Self-Reported Hypoglycemia in Insulin-Treated Patients with Diabetes: Results from the Philippine Cohort of the International Operations Hypoglycemia Assessment Tool (IO HAT) Study
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ABSTRACT: Objective
To determine the frequency of hypoglycemia in insulin-treated patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) in the non-interventional International Operations Hypoglycemia Assessment Tool (IO HAT) study. Methodology
This sub-analysis included Filipino patients with T1DM or T2DM, aged 18 years and older, treated with insulin for more than 12 months, who completed the two-part self-assessment questionnaires (SAQ1 and SAQ2) and patient diaries that recorded hypoglycemia during retrospective (6 months/4 weeks before baseline) and prospective period (4 weeks after baseline) (ClinicalTrials.gov number: NCT02306681). Results
A total of 671 patients were enrolled and completed the SAQ1 (62 patients with T1DM and 609 patients with T2DM). Almost all patients (100% in T1DM and 99.3% in T2DM) experienced at least 1 hypoglycemic event prospectively. The incidence of any hypoglycemia was also high in the prospective period compared to retrospective period (72.6 [95% CI: 64.8, 80.9] events PPY and 43.6 [95% CI: 37.8, 49.9] events PPY; p=0.001, respectively) in T1DM patients. Conclusion
Among insulin-treated patients, higher rates of hypoglycemia were reported prospectively than retrospectively. This indicates that the patients in real-life setting often under-report hypoglycemia. Patient education can help in accurate reporting and appropriate management of hypoglycemia and diabetes.
SUBMITTER: Mirasol R
PROVIDER: S-EPMC7784212 | biostudies-literature | 2018 Jan
REPOSITORIES: biostudies-literature
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Project description:IntroductionThe non-interventional International Operations Hypoglycemia Assessment Tool (IO-HAT) study assessed the incidence of hypoglycemia in patients with insulin-treated diabetes across nine countries, including a cohort of patients in Colombia.Materials and methodsHypoglycemia incidence among patients with insulin-treated diabetes was assessed across 26 sites in Colombia. Hypoglycaemic events (any, nocturnal or severe) were reported in self-assessment questionnaires (SAQ) and patient diaries based on capillary blood glucose measurement or symptoms. Retrospective events (severe events 6 months before baseline and any event 4 weeks before baseline) were recorded in SAQ, Part 1, and prospective events (4 weeks from baseline) were recorded in SAQ, Part 2, and patient diaries. Differences in hypoglycemia incidence reported in the retrospective and prospective periods were assessed using two-sided tests.ResultsOf the 664 patients assessed, 213 had type 1 diabetes (T1D) and 451 had type 2 diabetes (T2D). Nearly all patients experienced at least one hypoglycaemic event in the prospective period (97.1% T1D; 93.3% T2D). Rates of hypoglycemia (events per personyear, PPY) were higher prospectively than retrospectively for any hypoglycemia (T1D: 121.6 vs. 83.2, p<0.001; T2D: 28.1 vs. 24.6, p=0.127) and severe hypoglycemia (T1D: 15.3 vs. 9.2, p=0.605; T2D: 9.5 vs. 3.5 p=0.040).ConclusionThese results, the first from a patient-reported dataset on hypoglycemia in insulin-treated patients with diabetes in Colombia, show that patients reported higher rates of any hypoglycemia during the prospective period.Clinical trial registration numberNCT02306681.
| S-EPMC7357359 | biostudies-literature
Project description:Limited real-world data are currently available on hypoglycemia in diabetes patients. The International Operations Hypoglycemia Assessment Tool (IO HAT) study was designed to estimate hypoglycemia in insulin-treated type I (T1DM) and type II (T2DM) diabetes mellitus patients from 9 countries. The data from Turkey cohort are presented here.A non-interventional study to determine the hypoglycemia incidence, retrospectively and prospectively, in Turkish T1DM and T2DM patients using a 2-part self-assessment questionnaire.Overall, 2348 patients were enrolled in the Turkey cohort (T1DM?=?306 patients, T2DM?=?2042 patients). In T1DM patients, 96.8% patients reported hypoglycemic events (Incidence rate [IR]: 68.6 events per patient-year [ppy]), prospectively, while 74.0% patients reported hypoglycemic events (IR: 51.7 events ppy), retrospectively. In T2DM patients, 95.9% patients (IR: 28.3 events ppy) reported hypoglycemic events, prospectively, while 53.6% patients (IR: 23.0 events ppy) reported hypoglycemic events, retrospectively. Nearly all patients reported hypoglycemia during the prospective period.This is a first patient-reported dataset on hypoglycemia in Turkish, insulin-treated diabetes patients. A high incidence of patient-reported hypoglycemia confirms that hypoglycemia remains under-estimated. Hypoglycemia increased healthcare utilization impacting patients' quality of life. Hypoglycemia remains a common side effect with insulin-treatment and strategies to optimize therapy and reduce hypoglycemia occurrence in diabetes patients are required.Clinicaltrials.gov, NCT02306681 (Date of registration: 12 Nov 2014; retrospectively registered).
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Project description:Objectives:The objective of this study was to assess the incidence of hypoglycemia in patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) in Bangladeshi cohort of the International Operations-Hypoglycemia Assessment Tool study. Materials and Methods:Patients diagnosed with either T1DM or T2DM, aged ?18 years, treated with insulin (any regimen) for >12 months, and completed self-assessment questionnaires (SAQs) to record demography, treatment information, and hypoglycemia during the 6-month retrospective and 4-week prospective periods (a total of 7 months) were enrolled in the study. Results:A total of 1179 patients were enrolled and completed the SAQ1 (T1DM, n = 25; T2DM, n = 1154). Almost all patients (T1DM: 100.0% [95% confidence interval (CI): 86.3%, 100.0%] and T2DM: 97.0% [95% CI: 95.9%, 97.9%]) experienced at least 1 hypoglycemic event prospectively. The estimated rates of any and severe hypoglycemia were 26.6 (95% CI: 19.8, 35.0) and 14.1 (95% CI: 9.3, 20.4) events per patient-per year (PPY), respectively, for patients with T1DM and 18.3 (95% CI: 17.4, 19.2) and 12.1 (95% CI: 11.4, 12.9) events PPY, respectively, for patients with T2DM during the prospective period. At baseline, mean glycated hemoglobin (HbA1c) (±standard deviation) was 8.1 (±1.8%) for T1DM and 8.8 (±1.8%) for T2DM. Hypoglycemic rate was independent of HbA1c levels and types of insulin. Conclusions:This is the first patient dataset of self-reported hypoglycemia in Bangladesh; results confirm that hypoglycemia is underreported.
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Project description:ObjectiveTo provide real-world data on hypoglycaemia incidence in patients with type 1 (T1D) or type 2 diabetes (T2D) from the Southeast Asian cohort of the International Operations Hypoglycaemia Assessment Tool (IO HAT) study.MethodologyIO HAT was a non-interventional, multicentre, 6-month retrospective and 4-week prospective study of hypoglycaemic events among insulin-treated adults with T1D or T2D, including four countries in Southeast Asia (Singapore, Philippines, Indonesia, and Bangladesh). Data were collected using a two-part self-assessment questionnaire (SAQ1 for retrospective and SAQ2 for prospective). The primary endpoint was the percentage of patients experiencing at least one hypoglycaemic event during the 4-week prospective observational period (ClinicalTrials.gov Identifier: NCT02306681).ResultsA total of 2594 patients completed SAQ1. Nearly all patients reported experiencing any hypoglycaemic event in the 4-week prospective period (T1D, 100%; T2D, 97.3%), with all patients reporting higher rates in the prospective versus retrospective period. Severe hypoglycaemia was also reported higher prospectively (57.2% and 76.9%) than retrospectively (33.9% and 12.2%) in both T1D and T2D, respectively. Nocturnal hypoglycaemia was reported higher retrospectively than prospectively.ConclusionIncidence of any and severe hypoglycaemia in the Southeast Asian cohort of IO HAT was higher prospectively versus retrospectively, suggesting hypoglycaemia has previously been under-reported in this region.
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Project description:IntroductionHypoglycaemia constitutes a significant barrier to achieving glycaemic control with insulin in both Type 1 (T1DM) and Type 2 diabetes mellitus (T2DM). The International Operations Hypoglycaemia Assessment Tool (IO HAT) study was designed to determine the incidence of hypoglycaemia in insulin-treated patients with T1DM and T2DM.MethodsThe IO HAT study retrospectively and prospectively assessed the incidence of hypoglycaemia in patients with insulin-treated diabetes mellitus in nine countries. This sub-analysis included patients from Singapore with T1DM or T2DM who were aged ? 21 years and had completed two self-assessment questionnaires (SAQ1 and SAQ2).ResultsOf the 50 T1DM and 320 T2DM patients who completed the SAQ1, 39 T1DM and 265 T2DM patients completed SAQ2; 100% and 90.9%, respectively, experienced at least one hypoglycaemic event prospectively. The incidence rates of any hypoglycaemia were 49.5 events per patient-year (EPPY) and 16.1 EPPY for T1DM and T2DM patients, respectively, in the four-week prospective period. Hypoglycaemia rate did not differ in terms of glycated haemoglobin level. The vast majority of T1DM or T2DM patients (92.0% and 90.7%, respectively) knew the overall definition of hypoglycaemia before study participation, although over half of the patients (T1DM 54.0%, T2DM 51.9%) defined hypoglycaemia based only on symptoms.ConclusionHigh proportions of insulin-treated patients with diabetes mellitus in Singapore reported hypoglycaemic events prospectively, showing that they had underreported hypoglycaemic episodes retrospectively. Patient education can help in improving hypoglycaemia awareness and its management in the region.
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Project description:Data concerning true hypoglycaemic incidence in insulin-treated patients with diabetes in real-world clinical practice are lacking in Germany. The aim of this analysis was to determine the incidence of hypoglycaemia experienced by the German cohort of patients enrolled in the global Hypoglycaemia Assessment Tool (HAT) study. This was a non-interventional, 6-month retrospective and 4-week prospective study using self-assessment questionnaires and patient diaries assessing patients aged ≥18 years in Germany, with type 1 diabetes (T1D) (n=811) or type 2 diabetes (T2D) (n=1 619) treated with insulin for >12 months. The primary endpoint was the percentage of patients experiencing ≥1 hypoglycaemic event during the prospective observational period (4 weeks after baseline). Predictive and continuous factors (such as age, gender, duration of insulin use and HbA1c) contributing to hypoglycaemia risk were explored.During the prospective period, at least one hypoglycaemic event was reported by 81.3% of patients with T1D and 39.7% of patients with T2D, indicating that hypoglycaemia is a common acute complication among patients with insulin-treated diabetes. Severe hypoglycaemia was reported by 9.1% of patients with T1D and 5.4% of patients with T2D. Higher rates of any and severe hypoglycaemia were reported prospectively than retrospectively, regardless of diabetes type, indicating that patients retrospectively under-report hypoglycaemia. Prospective rates (events per patient-year) of any, nocturnal and severe hypoglycaemia were 80.3, 9.9 and 3.0 for T1D and 15.6, 2.4 and 1.1 for T2D, respectively. Given the potential for recall bias in retrospective reporting, this prospective assessment of hypoglycaemia appears more reliable than retrospective assessment. Trial number: NCT01696266.
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Project description:There are many misconceptions about the prevalence and effects of hypoglycemia in people with type 2 diabetes (T2D), including hypoglycemia does not occur or does not have adverse consequences in T2D. This narrative review aims to help dispel these myths. Around 25% of people with T2D taking insulin for >5 years were found to have severe hypoglycemic events, which is comparable to the severe hypoglycemia rate in adults with type 1 diabetes (T1D) diagnosed within 5 years. The total number of hypoglycemic events among insulin-treated T2D, including severe hypoglycemia, is as high or higher than among those with T1D. Recent evidence suggests serious consequences of hypoglycemia may, in some respects, be greater in individuals with T2D, particularly regarding effects on the cardiovascular system. Hypoglycemia is generally patient-reported. Issues with hypoglycemia unawareness, limited glucose testing, limited recall, lack of event logging and fear of failure or shaming limits the number of hypoglycemic episodes reported by people with diabetes. Barriers to healthcare provider inquiry and reporting include lack of knowledge regarding the problem's magnitude, competing priorities during patient visits, lack of incentives to report and limitations to documentation systems for adequate reporting. All people with diabetes should be encouraged to discuss their experiences with hypoglycemia without judgment or shame. Glucose targets, testing schedules (blood glucose or continuous glucose monitoring) and treatment plans should be reviewed often and individualized to the minimize risk of hypoglycemia. Finally, people with T2D on insulin should always be encouraged to have oral glucose and rescue medication immediately available.
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Project description:BackgroundHypoglycemia is a known risk of intensive postoperative glucose control in patients undergoing cardiac operations. However, neither the consequences of hypoglycemia relative to hyperglycemia, nor the possible interaction effects, have been well described. We examined the effects of postoperative hypoglycemia, hyperglycemia, and their interaction on short-term morbidity and mortality.MethodsSingle-institution Society of Thoracic Surgeons (STS) database patient records from 2010 to 2014 were merged with clinical data, including blood glucose values measured in the intensive care unit (ICU). Exclusion criteria included fewer than three glucose measurements and absence of an STS predicted risk of morbidity or mortality score. Primary outcomes were operative mortality and composite major morbidity (permanent stroke, renal failure, prolonged ventilation, pneumonia, or myocardial infarction). Secondary outcomes included ICU and postoperative length of stay. Hypoglycemia was defined as below 70 mg/dL, and hyperglycemia as above 180 mg/dL. Simple and multivariable regression models were used to evaluate the outcomes.ResultsA total of 2,285 patient records met the selection criteria for analysis. The mean postoperative glucose level was 140.8 ± 18.8 mg/dL. Overall, 21.4% of patients experienced a hypoglycemic episode (n = 488), and 1.05% (n = 24) had a severe hypoglycemic episode (<40 mg/dL). The unadjusted odds ratio (UOR) for operative mortality for patients with any hypoglycemic episode compared with those without was 5.47 (95% confidence interval [CI] 3.14 to 9.54), and the UOR for major morbidity was 4.66 (95% CI 3.55 to 6.11). After adjustment for predicted risk of morbidity or mortality and other significant covariates, the adjusted odds (AOR) of operative mortality were significant for patients with any hypoglycemia (AOR 4.88, 95% CI 2.67 to 8.92) and patients with both events (AOR 8.29, 95% CI 1.83 to 37.5) but not hyperglycemia alone (AOR 1.62, 95% CI 0.56 to 4.69). The AOR of major morbidity for patients with both hypoglycemic and hyperglycemic events was 14.3 (95% CI 6.50 to 31.4).ConclusionsPostoperative hypoglycemia is associated with both mortality and major morbidity after cardiac operations. The combination of both hyperglycemia and hypoglycemia represents a substantial increase in risk. Although it remains unclear whether hypoglycemia is a cause, an early warning sign, or a result of adverse events, this study suggests that hypoglycemia may be an important event in the postoperative period after cardiac operations.
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Project description:ObjectiveHypoglycemia is associated with an increased risk of cardiovascular disease including cardiac arrhythmias. We investigated the effect of hypoglycemia in the setting of acute glycemic fluctuations on cardiac rhythm and cardiac repolarization in insulin-treated patients with type 2 diabetes compared with matched controls without diabetes.DesignA non-randomized, mechanistic intervention study.MethodsInsulin-treated patients with type 2 diabetes (n = 21, age (mean ± s.d.): 62.8 ± 6.5 years, BMI: 29.0 ± 4.2 kg/m2, HbA1c: 6.8 ± 0.5% (51.0 ± 5.4 mmol/mol)) and matched controls (n = 21, age: 62.2 ± 8.3 years, BMI 29.2 ± 3.5 kg/m2, HbA1c: 5.3 ± 0.3% (34.3 ± 3.3 mmol/mol)) underwent a sequential hyperglycemic and hypoglycemic clamp with three steady-states of plasma glucose: (i) fasting plasma glucose, (ii) hyperglycemia (fasting plasma glucose +10 mmol/L) and (iii) hyperinsulinemic hypoglycemia (plasma glucose < 3.0 mmol/L). Participants underwent continuous ECG monitoring and blood samples for counterregulatory hormones and plasma potassium were obtained.ResultsBoth groups experienced progressively increasing heart rate corrected QT (Fridericia's formula) interval prolongations during hypoglycemia ((∆mean (95% CI): 31 ms (16, 45) and 39 ms (24, 53) in the group of patients with type 2 diabetes and controls, respectively) with similar increases from baseline at the end of the hypoglycemic phase (P = 0.43). The incidence of ventricular premature beats increased significantly in both groups during hypoglycemia (P = 0.033 and P < 0.0001, respectively). One patient with type 2 diabetes developed atrial fibrillation during recovery from hypoglycemia.ConclusionsIn insulin-treated patients with type 2 diabetes and controls without diabetes, hypoglycemia causes clinically significant and similar increases in cardiac repolarization that might increase vulnerability for serious cardiac arrhythmias and sudden cardiac death.
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