ResearchPad - 1866 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Independent effects of 15 commonly prescribed drugs on all-cause mortality among US elderly patients with type 2 diabetes mellitus]]> https://www.researchpad.co/article/elastic_article_9089 Most patients with type 2 diabetes mellitus (T2DM) also have hypertension and hyperlipidemia. Consequently, they are taking medications for all three conditions concurrently and the effect of one drug could be confounded with that of another. This study aimed to determine the independent effects of 15 commonly prescribed medications for three conditions on the risk of all-cause mortality among elderly patients with T2DM.Research design and methodsA cohort of 360 437 elderly patients with T2DM from 2007 to 2016 US Medicare data was traced along with cumulative uses of 8 diabetes, 6 hypertension and 1 hyperlipidemia drugs. The relative risk of all-cause mortality for each study drug was estimated using an extended Cox regression analysis adjusting for the concurrent use of other study drugs.ResultsCompared with the no use of each study medication, mortality risk declined with use of 3 diabetes drugs, sodium-glucose cotransporter-2 inhibitors (HR=0.73; 95% CI 0.64 to 0.84), glucagon-like peptide-1 receptor agonists (HR=0.75; 95% CI 0.70 to 0.80) and dipeptidyl peptidase-4 inhibitors (HR=0.94; 95% CI 0.91 to 0.98), the use of 3 blood pressure medications, diuretics (HR=0.89; 95% CI 0.87 to 0.92), angiotensin receptor blockers (HR=0.86; 95% CI 0.84 to 0.89), ACE inhibitors (HR=0.98; 95% CI 0.95 to 1.01) as well as statins (HR=0.83; 95% CI 0.80 to 0.85). It increased moderately with insulin (HR=1.55; 95% CI 1.51 to 1.59), sulfonylureas (HR=1.16; 95% CI 1.13 to 1.20), a small inconsistent amount with metformin (HR=1.05), beta-blockers (HR=1.07), dihydropyridine calcium-channel blockers (HR=0.99) and non-dihydropyridine calcium-channel blockers (HR=1.05). The use of thiazolidinedione had no effect.ConclusionAmong older patients with diabetes, mortality risk decreased importantly with three new diabetes drugs, 3 blood pressure drugs and statins. It increased moderately with sulfonylurea and insulin. Studies of aggressive use of new T2DM drugs instead of sulfonylureas and insulin are needed. Our statin results empirically validate two national guidelines for using statins in older patients with diabetes. However, 23% of study patients never took a statin, suggesting missed opportunities for prevention. ]]> <![CDATA[High or low glycemic index (GI) meals at dinner results in greater postprandial glycemia compared with breakfast: a randomized controlled trial]]> https://www.researchpad.co/article/elastic_article_7270 While circadian control of glucose metabolism is well known, how glycemic index (GI) of carbohydrate-rich meals interacts with time of consumption (breakfast or dinner) to influence postprandial (PP) glucose homeostasis is less well established. The objective of the study was to assess markers of PP glucose homeostasis following high or low GI test meals (TM) consumed either at breakfast or at dinner and following consumption of the subsequent standardized meals (SSM).Research design and methodsRandomized crossover trial in 34 healthy, Chinese, elderly volunteers (mean±SEM age, 56.8±0.83 years), who completed 4 separate study sessions per-protocol, consisting of a high-GI breakfast, low-GI breakfast, high-GI dinner and low-GI dinner TM, followed by a SSM at the subsequent eating occasion. Blood samples were taken for 3 hours after each TM and SSM for glucose, insulin, glucagon, free fatty acids (FFA) and triglycerides (TG) measurements.ResultsConsuming TM at dinner produced greater PP glycemia than breakfast both after TM and SSM (both p<0.0001), irrespective of GI. High-GI TM also produced greater PP glycemia than low-GI TM, both after TM and SSM (both p<0.01), irrespective of time of consumption. No interaction between GI and time were found on PP glycemia, indicating parallel, but independent effects. Combined total areas under the curve of TM+SSM for PP glucose (p<0.0001), PP TG (p<0.0001) and PP FFA (p<0.0001) were all greater when TM taken during dinner compared with breakfast.ConclusionsCarbohydrate-rich meals consumed at dinner leads to significantly worse PP glucose homeostasis than when consumed at breakfast, on top of the independent GI effect of the meal. This may have implications to future type 2 diabetes risk. Moreover, future studies investigating GI/glycemic load (GL) and disease risk associations should factor in timing of GL consumption as an additional variable.Trial registration numberNCT02927600. ]]> <![CDATA[Participation in structured diabetes mellitus self-management education program and association with lifestyle behavior: results from a population-based study]]> https://www.researchpad.co/article/N2893b47c-49fe-4efe-bb17-9d147f0126be Whether participation in structured diabetes self-management education programs (DSME) for participants with diabetes mellitus is associated with a healthy lifestyle in routine care apart from randomized-controlled studies remains unclear and is this studies’ research question.Research design and methodsWe identified 1300 persons with diabetes mellitus drawn from the cross-sectional population-based analysis German Health Update 2014/2015 (GEDA 2014/2015), which integrated the modules of the European Health Interview Survey (EHIS) wave 2. Of those, 816 were ever-DSME participants and 484 never-participants. We conducted multivariable weighted logistic regression analyses for lifestyle differences comparing ever-DSME and never-DSME participants. Lifestyle was defined by physical activity (PA), current smoking, fruit/vegetable consumption and body mass index (BMI). Age, sex, socioeconomic status, living together, limitation due to health problems for at least for 6 months, self-efficacy and attention to one’s health were included as confounders in the regression models.ResultsEver-DSME participants engaged significantly more often in cycling at least 1 day per week (OR 1.62, 95% CI: 1.15–2.30) and performed significantly more often aerobic endurance training of 150 min per week (including walking: OR 1.42, 95% CI: 1.03–1.94, without walking: OR 1.48, 95% CI: 1.08–2.03) compared with never-DSME participants. Ever-DSME participants were significantly more often ex-smoker compared with never-DSME participants (OR 1.39, 95% CI: 1.03–1.88). DSME attendance was not significantly associated with current smoking, BMI and fruit or vegetable consumption.ConclusionDSME participation is associated with a moderately healthier lifestyle particularly for PA even in routine healthcare. Study results emphasize the importance of a broadly dissemination of DSME access for nationwide diabetes healthcare. Future studies should adjust for DSME participation when investigating lifestyle in persons with diabetes. ]]> <![CDATA[Japanese radio calisthenics prevents the reduction of skeletal muscle mass volume in people with type 2 diabetes]]> https://www.researchpad.co/article/N8329fe6a-a8cf-40d2-a515-96865fea4fc2 Reduction of muscle mass and strength is an important treatment target for patients with type 2 diabetes. Recent studies have reported that high-intensity resistance training improves physical function; however, all patients found it difficult to perform high-intensity resistance training. Radio calisthenics, considered as therapeutic exercises to promote health in Japan, are simple exercises that can be performed regardless of age and help move the muscles and joints of the whole body effectively according to the rhythm of radio. We investigated the efficacy of radio calisthenics for muscle mass in patients with type 2 diabetes in this retrospective cohort study.Research design and methodsA total of 42 hospitalized patients with type 2 diabetes were recruited. The skeletal muscle mass index (SMI, kg/m2) was calculated as appendicular muscle mass (kg) divided by height squared (m2). We defined the change of SMI as the difference of SMI between the beginning and end of hospitalization.ResultsAmong 42 patients, 15 (11 men and 4 women) performed radio calisthenics. Body weights of both radio calisthenics exercisers and non-exercisers decreased during hospitalization. The change of SMI was significantly lesser in radio calisthenics exercisers than in non-exercisers (7.1±1.4 to 7.1±1.3, –0.01±0.09 vs 6.8±1.1 to 6.5±1.2, –0.27±0.06 kg/m2, p=0.016). The proportion of decreased SMI was 85.2% (23/27 patients) in non-radio calisthenics exercisers, whereas that in radio calisthenics exercisers was 46.7% (7/15 patients).ConclusionsRadio calisthenics prevent the reduction of skeletal muscle mass. Thus, radio calisthenics can be considered effective for patients with type 2 diabetes. ]]> <![CDATA[Combined therapy of photobiomodulation and adipose-derived stem cells synergistically improve healing in an ischemic, infected and delayed healing wound model in rats with type 1 diabetes mellitus]]> https://www.researchpad.co/article/Nf33faa00-8e61-4c6c-802b-624e8c484c86 We assessed the therapeutic effects of photobiomodulation (PBM) and adipose-derived stem cell (ADS) treatments individually and together on the maturation step of repairing of a delayed healing wound model in rats with type 1 diabetes mellitus (DM1).Research design and methodsWe randomly assigned 24 rats with DM1 to four groups (n=6 per group). Group 1 was the control (placebo) group. In group 2, allograft human ADSs were transplanted. Group 3 was subjected to PBM (wavelength: 890 nm, peak power output: 80 W, pulse frequency: 80 Hz, pulsed duration: 180 ns, duration of exposure for each point: 200 s, power density: 0.001 W/cm2, energy density: 0.2 J/cm2) immediately after surgery, which continued for 6 days per week for 16 days. Group 4 received both the human ADS and PBM. In addition, we inflicted an ischemic, delayed healing, and infected wound simulation in all of the rats. The wounds were infected with methicillin-resistant Staphylococcus aureus (MRSA).ResultsAll three treatment regimens significantly decreased the amount of microbial flora, significantly increased wound strength and significantly modulated inflammatory response and significantly increased angiogenesis on day 16. Microbiological analysis showed that PBM+ADS was significantly better than PBM and ADS alone. In terms of wound closure rate and angiogenesis, PBM+ADS was significantly better than the PBM, ADS and control groups.ConclusionsCombination therapy of PBM+ADS is more effective that either PBM or ADS in stimulating skin injury repair, and modulating inflammatory response in an MRSA-infected wound model of rats with DM1. ]]> <![CDATA[Better HbA1c during the first years after diagnosis of type 1 diabetes is associated with residual C peptide 10 years later]]> https://www.researchpad.co/article/N9310e1f5-f7e3-4437-a4f2-f0338a99cbd6 To identify the factors associated with residual C peptide production at least 10 years after diagnosis in children and adolescents with type 1 diabetes.Research design and methods73 children and adolescents (<25 years), born in 1988–2005, diagnosed with type 1 diabetes were included during the 4-year study period (2013–2016). At least 10 years after diagnosis, we measured any remaining C peptide concentration using an ultrasensitive C peptide ELISA (≥1.17 pmol/L). The average hemoglobin A1c (HbA1c) was calculated during each of the 10 years after diagnosis and further grand average was calculated for the entire study period.ResultsC peptide was detectable in 38% of participants. The C peptide concentration was 4.3±5.3 pmol/L. At onset of type 1 diabetes, participants were on average approximately 5 years of age, and their average HbA1c was 9.4% (79 mmol/mol). During the first 3 years after diagnosis, HbA1c was lower in the group with detectable C peptide at follow-up ≥10 years later. Moreover, detectable C peptide was more common among female participants. Body mass index SD scores had not increased since the 1-year follow-up, but were higher in patients with measurable C peptide. Nine participants (12%) had been diagnosed with celiac disease and two (3%) with hypothyreosis. Eighteen (25%) participants had retinopathy.ConclusionsChildren and adolescents with detectable C peptide after more than 10 years of diabetes duration were predominantly female and had better HbA1c than others during the first 3 years after diagnosis. ]]> <![CDATA[Can autonomy support have an effect on type 2 diabetes glycemic control? Results of a cluster randomized controlled trial]]> https://www.researchpad.co/article/N9c400ac6-5ee2-401e-b2aa-83d4cfaccd7a To assess whether social support or autonomy support intervention for patients with type 2 diabetes can achieve glycemic control at the end of intervention, and to test whether the glycemic control effect can be maintained for a long time.Research design and methodsIn this cluster randomized controlled trial, 18 community healthcare stations (CHSs) were randomized to the following: (1) usual care group (UCG) offering regular public health management services, (2) social support group (SSG) providing 3-month social support intervention based on problem solving principles, and (3) autonomy support group (ASG) offering 3-month autonomy support intervention based on self-determination theory. A total of 364 patients registered in the CHSs were enrolled into either of the three groups. The primary outcome was hemoglobin A1c (HbA1c), and secondary outcomes were diabetes self-management (DSM) behaviors. Assessment was conducted at baseline and at 3 and 6 months.ResultsPatients in ASG achieved better HbA1c reduction at the end of intervention (0.53% or 7.23 mmol/mol, p<0.001) than those in the UCG and successfully maintained it up to 6 months (0.42% or 5.41 mmol/mol, p<0.001). However, patients in SSG did not experience significant change in HbA1c at 3 or 6 months when compared with patients in UCG. Besides, patients in both the SSG (0.12, p<0.05) and ASG (0.22, p<0.001) experienced improvement in exercise at 3 months. Patients in ASG sustained improvement in exercise up to 6 months (0.21, p<0.001), but those in the SSG did not.ConclusionsAutonomy support for patients with type 2 diabetes could help achieve glycemic control at the end of intervention and successfully maintain it up to 6 months. These findings indicate that autonomy support has positive long-term effects on DSM behaviors and glycemic control and can be recommended in future diabetes intervention programs.Trial registration numberChiCTR1900024354. ]]> <![CDATA[Eye care providers’ emerging roles in early detection of diabetes and management of diabetic changes to the ocular surface: a review]]> https://www.researchpad.co/article/N5a4f6065-3bce-4af3-80f2-19c49f62004d US adults visit eye care providers more often than primary healthcare providers, placing these doctors in a prime position to help identify and manage patients with prediabetes and diabetes. Currently, diabetes is identified in eye clinics in an advanced stage, only after visible signs of diabetic retinopathy. Recent ophthalmic research has identified multiple subclinical and clinical changes that occur in the anterior segment of the eye with metabolic disease. The corneal epithelium exhibits increased defects and poor healing, including an increased risk of neurotrophic keratitis. Increased thickness and stiffness of the cornea artificially alters intraocular pressure. There is damage to the endothelial cells and changes to the bacterial species on the ocular surface, both of which can increase risk of complications with surgery. Decreased corneal sensitivity due to a loss of nerve density predispose patients with metabolic disease to further neurotrophic complications. Patients with diabetes have increased Meibomian gland dysfunction, blepharitis and reduced tear production, resulting in increased rates of dry eye disease and discomfort. Early detection of metabolic disease may allow eye care providers to be more proactive in recommending referral and intervention in order to reduce the risk of blindness and other diabetes-related morbidity. Continued research is needed to better understand the time course of changes to the anterior segment and what can be done to better detect and diagnose patients with prediabetes or undiagnosed diabetes and provide improved care for these patients.

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<![CDATA[Effects of the low carbohydrate, high fat diet on glycemic control and body weight in patients with type 2 diabetes: experience from a community-based cohort]]> https://www.researchpad.co/article/Ncf60e9d6-fb58-460e-8242-8978f6719601

Objective

The optimal diet to improve glycemia in patients with type 2 diabetes remains unclear. Low carbohydrate, high fat (LCHF) diets can improve glycemic control, but have not been investigated in real-world settings.

Research design and methods

We investigated effects of the LCHF diet compared with usual care in a community-based cohort of patients with type 2 diabetes by performing a retrospective study of 49 patients who followed the LCHF diet for ≥3 months, and compared glycemic outcomes with age-matched and body mass index (BMI)-matched controls who received usual care (n=75). The primary outcome was change in A1C from baseline to the end of follow-up.

Results

Compared with the usual care group, the LCHF group showed a significantly greater reduction in A1C (−1.29% (95% CI −1.75 to −0.82; p<0.001)) and body weight (−12.8 kg (95% CI −14.7 to −10.8; p<0.001) at the end of follow-up after adjusting for age, sex, baseline A1C, BMI, baseline insulin dose. Of the patients initially taking insulin therapy in the LCHF group, 100% discontinued it or had a reduction in dose, compared with 23.1% in the usual care group (p<0.001). The LCHF group also had significantly greater reduction in fasting plasma glucose (−43.5 vs −8.5 mg/mL; p=0.03) compared with usual care.

Conclusions

In a community-based cohort of type 2 diabetes, the LCHF diet was associated with superior A1C reduction, greater weight loss and significantly more patients discontinuing or reducing antihyperglycemic therapies suggesting that the LCHF diet may be a metabolically favorable option in the dietary management of type 2 diabetes.

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<![CDATA[Combined and sequential non-invasive approach to diagnosing non-alcoholic steatohepatitis in patients with non-alcoholic fatty liver disease and persistently normal alanine aminotransferase levels]]> https://www.researchpad.co/article/N3de2a33b-cd13-4e5d-999f-02bd0645b7ea

Background and aim

Imaging-confirmed non-alcoholic fatty liver disease (NAFLD) with normal alanine aminotransferase (nALT) levels is infrequently the subject for further evaluation. Early diagnosis of non-alcoholic steatohepatitis (NASH) is needed to prevent disease progression. Thus, we tested the clinical utility of serum Golgi protein 73 (GP73) levels and developed a new non-invasive score to diagnose NASH in patients with biopsy-confirmed NAFLD and persistent nALT levels.

Methods

Serum GP73 and cytokeratin-18 M30 fragments (CK18-M30) levels were measured in 345 patients with biopsy-proven NAFLD. We developed a new score, named G-NASH model (by incorporating serum GP73), and combined it with serum CK18-M30 measurement in a sequential non-invasive approach to accurately identify NASH among patients with NAFLD and persistent nALT levels.

Results

105 (30.4%) patients had persistent nALT, 53 of whom had histologically confirmed NASH. Both serum GP73 and CK18-M30 levels alone had poor diagnostic accuracy in identifying NASH (55.2% and 51.6%, respectively) in these patients. Conversely, G-NASH model performed better than other established non-invasive scoring systems, and by using our proposed sequential non-invasive approach 82.9% of patients with NASH were correctly identified.

Conclusions

NASH is highly prevalent in patients with NAFLD with persistent nALT levels. The G-NASH model accurately identifies NASH in this patient group.

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<![CDATA[Self-reported and objectively measured physical activity levels among Hispanic/Latino adults with type 2 diabetes]]> https://www.researchpad.co/article/Nab014b49-c706-4976-9f85-6b25a89314e7

Objective

In the USA, minority populations face a disproportionate burden from type 2 diabetes (T2D), in whom physical activity (PA) is recommended. The aim of this study was to determine levels of PA among a community of free-living Hispanic/Latino adults with T2D using a research accelerometer, a consumer device and a pictogram self-assessment questionnaire.

Research design and methods

This was a cross-sectional, observational study. Participants (57 women and 31 men, body mass index (kg/m2) 32.2±7.9 and 29.9±4.5, waist circumference 97.1±30.1 and 93.7±33.0 cm and hemoglobin A1c 8.0±2.0 and 8.1%±1.8%, respectively) wore an ActiGraph (AG) on the hip and a Fitbit (FB) on the wrist for 1 week to estimate daily steps and energy expenditure (EE). Participants reported type and intensity of PA using English-language or Spanish-language pictograms and a 10-point Likert scale (1=‘not active’ to 10=‘very, very active’).

Results

Steps per day were not normally distributed; AG median steps/weekday (Monday–Friday) was 6990 (range 1091–25 884) compared with 9329 (288–31 669) using FB (p≤0.01). Both devices recorded significantly more steps on weekdays versus weekends (p≤0.05). EE was also higher during the week. AG and FB were highly correlated to each other (p<0.01). Men were more active than women and maintained their PA throughout the week, whereas women decreased theirs on weekends. Spanish-language pictograms were preferred and self-reported PA matched objective assessments by both devices. Participants perceived themselves to be active (7.1±2.0) due to work.

Conclusions

Both objectively measured and self-reported levels of PA in Hispanic/Latino adults with T2D challenge the assumption that lack of PA may be commonplace for this group. AG and FB are different in their measurement of PA but are significantly correlated. New strategies, including use of pictograms, for interventions need to be considered if further increases or changes in PA are to be used as T2D therapy.

Trial registration number

NCT03736486

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<![CDATA[Predictive models of medication non-adherence risks of patients with T2D based on multiple machine learning algorithms]]> https://www.researchpad.co/article/N40de9110-994f-4542-bab6-d49ca4478640

Objective

Medication adherence plays a key role in type 2 diabetes (T2D) care. Identifying patients with high risks of non-compliance helps individualized management, especially for China, where medical resources are relatively insufficient. However, models with good predictive capabilities have not been studied. This study aims to assess multiple machine learning algorithms and screen out a model that can be used to predict patients’ non-adherence risks.

Methods

A real-world registration study was conducted at Sichuan Provincial People’s Hospital from 1 April 2018 to 30 March 2019. Data of patients with T2D on demographics, disease and treatment, diet and exercise, mental status, and treatment adherence were obtained by face-to-face questionnaires. The medication possession ratio was used to evaluate patients’ medication adherence status. Fourteen machine learning algorithms were applied for modeling, including Bayesian network, Neural Net, support vector machine, and so on, and balanced sampling, data imputation, binning, and methods of feature selection were evaluated by the area under the receiver operating characteristic curve (AUC). We use two-way cross-validation to ensure the accuracy of model evaluation, and we performed a posteriori test on the sample size based on the trend of AUC as the sample size increase.

Results

A total of 401 patients out of 630 candidates were investigated, of which 85 were evaluated as poor adherence (21.20%). A total of 16 variables were selected as potential variables for modeling, and 300 models were built based on 30 machine learning algorithms. Among these algorithms, the AUC of the best capable one was 0.866±0.082. Imputing, oversampling and larger sample size will help improve predictive ability.

Conclusions

An accurate and sensitive adherence prediction model based on real-world registration data was established after evaluating data filling, balanced sampling, and so on, which may provide a technical tool for individualized diabetes care.

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<![CDATA[Clinical characteristics and outcomes of patients with end-stage renal disease hospitalized with diabetes ketoacidosis]]> https://www.researchpad.co/article/N428c9960-3a70-4698-9033-257494017e84

Introduction

There is limited evidence to guide management in patients with end-stage renal disease (ESRD) on chronic hemodialysis admitted with diabetes ketoacidosis. Thus, we investigated the clinical characteristics and outcomes of patients with ESRD admitted with diabetic ketoacidosis (DKA).

Methods

In this observational study, we used International Classification of Diseases Ninth/Tenth Revision codes to identify adult (aged 18–80 years) patients admitted to Emory University Hospitals between 1 January 2006 and 31 December 2016. DKA and ESRD diagnoses were confirmed by reviewing medical records and by admission laboratory results.

Results

Among 307 patients with DKA meeting the inclusion and exclusion criteria, 22.1% (n: 68) had ESRD on hemodialysis and 77.9% (n: 239) had preserved renal function (estimated glomerular filtration rate >60 mL/min/1.73 m2). Compared with patients with preserved renal function, the admission blood glucose was higher (804.5±362.6 mg/dL vs 472.5±137.7 mg/dL) and the mean hemoglobin A1c was lower (9.6%±2.1 vs 12.0%±2.5) in patients with DKA and ESRD, both p<0.001. The rates of hypoglycemia <70 mg/dL (34% vs 14%, p=0.002) and <54 mg/dL (13% vs 5%, p=0.04) were higher in the ESRD group. During hospitalization, more patients with ESRD develop volume overload (28% vs 3%, p<0.001) and require mechanical ventilation (24% vs 3%, p=<0.001). There were no differences in hospital mortality (3% vs 0%, p=0.21), but length of stay (median 7.0 vs 3.0 days, p<0.001) was longer in the ESRD cohort. After adjusting for multiple covariates, patients with DKA and ESRD have higher odds of hypoglycemia (OR 3.3, 95% CI 1.51 to 7.21, p=0.003) and volume overload (OR 4.22, 95% CI 1.37 to 13.05, p=0.01) compared with patients with DKA with preserved renal function.

Conclusions

Patients with DKA and ESRD on chronic hemodialysis had worse clinical outcomes including higher rates of hypoglycemia, volume overload, need for mechanical ventilation and longer length of stay, compared with patients with preserved kidney function.

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<![CDATA[System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015]]> https://www.researchpad.co/article/Ned25163e-8c8c-45b2-8dd4-e6b861144660

Objective

Accuracy of 18 current-generation blood glucose monitoring systems (BGMS) available in Europe was evaluated applying criteria adapted from EN ISO 15197:2015 with one reagent system lot. BGMS were selected based on market research data.

Research design and methods

The BGMS ABRA, Accu-Chek Guide, AURUM, CareSens Dual, CERA-CHEK 1CODE, ContourNext One, eBsensor, FreeStyle Freedom Lite, GL50 evo, GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic GlucoTest, Rightest GM700S, TRUEyou, and WaveSense JAZZ Wireless were tested using capillary blood from 100 different subjects and assessing the percentage of results within ±15 mg/dL (0.83 mmol/L) or 15% of comparison method results for BG concentrations below or above 100 mg/dL (5.55 mmol/L), respectively. In addition, the minimal deviation from comparison method results within which ≥95% of results of the respective BGMS were found was calculated.

Results

In total, 14 BGMS had ≥95% of results within ±15 mg/dL (0.83 mmol/L) or ±15% and 3 BGMS had ≥95% of results within ±10 mg/dL (0.55 mmol/L) or ±10% of the results obtained with the comparison method. The smallest deviation from comparison method results within which ≥95% of results were found was ±7.7 mg/dL (0.43 mmol/L) or ±7.7%; the highest deviation was ±19.7 mg/dL (1.09 mmol/L) or ±19.7%.

Conclusions

This accuracy evaluation shows that not all CE-labeled BGMS fulfill accuracy requirements of ISO 15197 reliably and that there is considerable variation even among BGMS fulfilling these criteria. This safety-related information should be taken into account by patients and healthcare professionals when making therapy decisions.

Trial registration number

NCT03737188.

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<![CDATA[Therapeutic efficacy and safety of initial triple combination of metformin, sitagliptin, and lobeglitazone in drug-naïve patients with type 2 diabetes: initial triple study]]> https://www.researchpad.co/article/N077f8fbb-1820-434b-8b25-a86bde659b99

Objective

To compare the efficacy and safety of an initial triple therapy using metformin, a dipeptidyl peptidase-4 (DPP4) inhibitor, and thiazolidinedione with a stepwise approach using sulfonylurea and metformin in new-onset, drug-naïve patients with type 2 diabetes.

Research design and methods

Among drug-naïve patients with 9.0%–12.0% glycated hemoglobin (HbA1c) but no hyperglycemic symptoms, 100 subjects who started triple medications (metformin 1000 mg/day, sitagliptin 100 mg/day, and lobeglitazone 0.5 mg/day) were selected as an initial triple therapy group. Age and body mass index-matched subjects (n=100) who started glimepiride (≥2 mg/day with uptitration) and metformin (≥1000 mg/day with uptitration) were selected as a conventional therapy group. We investigated changes in HbA1c level, dynamic indexes for insulin sensitivity and β-cell function, and hypoglycemia.

Results

After 12 months of treatment, HbA1c levels decreased significantly in both groups: from 10.7%±1.0% to 6.7%±1.3% in the triple group, and from 10.5%±1.0% to 7.3%±1.2% in the conventional therapy group. At 12 months, achievement of the HbA1c target (<7.0%) was higher in the triple group than in the conventional group (70% vs 52%, p<0.01). Dynamic indexes related to β-cell function and insulin sensitivity improved, and albuminuria reduced significantly only in the triple group. Hypoglycemia was more common in the conventional group.

Conclusions

Initial triple combination therapy with the DPP4 inhibitor, metformin, and thiazolidinedione showed a higher achievement of the target HbA1c goal with a lower risk of hypoglycemia, better restoration of β-cell function, and multiple metabolic benefits, implying durable glycemic control. This strategy may be useful for patients presenting with type 2 diabetes and high HbA1c levels.

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<![CDATA[Screening for non-alcoholic fatty liver disease in type 2 diabetes using non-invasive scores and association with diabetic complications]]> https://www.researchpad.co/article/N3c140c07-cb84-4e77-97ed-cdf9105ac002

Objective

Non-alcoholic fatty liver disease (NAFLD) is prevalent in patients with type 2 diabetes. Here, we estimate the proportion of patients with type 2 diabetes that should be referred to hepatologists according to the European Association for the Study of the Liver (EASL)-European Association for the Study of Diabetes (EASD)-European Association for the Study of Obesity (EASO) Guidelines and evaluate the association between non-invasive biomarkers of steatosis and fibrosis and diabetic complications.

Research design and methods

This is a retrospective analysis of type 2 diabetes patients who attended on a regular basis our diabetes clinic between 2013 and 2018 (n=2770). Steatosis was assessed using Fatty Liver Index (FLI), Hepatic Steatosis Index and NAFLD Ridge Score and fibrosis using NAFLD Fibrosis Score (NFS), Fibrosis-4 (FIB-4), aspartate aminotransferase (AST) to platelet ratio index (APRI) and AST/alanine aminotransferase (ALT) ratio. Outcome measures were altered albumin excretion rate (AER), chronic kidney disease (CKD) and cardiovascular disease (CVD).

Results

The prevalence of advanced fibrosis varied from 1% (APRI) to 33% (NFS). The application of the guidelines using a sequential combination of FLI and FIB-4 would lead to referral of 28.3% of patients when using standard FIB-4 cut-offs, while this number dropped to 13.4% when age-adjusted FIB-4 thresholds were applied. A higher prevalence of altered AER was associated with liver steatosis (FLI: OR: 3.49; 95% CI 2.05 to 5.94, p<0.01), whereas liver fibrosis was associated with CKD (FIB-4: OR: 6.39; 95% CI 4.05 to 10.08, p<0.01) and CVD (FIB-4: OR: 2.62; 95% CI 1.69 to 4.04, p<0.01).

Conclusions

While specific fibrosis scores identify different proportion of patients with advanced fibrosis, the use of age-adjusted FIB-4 cut-offs leads to a drop in gray-zone results, making referrals to hepatologists more sustainable. Interestingly non-invasive biomarkers were consistently associated with a different pattern of diabetic complications.

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<![CDATA[Cholinesterase inhibitors in patients with diabetes mellitus and dementia: an open-cohort study of ~23 000 patients from the Swedish Dementia Registry]]> https://www.researchpad.co/article/Na55202dd-a2dc-4037-90e9-83e40b8da1b7

Objective

Cholinesterase inhibitors (ChEIs) and memantine are the only approved pharmacological treatments for Alzheimer’s disease (AD). Recent literature suggests reductions in cardiovascular burden and risk of stroke in ChEI users. However, the clinical effectiveness of these drugs in patients with diabetes mellitus (DM) and dementia has not been evaluated.

Research design and methods

We conducted a registry-based open-cohort study of 22 660 patients diagnosed with AD and mixed-pathology dementia registered in the Swedish Dementia Registry until December 2015. Information on drug use, comorbidity and mortality was extracted using the linkage with the National Patient Registry, the Prescribed Drug Registry and the Cause of Death Registry. In total, 3176 (14%) patients with DM and 19 484 patients without DM were identified. Propensity-score matching, Cox-regression and competing-risk regression models were applied to produce HRs with 95% CIs for differences in all-cause, cardiovascular and diabetes-related mortality rates in ChEI users and non-users.

Results

After matching the ChEI use in patients with DM was associated with 24% all-cause mortality reduction (HR 0.76 (95% CI 0.67 to 0.86)), compared with 20% reduction (0.80 (0.75 to 0.84)) in non-DM users. Donepezil and galantamine use were associated with a reduced mortality in both patients with DM (0.84 (0.74 to 0.96); 0.80 (0.66 to 0.97)) and patients without DM (0.85 (0.80 to 0.90); 0.93 (0.86 to 0.99)). Donepezil was further associated with reduction in cardiovascular mortality, however only in patients without DM (0.84 (0.75 to 0.94)). Rivastigmine lowered mortality only in the whole-cohort analysis and in patients without DM (0.82 (0.75 to 0.89)). Moreover, ChEI use was associated with 48% reduction in diabetes-related mortality (HR 0.52 (0.32 to 0.87)) in the whole-cohort analysis. Last, low and high doses were associated with similar benefit.

Conclusions

We found reductions in mortality in patients with DM and AD or mixed-pathology dementia treated with ChEIs, specifically donepezil and galantamine were associated with largest benefit. Future studies should evaluate whether ChEIs help maintain self-management of diabetes in patients with dementia.

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<![CDATA[Association of prestroke glycemic status with stroke mortality]]> https://www.researchpad.co/article/Ne778ea24-6e46-4362-833d-8362fa99bd1b

Objective

The role of diabetes as a predictor of mortality after stroke remains uncertain, and there are very few data for pre-diabetes. This study investigated the association of pre-diabetes and diabetes with 30-day and 1-year mortality after ischemic stroke (IS) and primary intracerebral hemorrhage (ICH).

Research design and methods

Between 2006 and 2013, 2076 patients with IS and 586 patients with ICH (median age 79) were admitted to hospital within 24 hours after stroke onset and were treated in a stroke unit, where they underwent measurement of glycated hemoglobin (HbA1c). Diabetes was retrospectively defined based on medical history, diagnosis during hospital stay or HbA1c ≥6.5% (48 mmol/mol). Pre-diabetes was defined as HbA1c of 5.7%–6.4% (39–47 mmol/mol). Stroke severity was measured using the National Institutes of Health Stroke Scale (NIHSS). HRs were used to test the association of pre-diabetes and diabetes with 30-day and 1-year mortality after stroke onset.

Results

Among patients with IS, 830 had pre-diabetes and 632 had diabetes; 280 died within 30 days and the other 77 within 1 year. Among patients with ICH, 106 had pre-diabetes and 56 had diabetes; 150 died within 30 days and the other 92 within 1 year. In both stroke subtypes, pre-diabetes and diabetes were associated with higher 30-day mortality. In IS, however, the association was limited to patients with prestroke disability and very severe stroke. At NIHSS 25, HR was 1.58 (95% CI 1.07 to 2.35) for pre-diabetes and 1.67 (95% CI 1.14 to 2.46) for diabetes compared with normoglycemia. In ICH, the association was limited to women for pre-diabetes (HR 1.93, 95% CI 1.15 to 3.24) and to men for diabetes (HR 1.78, 95% CI 1.02 to 3.12). Prestroke glycemic status was unrelated to 1-year mortality.

Conclusions

Both pre-diabetes and diabetes predict short-term mortality after acute stroke, but the association varies depending on both prestroke and stroke-related characteristics. These findings may explain the heterogeneous results obtained by previous studies.

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<![CDATA[Immune checkpoint inhibitors: an emerging cause of insulin-dependent diabetes]]> https://www.researchpad.co/article/5ca10fdad5eed0c48456c295

Objective

Insulin-dependent diabetes can occur with immune checkpoint inhibitor (ICI) therapy. We aimed to characterize the frequency, natural history and potential predictors of ICI-induced diabetes.

Research design and methods

We reviewed 1444 patients treated with ICIs over 6 years at our cancer center, and from the 1163 patients who received programmed cell death protein 1 (PD-1) inhibitors, we identified 21 such cases, 12 of which developed new-onset insulin-dependent diabetes and 9 experienced worsening of pre-existing type 2 diabetes.

Results

ICI-induced diabetes occurred most frequently with pembrolizumab (2.2%) compared with nivolumab (1%) and ipilimumab (0%). The median age was 61 years, and body mass index was 31 kg/m2, which are both higher than expected for spontaneous type 1 diabetes. Other immune-related adverse events occurred in 62%, the most common being immune mediated thyroid disease. New-onset insulin-dependent diabetes developed after a median of four cycles or 5 months; 67% presented with diabetic ketoacidosis and 83% with low or undetectable C-peptide. Autoantibodies were elevated in 5/7 (71%) at the time of new-onset diabetes. Diabetes did not resolve during a median follow-up of 1 year.

Conclusions

PD-1 inhibitors can lead to insulin deficiency presenting as new-onset diabetes or worsening of pre-existing type 2 diabetes, with a frequency of 1.8 %. The underlying mechanism appears similar to spontaneous type 1 diabetes but there is a faster progression to severe insulin deficiency. Better characterization of ICI-induced diabetes will improve patient care and enhance our understanding of immune-mediated diabetes.

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<![CDATA[Plant-derived polyunsaturated fatty acids and markers of glucose metabolism and insulin resistance: a meta-analysis of randomized controlled feeding trials]]> https://www.researchpad.co/article/5ca10fe2d5eed0c48456c371

The objective of this meta-analysis was to investigate the effects of plant-derived polyunsaturated fatty acids (PUFAs) on glucose metabolism and insulin resistance. Scopus and PubMed databases were searched until January 2018. Eligible studies were randomized controlled feeding trials that investigated the effects of a diet high in plant-derived PUFA as compared with saturated fatty acids (SFA) or carbohydrates and measured markers of glucose metabolism and insulin resistance as outcomes. Data from 13 relevant studies (19 comparisons of plant-derived PUFA with control) were retrieved. Plant-derived PUFA did not significantly affect fasting glucose (−0.01 mmol/L (95 % CI − 0.06 to 0.03 mmol/L)), but lowered fasting insulin by 2.6 pmol/L (−4.9 to −0.2 pmol/L) and homeostatic model assessment-insulin resistance (HOMA-IR) by 0.12 units (-0.23 to − 0.01 units). In dose–response analyses, a 5% increase in energy (En%) from PUFA significantly reduced insulin by 5.8 pmol/L (95% CI −10.2 to −1.3 pmol/L), but not glucose (change −0.07, 95% CI −0.17 to 0.04 mmol/L) and HOMA-IR (change − 0.24, 95% CI −0.56 to 0.07 units). In subgroup analyses, studies with higher PUFA dose (upper tertiles) reduced insulin (-6.7, –10.5 to −2.9 pmol/L) and HOMA-IR (-0.28, –0.45 to −0.12 units), but not glucose (−0.09, 95% CI −0.18 to 0.01 mmol/L), as compared with an isocaloric control. Subgroup analyses showed no differences in effects between SFA and carbohydrates as replacement nutrients (p interaction ≥0.05). Evidence from randomized controlled trials indicated that plant-derived PUFA as an isocaloric replacement for SFA or carbohydrates probably reduces fasting insulin and HOMA-IR in populations without diabetes.

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