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1.
Tunis Med ; 102(4): 235-240, 2024 Apr 05.
Article in French | MEDLINE | ID: mdl-38746964

ABSTRACT

INTRODUCTION-AIM: Flexible insulin therapy is currently considered the gold standard therapy of type 1 diabetes. We aimed to study the evolution of glycemic control, weight and nutritional intake of a group of patients with type 1 diabetes, three months after the initiation of functional insulin therapy (FIT). METHODS: This was a prospective longitudinal study having included 30 type 1 diabetic patients hospitalized for education to FIT. Each patient underwent an assessment of glycemic control (glycated hemoglobin (A1C) and number of hypoglycemia), weight and nutritional intake before FIT and 3 months after the initiation of this educative approach. RESULTS: The mean age of patients was 21,8 ± 7,9 years and the sex ratio was 0,5. The mean duration of diabetes was 7,2 ± 6 years. Three months after initiation of FIT, we observed a significant lowering of A1C, which went from 9,2 ± 1,6% to 8,3 ± 1,4% (p<0,001) of the number of minor hypoglycemia (p=0,001) and that of severe hypoglycemia (p= 0,021). the average weight went from 64,6 ± 13,1 kg to 65,5 ± 13,5 kg (p = 0,040) with a significant increase in BMI (p = 0,041). Weight gain was observed in 67% of patients. This weight gain contrasted with a significant decrease in caloric (p = 0,040) and in carbohydrates intakes (p = 0,027). CONCLUSION: Weight gain, associated with better glycemic control, should encourage the healthcare team to strengthen therapeutic education of patients undergoing FIT in order to limit weight gain.


Subject(s)
Body Weight , Diabetes Mellitus, Type 1 , Hypoglycemic Agents , Insulin , Humans , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/blood , Female , Male , Insulin/administration & dosage , Insulin/therapeutic use , Adult , Young Adult , Prospective Studies , Longitudinal Studies , Adolescent , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/therapeutic use , Body Weight/physiology , Glycated Hemoglobin/analysis , Glycated Hemoglobin/metabolism , Hypoglycemia/prevention & control , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Glycemic Control/methods , Energy Intake , Weight Gain/physiology , Weight Gain/drug effects , Time Factors , Blood Glucose/analysis , Blood Glucose/metabolism
2.
BMC Pregnancy Childbirth ; 24(1): 335, 2024 May 02.
Article in English | MEDLINE | ID: mdl-38698309

ABSTRACT

BACKGROUND: Diabetes mellitus (DM) is the most common metabolic disorder in pregnancy. Women with Type 2 DM seems to have no better perinatal outcomes than those with Type 1 DM. METHODS: Single-center prospective cohort observational study. Pregnant women with diabetes (141 with Type 1 DM and 124 with Type 2 DM) that were followed in the university hospital between 2009 and 2021 were included in this study. Clinical data and obstetric and perinatal outcomes were collected. RESULTS: As expected, women with Type 1 DM were younger and had a longer duration of diabetes than women with Type 2 DM. Obesity and chronic hypertension were higher in the group of women with Type 2 DM and their value of HbA1c in the second and third trimesters were lower than in Type 1 DM. No differences in prematurity were found, but more extreme prematurity was observed in Type 2 DM, as well as a higher rate of congenital malformations. The frequency of hypoglycemia and the weight of the newborn was higher in Type 1 DM. The maternal independent factors related to the weight of the newborn were: the glycemic control at the third trimester, the weight gain during pregnancy, and pregestational BMI. CONCLUSIONS: Newborns born to mothers with Type 1 DM were larger and had a higher frequency of hypoglycemia, while congenital malformations and precocious preterm was more associated to Type 2 DM. Metabolic control, weight gain and pregestational weight were important determinants of both obstetric and neonatal complications.


Subject(s)
Congenital Abnormalities , Diabetes Mellitus, Type 1 , Diabetes Mellitus, Type 2 , Pregnancy in Diabetics , Premature Birth , Humans , Female , Pregnancy , Pregnancy in Diabetics/epidemiology , Diabetes Mellitus, Type 1/complications , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/epidemiology , Adult , Prospective Studies , Infant, Newborn , Congenital Abnormalities/epidemiology , Premature Birth/epidemiology , Hypoglycemia/epidemiology , Hypoglycemia/etiology , Birth Weight , Body Mass Index , Glycated Hemoglobin/analysis , Pregnancy Outcome/epidemiology
3.
BMJ Open Diabetes Res Care ; 12(3)2024 May 14.
Article in English | MEDLINE | ID: mdl-38749508

ABSTRACT

The objective of this review was to comprehensively present and summarize trends in reported rates of hypoglycemia with one or two times per day basal insulin analogs in individuals with type 2 diabetes to help address and contextualize the emerging theoretical concern of increased hypoglycemic risk with once-weekly basal insulins.Hypoglycemia data were extracted from treat-to-target randomized clinical trials conducted during 2000-2022. Published articles were identified on PubMed or within the US Food and Drug Administration submission documents. Overall, 57 articles were identified: 44 assessed hypoglycemic outcomes in participants receiving basal-only therapy (33 in insulin-naive participants; 11 in insulin-experienced participants), 4 in a mixed population (insulin-naive and insulin-experienced participants) and 9 in participants receiving basal-bolus therapy. For the analysis, emphasis was placed on level 2 (blood glucose <3.0 mmol/L (<54 mg/dL)) and level 3 (or severe) hypoglycemia.Overall, event rates for level 2 or level 3 hypoglycemia across most studies ranged from 0.06 to 7.10 events/person-year of exposure (PYE) for participants receiving a basal-only insulin regimen; the rate for basal-bolus regimens ranged from 2.4 to 13.6 events/PYE. Rates were generally lower with second-generation basal insulins (insulin degludec or insulin glargine U300) than with neutral protamine Hagedorn insulin or first-generation basal insulins (insulin detemir or insulin glargine U100). Subgroup categorization by sulfonylurea usage, end-of-treatment insulin dose or glycated hemoglobin reduction did not show consistent trends on overall hypoglycemia rates. Hypoglycemia rates reported so far for once-weekly basal insulins are consistent with or lower than those reported for daily-administered basal insulin analogs.


Subject(s)
Diabetes Mellitus, Type 2 , Hypoglycemia , Hypoglycemic Agents , Randomized Controlled Trials as Topic , Humans , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/administration & dosage , Blood Glucose/analysis , Insulin/therapeutic use , Insulin/analogs & derivatives , Insulin/administration & dosage , Insulin/adverse effects , Insulin, Long-Acting/therapeutic use , Insulin, Long-Acting/adverse effects , Insulin Glargine/therapeutic use , Insulin Glargine/administration & dosage , Insulin Glargine/adverse effects , Glycated Hemoglobin/analysis
4.
Medicina (Kaunas) ; 60(4)2024 Mar 28.
Article in English | MEDLINE | ID: mdl-38674198

ABSTRACT

Background and Objectives: Liver cancer poses a significant global health threat, ranking among the top three causes of cancer-related deaths. Patients with hepatocellular carcinoma (HCC) often present with symptoms associated with neoplasms or unusual clinical features such as paraneoplastic syndromes (PNS), including hypoglycemia, hypercholesterolemia, thrombocytosis, and erythrocytosis. Our study aimed to investigate the prevalence, clinical characteristics, and survival outcomes associated with PNS in HCC patients and assess each PNS's impact on patient survival. Materials and Methods: We conducted a retrospective analysis of PNS clinical features and survival among consecutive HCC patients diagnosed at our department over seven years, comparing them with HCC patients without PNS. The study involved a retrospective data evaluation from 378 patients diagnosed with HCC between January 2016 and October 2023. Results: We obtained a PNS prevalence of 25.7%, with paraneoplastic hypercholesterolemia at 10.9%, hypoglycemia at 6.9%, erythrocytosis at 4.5%, and thrombocytosis at 3.4%. Patients with PNS tended to be younger and predominantly male. Multivariate analysis revealed a strong correlation between PNS and levels of alpha-fetoprotein and tumor size, with diabetes also showing a significant statistical association (p < 0.05). Subgroup analysis based on specific paraneoplastic syndromes demonstrated shorter survival in patients with PNS, albeit without significant statistical differences, except for hypoglycemia (p < 0.0001). Matched analysis indicated a shorter survival rate for patients with PNS, although no significant statistical differences were observed. Conclusions: PNS are frequently observed in HCC cases and are associated with unfavorable prognoses and decreased survival rates due to their correlation with increased tumor burdens. However, they do not independently predict poor survival. The impact of individual PNS on HCC prognosis varies.


Subject(s)
Carcinoma, Hepatocellular , Liver Neoplasms , Paraneoplastic Syndromes , Humans , Male , Retrospective Studies , Carcinoma, Hepatocellular/mortality , Carcinoma, Hepatocellular/epidemiology , Carcinoma, Hepatocellular/complications , Female , Paraneoplastic Syndromes/epidemiology , Paraneoplastic Syndromes/mortality , Middle Aged , Liver Neoplasms/mortality , Liver Neoplasms/epidemiology , Liver Neoplasms/complications , Aged , Prevalence , Adult , Survival Analysis , Hypercholesterolemia/epidemiology , Hypercholesterolemia/complications , Hypoglycemia/epidemiology , Hypoglycemia/complications , Polycythemia/epidemiology , Polycythemia/complications , Aged, 80 and over , Thrombocytosis/epidemiology , Thrombocytosis/complications
5.
PLoS Med ; 21(4): e1004369, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38607977

ABSTRACT

BACKGROUND: Older adults with diabetes are at high risk of severe hypoglycemia (SH). Many machine-learning (ML) models predict short-term hypoglycemia are not specific for older adults and show poor precision-recall. We aimed to develop a multidimensional, electronic health record (EHR)-based ML model to predict one-year risk of SH requiring hospitalization in older adults with diabetes. METHODS AND FINDINGS: We adopted a case-control design for a retrospective territory-wide cohort of 1,456,618 records from 364,863 unique older adults (age ≥65 years) with diabetes and at least 1 Hong Kong Hospital Authority attendance from 2013 to 2018. We used 258 predictors including demographics, admissions, diagnoses, medications, and routine laboratory tests in a one-year period to predict SH events requiring hospitalization in the following 12 months. The cohort was randomly split into training, testing, and internal validation sets in a 7:2:1 ratio. Six ML algorithms were evaluated including logistic-regression, random forest, gradient boost machine, deep neural network (DNN), XGBoost, and Rulefit. We tested our model in a temporal validation cohort in the Hong Kong Diabetes Register with predictors defined in 2018 and outcome events defined in 2019. Predictive performance was assessed using area under the receiver operating characteristic curve (AUROC), area under the precision-recall curve (AUPRC) statistics, and positive predictive value (PPV). We identified 11,128 SH events requiring hospitalization during the observation periods. The XGBoost model yielded the best performance (AUROC = 0.978 [95% CI 0.972 to 0.984]; AUPRC = 0.670 [95% CI 0.652 to 0.688]; PPV = 0.721 [95% CI 0.703 to 0.739]). This was superior to an 11-variable conventional logistic-regression model comprised of age, sex, history of SH, hypertension, blood glucose, kidney function measurements, and use of oral glucose-lowering drugs (GLDs) (AUROC = 0.906; AUPRC = 0.085; PPV = 0.468). Top impactful predictors included non-use of lipid-regulating drugs, in-patient admission, urgent emergency triage, insulin use, and history of SH. External validation in the HKDR cohort yielded AUROC of 0.856 [95% CI 0.838 to 0.873]. Main limitations of this study included limited transportability of the model and lack of geographically independent validation. CONCLUSIONS: Our novel-ML model demonstrated good discrimination and high precision in predicting one-year risk of SH requiring hospitalization. This may be integrated into EHR decision support systems for preemptive intervention in older adults at highest risk.


Subject(s)
Diabetes Mellitus , Hypoglycemia , Humans , Aged , Electronic Health Records , Retrospective Studies , Hypoglycemia/diagnosis , Hypoglycemia/epidemiology , Diabetes Mellitus/diagnosis , Diabetes Mellitus/epidemiology , Hospitalization , Machine Learning
6.
Diabetes Care ; 47(6): 1065-1073, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38640020

ABSTRACT

OBJECTIVE: To examine trends in incidence of acute diabetes complications in individuals with type 1 or type 2 diabetes with and without severe mental illness (SMI) in Denmark by age and calendar year. RESEARCH DESIGN AND METHODS: We conducted a cohort study using nationwide registers from 1996 to 2020 to identify individuals with diabetes, ascertain SMI status (namely, schizophrenia, bipolar disorder, or major depression) and identify the outcomes: hospitalization for hypoglycemia and diabetic ketoacidosis (DKA). We used Poisson regression to estimate incidence rates (IRs) and incidence rate ratios (IRRs) of recurrent hypoglycemia and DKA events by SMI, age, and calendar year, accounting for sex, diabetes duration, education, and country of origin. RESULTS: Among 433,609 individuals with diabetes, 8% had SMI. Risk of (first and subsequent) hypoglycemia events was higher for individuals with SMI than for those without SMI (for first hypoglycemia event, IRR: type 1 diabetes, 1.77 [95% CI 1.56-2.00]; type 2 diabetes, 1.64 [95% CI 1.55-1.74]). Individuals with schizophrenia were particularly at risk for recurrent hypoglycemia events. The risk of first DKA event was higher in individuals with SMI (for first DKA event, IRR: type 1 diabetes, 1.78 [95% CI 1.50-2.11]; type 2 diabetes, 1.85 [95% CI 1.64-2.09]). Except for DKA in the type 2 diabetes group, IR differences between individuals with and without SMI were highest in younger individuals (<50 years old) but stable across the calendar year. CONCLUSIONS: SMI is an important risk factor for acute diabetes complication and effective prevention is needed in this population, especially among the younger population and those with schizophrenia.


Subject(s)
Diabetes Mellitus, Type 1 , Diabetes Mellitus, Type 2 , Diabetic Ketoacidosis , Hospitalization , Hypoglycemia , Humans , Hypoglycemia/epidemiology , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 2/complications , Diabetic Ketoacidosis/epidemiology , Denmark/epidemiology , Male , Diabetes Mellitus, Type 1/epidemiology , Diabetes Mellitus, Type 1/complications , Female , Adult , Middle Aged , Hospitalization/statistics & numerical data , Incidence , Aged , Young Adult , Adolescent , Mental Disorders/epidemiology , Cohort Studies
7.
Diabetes Obes Metab ; 26(7): 2811-2819, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38637981

ABSTRACT

AIM: To assess the impact of insulin glargine (100 U/mL) and lixisenatide (iGlarLixi) fixed-ratio combination therapy on the overall management of glycaemia in patients with type 2 diabetes (T2D), previously inadequately controlled with oral antidiabetic drugs ± basal insulin or glucagon-like peptide-1 receptor agonists (GLP-1 RAs). MATERIALS AND METHODS: This 12-month, international, multicentre, prospective, observational study included patients (age ≥ 18 years) with T2D who had initiated iGlarLixi within 1 month prior to study inclusion. Data were collected at study inclusion, month 3, month 6 and month 12 from patient diaries, self-measured plasma glucose, and questionnaires. The primary endpoint was change in HbA1c from baseline to month 6. RESULTS: Of the 737 eligible participants (mean age: 57.8 [standard deviation: 11.2] years; male: 49%), 685 had baseline and post-baseline HbA1c data available. The least squares mean change in HbA1c from baseline to month 6 was -1.4% (standard error [95% confidence interval (CI)]: 0.05 [-1.5, -1.3]). The absolute change from baseline at month 12 was -1.7% ± 1.9% (95% CI: -1.9, -1.5). There were 72 hypoglycaemia events reported during the study period, with a very low incidence of severe hypoglycaemia (two participants [rate: 0.003 events per patient-year]). CONCLUSIONS: This real-world observational study shows that initiation of iGlarLixi in people with T2D inadequately controlled on oral antidiabetic drugs ± basal insulin or GLP-1 RAs improves glycaemic control with a low incidence of hypoglycaemia.


Subject(s)
Diabetes Mellitus, Type 2 , Glycated Hemoglobin , Hypoglycemia , Hypoglycemic Agents , Insulin Glargine , Peptides , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/blood , Male , Female , Middle Aged , Insulin Glargine/administration & dosage , Insulin Glargine/therapeutic use , Insulin Glargine/adverse effects , Prospective Studies , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/adverse effects , Aged , Glycated Hemoglobin/analysis , Glycated Hemoglobin/drug effects , Glycated Hemoglobin/metabolism , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Peptides/administration & dosage , Peptides/therapeutic use , Peptides/adverse effects , Blood Glucose/drug effects , Blood Glucose/metabolism , Treatment Outcome , Adult , Drug Therapy, Combination , Glucagon-Like Peptide-2 Receptor
8.
J Diabetes Complications ; 38(5): 108742, 2024 05.
Article in English | MEDLINE | ID: mdl-38581842

ABSTRACT

AIMS: To compare the efficacy and safety of basal-plus (BP) insulin regimen with or without sitagliptin in non-critically ill patients with type 2 diabetes (T2D). METHODS: This open-label, randomized clinical trial included inpatients with a previous diagnosis of T2D and blood glucose (BG) between 180 and 400 mg/dL. Participants received basal and correctional insulin doses (BP regimen) either with or without sitagliptin. The primary outcome was the difference in the mean daily BG among the groups. RESULTS: Seventy-six patients (mean age 60 years, 64 % men) were randomized. Compared with BP insulin therapy alone, the sitagliptin-BP combination led to a lower mean daily BG (158.8 vs 175.0 mg/dL, P = 0.014), a higher percentage of readings within a BG range of 70-180 mg/dL (75.9 % vs 64.7 %, P < 0.001), and a lower number of BG readings >180 mg/dL (P < 0.001). Sitagliptin-BP resulted in fewer basal and supplementary insulin doses (P = 0.024 and P = 0.017, respectively) and lower daily insulin injections (P = 0.023) than those with insulin alone. The proportion of patients with hypoglycemia was similar in the two groups. CONCLUSIONS: For inpatients with T2D and hyperglycemia, the sitagliptin and BP regimen combination is safe and more effective than insulin therapy alone. CLINICALTRIALS: gov identifier: NCT05579119.


Subject(s)
Blood Glucose , Diabetes Mellitus, Type 2 , Drug Therapy, Combination , Hypoglycemic Agents , Sitagliptin Phosphate , Humans , Sitagliptin Phosphate/administration & dosage , Sitagliptin Phosphate/therapeutic use , Sitagliptin Phosphate/adverse effects , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/blood , Male , Middle Aged , Female , Aged , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Blood Glucose/drug effects , Blood Glucose/analysis , Blood Glucose/metabolism , Insulin/administration & dosage , Insulin/adverse effects , Insulin/therapeutic use , Hospitalization/statistics & numerical data , Treatment Outcome , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology
9.
PLoS One ; 19(4): e0301803, 2024.
Article in English | MEDLINE | ID: mdl-38687725

ABSTRACT

BACKGROUND: Hypoglycemia is the commonest metabolic abnormality encountered in newborns. Besides, there is a growing body of evidence that links the causes of early neonatal mortality to neonatal hypoglycemia in Tanzania. However exact factors associated with asymptomatic hypoglycemia in preterm newborns are not known. OBJECTIVE: To assess factors associated with asymptomatic hypoglycemia among preterm newborns. MATERIALS AND METHODS: A cross sectional, analytical hospital- based study was carried out at Dar es salaam public regional referral hospitals. Preterm newborns with asymptomatic hypoglycemia were the target population. Data on demographic and clinical characteristics of preterm newborns and their mothers were collected and analyzed using Epi-Info™ software version 7.4. Main data analysis was done by applying a multivariable binary logistic regression model with neonatal random glycaemia coded in a binary fashion at a cut-off point of 2.6 mmol/L. An α-level of 5% was used as a limit of type I error. RESULTS: We recruited and analysed 217 preterm newborns within 6-24 hours post-delivery. Male: Female = 1.1:1 (females n = 105, 48.4%). Median glycemic level was 2.6 (IQR; 2.1-3.9) mmol/L. Median gestational age at delivery was 33 (IQR: 30-35) weeks. Breastfeeding within 1st hour post-delivery was a statistically significant factor against glycemic levels associated with hypoglycemia (OR; 0.123, 95%-CI; 0.052-0.287) in a fitted multivariable logistic regression model. CONCLUSION: About half of all preterm newborns studied had glycemic values in a statistical range associated with hypoglycemia. Exclusive breast feeding within 1st hour post-delivery was associated with glycemic levels protective from risk of asymptomatic neonatal hypoglycemia. RECOMMENDATIONS: Exclusive breastfeeding practices within 1st hour post-delivery may need to be emphasized to all expectant mothers in order to avoid potential risk of asymptomatic hypoglycemia in preterm newborns.


Subject(s)
Hypoglycemia , Infant, Premature , Humans , Hypoglycemia/epidemiology , Infant, Newborn , Female , Cross-Sectional Studies , Male , Blood Glucose/analysis , Blood Glucose/metabolism , Tanzania/epidemiology , Gestational Age , Breast Feeding , Adult , Risk Factors , Logistic Models
10.
JAMA Netw Open ; 7(3): e243683, 2024 Mar 04.
Article in English | MEDLINE | ID: mdl-38530314

ABSTRACT

Importance: The circumstances under which neonatal hypoglycemia leads to brain damage remain unclear due to a lack of long-term data on the neurodevelopment of affected children. As a result, diagnostic strategies and treatment recommendations are inconsistent. Objective: To evaluate whether the occurrence of severe transitional neonatal hypoglycemia (defined as having at least 1 blood glucose measurement of 30 mg/dL or below) is associated with adverse neurodevelopment in midchildhood. Design, Setting, and Participants: This cohort study using neurodevelopmental testing of a retrospectively recruited cohort was conducted at a single-center tertiary hospital in Germany between March 2022 and February 2023. Children with neonatal blood glucose screening data were randomly selected from all births between 2010 and 2015. Frequency matching for sex, birth weight, gestational age, socioeconomic status, and primary risk factors for neonatal hypoglycemia was performed. Children with persistent hypoglycemia diseases or any risk factor for adverse neurodevelopment except hypoglycemia were excluded. Data were analyzed between February 2023 and March 2023. Exposure: At least 1 neonatal hypoglycemia measurement with blood glucose measuring 30 mg/dL or below vs all measured blood glucose levels above 30 mg/dL during postnatal blood glucose screening starting on the first day of life. Main Outcomes and Measures: Cognitive function measured by full-scale IQ test. Secondary outcomes included standardized scales of motor, visual, and executive functions, and child behavior, each measured at ages 7 to 11 years. Results: A total of 140 children (mean [SD] age 9.1 [1.3] years; 77 male [55.0%]) participated in the study. Children with severe neonatal hypoglycemia had a 4.8 points lower mean full-scale IQ than controls (107.0 [95% CI, 104.0-109.9] vs 111.8 [95% CI, 108.8-114.8]). They showed a 4.9-fold (95% CI, 1.5-15.5) increased odds of abnormal fine motor function and a 5.3-fold (95% CI, 2.1-13.3) increased odds of abnormal visual-motor integration. Significantly higher T scores for attention problems (58.2 [95% CI, 56.1-60.2] vs 54.6 [95% CI, 52.6-56.6]) and attention-deficit/hyperactivity disorder symptoms (58.2 [95% CI, 56.2-60.2] vs 54.7 [95% CI, 52.8-56.7]) were reported by parents. Conclusions and Relevance: Neonatal hypoglycemia with blood glucose levels of 30 mg/dL or below was associated with an increased risk for suboptimal neurodevelopmental outcomes in midchildhood. These findings imply that treatment strategies should aim to prevent episodes of hypoglycemia at these severely low levels.


Subject(s)
Hypoglycemia , Infant, Newborn, Diseases , Child , Infant, Newborn , Humans , Male , Blood Glucose , Cohort Studies , Retrospective Studies , Hypoglycemia/diagnosis , Hypoglycemia/epidemiology , Infant, Newborn, Diseases/diagnosis , Infant, Newborn, Diseases/epidemiology , Acute Disease
11.
Diabetes Res Clin Pract ; 210: 111642, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38548109

ABSTRACT

AIMS: We examined severe hospitalised hypoglycaemia (SHH) rates in people with type 1 and type 2 diabetes in Scotland during 2016-2022, stratifying by sociodemographics. METHODS: Using the Scottish National diabetes register (SCI-Diabetes), we identified people with type 1 and type 2 diabetes alive anytime during 2016-2022. SHH events were determined through linkage to hospital admission and death registry data. We calculated annual SHH rates overall and by age, sex, and socioeconomic status. Summary estimates of time and stratum effects were obtained by fitting adjusted generalised additive models using R package mgcv. RESULTS: Rates for those under 20 with type 1 diabetes reached their minimum at the 2020-2021 transition, 30% below the study period average. A gradual decline over time also occurred among 20-49-year-olds with type 1 diabetes. Overall, females had 15% higher rates than males with type 2 diabetes (rate ratio 1.15, 95% CI 1.08-1.22). People in the most versus least deprived quintile experienced 2.58 times higher rates (95% CI 2.27-2.93) in type 1 diabetes and 2.33 times higher (95% CI 2.08-2.62) in type 2 diabetes. CONCLUSIONS: Despite advances in care, SHH remains a significant problem in diabetes. Future efforts must address the large socioeconomic disparities in SHH risks.


Subject(s)
Diabetes Mellitus, Type 1 , Diabetes Mellitus, Type 2 , Hypoglycemia , Male , Female , Humans , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 1/complications , Diabetes Mellitus, Type 1/epidemiology , Cohort Studies , Hypoglycemia/epidemiology , Scotland/epidemiology
12.
Diabetes Obes Metab ; 26(6): 2248-2256, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38456558

ABSTRACT

AIM: To evaluate the long-term safety and efficacy of enavogliflozin 0.3 mg/day added to metformin in patients with type 2 diabetes mellitus. MATERIALS AND METHODS: After 24 weeks of a randomized, double-blind treatment period with enavogliflozin 0.3 mg/day (n = 101) or dapagliflozin 10 mg/day (n = 99) added to metformin, all patients received enavogliflozin 0.3 mg/day plus metformin for an additional 28 weeks during the open-label extension period. RESULTS: Eighty-two patients continued enavogliflozin (maintenance group), and 77 were switched from dapagliflozin to enavogliflozin (switch group). All adverse drug reactions (ADR) were mild in severity. In the maintenance group, ADRs (cystitis and vaginal infection) were reported in two patients (2.44%) during 52 weeks. In the switch group, ADR (hypoglycaemia) was reported in one patient (1.30%) during a 28-week open-label extension period. At week 52, glycated haemoglobin and fasting plasma glucose were significantly lower than at the baseline, by 0.85% and 29.08 mg/dl, respectively, in the maintenance group (p < .0001 for both), and by 0.81% and 32.77 mg/dl, respectively, in the switch group (p < .0001 for both). At week 52, 68.92% of patients from the maintenance group and 64.29% from the switch group achieved glycated haemoglobin <7%. A significant increase in the urine glucose-creatinine ratio was observed at week 52, by 58.81 g/g and 63.77 g/g in the maintenance and switch groups, respectively (p < .0001). CONCLUSIONS: Enavogliflozin added to metformin was tolerated well for up to 52 weeks and provided continual glycaemic control in type 2 diabetes mellitus, along with a significant increase in the urine glucose-creatinine ratio.


Subject(s)
Benzhydryl Compounds , Blood Glucose , Diabetes Mellitus, Type 2 , Drug Therapy, Combination , Glucosides , Glycated Hemoglobin , Hypoglycemic Agents , Metformin , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/complications , Benzhydryl Compounds/adverse effects , Benzhydryl Compounds/therapeutic use , Glucosides/adverse effects , Glucosides/therapeutic use , Glucosides/administration & dosage , Metformin/adverse effects , Metformin/therapeutic use , Metformin/administration & dosage , Female , Middle Aged , Male , Drug Therapy, Combination/adverse effects , Double-Blind Method , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/administration & dosage , Glycated Hemoglobin/analysis , Glycated Hemoglobin/metabolism , Glycated Hemoglobin/drug effects , Blood Glucose/drug effects , Blood Glucose/metabolism , Aged , Treatment Outcome , Sodium-Glucose Transporter 2 Inhibitors/adverse effects , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Sodium-Glucose Transporter 2 Inhibitors/administration & dosage , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Adult , Benzofurans
13.
Am J Obstet Gynecol MFM ; 6(5): 101346, 2024 May.
Article in English | MEDLINE | ID: mdl-38479488

ABSTRACT

OBJECTIVE: This was a systematic review and meta-analysis comparing maternal and neonatal outcomes of patients screened with the 1-step or 2-step screening method for gestational diabetes mellitus. DATA SOURCES: PubMed, Scopus, Cochrane, ClinicalTrials.gov, and LILACS were searched from inception up to September 2022. STUDY ELIGIBILITY CRITERIA: Only randomized controlled trials were included. Studies that had overlapping populations were excluded (International Prospective Register of Systematic Review registration number: CRD42022358903). METHODS: Risk ratios were computed with 95% confidence intervals by 2 authors. Unpublished data were requested. Large for gestational age was the primary outcome. RESULTS: The search yielded 394 citations. Moreover, 7 randomized controlled trials met the inclusion criteria. A total of 54,650 participants were screened for gestational diabetes mellitus by either the 1-step screening method (n=27,163) or the 2-step screening method (n=27,487). For large for gestational age, there was no significant difference found between the groups (risk ratio, 0.99; 95% confidence interval, 0.93-1.05; I2=0%). Newborns of patients who underwent 1-step screening had higher rates of neonatal hypoglycemia (risk ratio, 1.24; 95% confidence interval, 1.14-1.34; I2=0%) and neonatal intensive care unit admissions (risk ratio, 1.13; 95% confidence interval, 1.04-1.21; I2=0%) than newborns of patients who underwent 2-step screening. Patients in the 1-step screening method group were more likely to be diagnosed with gestational diabetes mellitus (risk ratio, 1.73; 95% confidence interval, 1.44-2.09; I2=80%) than patients in the 2-step screening method group. In addition, among trials that tested all patients before randomization and excluded patients with pregestational diabetes mellitus, newborns were more likely to have macrosomia (risk ratio, 1.27; 95% confidence interval, 1.21-1.34; I2=0%). Overall risk of bias assessment was of low concern. CONCLUSION: Large for gestational age did not differ between patients screened using the 1-step screening method and those screened using the 2-step screening method. However, patients randomized to the 1-step screening method had higher rates of neonatal hypoglycemia and neonatal intensive care unit admission and maternal gestational diabetes mellitus diagnosis than the patients randomized to the 2-step screening method.


Subject(s)
Diabetes, Gestational , Pregnancy Outcome , Humans , Diabetes, Gestational/diagnosis , Diabetes, Gestational/epidemiology , Pregnancy , Female , Infant, Newborn , Pregnancy Outcome/epidemiology , Mass Screening/methods , Fetal Macrosomia/epidemiology , Fetal Macrosomia/diagnosis , Hypoglycemia/diagnosis , Hypoglycemia/epidemiology , Randomized Controlled Trials as Topic/methods
14.
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
15.
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
16.
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
17.
Endocrinol Metab (Seoul) ; 39(1): 109-126, 2024 02.
Article in English | MEDLINE | ID: mdl-38417828

ABSTRACT

BACKGRUOUND: No recent meta-analysis has holistically analyzed and summarized the efficacy and safety of omarigliptin in type 2 diabetes mellitus (T2DM). We conducted a meta-analysis to address this knowledge gap. METHODS: Electronic databases were searched to identify randomized controlled trials (RCTs) that included patients with T2DM who received omarigliptin in the intervention arm. The control arm consisted of either a placebo (passive control group [PCG]) or an active comparator (active control group [ACG]). The primary outcome assessed was changes in hemoglobin A1c (HbA1c), while secondary outcomes included variations in glucose levels, achievement of glycemic targets, adverse events (AEs), and hypoglycemic events. RESULTS: From 332 initially screened articles, data from 16 RCTs involving 8,804 subjects were analyzed. Omarigliptin demonstrated superiority over placebo in reducing HbA1c levels (mean difference, -0.58%; 95% confidence interval, -0.75 to -0.40; P<0.00001; I2=91%). Additionally, omarigliptin outperformed placebo in lowering fasting plasma glucose, 2-hour postprandial glucose, and in the percentage of participants achieving HbA1c levels below 7.0% and 6.5%. The glycemic efficacy of omarigliptin was similar to that of the ACG across all measures. Although the omarigliptin group experienced a higher incidence of hypoglycemic events compared to the PCG, the overall AEs, serious AEs, hypoglycemia, and severe hypoglycemia were comparable between the omarigliptin and control groups (PCG and ACG). CONCLUSION: Omarigliptin has a favorable glycemic efficacy and safety profile for managing T2DM.


Subject(s)
Diabetes Mellitus, Type 2 , Dipeptidyl-Peptidase IV Inhibitors , Heterocyclic Compounds, 2-Ring , Hypoglycemia , Pyrans , Humans , Dipeptidyl-Peptidase IV Inhibitors/adverse effects , Glycated Hemoglobin , Blood Glucose/analysis , Hypoglycemic Agents/adverse effects , Diabetes Mellitus, Type 2/complications , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Dipeptidyl-Peptidases and Tripeptidyl-Peptidases/therapeutic use
18.
Diabetes Res Clin Pract ; 209: 111567, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38341039

ABSTRACT

AIM: To investigate safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus (T2DM) observing fast during Ramadan from Gulf countries. METHODS: This planned subgroup analysis of the SoliRam - a multinational, prospective, non-interventional, real-world, observational study - focused on participants from Gulf countries. Primary endpoint was proportion of participants experiencing ≥1 episode of severe and/or symptomatic documented (<70 mg/dL [<3.9 mmol/L]) hypoglycemia. RESULTS: A total of 241 individuals with T2DM (mean age: 58.1 years; male: 54.4%; mean duration of diabetes: 13.3 years) were included. All 234 eligible participants followed during Ramadan were able to fast for ≥25 days and no participants broke fast due to hypoglycemia. Primary endpoint was reported in one participant (0.5%) during fasting hours during Ramadan. Improvements (mean ± SD change) in HbA1c (-1.0 ± 1.0% [-11 ± 10 mmol/mol]), FPG (-22.5 ± 29.7 mg/dL), and body weight (-1.5 ± 2.0 kg) were observed from pre-Ramadan to post-Ramadan. Three participants (1.2 %) reported an adverse event (AE) of any cause and one (0.4%) reported a gastrointestinal AE. CONCLUSIONS: iGlarLixi is an effective and well-tolerated treatment in people with T2DM from Gulf countries, including during Ramadan fasting, and is associated with low risk of hypoglycemia.


Subject(s)
Diabetes Mellitus, Type 2 , Hypoglycemia , Adult , Humans , Male , Middle Aged , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/chemically induced , Hypoglycemic Agents/adverse effects , Prospective Studies , Fasting/adverse effects , Hypoglycemia/epidemiology , Hypoglycemia/chemically induced , Islam , Blood Glucose
19.
Diabetes Res Clin Pract ; 209: 111572, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38341041

ABSTRACT

OBJECTIVE: To describe changes in glucose-lowering drug (GLD) dispensing by frailty status for people with diabetes following admission for hypoglycaemia or hyperglycaemia. METHODS: This study included all people with probable type 2 diabetes in the state of Victoria, Australia, admitted to hospital for hypoglycaemia (n = 2,506 admissions) or hyperglycaemia (n = 1,693) between 1 July 2013 and 29 June 2017. Frailty was defined via the Hospital Frailty Risk Score (HFRS). We examined differences in dispensing of GLDs in the year before and after admission using linear regression models adjusted for age, sex, comorbidities, and socioeconomic status. RESULTS: Dispensing of GLDs decreased following hypoglycaemia admission. Decreased dispensing was strongly associated with frailty status, with a change in mean annual GLD dispensing count of -4.11 (-5.05, -3.17) for an HFRS of 15 vs. -0.99 (-1.47, -0.50) for an HFRS of 0. Changes were greatest for metformin and sulfonylureas. Following hyperglycaemia admission, the mean number of annual GLD dispensings increased, with a smaller increase with increasing frailty: 2.44 (1.32, 3.56) for an HFRS of 0 vs. 1.16 (0.18, 2.14) for an HFRS of 15. CONCLUSIONS: Frailty was associated with more conservative diabetes medication management following hypoglycaemia and hyperglycaemia admissions.


Subject(s)
Diabetes Mellitus, Type 2 , Frailty , Hyperglycemia , Hypoglycemia , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/epidemiology , Hyperglycemia/drug therapy , Hyperglycemia/epidemiology , Patient Discharge , Frailty/epidemiology , Aftercare , Hypoglycemia/drug therapy , Hypoglycemia/epidemiology , Retrospective Studies
20.
Early Hum Dev ; 190: 105970, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38354454

ABSTRACT

High rates of academic underachievement at 9-10 years have been identified in children born at risk of neonatal hypoglycaemia. This study investigated the stability of behaviour from early to mid-childhood and how this relates to academic outcomes in children born with at least one risk factor of neonatal hypoglycaemia in Aotearoa, New Zealand. Behaviour data was collected using the Bayley Scales of Infant and Toddler Development, Child Behaviour Checklist 1.5-5, and the Strengths and Difficulties Questionnaire for 466 children (52 % male; 27 % Maori, 60 % New Zealand European, 2 % Pacific, 11 % Other) at multiple timepoints between ages 2 and 10 years. Academic data was collected at 9-10 years using the e-asTTle online learning and assessment tool. Findings revealed a link between early childhood behaviour and academic outcomes could be detected as early as age 2, suggesting that identifying and addressing early behavioural issues in children at risk of neonatal hypoglycaemia could aid in targeted interventions.


Subject(s)
Child Behavior Disorders , Hypoglycemia , Child , Child, Preschool , Female , Humans , Male , Child Behavior , Hypoglycemia/epidemiology , Maori People , Risk Factors , White
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