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3.
JACC Cardiovasc Interv ; 17(10): 1200-1210, 2024 May 27.
Article in English | MEDLINE | ID: mdl-38811102

ABSTRACT

BACKGROUND: Fasting before coronary procedures is currently recommended to reduce complications despite the lack of scientific evidence. OBJECTIVES: The TONIC (Comparison Between Fasting and No Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events) noninferiority trial investigated the safety and comfort of a nonfasting strategy (ad libitum food and drinks) vs traditional fasting (>6 hours for solid food and liquids) before coronary procedures. METHODS: In this monocentric, prospective, single-blind randomized controlled trial, 739 patients undergoing coronary procedures were included and randomized to a fasting or a nonfasting strategy. Emergency procedures were excluded. The primary endpoint was a composite of vasovagal reaction, hypoglycemia (defined by blood sugar ≤0.7 g/L), and isolated nausea and/or vomiting. Noninferiority margin was 4%. Secondary endpoints were contrast-induced nephropathy and patients' satisfaction. RESULTS: Among the 739 procedures (697 elective and 42 semiurgent), 517 angiographies, and 222 angioplasties (including complex and high-risk procedures) were performed. The primary endpoint occurred in 30 of 365 nonfasting patients (8.2%) vs 37 of 374 fasting patients (9.9%), demonstrating noninferiority (absolute between-group difference, -1.7%; 1-sided 95% CI upper limit: 1.8%). No food-related adverse event occurred, and contrast-related acute kidney injuries were similar between groups. Overall, procedure satisfaction and perceived pain were similar in both groups, but nonfasting patients reported less hunger and thirst (P < 0.01). In case of redo coronary procedures, most patients (79%) would choose a nonfasting strategy. CONCLUSIONS: The TONIC randomized trial demonstrates the noninferiority of a nonfasting strategy to the usual fasting strategy for coronary procedures regarding safety, while improving patients' comfort.


Subject(s)
Fasting , Patient Satisfaction , Humans , Fasting/blood , Male , Female , Prospective Studies , Single-Blind Method , Middle Aged , Treatment Outcome , Aged , Time Factors , Risk Factors , Percutaneous Coronary Intervention/adverse effects , Coronary Angiography/adverse effects , Hypoglycemia/chemically induced , Hypoglycemia/blood , Syncope, Vasovagal/etiology , Syncope, Vasovagal/prevention & control , Blood Glucose/metabolism , Coronary Artery Disease/therapy , Coronary Artery Disease/diagnostic imaging , Risk Assessment
4.
Front Endocrinol (Lausanne) ; 15: 1352829, 2024.
Article in English | MEDLINE | ID: mdl-38686202

ABSTRACT

Background: Hypoglycemia is common in individuals with type 1 diabetes, especially during exercise. We investigated the accuracy of two different continuous glucose monitoring systems during exercise-related hypoglycemia in an experimental setting. Materials and methods: Fifteen individuals with type 1 diabetes participated in two separate euglycemic-hypoglycemic clamp days (Clamp-exercise and Clamp-rest) including five phases: 1) baseline euglycemia, 2) plasma glucose (PG) decline ± exercise, 3) 15-minute hypoglycemia ± exercise, 4) 45-minute hypoglycemia, and 5) recovery euglycemia. Interstitial PG levels were measured every five minutes, using Dexcom G6 (DG6) and FreeStyle Libre 1 (FSL1). Yellow Springs Instruments 2900 was used as PG reference method, enabling mean absolute relative difference (MARD) assessment for each phase and Clarke error grid analysis for each day. Results: Exercise had a negative effect on FSL1 accuracy in phase 2 and 3 compared to rest (ΔMARD = +5.3 percentage points [(95% CI): 1.6, 9.1] and +13.5 percentage points [6.4, 20.5], respectively). In contrast, exercise had a positive effect on DG6 accuracy during phase 2 and 4 compared to rest (ΔMARD = -6.2 percentage points [-11.2, -1.2] and -8.4 percentage points [-12.4, -4.3], respectively). Clarke error grid analysis showed a decrease in clinically acceptable treatment decisions during Clamp-exercise for FSL1 while a contrary increase was observed for DG6. Conclusion: Physical exercise had clinically relevant impact on the accuracy of the investigated continuous glucose monitoring systems and their ability to accurately detect hypoglycemia.


Subject(s)
Blood Glucose Self-Monitoring , Blood Glucose , Diabetes Mellitus, Type 1 , Exercise , Glucose Clamp Technique , Hypoglycemia , Humans , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/complications , Hypoglycemia/blood , Hypoglycemia/diagnosis , Hypoglycemia/etiology , Male , Female , Adult , Blood Glucose/analysis , Blood Glucose Self-Monitoring/methods , Young Adult , Middle Aged , Continuous Glucose Monitoring
5.
ACS Biomater Sci Eng ; 10(5): 3086-3096, 2024 May 13.
Article in English | MEDLINE | ID: mdl-38588325

ABSTRACT

The timely administration of glucagon is a standard clinical practice for the treatment of severe hypoglycemia. However, the process involves cumbersome steps, including the reconstitution of labile glucagon and filling of the syringe, which cause considerable delays in emergency situations. Moreover, multiple dosages are often required to prevent the recurrence of the hypoglycemic episode because of the short half-life of glucagon in plasma. Herein, we develop a glucagon-loaded long-dissolving microneedle (GLMN) patch that exhibits the properties of fast onset and sustained activity for the effective treatment of severe hypoglycemia. Three types of MN patches were fabricated with different dimensions (long, medium, and short). The longer MN patch packaged a higher dosage of glucagon and exhibited supreme mechanical strength compared to the shorter one. Additionally, the longer MN patch could insert more deeply into the skin, resulting in higher permeability of glucagon across the skin tissue and more rapid systemic absorption as compared with the shorter MN patch. The GLMN patch was observed to reverse the effects of hypoglycemia within 15 min of application in animal models (specifically, rat and rhesus monkey models) and maintained long-term glycemic control, owing to highly efficient drug permeation and the drug reservoir effect of the MN base. The current study presents a promising strategy for the rapid reversal of severe hypoglycemia that exhibits the desirable properties of easy use, high efficiency, and sustained action.


Subject(s)
Glucagon , Hypoglycemia , Macaca mulatta , Needles , Animals , Glucagon/administration & dosage , Glucagon/pharmacokinetics , Hypoglycemia/drug therapy , Hypoglycemia/blood , Rats , Male , Rats, Sprague-Dawley , Transdermal Patch , Administration, Cutaneous , Drug Delivery Systems/instrumentation , Blood Glucose/analysis , Blood Glucose/drug effects
8.
Prim Care Diabetes ; 18(3): 333-339, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38677966

ABSTRACT

We aimed to evaluate the utility of the FreeStyle Libre 2 device for reducing time below range level 1 and level 2 compared with the Freestyle Libre device (without alarms) in people with type 1 diabetes mellitus. We conducted longitudinal observational follow-up study of a cohort of 100 people with type 1 diabetes mellitus who had switched from FreeStyle Libre to FreeStyle Libre 2 as part of routine clinical practice. Three months after switching to FreeStyle Libre 2, compared with results with FreeStyle Libre, there were a significant improvements in time below range level 1 (p = 0.02) and level 2 (p <0.001), time in range (p <0.001), time above range level 1 (p = 0.002), glucose management indicator (p= 0.04) and mean glucose (p= 0.04) during follow-up. Furthermore there was a significant direct association between age and change in TIR with a coefficient of 0.23, and a significant inverse association between age and change in TAR-1 with a coefficient of 0.11. Switching to a flash glucose monitoring system with alarms improves time below range, time in range and coefficient of variation in people with type 1 diabetes mellitus.


Subject(s)
Biomarkers , Blood Glucose Self-Monitoring , Blood Glucose , Clinical Alarms , Diabetes Mellitus, Type 1 , Hypoglycemia , Predictive Value of Tests , Humans , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/diagnosis , Diabetes Mellitus, Type 1/drug therapy , Blood Glucose Self-Monitoring/instrumentation , Blood Glucose/metabolism , Male , Female , Adult , Time Factors , Hypoglycemia/blood , Hypoglycemia/diagnosis , Hypoglycemia/chemically induced , Middle Aged , Biomarkers/blood , Longitudinal Studies , Glycemic Control/instrumentation , Follow-Up Studies , Equipment Design , Hypoglycemic Agents/therapeutic use , Young Adult , Reproducibility of Results
9.
JAMA Pediatr ; 178(6): 577-585, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38557708

ABSTRACT

Importance: Perinatal stress and fetal growth restriction increase the risk of neonatal hypoglycemia. The underlying pathomechanism is poorly understood. In a sheep model, elevated catecholamine concentrations were found to suppress intrauterine insulin secretion, followed by hyperresponsive insulin secretion once the adrenergic stimulus subsided. Objective: To determine whether neonates with risk factors for hypoglycemia have higher catecholamine concentrations in umbilical cord blood (UCB) and/or amniotic fluid (AF) and whether catecholamines are correlated with postnatal glycemia. Design, Setting, and Participants: In a prospective cohort study of 328 neonates at a tertiary perinatal center from September 2020 through May 2022 in which AF and UCB were collected immediately during and after delivery, catecholamines and metanephrines were analyzed using liquid chromatography with tandem mass spectrometry. Participants received postnatal blood glucose (BG) screenings. Exposure: Risk factor for neonatal hypoglycemia. Main Outcomes and Measures: Comparison of catecholamine and metanephrine concentrations between at-risk neonates and control participants, and correlation of concentrations of catecholamines and metanephrines with the number and severity of postnatal hypoglycemic episodes. Results: In this study of 328 neonates (234 in the risk group: median [IQR] gestational age, 270 [261-277] days; and 94 in the control group: median [IQR] gestational age, 273 [270-278] days), growth-restricted neonates showed increased UCB median (IQR) concentrations of norepinephrine (21.10 [9.15-42.33] vs 10.88 [5.78-18.03] nmol/L; P < .001), metanephrine (0.37 [0.13-1.36] vs 0.12 [0.08-0.28] nmol/L; P < .001), and 3-methoxytyramine (0.149 [0.098-0.208] vs 0.091 [0.063-0.149] nmol/L; P = .001). Neonates with perinatal stress had increased UCB median (IQR) concentrations of norepinephrine (22.55 [8.99-131.66] vs 10.88 [5.78-18.03] nmol/L; P = .001), normetanephrine (1.75 [1.16-4.93] vs 1.25 [0.86-2.56] nmol/L; P = .004), and 3-methoxytyramine (0.120 [0.085-0.228] vs 0.091 [0.063-0.149] nmol/L; P = .008) (P < .0083 was considered statistically significant). Concentrations of UCB norepinephrine, metanephrine, and 3-methoxytyramine were negatively correlated with AF C-peptide concentration (rs = -0.212, P = .005; rs = -0.182, P = .016; and rs = -0.183, P = .016, respectively [P < .017 was considered statistically significant]). Concentrations of UCB norepinephrine, metanephrine, and 3-methoxytyramine were positively correlated with the number of hypoglycemic episodes (BG concentration of 30-45 mg/dL) (rs = 0.146, P = .01; rs = 0.151, P = .009; and rs = 0.180, P = .002, respectively). Concentrations of UCB metanephrine and 3-methoxytyramine were negatively correlated with the lowest measured BG concentration (rs = -0.149, P = .01; and rs = -0.153, P = .008, respectively). Conclusions and Relevance: Neonates at risk for hypoglycemia displayed increased catecholamine and metanephrine concentrations that were correlated with postnatal hypoglycemic episodes and lower BG levels; these results are consistent with findings in a sheep model that fetal catecholamines are associated with neonatal ß-cell physiology and that perinatal stress or growth restriction is associated with subsequent neonatal hyperinsulinemic hypoglycemia. Improving the pathomechanistic understanding of neonatal hypoglycemia may help to guide management of newborns at risk for hypoglycemia.


Subject(s)
Catecholamines , Hypoglycemia , Humans , Hypoglycemia/metabolism , Hypoglycemia/diagnosis , Hypoglycemia/blood , Infant, Newborn , Female , Catecholamines/metabolism , Catecholamines/blood , Male , Prospective Studies , Fetal Blood/metabolism , Fetal Blood/chemistry , Risk Factors , Amniotic Fluid/metabolism , Amniotic Fluid/chemistry , Metanephrine/blood , Blood Glucose/analysis , Blood Glucose/metabolism , Pregnancy , Infant, Newborn, Diseases/metabolism
10.
Peptides ; 176: 171185, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38462093

ABSTRACT

Plasma copeptin is a biomarker that reflects arginine vasopressin (AVP) secretion. In this study we measured copeptin during insulin tolerance test (ITT) in 65 patients referred to our department for evaluation of anterior pituitary function. Plasma for measurements of copeptin were collected at the start of the test and regurarly up to 120 minutes thereafter. Of 60 patients who developed significant hypoglycemia and were included in the analyses, 13 (22%) had corticotropic deficiency, 11 (18%) had thyreotropic deficiency, 33 (55%) had growth hormone deficiency and 4 (6%) had AVP deficieny (AVPD). Thirty-seven (62%) patients had at least one anterior pituitary deficiency. In patients without AVPD, median (range) copeptin increased from 4.5 pmol/L (1.3-33.0) to a maximum of 6.2 pmol/L (2.0-34.4; p<0.001). Baseline copeptin was similar in men and women, but maximal copeptin during ITT was higher in men. Copeptin concentrations were not affected by age, BMI, somatotropic, or corticotropic function. Copeptin concentrations were lower in patients with AVPD than patiets without AVPD, and in patients with thyrotropic deficiency, compared to patients with intact thyrotropic function, both at baseline and during ITT. In conclusion, copeptin increases significantly during insulin induced hypoglycemia but is of limited value in predicting anterior pituitary hormonal function.


Subject(s)
Adrenal Insufficiency , Glycopeptides , Hypoglycemia , Insulin , Humans , Glycopeptides/blood , Male , Female , Middle Aged , Hypoglycemia/blood , Hypoglycemia/chemically induced , Insulin/blood , Adult , Aged , Arginine Vasopressin/blood , Biomarkers/blood
11.
J Diabetes Sci Technol ; 18(3): 541-548, 2024 May.
Article in English | MEDLINE | ID: mdl-38454631

ABSTRACT

BACKGROUND: Hyperglycemia occurs in 22% to 46% of hospitalized patients, negatively affecting patient outcomes, including mortality, inpatient complications, length of stay, and hospital costs. Achieving inpatient glycemic control is challenging due to inconsistent caloric intake, changes from home medications, a catabolic state in the setting of acute illness, consequences of acute inflammation, intercurrent infection, and limitations in labor-intensive glucose monitoring and insulin administration. METHOD: We conducted a retrospective cross-sectional analysis at the University of California San Francisco hospitals between September 3, 2020 and September 2, 2021, comparing point-of-care glucose measurements in patients on nil per os (NPO), continuous total parenteral nutrition, or continuous tube feeding assigned to our novel automated self-adjusting subcutaneous insulin algorithm (SQIA) or conventional, physician-driven insulin dosing. We also evaluated physician efficiency by tracking the number of insulin orders placed or modified. RESULTS: The proportion of glucose in range (70-180 mg/dL) was higher in the SQIA group than in the conventional group (71.0% vs 69.0%, P = .153). The SQIA led to a lower proportion of severe hyperglycemia (>250 mg/dL; 5.8% vs 7.2%, P = .017), hypoglycemia (54-69 mg/dL; 0.8% vs 1.2%, P = .029), and severe hypoglycemia (<54 mg/dL; 0.3% vs 0.5%, P = .076) events. The number of orders a physician had to place while a patient was on the SQIA was reduced by a factor of more than 12, when compared with while a patient was on conventional insulin dosing. CONCLUSIONS: The SQIA reduced severe hyperglycemia, hypoglycemia, and severe hypoglycemia compared with conventional insulin dosing. It also improved physician efficiency by reducing the number of order modifications a physician had to place.


Subject(s)
Algorithms , Blood Glucose , Glycemic Control , Hypoglycemic Agents , Insulin , Humans , Retrospective Studies , Insulin/administration & dosage , Insulin/adverse effects , Female , Male , Middle Aged , Blood Glucose/analysis , Blood Glucose/drug effects , Cross-Sectional Studies , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/adverse effects , Glycemic Control/adverse effects , Glycemic Control/methods , Aged , Hyperglycemia/blood , Hyperglycemia/drug therapy , Hospitalization , Injections, Subcutaneous , Hypoglycemia/chemically induced , Hypoglycemia/prevention & control , Hypoglycemia/blood , Hypoglycemia/epidemiology
12.
J Diabetes Sci Technol ; 18(3): 577-583, 2024 May.
Article in English | MEDLINE | ID: mdl-38454549

ABSTRACT

OBJECTIVE: To assess the growing use of continuous glucose monitoring (CGM) systems by older adults and explore additional areas integration that could benefit adults with frailty. BACKGROUND: The use of CGM devices has expanded rapidly in the last decade. This has been supported by substantial data showing significant benefit in glycemic metrics: hemoglobin A1c improvements, less hypoglycemia, and improved quality of life. However, sub-populations, such as older persons, exist where available data are limited. Furthermore, frail older adults represent a heterogeneous population with their own unique challenges to the management of diabetes. This group has some of the poorest outcomes related to the sequela of diabetes. For example, hypoglycemia resulting in significant morbidity and mortality is more frequent in older person with diabetes than in younger persons with diabetes. METHOD: We present a concise literature review on CGM use in the older adult as well as expand upon glycemic and nonglycemic benefits of CGM for patients, caregivers, and providers. Retrospective analysis of inpatient glycemic data of 16,935 older adults with Type 2 diabetes mellitus at Atrium Health Wake Forest Baptist indicated those with fraility managed with insulin or sulfonylurea had the highest rates of delirium (4.8%), hypoglycemia (3.5%), cardiovascular complications (20.2%) and ED visits/hospitalizatoins (49%). In addition, we address special consideration of specific situations including inpatient, palliative and long term care settings. CONCLUSION: This review article summarizes the available data for CGM use in older adults, discusses the benefits and obstacles with CGM use in this population, and identifies areas of future research needed for improved delivery of care to older persons with diabetes.


Subject(s)
Blood Glucose Self-Monitoring , Blood Glucose , Diabetes Mellitus, Type 2 , Humans , Aged , Blood Glucose/analysis , Blood Glucose/drug effects , Diabetes Mellitus, Type 2/blood , Aged, 80 and over , Hypoglycemia/blood , Hypoglycemia/epidemiology , Female , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/adverse effects , Male , Glycated Hemoglobin/analysis , Frail Elderly , Glycemic Control , Continuous Glucose Monitoring
13.
Diabetologia ; 67(6): 1095-1106, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38427076

ABSTRACT

AIMS/HYPOTHESIS: As a result of early loss of the glucagon response, adrenaline is the primary counter-regulatory hormone in type 1 diabetes. Diminished adrenaline responses to hypoglycaemia due to counter-regulatory failure are common in type 1 diabetes, and are probably induced by exposure to recurrent hypoglycaemia, however, the metabolic effects of adrenaline have received less research attention, and also there is conflicting evidence regarding adrenaline sensitivity in type 1 diabetes. Thus, we aimed to investigate the metabolic response to adrenaline and explore whether it is modified by prior exposure to hypoglycaemia. METHODS: Eighteen participants with type 1 diabetes and nine healthy participants underwent a three-step ascending adrenaline infusion during a hyperinsulinaemic-euglycaemic clamp. Continuous glucose monitoring data obtained during the week before the study day were used to assess the extent of hypoglycaemia exposure. RESULTS: While glucose responses during the clamp were similar between people with type 1 diabetes and healthy participants, plasma concentrations of NEFAs and glycerol only increased in the group with type 1 diabetes (p<0.001). Metabolomics revealed an increase in the most common NEFAs (p<0.01). Other metabolic responses were generally similar between participants with type 1 diabetes and healthy participants. Exposure to hypoglycaemia was negatively associated with the NEFA response; however, this was not statistically significant. CONCLUSIONS/INTERPRETATION: In conclusion, individuals with type 1 diabetes respond with increased lipolysis to adrenaline compared with healthy participants by mobilising the abundant NEFAs in plasma, whereas other metabolic responses were similar. This may suggest that the metabolic sensitivity to adrenaline is altered in a pathway-specific manner in type 1 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05095259.


Subject(s)
Blood Glucose , Diabetes Mellitus, Type 1 , Epinephrine , Glucose Clamp Technique , Hypoglycemia , Adult , Female , Humans , Male , Young Adult , Blood Glucose/metabolism , Blood Glucose/drug effects , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/metabolism , Diabetes Mellitus, Type 1/blood , Epinephrine/blood , Epinephrine/administration & dosage , Fatty Acids, Nonesterified/blood , Glucagon/blood , Glycerol/blood , Glycerol/administration & dosage , Hypoglycemia/blood , Insulin/administration & dosage , Case-Control Studies
14.
Diabetes Metab Syndr ; 18(3): 102977, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38503114

ABSTRACT

AIMS: To investigate differences in maternal and foetal outcomes in pregnancy, where patients developed hypoglycaemia following the 2-hour 75g oral glucose tolerance test (OGTT). METHOD: A retrospective cohort study of 200 pregnancies attending the Antenatal Clinic at Tameside General Hospital between 2018 and 2022. Outcomes were compared between 4 groups: normal OGTT [G1; (n = 39, 20%), diagnosis of gestational diabetes mellitus (GDM) based on OGTT [G2; BG ≥ 5.6 mmol/L or 2-h OGTT ≥7.8 (n = 41, 21%)], hypoglycaemia [G3; 2 h OGTT 3.0-3.9 mmol/L (n = 93, 47%)], or clinically significant hypoglycaemia [G4; 2 h OGTT <3.0 mmol/L (n = 27, 14%)]. Maternal BMI, foetal birth weight (FBW), neonatal complications, neo-natal intensive care unit (NICU) stay and conversion to GDM were assessed. RESULTS: Maternal BMI was lower in G3 and G4 (27.3 kg/m2 and 28.1 kg/m2 respectively) compared to G1 (30.4 kg/m2) (p = 0.02). NICU stay was more frequent in G3 (12%, n = 11) and G4 (8%, n = 2) compared to G1 (5%, n = 2). Foetal complications occurred in 27% of G3 (n = 25) and 33% of G4 (n = 9) compared to 23% in G1 (n = 9) and 17% in G2 (n = 7). FBW was similar in G1 when compared to G3 and G4 (p = 0.34). Of the 120 patients in G3 and G4, 25 patients self-monitored blood glucose for two weeks; 28% (n = 7) subsequently developed GDM. CONCLUSION: Higher rates of NICU stay and foetal complications were seen in both hypoglycaemic groups. In patients with hypoglycaemia following OGTT there is evidence to support self-monitoring blood glucose as 28% were later diagnosed with GDM.


Subject(s)
Diabetes, Gestational , Glucose Tolerance Test , Hypoglycemia , Pregnancy Outcome , Humans , Pregnancy , Female , Hypoglycemia/epidemiology , Hypoglycemia/blood , Hypoglycemia/diagnosis , Retrospective Studies , Adult , Diabetes, Gestational/blood , Infant, Newborn , Blood Glucose/analysis , Prognosis , Follow-Up Studies , Biomarkers/blood , Biomarkers/analysis , Pregnancy Complications/blood
15.
Diabetes Metab J ; 48(3): 429-439, 2024 May.
Article in English | MEDLINE | ID: mdl-38476023

ABSTRACT

BACKGRUOUND: This study investigated the optimal coefficient of variance (%CV) for preventing hypoglycemia based on real-time continuous glucose monitoring (rt-CGM) data in people with type 1 diabetes mellitus (T1DM) already achieving their mean glucose (MG) target. METHODS: Data from 172 subjects who underwent rt-CGM for at least 90 days and for whom 439 90-day glycemic profiles were available were analyzed. Receiver operator characteristic analysis was conducted to determine the cut-off value of %CV to achieve time below range (%TBR)<54 mg/dL <1 and =0. RESULTS: Overall mean glycosylated hemoglobin was 6.8% and median %TBR<54 mg/dL was 0.2%. MG was significantly higher and %CV significantly lower in profiles achieving %TBR<54 mg/dL <1 compared to %TBR<54 mg/dL ≥1 (all P<0.001). The cut-off value of %CV for achieving %TBR<54 mg/dL <1 was 37.5%, 37.3%, and 31.0%, in the whole population, MG >135 mg/dL, and ≤135 mg/dL, respectively. The cut-off value for %TBR<54 mg/dL=0% was 29.2% in MG ≤135 mg/dL. In profiles with MG ≤135 mg/dL, 94.2% of profiles with a %CV <31 achieved the target of %TBR<54 mg/dL <1, and 97.3% with a %CV <29.2 achieved the target of %TBR<54 mg/ dL=0%. When MG was >135 mg/dL, 99.4% of profiles with a %CV <37.3 achieved %TBR<54 mg/dL <1. CONCLUSION: In well-controlled T1DM with MG ≤135 mg/dL, we suggest a %CV <31% to achieve the %TBR<54 mg/dL <1 target. Furthermore, we suggest a %CV <29.2% to achieve the target of %TBR<54 mg/dL =0 for people at high risk of hypoglycemia.


Subject(s)
Blood Glucose Self-Monitoring , Blood Glucose , Diabetes Mellitus, Type 1 , Glycated Hemoglobin , Hypoglycemia , Hypoglycemic Agents , Humans , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/complications , Hypoglycemia/blood , Male , Female , Adult , Blood Glucose/analysis , Blood Glucose Self-Monitoring/methods , Glycated Hemoglobin/analysis , Middle Aged , Hypoglycemic Agents/therapeutic use , Glycemic Control/methods , Young Adult , Insulin/blood , Risk Factors , Aged , Retrospective Studies , Adolescent
16.
J Vet Intern Med ; 38(3): 1906-1916, 2024.
Article in English | MEDLINE | ID: mdl-38526076

ABSTRACT

BACKGROUND: Sepsis is a life-threatening condition for which critically important antimicrobials are often indicated. The value of blood culture for sepsis is indisputable, but appropriate guidelines on sampling and interpretation are currently lacking in cattle. OBJECTIVE: Compare the diagnostic accuracy of 2 blood culture media (pediatric plus [PP] and plus aerobic [PA]) and hypoglycemia for bacteremia detection. Estimate the contamination risk of blood cultures in critically ill calves. ANIMALS: One hundred twenty-six critically ill calves, 0 to 114 days. METHODS: Retrospective cross-sectional study in which the performance of PP, PA and hypoglycemia to diagnose sepsis was assessed using a Bayesian latent class model. A Cox proportional hazards model was used to compare time to positivity (TTP). Potential contamination was descriptively analyzed. Isolates were considered relevant when they were; member of the Enterobacterales, isolated from both blood cultures vials, or well-known, significant bovine pathogens. RESULTS: The sensitivities for PP, PA, and hypoglycemia were higher when excluding assumed contaminants; 68.7% (95% credibility interval = 30.5%-93.7%), 87.5% (47.0%-99.5%), and 61.3% (49.7%-72.4%), respectively. Specificity was estimated at 95.1% (82.2%-99.7%), 94.2% (80.7%-99.7%), and 72.4% (64.6%-79.6%), respectively. Out of 121 interpretable samples, 14.9% grew a presumed contaminant in PA, PP, or both. There was no significant difference in the TTP between PA and PP. CONCLUSIONS AND CLINICAL IMPORTANCE: PA and PP appear to outperform hypoglycemia as diagnostic tests for sepsis. PA seems most sensitive, but a larger sample size is required to verify this. Accuracy increased greatly after excluding assumed contaminants. The type of culture did not influence TTP or the contamination rate.


Subject(s)
Bayes Theorem , Blood Culture , Cattle Diseases , Culture Media , Hypoglycemia , Sensitivity and Specificity , Sepsis , Animals , Cattle , Blood Culture/veterinary , Cattle Diseases/diagnosis , Cattle Diseases/microbiology , Cattle Diseases/blood , Hypoglycemia/veterinary , Hypoglycemia/diagnosis , Hypoglycemia/blood , Retrospective Studies , Sepsis/veterinary , Sepsis/diagnosis , Sepsis/microbiology , Cross-Sectional Studies , Male , Female
17.
Neurogastroenterol Motil ; 36(5): e14763, 2024 May.
Article in English | MEDLINE | ID: mdl-38342974

ABSTRACT

BACKGROUND: Altered prandial glycemic response after Roux-en-Y gastric bypass (RYGB) is exaggerated in patients with post-RYGB hypoglycemia. Increased contribution of glucagon-like peptide 1 (GLP-1) to prandial insulin secretion plays a key role in developing hypoglycemia after RYGB, but the role of nonhormonal gut factors remains unknown. Here, the effect of vagal activation on prandial bile acid (BA) composition in relation to glucose, insulin and gut hormone responses was examined in a small size group of nondiabetic subjects after RYGB with intact gallbladder compared to nonoperated controls. METHODS: Concentrations of blood glucose, hormones, and BAs were measured in two RYGB subjects with documented hypoglycemia (HGB), three asymptomatic RYGB-treated subjects (AGB), and four nonoperated controls with intact gallbladders during a meal-tolerance test with (MTT-Sham) and without (MTT) preceding modified sham feeding (chew and spit). KEY RESULTS: Meal ingestion raised serum total BAs in RYGB-treated subjects without any effect in nonoperated controls. Modified sham feeding similarly increased meal-induced responses of conjugated BAs (CBAs) in all subjects (p < 0.05 compared to MTT alone), whereas unconjugated BAs (UBAs), mainly deoxycholic and chenodeoxycholic acid, were raised only in the HGB group (p < 0.001 for interaction). Prandial UBAs had an inverse correlation with glucose nadir (r = -0.75, p < 0.05) and were directly associated with ISR and GLP-1 during MTT-Sham. CONCLUSIONS & INFERENCES: In this small cohort, vagal activation by modified sham feeding increases prandial CBAs in both operated and nonoperated subjects but enhances UBAs only in patients with documented post-RYGB hypoglycemia. Our findings highlight a potential role for nonhormonal gut factors, such as BA and gut microbiome, in glucose abnormalities after RYGB.


Subject(s)
Bile Acids and Salts , Blood Glucose , Gastric Bypass , Hypoglycemia , Vagus Nerve , Humans , Gastric Bypass/adverse effects , Bile Acids and Salts/blood , Blood Glucose/metabolism , Male , Female , Adult , Hypoglycemia/etiology , Hypoglycemia/blood , Middle Aged , Glucagon-Like Peptide 1/blood , Insulin/blood
18.
Diabetes Technol Ther ; 26(5): 298-306, 2024 May.
Article in English | MEDLINE | ID: mdl-38277155

ABSTRACT

Objective: Determine whether continuous glucose monitor (CGM) metrics can provide actionable advance warning of an emergency department (ED) visit or hospitalization for hypoglycemic or hyperglycemic (dysglycemic) events. Research Design and Methods: Two nested case-control studies were conducted among insulin-treated diabetes patients at Kaiser Permanente, who shared their CGM data with their providers. Cases included dysglycemic events identified from ED and hospital records (2016-2021). Controls were selected using incidence density sampling. Multiple CGM metrics were calculated among patients using CGM >70% of the time, using CGM data from two lookback periods (0-7 and 8-14 days) before each event. Generalized estimating equations were specified to estimate odds ratios and C-statistics. Results: Among 3626 CGM users, 108 patients had 154 hypoglycemic events and 165 patients had 335 hyperglycemic events. Approximately 25% of patients had no CGM data during either lookback; these patients had >2 × the odds of a hypoglycemic event and 3-4 × the odds of a hyperglycemic event. While several metrics were strongly associated with a dysglycemic event, none had good discrimination. Conclusion: Several CGM metrics were strongly associated with risk of dysglycemic events, and these can be used to identify higher risk patients. Also, patients who are not using their CGM device may be at elevated risk of adverse outcomes. However, no CGM metric or absence of CGM data had adequate discrimination to reliably provide actionable advance warning of an event and thus justify a rapid intervention.


Subject(s)
Blood Glucose Self-Monitoring , Blood Glucose , Emergency Service, Hospital , Hospitalization , Hyperglycemia , Hypoglycemia , Humans , Hypoglycemia/epidemiology , Hypoglycemia/blood , Emergency Service, Hospital/statistics & numerical data , Male , Female , Hyperglycemia/epidemiology , Hyperglycemia/blood , Middle Aged , Hospitalization/statistics & numerical data , Blood Glucose/analysis , Case-Control Studies , Blood Glucose Self-Monitoring/instrumentation , Aged , Predictive Value of Tests , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/adverse effects , Adult , Insulin/administration & dosage , Insulin/therapeutic use , Insulin/adverse effects , Diabetes Mellitus, Type 2/blood , Emergency Room Visits
19.
Diabetes Technol Ther ; 26(5): 313-323, 2024 May.
Article in English | MEDLINE | ID: mdl-38156962

ABSTRACT

Background: Few studies have evaluated the implications of the alarm thresholds of continuous glucose monitoring (CGM) systems for individuals with diabetes. The present study aimed to investigate the influence of hypoglycemia and hyperglycemia alarm thresholds on glycemic control in adults with type 1 diabetes (T1DM) and the characteristics of patients who use these alarms more frequently. Methods: This observational cross-sectional study included 873 users of the FreeStyle Libre 2 system (501 men, median age 48 years, range 18-90 years) with T1DM from a single center. We investigated the role of demographic and metabolic factors on the use of alarms and the impact of hypoglycemia and hyperglycemia alarms and their thresholds on glycemic control. Results: Alarm users were older than nonusers (median age 49 vs. 43 years, respectively; P < 0.001). The hypoglycemia alarms were set by 76.1% of women and by 69.1% of men (P = 0.022). The hypoglycemia alarms reduced hypoglycemia features and glucose variability, although at the expense of shorter time in range. The higher the hypoglycemia alarm threshold, the greater these effects. The hyperglycemia alarms were effective in reducing hyperglycemia and lowering the glucose management indicator, although at the expense of a greater tendency to hypoglycemia. The lower the hyperglycemia alarm threshold, the greater these effects. Conclusions: CGM alarms contribute to better glycemic control. However, hypoglycemia and hyperglycemia alarms have advantages and disadvantages. Adults with T1DM should explore, under medical supervision, which alarm thresholds will best help them achieve their individual glycemic goals.


Subject(s)
Blood Glucose Self-Monitoring , Blood Glucose , Clinical Alarms , Diabetes Mellitus, Type 1 , Glycemic Control , Hyperglycemia , Hypoglycemia , Humans , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/complications , Male , Adult , Female , Middle Aged , Hypoglycemia/prevention & control , Hypoglycemia/blood , Cross-Sectional Studies , Aged , Blood Glucose Self-Monitoring/instrumentation , Hyperglycemia/blood , Young Adult , Adolescent , Blood Glucose/analysis , Aged, 80 and over , Continuous Glucose Monitoring
20.
Clin Chim Acta ; 548: 117516, 2023 Aug 01.
Article in English | MEDLINE | ID: mdl-37598742

ABSTRACT

BACKGROUND: Insulin is essential for glycemic regulation but diseases can cause a default or an excess of insulin secretion leading to dysregulated glycemia. Hence, measurement of insulinemia is useful to investigate hypoglycemia, determine the pathogenesis of diabetes and evaluate ß-cell function. Thus, diabetic patients need supplementation with recombinant human insulin and/or insulin analogues. Analogues have primary sequences different from native human insulin and may not be detected by some immunoassays. The objective of our study was to evaluate new insulin immunoassays by determining their ability to detect different types of human insulin or analogues. METHODS: This study compared the reactivity of two new insulin immunoassays with five well-established immunoassays on ten commercial insulins. We also measured insulin in blood samples from diabetic or pancreas transplant patients with known treatment. RESULTS: Contrary to recombinant human insulin, there were differences in the specificity to insulin analogues. We distinguished three immunoassay categories: those recognizing all types of insulin such as the non-specific BI-INS-IRMA®, Architect® and Access® immunoassays; those recognizing human insulin only (Cobas®); and those recognizing human insulin and analogues in variable proportions (Liaison XL®, iFlash® and Maglumi®). CONCLUSION: An accurate biological interpretation of insulinemia relies on knowledge of the specificity of the immunoassay used.


Subject(s)
Insulin Secretion , Insulin , Humans , Hypoglycemia/blood , Immunoassay , Insulin/blood , Insulin-Secreting Cells
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