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Reliability of Trained Dogs to Alert to Hypoglycemia in Patients With Type 1 Diabetes.

ABSTRACT: We examined the reliability of trained dogs to alert to hypoglycemia in individuals with type 1 diabetes.Patients with type 1 diabetes who currently used diabetes alert dogs participated in this exploratory study. Subjects reported satisfaction, perceived dog glucose sensing ability and reasons for obtaining a trained dog. Reliability of dog alerts was assessed using capillary blood glucose (CBG) and blinded continuous glucose monitoring (CGM) as comparators in 8 subjects (age 4-48). Hypoglycemia was defined as CBG or CGM <70 mg/dL.Dog users were very satisfied (8.9/10 on a Likert-type scale) and largely confident (7.9/10) in their dog's ability to detect hypoglycemia. Detection of hypoglycemia was the primary reason for obtaining a trained dog. During hypoglycemia, spontaneous dog alerts occurred at a rate 3.2 (2.0-5.2, 95% CI) times higher than during euglycemia (70-179 mg/dL). Dogs provided timely alerts in 36% (sensitivity) of all hypoglycemia events (n = 45). Due to inappropriate alerts, the PPV of a dog alert for hypoglycemia was 12%. When there was concurrence of a hypoglycemic event between the dog alert and CGM (n = 30), CGM would have alerted prior to the dog in 73% of events (median 22-minute difference).This is the first study evaluating reliability of trained dogs to alert to hypoglycemia under real-life conditions. Trained dogs often alert a human companion to otherwise unknown hypoglycemia; however due to high false-positive rate, a dog alert alone is unlikely to be helpful in differentiating hypo-/hyper-/euglycemia. CGM often detects hypoglycemia before a trained dog by a clinically significant margin.

SUBMITTER: Los EA

PROVIDER: S-EPMC5505410 | biostudies-other | 2017 May

REPOSITORIES: biostudies-other

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Dogs Can Be Successfully Trained to Alert to Hypoglycemia Samples from Patients with Type 1 Diabetes.

Project description:IntroductionHypoglycemia (Hypo) is the most common side effect of insulin therapy in people with type 1 diabetes (T1D). Over time, patients with T1D become unaware of signs and symptoms of Hypo. Hypo unawareness leads to morbidity and mortality. Diabetes alert dogs (DADs) represent a unique way to help patients with Hypo unawareness. Our group has previously presented data in abstract form which demonstrates the sensitivity and specificity of DADS. The purpose of our current study is to expand evaluation of DAD sensitivity and specificity using a method that reduces the possibility of trainer bias.MethodsWe evaluated 6 dogs aging 1-10 years old who had received an average of 6 months of training for Hypo alert using positive training methods. Perspiration samples were collected from patients during Hypo (BG 46-65 mg/dL) and normoglycemia (BG 85-136 mg/dl) and were used in training. These samples were placed in glass vials which were then placed into 7 steel cans (1 Hypo, 2 normal, 4 blank) randomly placed by roll of a dice. The dogs alerted by either sitting in front of, or pushing, the can containing the Hypo sample. Dogs were rewarded for appropriate recognition of the Hypo samples using a food treat via a remote control dispenser. The results were videotaped and statistically evaluated for sensitivity (proportion of lows correctly alerted, "true positive rate") and specificity (proportion of blanks + normal samples not alerted, "true negative rate") calculated after pooling data across all trials for all dogs.ResultsAll DADs displayed statistically significant (p value <0.05) greater sensitivity (min 50.0%-max 87.5%) to detect the Hypo sample than the expected random correct alert of 14%. Specificity ranged from a min of 89.6% to a max of 97.9% (expected rate is not defined in this scenario).ConclusionsOur results suggest that properly trained DADs can successfully recognize and alert to Hypo in an in vitro setting using smell alone.

| S-EPMC4674474 | biostudies-literature

Diabetes Alert Dogs (DADs): An assessment of accuracy and implications.

Project description:AimsTo test the accuracy of Diabetes Alert Dogs (DADs) by comparing recorded alerts to continuous glucose monitoring (CGM) device readings during waking and sleeping hours.Methods14 individuals (7 adults with type 1 diabetes and 7 youth with type 1 diabetes/parents) who owned DADs for ≥6 mos wore masked CGM devices over a several-week period while recording DAD alerts electronically and in paper diaries.ResultsDuring waking hours, sensitivity scores across participants were 35.9% for low BG events and 26.2% for high BG events. DAD accuracy was highly variable with 3/14 individual dogs performing statistically higher than chance. Sensitivity scores were lower during sleep hours of the person with diabetes (22.2% for low BG events and 8.4% for high BG events). DAD accuracy during sleeping hours was also highly variable, with 1/11 individual dogs performing statistically better than chance. Rate of change analyses indicated that DADs were responding to absolute BG level, rather than rapid shifts in glucose levels.ConclusionsIn this study the majority of DADs did not demonstrate accurate detection of low and high BG events. However, performance varied greatly across DADs and additional studies are needed to examine factors contributing to this variability. Additionally, more research is needed to investigate the significant gap between the positive experiences and clinical outcomes reported by DAD owners and the mixed research findings on DAD accuracy.

| S-EPMC5723560 | biostudies-literature

Patients with type 1 diabetes exhibit altered cerebral metabolism during hypoglycemia.

Project description:Patients with type 1 diabetes mellitus (T1DM) experience, on average, 2 to 3 hypoglycemic episodes per week. This study investigated the effect of hypoglycemia on cerebral glucose metabolism in patients with uncomplicated T1DM. For this purpose, hyperinsulinemic euglycemic and hypoglycemic glucose clamps were performed on separate days, using [1-13C]glucose infusion to increase plasma 13C enrichment. In vivo brain 13C magnetic resonance spectroscopy was used to measure the time course of 13C label incorporation into different metabolites and to calculate the tricarboxylic acid cycle flux (VTCA) by a one-compartment metabolic model. We found that cerebral glucose metabolism, as reflected by the VTCA, was not significantly different comparing euglycemic and hypoglycemic conditions in patients with T1DM. However, the VTCA was inversely related to the HbA1C and was, under hypoglycemic conditions, approximately 45% higher than that in a previously investigated group of healthy subjects. These data suggest that the brains of patients with T1DM are better able to endure moderate hypoglycemia than those of subjects without diabetes.

| S-EPMC3561817 | biostudies-other

Severe hypoglycemia in patients with liver cirrhosis and type 2 diabetes.

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| S-EPMC9845885 | biostudies-literature

Hypoglycemia unawareness in type 1 diabetes suppresses brain responses to hypoglycemia.

Project description:Among nondiabetic individuals, mild glucose decrements alter brain activity in regions linked to reward, motivation, and executive control. Whether these effects differ in type 1 diabetes mellitus (T1DM) patients with and without hypoglycemia awareness remains unclear.Forty-two individuals (13 healthy control [HC] subjects, 16 T1DM individuals with hypoglycemia awareness [T1DM-Aware], and 13 T1DM individuals with hypoglycemia unawareness [T1DM-Unaware]) underwent blood oxygen level-dependent functional MRI brain imaging during a 2-step hyperinsulinemic euglycemic (90 mg/dl)-hypoglycemic (60 mg/dl) clamp for assessment of neural responses to mild hypoglycemia.Mild hypoglycemia in HC subjects altered activity in the caudate, insula, prefrontal cortex, and angular gyrus, whereas T1DM-Aware subjects showed no caudate and insula changes, but showed altered activation patterns in the prefrontal cortex and angular gyrus. Most strikingly, in direct contrast to HC and T1DM-Aware subjects, T1DM-Unaware subjects failed to show any hypoglycemia-induced changes in brain activity. These findings were also associated with blunted hormonal counterregulatory responses and hypoglycemia symptom scores during mild hypoglycemia.In T1DM, and in particular T1DM-Unaware patients, there is a progressive blunting of brain responses in cortico-striatal and fronto-parietal neurocircuits in response to mild-moderate hypoglycemia. These findings have implications for understanding why individuals with impaired hypoglycemia awareness fail to respond appropriately to falling blood glucose levels.This study was supported in part by NIH grants R01DK020495, P30 DK045735, K23DK109284, K08AA023545. The Yale Center for Clinical Investigation is supported by an NIH Clinical Translational Science Award (UL1 RR024139).

| S-EPMC5873861 | biostudies-other

Economic Burden of Hypoglycemia in Patients with Type 2 Diabetes Mellitus from Korea.

Project description:BACKGROUND:Hypoglycemia is a very serious complication in patients with type 2 diabetes mellitus (T2DM) and affects the economic burden of treatment. This study aims to create models of the cost of treating hypoglycemia in patients with T2DM based upon physician estimates of medical resource usage. METHODS:Using a literature review and personal advice from endocrinologists and emergency physicians, we developed several models for managing patients with hypoglycemia. The final model was approved by the consulting experts. We also developed 3 unique surveys to allow endocrinologists, emergency room (ER) physicians, and primary care physicians to evaluate the resource usage of patients with hypoglycemia. Medical costs were calculated by multiplying the estimated medical resource usage by the corresponding health insurance medical care costs reported in 2014. RESULTS:In total, 40 endocrinologists, 20 ER physicians, and 30 primary care physicians completed the survey. We identified 12 types of standard medical models for secondary or tertiary hospitals and 4 for primary care clinics based on the use of ER, general ward, or intensive care unit (ICU) and patients' status of consciousness and self-respiration. Estimated medical costs per person per hypoglycemic event ranged from $17.28 to $1,857.09 for secondary and tertiary hospitals. These costs were higher for patients who were unconscious and for those requiring ICU admission. CONCLUSION:Hypoglycemia has a substantial impact on the medical costs and its prevention will result in economic benefits for T2DM patients and society.

| S-EPMC4790854 | biostudies-literature

Detection of Hypoglycemia Using Measures of EEG Complexity in Type 1 Diabetes Patients.

Project description:Previous literature has demonstrated that hypoglycemic events in patients with type 1 diabetes (T1D) are associated with measurable scalp electroencephalography (EEG) changes in power spectral density. In the present study, we used a dataset of 19-channel scalp EEG recordings in 34 patients with T1D who underwent a hyperinsulinemic-hypoglycemic clamp study. We found that hypoglycemic events are also characterized by EEG complexity changes that are quantifiable at the single-channel level through empirical conditional and permutation entropy and fractal dimension indices, i.e., the Higuchi index, residuals, and tortuosity. Moreover, we demonstrated that the EEG complexity indices computed in parallel in more than one channel can be used as the input for a neural network aimed at identifying hypoglycemia and euglycemia. The accuracy was about 90%, suggesting that nonlinear indices applied to EEG signals might be useful in revealing hypoglycemic events from EEG recordings in patients with T1D.

| S-EPMC7516516 | biostudies-literature

Associations Between the Time in Hypoglycemia and Hypoglycemia Awareness Status in Type 1 Diabetes Patients Using Continuous Glucose Monitoring Systems.

Project description:Background: Continuous glucose monitoring (CGM) systems help reduce hypoglycemia in patients with type 1 diabetes (T1D). It remains unclear whether T1D patients with impaired awareness of hypoglycemia (IAH) continue to develop more hypoglycemia than those with normal hypoglycemia awareness (NA) despite CGM use. Materials and Methods: For this cross-sectional observational study, 99 T1D patients using real-time CGMs for ≥86% of time were recruited. Fifty and 49 patients were found to have NA and IAH (based on the Clarke questionnaire), respectively. Two-week CGM hypoglycemia data were collected. Results: IAH was associated with greater percentages of CGM values <70 and <54 mg/dL (P = 0.012, P = 0.004) compared to NA. Clarke scores correlated positively with the percentage of CGM values <70 and <54 mg/dL (P = 0.013, P = 0.004). IAH was also related to more events with glucose <70 and <54 mg/dL determined either with at ≥1 time point (P = 0.048, P = 0.003) or lasting ≥20 min (P = 0.016, P = 0.004). IAH patients presented with more day-time events with glucose <54 mg/dL (P = 0.015), nocturnal events with glucose levels <70 and <54 mg/dL (P = 0.009, P = 0.007) and longer day-time event duration with glucose levels <70 and <54 mg/dL (P < 0.001, P = 0.006), respectively. Conclusions: T1D patients with IAH continue to experience more hypoglycemia despite dedicated CGM use.

| S-EPMC7699009 | biostudies-literature

The Incidence of Hypoglycemia among Insulin-Treated Patients with Type 1 or Type 2 Diabetes: Bangladeshi Cohort of International Operations-Hypoglycemia Assessment Tool Study.

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.

| S-EPMC6063185 | biostudies-literature

Association between impaired cardiovascular autonomic function and hypoglycemia in patients with type 1 diabetes.

Project description:We studied the association between glycemic variability (GV) reflecting hypoglycemic stress and cardiovascular autonomic function in subjects with type 1 diabetes.Forty-four type 1 diabetic patients (mean age 34 ± 13 years, 40% male, 86% Caucasian, mean diabetes duration 13 ± 6 years, mean hemoglobin A1c [HbA1c] 8.0 ± 1.2% [64 ± 5 mmol/mol]) without cardiovascular disease, dyslipidemia, or hypertension participated in this pilot study. Indices of GV reflective of hypoglycemic stress (low blood glucose index [LBGI] and area under the curve [AUC] for hypoglycemia) were computed using data obtained during 5-day continuous glucose monitoring. Cardiovascular autonomic neuropathy (CAN) was assessed using standardized cardiovascular reflex testing and measures of heart rate variability (HRV), which were analyzed as time and frequency domain measures.Both LBGI and AUC hypoglycemia had a significant negative association with the low-frequency power of HRV (r = -0.47, P = 0.002; r = -0.43, P = 0.005, respectively) and with the high-frequency power of HRV (r = -0.37, P = 0.018; r = -0.38, P = 0.015, respectively). These inverse associations persisted after adjusting for HbA1c, although they were attenuated in multivariable analysis after adjustment for age, diabetes duration, and several other covariates.Increased GV promoting hypoglycemic stress was associated with reduced HRV independent of glycemic control as assessed by HbA1c. These pilot data suggest that glucose variability may contribute to cardiovascular autonomic dysfunction among adults with type 1 diabetes.

| S-EPMC4140160 | biostudies-literature

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