group time in range 70-180 mg/dL difference from beginning to end of follow-up. RESULTS: One hundred fifty participants were included, with 75 initiating each system (age: 39.9 ± 11.4 years [16-72]; 64% female; diabetes duration: 21.6 ± 11.9 years). Time in range increased from 61.53 ± 14.01% to 76.17 ± 9.48% (P < 0.001), with no between-group differences (P = 0.591). HbA1c decreased by 0.56% (95% CI 0.44%, 0.68%) (6 mmol/mol, 95% CI 5, 7) (P < 0.001), from 7.43 ± 1.07% to 6.88 ± 0.60% (58 ± 12 to 52 ± 7 mmol/mol) in the MM780G group, and from 7.14 ± 0.70% to 6.56 ± 0.53% (55 ± 8 to 48 ± 6 mmol/mol) in the Control-IQ group (both P < 0.001 to baseline, P = 0.819 between groups). No superiority of one AHCL over the other regarding fear of hypoglycemia or quality of life was found. Improvement in diabetes-related distress was higher in Control-IQ users (P = 0.012). Sleep quality was improved (PSQI: from 6.94 ± 4.06 to 6.06 ± 4.05, P = 0.004), without differences between systems. Experience with AHCL, evaluated by the INSPIRE measures, exceeded the expectations. CONCLUSIONS: The two AHCL provide significant improvement in glucose control and satisfaction, with no superiority of one AHCL over the other.

Reproducibility of continuous glucose monitoring results under real-life conditions in an adult population: a functional data analysis.

Continuous glucose monitoring systems (CGM) are a very useful tool to understand the behaviour of glucose in different situations and populations. Despite the widespread use of CGM systems in both clinical practice and research, our understanding of the reproducibility of CGM data remains limited. The present work examines the reproducibility of the results provided by a CGM system in a random sample of a free-living adult population, from a functional data analysis approach. Functional intraclass correlation coefficients (ICCs) and their 95% confidence intervals (CI) were calculated to assess the reproducibility of CGM results in 581 individuals. 62% were females 581 participants (62% women) mean age 48 years (range 18-87) were included, 12% had previously been diagnosed with diabetes. The inter-day reproducibility of the CGM results was greater for subjects with diabetes (ICC 0.46 [CI 0.39-0.55]) than for normoglycaemic subjects (ICC 0.30 [CI 0.27-0.33]); the value for prediabetic subjects was intermediate (ICC 0.37 [CI 0.31-0.42]). For normoglycaemic subjects, inter-day reproducibility was poorer among the younger (ICC 0.26 [CI 0.21-0.30]) than the older subjects (ICC 0.39 [CI 0.32-0.45]). Inter-day reproducibility was poorest among normoglycaemic subjects, especially younger normoglycaemic subjects, suggesting the need to monitor some patient groups more often than others.

Time above range for predicting the development of type 2 diabetes.

Aim: To investigate the prognostic value of time range metrics, as measured by continuous glucose monitoring, with respect to the development of type 2 diabetes (T2D). Research design and methods: A total of 499 persons without diabetes from the general population were followed-up for 5 years. Time range metrics were measured at the start and medical records were checked over the period study. Results: Twenty-two subjects (8.3 per 1,000 person-years) developed T2D. After adjusting for age, gender, family history of diabetes, body mass index and glycated hemoglobin concentration, multivariate analysis revealed 'time above range' (TAR, i.e., with a plasma glucose concentration of >140 mg/dL) to be significantly associated with a greater risk (OR = 1.06, CI 1.01-1.11) of developing diabetes (AUC = 0.94, Brier = 0.035). Conclusions: Time above range provides additional information to that offered by glycated hemoglobin to identify patients at a higher risk of developing type 2 diabetes in a population-based study.

Educational programs in type 2 diabetes designed for community-dwelling older adults: A systematic review.

AIMS: This systematic review aimed to assess the effectiveness of educational interventions in type 2 diabetes specifically designed for community-dwelling older adults. METHODS: In accordance with PRISMA guidelines, a systematic search of studies published between 2010 and 2021 was conducted across five electronic databases and manual sources. The study protocol was previously registered in PROSPERO (CRD42021288236). RESULTS: Twelve papers matched the inclusion criteria and were appraised using MERSQI. The features of the educational programs were heterogeneous, and none complied with the ten suggested standards for diabetes self-management education and support. Comprehensive gerontological assessment was not considered. Outcomes included biomedical, psychosocial, behavioral, and knowledge measures. HbA1c and knowledge showed improvements with a high certainty level according to GRADE. CONCLUSIONS: Structured DSME programs aimed at older adults have great potential, however there is still room to improve. Applying the principles of a comprehensive gerontological approach and the standards for DSME as continuous monitoring and support could increase their benefits.

Aging of glucose profiles in an adult population without diabetes.

AIMS: This study aimed to determine the effect of aging on glucose profiles in a population without diabetes. METHODS: We investigated the evolution of glucose profiles in an adult population without diabetes using continuous glucose monitoring (CGM) in two periods separated by 5 years. Anthropometrics, laboratory tests (HbA1c, fasting blood glucose) and CGM data (mean glycemia level, coefficient of variation, time in range) were measured in both periods to study the change in values over time. RESULTS: 125 participants (68% women) mean age 43.1 ± 12.4 years and classified as normoglycemic at baseline were included. Of the total population 15.2% had worsened glycemic status after 5 years, age and baseline glucose values (HbA1c and percentage of values above 175 mg/dL) were the variables related with this change. Related to CGM, we found that after 5 years there was a decrease in the percentage of values between 70 and 99 mg/dl (45.0% to 38.7%, p = 0.002) and an increase in the 100-139 mg/dL range (52.9% to 57.5% p = 0.016). CONCLUSIONS: Our results indicate that in an adult population without diabetes there are changes in glucose profiles with aging highlighting the reduction of blood glucose values below 100 mg/dL.

Blood donation attitudes and knowledge in Spanish undergraduates with roles in health-education.

BACKGROUND: Recent investigations highlight how important it is to identify the key factors involved in the design of strategies to promote blood donation among undergraduates as a public health concern. The study aims to investigate attitudes and knowledge towards blood donation in university students with health education roles and examine the way sociodemographic and educational characteristics play a part in it. MATERIALS AND METHODS: A cross-sectional and multi-center design was used. A structured questionnaire was answered by 1128 Spanish university students (Schools of Health Sciences and Education Sciences). RESULTS: The knowledge test indicated a low score (M = 4.2 out of 10), being Me = 3.00 in the case of Education Sciences and Me = 5.00 in Health Sciences students. The greatest degree of importance is found in the "external incentives" dimension (M = 3.7 out of 5). Health science students and participants with relatives who needed a donation showed fewer "fears" (p ≤ 0.001) and "pretexts" (p ≤ 0.01). CONCLUSIONS: The low knowledge score stresses the need to develop valuable health education-related strategies in the curriculum of studies related with health education; showing room for improvement particularly in Education Science students. Health education interventions aimed at increasing donors in the university environment should be designed while considering differences among undergraduates. Based on their better attitudes, health science students might play a relevant role in promoting blood donation.

Evaluation of a Clinical Pathway for Thyroid Nodular Disease: Timings and Delays in the Diagnosis and Treatment of Thyroid Cancer.

BACKGROUND: Due to the high prevalence of nodular thyroid disease in the general population and the need to rule out malignant tumours, a clinical pathway for nodular thyroid disease was created at our tertiary-level hospital. Our study aimed to quantify timings and delays in diagnosis and treatment in this clinical pathway, specifically for patients who were diagnosed with thyroid cancer. METHODS: A retrospective review was conducted of patients who were newly diagnosed with thyroid cancer and who had been previously evaluated in the clinical pathway for nodular thyroid disease at our institution during 2015-2017. Patient demographics, previous diagnostic studies, cytological results, tumour details and key dates were analysed to identify wait times in diagnosis and treatment. RESULTS: Forty patients with thyroid cancer were included. The diagnostic delay had a median time of 60 days, and the treatment delay was dependent on cytopathological results. The main cause for delay in the diagnostic phase was the timing of the thyroid ultrasound performed by the radiology department. In the treatment phase, patients with a cytological result of Bethesda III, V or VI underwent surgery at the suggested time, while those in the Bethesda II or IV category did not. CONCLUSIONS: The major delay found in the diagnostic phase was the timing of the thyroid ultrasound performed by the radiology department. We are not suggesting that this step must be eliminated, though the implementation of routine ultrasonography in a thyroid clinic can help identify patients who need more urgent evaluation for fine needle aspiration cytology. In our hospital, decision for surgery is based mainly on the cytopathological report. Imaging studies and/or molecular testing could be considered to reduce treatment delays.

Attitudes and knowledge in blood donation among nursing students: A cross-sectional study in Spain and Portugal.

BACKGROUND: Blood donors are key in meeting the ever-increasing blood requirements worldwide. The Spanish and Portuguese donation systems are based on altruism and voluntariness. However, nursing students may not be fully aware of the importance of this social responsibility and their professional skills in this field. OBJECTIVES: This study aimed to identify differences regarding attitudes towards and knowledge about blood donation among Spanish and Portuguese undergraduate Nursing students (1st to 8th semester), as well as to analyse how different variables account for them. DESIGN: A multicentre cross-sectional study was carried out. PARTICIPANTS/SETTINGS: The participants of the study were 1038 nursing students from four Schools of Nursing in two countries, Spain and Portugal. METHODS: The web-based CADS-19 questionnaire to measure attitudes and knowledge was used during the academic years 2018-2019 and 2019-2020. Additionally, sociodemographic data were collected. RESULTS: The mean knowledge score was 3.079 out of 10 (SD = 1.429). The level of knowledge differed significantly by gender, where females scored higher, along with older students and previous donors. The highest mean attitude score corresponded to the "external incentives" dimension, significant differences were found between countries. In barriers and incentives, some differences were found depending on gender or sexual orientation, among others, with slightly better attitudes in Spanish participants. CONCLUSIONS: The level of knowledge was lower than expected, considering participants were nursing students. The attitude's comparative analysis between both countries showed significant differences, especially in the pretext dimension. As for greater donation rates found in Spanish students, nurse-led international partnerships could be designed to enhance health literacy and sensitivity among nursing undergraduates. Interventions should focus on specific theoretical and practical training programs and educative actions should contribute to a greater awareness, motivation, and sensitise students to blood donation.

Postprandial glycemic response in a non-diabetic adult population: the effect of nutrients is different between men and women.

BACKGROUND: There is a growing interest in the pathopysiological consequences of postprandial hyperglycemia. It is well known that in diabetic patients 2 h plasma glucose is a better risk predictor for coronary heart disease than fasting plasma glucose. Data on the glycemic response in healthy people are scarce. OBJECTIVE: To evaluate the effect of macronutrients (carbohydrates, fats, and proteins) and fiber on postprandial glycemic response in an observational study of a non-diabetic adult population. DESIGN: Cross-sectional study. 150 non-diabetic adults performed continuous glucose monitoring for 6 days. During this period they recorded food and beverage intake. The participants were instructed not to make changes in their usual diet and physical exercise.Variables analyzed included clinical parameters (age, sex, body weight, height, body mass index, blood pressure, and waist measurement), meal composition (calories, carbohydrates, fats, proteins, and fiber) and glycemic postprandial responses separated by sexes.The study period was defined from the start of dinner to 6 h later. RESULTS: A total of 148 (51% women) subjects completed all study procedures. Dinner intake was higher in males than in females (824 vs 531 kcal). Macronutrient distribution was similar in both sexes. No significant differences were found in fiber intake between men and women (5.5 g vs 4.5 g).In both sexes, the higher intake of carbohydrates corresponded to a significantly higher glycemic response (p = 0.0001 in women, p = 0.022 in men). Moreover, in women, as fat intake was higher, a flattening of the postprandial glycemic curve was observed (p = 0.003). With respect to fiber, a significantly lower glycemic response was observed in the group of women whose fiber intake at dinner was higher (p = 0.034). CONCLUSIONS: Continuous glucose monitoring provides important information about glucose levels after meals. In this study, the postprandial glycemic response in women was different from that of men, and carbohydrates were the main determinant of elevated postprandial glucose levels.

Prediabetes defined by HbA1c and by fasting glucose: differences in risk factors and prevalence.

AIMS: To investigate, in a sample of nondiabetic adults from a Spanish community, the differences between prediabetes as defined by HbA1c ("H-prediabetes") and by fasting plasma glucose (FPG) ("F-prediabetes") in regard to prevalence and the influence of potential risk factors, adjusting the latter for confounders. METHODS: A total of 1328 nondiabetic participants aged ≥ 18 years were classified as normoglycemic, H-prediabetic [HbA1c 5.7-6.4% (39-47 mmol/mol)] or F-prediabetic (FPG 5.6-6.9 mmol/L). Multivariable analyses were used to compare the impacts of risk factors on the prevalence of H-prediabetes, F-prediabetes and their conjunctive and disjunctive combinations ("HaF-prediabetes" and "HoF-prediabetes," respectively). RESULTS: Some 29.9% of participants were HoF-prediabetic, 21.7% H-prediabetic, 16.3% F-prediabetic and only 8.1% HaF-prediabetic. Whatever the definition of prediabetes, increasing age, fasting insulin and LDL cholesterol were each a risk factor after adjustment for all other variables. Increasing BMI and decreasing mean corpuscular hemoglobin (MCH) were additional risk factors for H-prediabetes; male sex and increasing uric acid for F-prediabetes and increasing BMI for HaF-prediabetes. The participants satisfying the compound condition "hypertension or hyperlipidemia or obesity or hyperuricemia" (59.9% of the whole study group) included 83.1% of all subjects with HoF-prediabetes. CONCLUSIONS: In this population, the most sensitive risk factor for detection of prediabetes was age, followed by fasting insulin, LDL cholesterol, BMI, MCH, male sex and uric acid, with differences depending on the definition of prediabetes. MCH, an indirect measure of erythrocyte survival, significantly influences the prevalence of HbA1c-defined prediabetes. This study suggests that screening of individuals with selected risk factors may identify a high proportion of prediabetic persons.

Clinical value of Flash glucose monitoring in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion.

AIM: To analyze the clinical impact of the Flash glucose monitoring system in patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII). METHODS: A 24-week retrospective cohort study in CSII-treated T1DM patients exposed (1:1) to the Flash glucose monitoring system vs. self-monitoring of capillary blood glucose (SMBG). The primary outcome was the difference in hemoglobin A1c (HbA1c) levels between both groups at the end of the study. RESULTS: Thirty-six patients with a mean age of 38.2 years (range 22-55) and a mean T1DM duration of 20.9±7.8 years, treated with CSII for 7.1±5.4 years, were enrolled into the study. At the end of the study, mean HbA1c levels improved in patients in the Flash group (7.1±0.7 vs. 7.8±1.0, p=0.04). Only the Flash group showed a significant decrease in HbA1c levels of -0.4% (95% CI, -0.6, -0.2; p=0.004) during follow-up. Flash patients captured 93.9% of data through 17.8±9.9 scans daily. In fact, the Flash cohort showed a three-fold increase in daily self-monitoring of glucose, while daily frequency of SMBG decreased during the study (-1.8 tests/24h (95% CI -3, -0.7; p=0.01). No safety issues related to Flash use were recorded. CONCLUSIONS: The Flash glucose monitoring system is a novel approach to improve blood glucose control in CSII-treated T1DM patients. Randomized controlled trials are needed to assess the effectiveness of this system in CSII-treated T1DM patients.

Continuous glucose monitoring is more sensitive than HbA1c and fasting glucose in detecting dysglycaemia in a Spanish population without diabetes.

AIMS: To investigate whether continuous glucose monitoring (CGM) reveals patterns of glycaemic behaviour, the detection of which might improve early diagnosis of dysglycaemia. METHODS: A total 1521 complete days of valid CGM data were recorded under real-life conditions from a healthy sample of a Spanish community, as were matching FPG and HbA1C data. No participant was pregnant, had a history of kidney or liver disease, or was taking drugs known to affect glycaemia. RESULTS: CGM and fingerstick measurements showed a mean relative absolute difference of 6.9 ±â€¯2.2%. All subjects were normoglycaemic according to FPG and HbA1C except 21% who were prediabetic. The normoglycaemic subjects had a 24-hour mean blood glucose concentration (MBG) of 5.7 ±â€¯0.4 mmol/L, spending a median of 97% of their time within the target range (3.9-7.8 mmol/L). 73% of them experienced episodes with blood glucose levels above the threshold for impaired glucose tolerance, and 5% levels above the threshold for diabetes. These normoglycaemic participants with episodes of high glycaemia had glycaemic variabilities similar to those of prediabetic subjects with episodes of similar intensity or combined duration. CONCLUSIONS: CGM is a better indicator of possible early dysglycaemia than either FPG or HbA1c.

Glycemic Variability and Its Association With Demographics and Lifestyles in a General Adult Population.

OBJECTIVE: The objective was to investigate glycemic variability indices in relation to demographic factors and common environmental lifestyles in a general adult population. METHODS: The A Estrada Glycation and Inflammation Study is a cross-sectional study covering 1516 participants selected by sampling of the population aged 18 years and over. A subsample of 622 individuals participated in the Glycation project, which included continuous glucose monitoring procedures. Five glycemic variability indices were analyzed, that is, SD, MAGE, MAG, CONGA1, and MODD. RESULTS: Participants had a mean age of 48 years, 62% were females, and 12% had been previously diagnosed with diabetes. In the population without diabetes, index distributions were not normal but skewed to the right. Distributional regression models that adjusted for age, gender, BMI, alcohol intake, smoking status, and physical activity confirmed that all indices were positively and independently associated with fasting glucose levels and negatively with heavy drinking. SD, MAGE, and CONGA1 were positively associated with aging, and MAG was negatively associated with BMI. None of the GVI studied were influenced by physical activity. Age-group-specific reference values are given for the indices. CONCLUSIONS: This study yielded age-specific reference values for glucose variability indices in a general adult population. Significant increases were observed with aging. Heavy drinking of more than 140 g/week was associated with significant decreases in variability indices. No differences were found between males and females. These normative ranges provide a guide for clinical care, and may offer an alternative treatment target among persons with diabetes.

High incidence of hypoglycemia in stable insulin-treated type 2 diabetes mellitus: continuous glucose monitoring vs. self-monitored blood glucose. Observational prospective study.

OBJECTIVES: Hypoglycemia is a limiting factor in the achievement of strict glycemic control. The primary objective of this 9-week study was to determine the frequency of hypoglycemia in patients with stable insulin-treated type 2 diabetes mellitus by comparing self-monitored blood glucose (SMBG) measurement with continuous glucose monitoring (CGM). METHODS: This was an observational prospective study. Included in the study were 63 stable, insulin-treated patients with type 2 diabetes. They were instructed to record 2 daily capillary blood glucose readings, pre- and/or postprandial, in a sequential way during 8 consecutive weeks. A CGM system was worn during an additional week. We evaluated the frequency of hypoglycemia using the 8-week SMBG profile and the 1 CGM week. RESULTS: SMBG revealed that 50% of the patients had experienced hypoglycemia. CGM found hypoglycemia in 59% of patients. Significantly higher percentages of hyperglycemic and hypoglycemic episodes were detected by CGM than by capillary blood glucose measurements (61.1% vs. 50.8%; p=0.047) and (3.8% vs. 1.7%; p=0.016); 33% of patients experienced nocturnal hypoglycemia, and 19% of patients who had no data concerning hypoglycemia recorded in the capillary blood glucose diary had experienced hypoglycemia as measured by CGM, and the hypoglycemia occurred mainly during the nocturnal period. CONCLUSIONS: In stable well-controlled, insulin-treated patients with type 2 diabetes, CGM showed higher numbers of hypoglycemic events than did SMBG, especially at night. CGM is a useful tool that provides clinically valuable information about glucose control in these patients.

Should the amounts of fat and protein be taken into consideration to calculate the lunch prandial insulin bolus? Results from a randomized crossover trial.

BACKGROUND: Concerning continuous subcutaneous insulin infusion (CSII), there are controversial results related to changes in glycemic response according to the meal composition and bolus design. Our aim is to determine whether the presence of protein and fat in a meal could involve a different postprandial glycemic response than that obtained with only carbohydrates (CHs). SUBJECTS AND METHODS: This was a crossover, randomized clinical trial. Seventeen type 1 diabetes (T1D) patients on CSII wore a blinded continuous glucose monitoring system sensor for 3 days. They ingested two meals (meal 1 vs. meal 2) with the same CH content (50 g) but different fat (8.9 g vs. 37.4 g) and protein (3.3 g vs. 28.9 g) contents. A single-wave insulin bolus was used, and the interstitial glucose values were measured every 30 min for 3 h. We evaluated the different postprandial glycemic response between meal 1 and meal 2 by using mixed-effects models. RESULTS: The postmeal glucose increase was 22 mg/dL for meal 1 and 31 mg/dL for meal 2. In univariate analysis, at different times not statistically significant differences in glucose levels between meals occurred. In mixed-model analysis, a time×meal interaction was found, indicating a different response between treatments along the time. However, most of the patients remained in the normoglycemic range (70-180 mg/dL) during the 3-h postmeal period (84.4% for meal 1 and 93.1% for meal 2). CONCLUSIONS: The presence of balanced amounts of protein and fat determined a different glycemic response from that obtained with only CH up to 3 h after eating. The clinical relevance of this finding remains to be elucidated.

[Benefits of subcutaneous continuous insulin infusion in type 1 diabetic patients with high glycemic variability]. / Beneficios de la terapia con infusión subcutánea continua de insulina en pacientes diabéticos tipo 1 que presentan gran variabilidad glucémica.

BACKGROUND: Hypoglycemia limits the efficacy of intensive insulin therapy, especially in patients with great glucose variability. The extent to which continuous subcutaneous insulin infusion (CSII) overcomes this limitation is unclear. Our aim was to determine whether CSII is helpful for decreasing glucose variability and hypoglycemia, mainly in patients with the greatest variability. METHOD: Twenty-four patients with type 1 diabetes wore a continuous glucose monitoring system sensor for three days before starting therapy with CSII and 6 months later. Glucose variability (SD, MAGE, M) and hypoglycemia duration (area under the curve (AUC) <70mg/dL) were compared in all patients and in those with the greatest MAGE (highest quartile). RESULTS: At 6 months, a decreased glucose variability was seen, as measured by MAGE, M, and SD (median: -28mg/dL (interquartile range, -48 to 1), p=0.03; -22(-40 to 0), p=0.04; -11(-23 to 0), p=0.009; respectively). Patients with the greatest initial glucose variability (MAGE quartile 4) showed a greater decrease in both MAGE (-47mg/dL (-103 to -34) vs -20 (-36 to 17), p=0.01) and AUC <70 (-10.7mg/dL x day (-15 to 0) vs -1.1 (-4.7 to 3.8), p=0.03) as compared to all others. Patients with longer initial hypoglycemia (AUC quartile 4) achieved a greater reduction in AUC <70 (-9.7mg/dL x day(-15 to -6.5) vs -0.08 (-2.9 to 3.8), p=0.003). A correlation was found between ΔMAGE-ΔAUC (r 0.4, p=0.03). CONCLUSIONS: During CSII, glucose variability significantly decreased, especially in patients with the greatest initial variability. Hypoglycemia was also markedly less in patients with greater variability, with the greatest reduction occurring in those who experienced more marked hypoglycemia with CSII.