Point-of-Care Testing of Blood Glucose: Clinical Performance and Laboratory Efficiency

Diabetes prevalence is increasing globally especially in the Asian subcontinent. It is expected that by the year 2030 there may be close to 400 million people with diabetes. All of the research in the past 25 years has clearly documented the effectiveness of improving glucose control in reducing long-term complications of diabetes, both microvascular and macrovascular. The improvement in glucose control usually requires continuous intensive diabetes management, particularly in insulin-requiring patients, which must include home self-monitoring of blood glucose (SMBG). Despite the convincing evidence, the role of SMBG in diabetes management is still being debated even though its availability in the past 35 years has revolutionised diabetes care, especially at home. The International Diabetes Federation (IDF) recently published guidelines for SMBG use in non-insulin-treated diabetic patients, recommending that SMBG should be used only when patients and/or their clinicians possess the ability, willingness and knowledge to incorporate SMBG and therapy adjustment into their diabetes care plan. The IDF also recommends that structured SMBG be performed with the choice of applying different defined blood glucose testing algorithms to patients' individual diabetes care plans. These defined blood glucose testing algorithms give SMBG a medically meaningful structure to collect high quality glucose information and are called structured SMBG. Former SMBG studies have demonstrated SMBG to be beneficial when patients receive feedback regarding the impact of their behaviours on SMBG results. Other studies which did not link SMBG results to these principal behaviours have shown no SMBG benefit. A new wave of clinical studies performed after the release of the IDF guideline have recently been published and have proved the success of the new application of SMBG. The reasons for this ongoing debate may in part be due to rising healthcare costs globally, lack of convincing data in non-insulin-requiring patients with type 2 diabetes in randomised controlled clinical trials and multiple controversial meta-analyses performed on several studies. Sometimes the decisions are extended to insulin-requiring patients, even those with type 1 diabetes. For example, last year in the state of Washington in the USA, legislators were going to stop reimbursing glucose test strips for children with type 1 diabetes. After much debate with committee members (who were not diabetologists and or endocrinologists) and law makers, not only SMBG but even in some cases continuous glucose monitoring (CGM) is now reimbursed. The issue was simply educating non-understanding but well-meaning people whose main concern is saving money. In the end, no one, even those not familiar with paediatric type 1 diabetes, can disagree about the need for SMBG in this age group. It seems to us that we should instead be spending our time and effort in advancing the field and improving diabetes management for patients through newer technologies like CGM and closed-loop systems. As discussed in the section on CGM (Chapter 2) there is ample data from both non-randomised and randomised clinical trials showing the efficacy in reducing time spent in hypoglycaemia and hyperglycaemia along with improvement in glucose control without introducing any additional medication. We hope that the future will be spent in advancing the care rather than useless meta-analyses or going back in time. It is worthwhile to review existing evidence about SMBG to learn, transfer and apply knowledge about the core requirement for good diabetes management, glucose information. Fendler W, Hogendorf A, Szadkowska A, Młynarski W Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz, Poland Pediatr Endocrinol Diabetes Metab 2011; 17 : 57–63 Background: SMBG is one of the major components of diabetes management. Aims: To evaluate the potential for miscoding of a personal glucometer, to define a target population among paediatric patients with diabetes for a non-coding glucometer and to assess the accuracy of the Contour TS non-coding system. Methods: Potential for miscoding during SMBG was evaluated by means of an anonymous questionnaire, with worst and best case scenarios evaluated depending on the response pattern. Testing of the Contour TS system was performed according to the national committee for clinical laboratory standards guidelines. Results: The estimated frequency of individuals prone to non-coding ranged from 68.21% [95% confidence interval (CI) 60.70%–75.72%] to 7.95% (95% CI 3.86%–12.31%) for the worse and best case scenarios, respectively. Factors associated with increased likelihood of non-coding were a smaller number of tests per day, a greater number of individuals involved in testing and self-testing by the patient. The Contour TS device showed intra- and inter-assay accuracy of –95%, a linear association with laboratory measurements (R2 = 0.99, p < 0.0001) and small bias of –1.12% (95% CI –3.27% to 1.02%). Clarke error grid analysis showed 4% of values within the benign error zone (B) with the other measurements yielding an acceptably accurate result (zone A). Conclusions: The Contour TS system showed sufficient accuracy to be safely used in the monitoring of paediatric patients with diabetes. Patients from families with a high throughput of test-strips or multiple individuals involved in SMBG using the same meter are candidates for clinical use of such devices due to an increased risk of calibration errors. Comment: This study further highlights the role of making SMBG simpler and easier so that patients can monitor the glucose more effectively. The current study used the Contour TS system which does not require coding by the patient and thus removes the barrier of mis-coding of SMBG. We personally think that all meters going forward must be non-coding meters. Nerhus K 1 , Rustad P 2 , Sandberg S 1,3 1 Norwegian Centre for Quality Improvement of Primary Care Laboratories, Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway, 2 Norwegian Clinical Chemistry EQA-Program, Fürst Medical Laboratory, Oslo, Norway, 3 Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway Diabetes Technol Ther 2011; 13: 883–92 Background: Analytical quality of SMBG can be affected by environmental conditions. Aims: To determine the influence of a shift in the ambient temperature immediately before measurement and taking measurements in the lower and upper part of the operating temperature range. Methods: Different SMBG systems (n = 9) available on the Norwegian market were tested with heparinised venous blood (4.8 and 19.0 mmol/l). To test the effect of a shift in ambient temperature, the glucometer and strips were equilibrated for 1 h at 5 °C or 30 °C before the meter and strips were moved to room temperature, and measurements were performed after 0, 5, 10, 15 and 30 min. To test the lower and upper temperature range, measurements were performed at 10 °C and at 39 °C after 1 h for temperature equilibration of the glucometer and strips. All the measurements were compared with measurements performed simultaneously on a meter and strips kept the whole time at room temperature. Results: Six of nine SMBG systems overestimated and/or underestimated results by more than 5% after moving meters and strips from 5 °C or 30 °C to room temperature immediately before the measurements. Two systems underestimated the results at 10 °C. One system overestimated and another underestimated the results by more than 5% at 39 °C. Conclusions: A rapid shift in the ambient temperature affects analytical performance. Therefore patients need to wait at least 15 min for temperature equilibration of affected meters and strips before measuring blood glucose. Comment: This study highlights the importance of ambient temperature on analytical performance of SMBG. The study shows that rapid shift in ambient temperature may affect the accuracy and bias in SMBG measurement and highlights the need for 15 min temperature equilibration. In addition to what has been highlighted in the study, future studies also need to assess the accuracy of existing meters (especially the one using glucose oxidase) at higher altitudes (10,000 feet or higher). It is known that many of these meters do not perform well at high altitudes. McAndrew LM 1,2 , Horowitz CR 3 , Lancaster KJ 4 , Quigley KS 2,5,6 , Pogach LM 1,2 , Mora PA 7 , Leventhal H 8 1 War Related Illness and Injury Study Center and REAP Center for Healthcare Knowledge Management, Department of Veterans Affairs, New Jersey Health Care System, East Orange, NJ, USA, 2 University of Medicine and Dentistry of New Jersey, Newark, NJ, USA, 3 Department of Health Evidence and Policy, Mount Sinai School of Medicine,New York, NY, USA, 4 Department of Nutrition, Food Studies and Public Health, New York University, New York, NY, USA, 5 Department of Veterans Affairs, Edith Nourse Rogers Memorial VA Hospital, Bedford, MA, USA, 6 Department of Psychology, Northeastern University, Boston, MA, USA, 7 Psychology Department, University of Texas at Arlington, Arlington, TX, USA, and 8 Institute for Health, Health Care Policy and Research, Rutgers University, New Brunswick, NJ, USA J Diabetes 2011; 3 : 147–52; Comment in J Diabetes 2011; 3 : 93–4 Background: It is unknown whether SMBG can motivate adherence to dietary recommendations. Aims: To evaluate if patients who used more SMBG would also report lower fat and greater fruit and vegetable consumption. Methods: This was a cross-sectional study of primarily minority individuals living with diabetes in East Harlem, New York (n = 401). Fat intake and fruit and vegetable consumption were measured with the Block Fruit/Vegetable/Fiber and Fat Screeners. Results: Greater frequency of SMBG was associated with lower fat intake [r(s) = –0.15; p < 0.01], but not fruit and vegetable consumption. The effects of SMBG were not moderated by insulin use. A significant interaction was found between frequency of SMBG and changing one's diet in response to SMBG on total fat intake. Conclusions: The frequency of SMBG was associated with lower fat intake. The data suggest that participants who use SMBG to guide their diet do not have to monitor multiple times a day to benefit. Comment: This study further highlights the importance of SMBG in daily lifestyle changes. Subjects with higher frequency of SMBG consumed less fat, in part related to overall education and seeing the impact from making dietary changes on SMBG levels. Kuo CY 1,2 , Hsu CT 3 , Ho CS 3 , Su TE 3 , Wu MH 4 , Wang CJ 2,5 1 Department of Clinical Laboratory, Tai-An Hospital, Taichung, Taiwan, 2 Institute of Biochemistry and Biotechnology, Chung Shan Medical University, Taichung, Taiwan, 3 Department of Core Technical Research, Bionime Corporation, Taichung, Taiwan, 4 Department of Laboratory Medicine, Min-Sheng General Hospital, Taoyuan, Taiwan, 5 Department of Medical Research, Chung Shan Medical University Hospital, Taichung, Taiwan Diabetes Technol Ther 2011; 13 : 596–600 Background: SMBG systems should at least meet the minimal requirement of the World Health Organization's ISO 15197:2003. For tight glycaemic control, a tighter accuracy requirement is needed. Methods: Seven SMBG systems were evaluated for accuracy and precision: Bionime Rightest™ GM550 (Bionime Corp., Dali City, Taiwan), Accu-Chek® Performa (Roche Diagnostics, Indianapolis, IN, USA), OneTouch® Ultra®2 (LifeScan Inc., Milpitas, CA, USA), MediSense® Optium™ Xceed (Abbott Diabetes Care Inc., Alameda, CA, USA), Medisafe (TERUMO Corp., Tokyo, Japan), Fora® TD4227 (Taidac Technology Corp., Wugu Township, Taiwan) and Ascensia Contour® (Bayer HealthCare LLC, Mishawaka, IN, USA). The 107 participants were 23–91 years old. The analytical results of seven SMBG systems were compared with those of plasma analysed with the hexokinase method (Olympus AU640, Olympus America Inc., Center Valley, PA, USA). Results: The imprecision of the seven blood glucose meters ranged from 1.1% to 4.7%. Three of the seven blood glucose meters (42.9%) fulfilled the minimum accuracy criterion of ISO 15197:2003. The mean absolute relative error value for each blood glucose meter was calculated and ranged from 6.5% to 12.0%. Conclusions: More than 40% of evaluated SMBG systems meet the minimal accuracy criterion requirement of ISO 15197:2003. However, considering a tighter criterion for accuracy of ±15%, only the Bionime Rightest GM550 meets this requirement. Manufacturers have to try to improve accuracy and precision and to ensure the good quality of blood glucose meters and test strips. Comment: This study further highlights the need for more accurate SMBG systems. Their data concluded that more than 40% of the evaluated SMBG systems meet the minimum ISO criteria. Since patients use blood glucose information for adjusting their insulin dose and/or treating hypoglycaemia, the accuracy of the glucose meters has to be consistent and improved. Hortensius J 1 , Slingerland RJ 2 , Kleefstra N 1,3,4 , Logtenberg SJ 1 , Groenier KH 5 , Houweling ST 3,6 , Bilo HJ 1,4 1 Diabetes Centre, Isala Clinics, Zwolle, The Netherlands, 2 Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands, 3 Medical Research Group, Langerhans, The Netherlands, 4 Department of Internal Medicine, University Medical Center, Groningen, The Netherlands, 5 Department of General Practice, University of Groningen, Groningen, The Netherlands, and 6 General Practice Sleeuwijk, Sleeuwijk, The Netherlands Diabetes Care 2011; 34 : 556–60 Background: There is no agreement regarding the use of the first or second drop of blood for glucose monitoring. Aims: To investigate whether capillary glucose concentrations, as measured in the first and second drops of blood, differed ≥10% compared with a control glucose concentration in different situations. Methods: Capillary glucose concentrations were measured in two consecutive drops of blood in 123 patients with diabetes in the following circumstances: without washing hands, after exposing the hands to fruit, after washing the fruit-exposed hands, and during application of different amounts of external pressure around the finger. The results were compared with control measurements. Results: Not washing hands led to a difference of ≥10% in glucose concentration in the first and in the second drops of blood in 11% and 4% of the participants, respectively. In fruit exposed fingers, these differences were found in 88% and 11% of the participants, respectively. Different external pressures led to ≥10% differences in glucose concentrations in 5%–13% of the participants. Conclusions: Washing hands with soap and water, drying them, and using the first drop of blood for SMBG is recommended. If washing hands is not possible, it is acceptable to use the second drop of blood after wiping away the first drop. External pressure may lead to unreliable readings. Comment: Over the years we have probably under-emphasised the importance of technique with SMBG. One has to wonder how much iatrogenic hypoglycaemia has occurred due to unintended exposure to glucose on the hands, and how often CGM devices are due to technique with SMBG use. 1,2 , 3 , 4 , 5 , 6 , 7 , 8 , 8 , 8 1 University of CA, USA, 2 Diabetes CA, USA, 3 University of CA, USA, 4 University Health System, USA, 5 America Diabetes USA, 6 Health IN, USA, 7 USA, and 8 Diagnostics, Indianapolis, IN, USA Diabetes Care 2011; 34 : To assess the effectiveness of structured blood glucose testing in controlled patients with type 2 diabetes without insulin Methods: A study patients with type 2 diabetes (n = and glycaemic control from 34 care in the were randomised to an control with care or a structured testing with care and at least use of structured SMBG. patients and were to use a to glucose consecutive The was measured at Results: The analysis = = showed greater in mean in the compared with the = p = analysis = = showed even greater mean in the compared with the p < more patients a at the first compared with patients, of the p < and patients significant < 0.0001) in Conclusions: use of structured SMBG glycaemic control and more changes in patients with type 2 diabetes without Comment: It is with an healthcare using a structured glucose testing can improve glucose control in non-insulin-treated Potential are of this can be in a with the more time in a care to be , 5 , 6 , 1,4 1 Department of and Laboratory Medicine, University of 2 Department of and University of 3 Department of Pediatrics, University of 4 Laboratory 5 Corporation, MA, USA, and 6 Department of Health University of J Diabetes Technol 4 : Aims: To analytical error in and glucose meters by in and Methods: The of and were tested and in with each glucose meter and with a plasma glucose method at glucose was by consecutive analysis (n = at glucose levels. analysis was used to the bias associated with the and in Results: Three meters demonstrated bias that was glucose bias on the and the of bias was on small significant on meters. of and of increased the bias and was by of total analytical the glucose meter devices of total analytical error in glucose measurement ranged from to the Conclusions: The of glucose meters to significant analytical is the analytical Comment: with to for SMBG and the research is it does not that many people the This has impact on as new guidelines for greater of are the impact on SMBG accuracy be particularly by the device should be a 1 , 1 , 2 , 3 1 Health and 2 Health, and 3 of and Department of Internal Medicine, : Aims: To evaluate the of SMBG in patients with type 2 diabetes with in Methods: In a study a of diabetes was used to from a published study of SMBG in patients with type 2 diabetes, with and with no of a time was from the of a healthcare and clinical were at Results: or times daily SMBG was associated with in which led to increased and and of diabetes complications compared with no SMBG in type 2 diabetes patients on costs increased by and in patients SMBG or times daily compared with those not using SMBG. were well at and per year respectively. Conclusions: SMBG is to be by standards in patients on in the Comment: This analysis is on a showing of and The concern of is that this analysis is not a randomised controlled and at best the data are about the efficacy of this population using this analysis is probably on controversial 1,2 , 3 , S 3 , 1 Health Research, University School of Medicine, Indianapolis, IN, USA, 2 Institute for Health Care, Indianapolis, IN, USA, 3 of University School of Medicine, Indianapolis, IN, USA, and 4 Diabetes and Center, University School of Medicine, Indianapolis, IN, USA Diabetes 2011; : To assess the and of a glucose monitoring system for with type 1 diabetes and their Methods: Patients with type 1 diabetes who been for at least 1 year in the used the system for 6 3 to and with the glucose monitoring as well as how use of the system affect quality of and diabetes management. Results: about the a number of significant that affected use of the all that the in monitoring testing was The use of the did not the quality of their of with their their of diabetes, or their glycaemic control within the time of the Conclusions: This that glucose monitoring can be used in an population to and in self-monitoring Comment: for both SMBG and CGM is clearly the future for with type 1 diabetes. The will be to how to best use this to improve in this To the is new to how best to use more studies will be to this P 1 , 2 , ST 3 , 2 , 2 , 4 , Bilo 5 , Bilo HJ 1 Department of Internal Medicine, Hospital, The Netherlands, 2 Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands, 3 Department of Isala Clinics, Zwolle, The Netherlands, 4 Centre for The Netherlands, 5 Department of Internal Medicine, Isala Clinics, Zwolle, The Netherlands, and 6 Department of Internal Medicine, University Medical Centre, Groningen, The Netherlands One 5 : Background: Patients with diabetes part in and thus blood glucose meters are studies bias in blood glucose measurements using different at high To evaluate if glucose are more by the lower pressure at than glucose Methods: measurements at of nine glucose glucose were compared with glucose measurement on a at and with a laboratory glucose blood of different glucose were were at a bias from glucose and from glucose mmol/l). Results: significant difference was between measurements at and for glucose or glucose as a Two glucose did not meet performance criteria. Conclusions: high all tested glucose did not influence of All for two glucose performed within criteria. are glucose concentration at high high one glucose best precision and Comment: testing for SMBG meters may be In glucose test strips should be at high altitudes. not in this it should be that patients do not this into when or 1 , J 2 , 2 , 1 , 3 , 4 , J 3 , 5 , J 6 , 7 , 7 , 8 1 Department of Health University of Health Center, USA, 2 and Health Department of Medical and University of USA, 3 Department of and Health University of USA, 4 Diabetes Care Center, Medical USA, 5 Department of University of USA, 6 Medicine Technology Center USA, 7 Department of Medicine, University of USA, and 8 Health Research USA J Aims: To assess the and of using as part of an existing system for between patients with diabetes and a care Methods: In glucose meter and two to feedback on glycaemic control were Results: glucose meter with and data feedback were the system to an and feedback system for value in the system as an to the and Conclusions: diabetes management systems may one to improve the quality of diabetes Comment: best to in a care for type 2 diabetes is still It is that there will be different of that will for different patient the use of the as a means of that device like the of in diabetes management. the now seems to be how to is a It may be that will be the only for many the of time this population 1 , 2 1 Centre for Policy Research, of Health Health Policy and Research, University of and 2 Institute for Medicine, and Health University Medical Centre 2011; : Background: the of and in Patients with 2 Diabetes a in the risk of in patients with type 2 diabetes who performed SMBG. Aims: To evaluate if these are by a that time Methods: The bias in the study was and demonstrated that it is to the effect of SMBG on Results: In the study, patients were as exposed to SMBG for their whole time if performed SMBG for at least 1 year during the study the time between and the after 1 year of self-monitoring was performed is for patients with SMBG. Patients to at least 1 year to be as exposed to this and were from The total of in the SMBG is at least of at risk After of as the relative risk from to Conclusions: The effect of SMBG on in the study is by time Comment: The study is one of the trials in the of SMBG. Study is probably a major for between the studies. Kleefstra N 1,2 , Hortensius J 1 , Logtenberg SJ 1 , 3 , Groenier K 4 , Houweling ST 2,5 , 6 , 2 , Bilo HJ 1 Diabetes Centre, Isala Clinics, Zwolle, The Netherlands, 2 Medical Research Langerhans, Zwolle, The Netherlands, 3 Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands, 4 Department of General Practice, University of Groningen, Groningen, The Netherlands, 5 General Practice Sleeuwijk, Sleeuwijk, The Netherlands, 6 Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands J : Background: It is not if SMBG glycaemic control in patients with type 2 diabetes. To investigate the effects of SMBG in patients with type 2 diabetes who were in glycaemic Methods: Patients years with an of using one to two blood glucose were in the Patients (n = were to receive SMBG to care or to with care for 1 A glucose value and glucose values were measured The efficacy was quality of and were using the Health the the Diabetes and the Results: in between was (95% CI to p = There were no significant changes between on the type or for the which was lower in the difference (95% CI to Conclusions: type 2 diabetes patients some of their the use of SMBG in these patients is and its use should be Comment: This is another SMBG study in non-insulin-treated type 2 the of not patients what to do with the information is one has to wonder if this at some to have some of the it is to that the in care is to more education and time than is in many of these studies. A 1 , 1 , 1 , S 2 , S 3 , A 1 , A 1 , 1 , 4 , 3 , 3 , 1 1 Department of and School of Medicine, 2 Department of School of Medicine, 3 Department of Biochemistry, School of Medicine, and 4 Department of School of Medicine, Diabetes Technol Ther : Background: glucose meters may not be accurate to Aims: of the accuracy and the capillary and venous of different Xceed (Abbott Diabetes Care, Alameda, CA, USA), Contour TS (Bayer Diabetes Care, (Roche Milpitas, CA, and Inc., in an Methods: The insulin hypoglycaemia test was performed for of mean age was measured from venous blood and capillary before and after of insulin were analysed in the laboratory by the hexokinase In tests for method and precision were also performed by the venous Results: All to hypoglycaemia to some was in error zone and was in the error zone Xceed and Contour TS and were than the other two according to error grid analysis or International for criteria. The in tests were consistent with the clinical The capillary and venous of and were than the other Not all are accurate in blood glucose levels. The patients and the should be of these of the and give more to the hypoglycaemia than the values with the These results that there is a need for the of accuracy standards of at blood glucose levels. Comment: We have the that meters are from especially at levels. patients can state a time when an The are not only for the of hypoglycaemia but also as we forward with CGM about how this about this the with the for use of the meters our clinical with patient error us that accuracy a for glucose meters at levels. has research from Inc., Corporation, Inc., and is a for Diagnostics, Diabetes Care and

The aim of the study was to determine the feasibility of conducting a case-finding programme for Type 2 diabetes mellitus in primary health care and to see whether random urinary glucose or random capillary blood glucose testing is the most suitable instrument for the early detection of Type 2 diabetes. Residents in the community of Låxa aged 35-64 years were subjected to testing during 1983-1987; those aged 65-79 were included from July 1985 and onwards. The urinary glucose testing was considered positive if a urinary dipstick was not unequivocally negative. The random blood glucose test was regarded as positive when > or = 8.0 mmol l-1. A diagnosis of Type 2 diabetes made within a follow-up period of 3 years from the initial examination was regarded as a positive outcome. Random blood glucose testing was performed on 3268 persons which was close to 85% of the eligible population. Urinary glucose tests were missing in 67 subjects. The random blood glucose test was positive in 220 persons and the urinalysis in 42 persons. A total of 234 individuals had a positive test, out of which 66 new diabetic cases were found. Sixty-four of these were detected by the random blood glucose testing and 20 by the urinalysis. The sensitivity for the random blood glucose and urinary glucose testing was 73 and 23%, the specificity was 95 and 99%, the positive predictive value 29 and 48%, and the negative predictive value 99 and 98%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Summary Blood glucose meters and test strips for self-monitoring of blood glucose (SMBG) are often inaccessible to, and infrequently used by, people with diabetes in countries with limited resources for health care. Supplies for measuring blood glucose can also be scarce in health facilities, despite being needed in a myriad of clinical settings at all levels of the health system. Numerous studies and international guidelines emphasise the value of SMBG in diabetes care, particularly in people with type 1 diabetes. In this Review, we assess global access to blood glucose meters and test strips, collating published information on cost, availability, system accuracy, competitive bidding, technological trends, and non-financial barriers. We also provide new information on global market share data and prices, taxes and tariffs, and product availability. Blood glucose meters and test strips should be viewed similarly to essential medicines, with issues of access prioritised by relevant international agencies. Efforts are needed to reduce tariffs and taxes and to create unified global system accuracy requirements and accountable post-marketing evaluations. Preferential pricing arrangements, pooled procurement, and best-purchasing practices could help to lower direct costs. SMBG supplies should also be included in national health insurance schemes. Enhanced diabetes education of health professionals and patients is crucial to ensure effective use of SMBG. Finally, as technology advances for people who can afford new interstitial fluid glucose monitoring systems, blood glucose meters and test strips must remain available and become more affordable in low-resource settings.

BackgroundThis study aimed to evaluate how the tests for blood glucose (BG) and diabetic complications have been utilized in a hospital in Thailand.Material/MethodsPatient medical records having the results of BG, HbA1c, and/or urine microalbumin presented and the records of DM patients having the results of serum lipids, serum LDL-C, and/or serum creatinine presented were selected. The data of diagnosis, ordered tests, and testing results in these records were extracted for evaluation.ResultsThis study recruited 1066 patients diagnosed with DM and 3081 patients diagnosed with other diseases. Point-of-care testing (POCT) for BG was repeatedly used in 371 non-DM cases; most of its results were normal. The results of BG and HbA1c were often used together. There was a good relationship between them, and these test results indicated poor glycemic control in 58% of DM cases. In non-DM cases, the test results agreed, indicating normoglycemia in 17.32%, pre-diabetes in 20.47%, and diabetes in 21.78%. To prevent diabetic nephropathy, serum creatinine was frequently used, whereas urine microalbumin, the recommended test, was underutilized. The result of LDL-C from both direct measurement and calculation were used; however, based on the same guidelines, the results of measured LDL-C indicated risk of cardiovascular diseases in a higher percentage of DM cases than did the results of calculated LDL-C.ConclusionsThe use of POCT for BG in hospitalized patients may be inappropriate. The utilization of urine microalbumin should be promoted to effectively prevent diabetic nephropathy.

Objectives: To examine metabolic monitoring rates in commercially insured children and adolescents treated with a second-generation antipsychotic (SGA) during calendar years (CYs) 2016 and 2017. Methods: In this retrospective study, data were collected from a large national commercial health plan for the period covering January 1, 2016 to December 31, 2017. Commercially insured children and adolescents, aged 8-19 years with ≥2 SGA prescription claims during the CY, were identified for the CY2016 and CY2017 cohorts. The primary outcome of interest was the percentage of subjects with any glucose or lipid metabolism parameter monitoring. Other calculated metabolic testing rates included glucose, hemoglobin A1c (HbA1c), low-density lipoprotein cholesterol (LDL-C), other cholesterol (including triglycerides), and combined glucose and lipid metabolism testing (≥1 test for blood glucose or HbA1c and ≥1 test for LDL-C or other cholesterol). Results: In CY2016 and CY2017, 1502 and 1239 subjects, respectively, were identified for this study. The most common psychiatric diagnoses in CY2016 and CY2017 were major depressive disorder (57.1%, 56.5%, respectively), anxiety disorders (42.9%, 47.5%), attention-deficit/hyperactivity disorder (41.6%, 45.8%), and bipolar disorder (24.1%, 25.9%). The rate of any metabolic testing was 53.5% in CY2016 and 51.3% in CY2017. Glucose testing (50.3%, 46.9%, respectively) was most common in both CYs, followed by LDL-C testing (31.2%, 28.5%). Rates of combined glucose and lipid metabolism testing were 30.7% in CY2016 and 26.9% in CY2017. Conclusions: Given the known potential for adverse cardiometabolic effects, rates of metabolic monitoring associated with SGA use in children and adolescents urgently need to be improved. There is a critical need for understanding barriers to routine monitoring, particularly of lipids, and developing interventions to enhance metabolic monitoring.

Blood glucose measurement is commonly used to screen for and monitor diabetes, a chronic condition characterized by the inability to effectively modulate blood glucose that can lead to heart disease, vision loss, and kidney failure. Early detection of prediabetes can forestall or reverse more serious illness if healthy lifestyle adjustments or medical interventions are made in a timely manner. Current diabetes screening methods require visits to a healthcare facility and use of over-the-counter glucose-testing devices (glucometers), both of which are costly or inaccessible for many populations, reducing the chances of early disease detection. We therefore developed GlucoScreen, a readerless glucose test strip that enables affordable, single-use, at-home glucose testing, leveraging the user's touchscreen cellphone for reading and displaying results. By integrating minimal, low-cost electronics with commercially available blood glucose testing strips, the GlucoScreen prototype introduces a new type of low-cost, battery-free glucose testing tool that works with any smartphone, obviating the need to purchase a separate dedicated reader. Our key innovation is using the phone's capacitive touchscreen for the readout of the minimally modified commercially available glucose test strips. In an in vitro evaluation with artificial glucose solutions, we tested GlucoScreen with five different phones and compared the findings to two common glucometers, AccuChek and True Metrix. The mean absolute error (MAE) for our GlucoScreen prototype was 4.52 mg/dl (Accu-Chek test strips) and 3.7 mg/dl (True Metrix test strips), compared to 4.98 mg/dl and 5.44 mg/dl for the AccuChek glucometer and True Metrix glucometer, respectively. In a clinical investigation with 75 patients, GlucoScreen had a MAE of 10.47 mg/dl, while the AccuChek glucometer had a 9.88 mg/dl MAE. These results indicate that GlucoScreen's performance is comparable to that of commonly available over-the-counter blood glucose testing devices. With further development and validation, GlucoScreen has the potential to facilitate large-scale and lower cost diabetes screening. This work employs GlucoScreen's smartphone-based technology for glucose testing, but it could be extended to build other readerless electrochemical assays in the future.

Objective To observe and analyze the effect of community health intervention on patients with pre- diabetes mellitus (PDM). Methods From January 2016 to October 2017, 79 patients with IGR status diagnosed by blood glucose test in the community were selected. 79 patients received community health intervention for 6 months, and the clinical parameters before and after community health intervention were compared. Results The awareness rate of disease knowledge, blood pressure control rate, the rates of reasonable diet control, exercise therapy, self-management, prevention and treatment, high-salt diet, alcohol consumption, and smoking of patients with PDM significantly improved after community health intervention (P<0.05); the levels of FBG, OGTT2h PG and HbA1c significantly decreased (P<0.05); the scores of physical status, mental status, emotional status, social function, and the overall health score significantly increased (P<0.05). Conclusion Individualized community health intervention can effectively improve unhealthy lifestyles and behavioral habits of PDM patients, significantly improve their blood glucose and blood lipid levels, and effectively improve QOL. Key words: Pre- diabetes mellitus; Community; Health intervention; Blood glucose

Objective To investigate the clinical diagnosis value of fasting blood-glucose combined with glycosylated hemoglobin on patients with diabetes.Methods Two hundreds patients who had blood glucose test in our hospital were choosed as study objectives.Fasting plasma glucose alone and glycosylated hemoglobin alone were tested for all patients,then combined the two methods to proceed detection,diabetes' test rate,levels of fasting blood-glucose and glycosylated hemoglobin.Results Fasting blood-glucose combined with glycated hemoglobin test rate(72.00％) was significantly higher than fasting glucose alone (62.00％),and glycated hemoglobin (58.00％),and fasting blood-glucose and glycosylated hemoglobin in patients with diabetes were significantly higher than healthy fasting blood-glucose and glycated hemoglobin,the difference were statistically significant (P ＜ 0.05).Conclusions Fasting blood-glucose combined with glycated hemoglobin test for patients with diabetes are significantly better than fasting glucose and glycated hemoglobin test alone,and it can help the doctor to make accurate diagnosis,thus take effective measures to control blood-glucose. Key words: Diabetes ; Fasting blood-glucose ; Glycated hemoglobin ; Value

Background: Nomophobia, the fear of being without a mobile phone, is increasingly prevalent among nursing students and may impact their clinical performance. Understanding this relationship is essential for developing strategies to enhance focus and professional competence in clinical settings. This study aimed to address this research gap by investigating the relationship between nomophobia and clinical performance among nursing students. Objectives: This study aimed to address this research gap by investigating the relationship between nomophobia and clinical performance among nursing students. Methods: A cross-sectional study was conducted from September 2024 to January 2025 to examine the relationship between nomophobia and clinical performance among nursing students at Islamic Azad University of Kashan and Kashan University of Medical Sciences. Using a convenience sampling method, 200 undergraduate nursing students aged 19 - 27 years were recruited. Data were collected through self-administered pencil-and-paper questionnaires, including the Nomophobia Questionnaire (NMP-Q) to assess nomophobia levels and the Clinical Performance Questionnaire to evaluate self-efficacy in clinical performance. Statistical analyses were conducted using SPSS version 26, employing a general linear model (GLM) to assess the impact of nomophobia on clinical performance while controlling for demographic variables. Results: Among the participants, 62.5% were female, and 70.5% were aged 19 - 21 years. Moderate nomophobia was the most prevalent (56%), followed by mild (29%) and severe nomophobia (4%). The GLM analysis revealed that nursing students with mild nomophobia had significantly higher clinical performance scores (B = 34.24, P = 0.002) compared to those with severe nomophobia. Additionally, students who checked their smartphones 10 - 29 times per day had significantly higher clinical performance scores (B = 22.19, P = 0.01) than those who checked their phones more than 100 times daily. Gender (B = -10.09, P = 0.01) and smartphone ownership duration (B = -14.20, P = 0.02) also demonstrated significant associations with clinical performance. Conclusions: This study found that higher levels of nomophobia were associated with lower clinical performance in nursing students. Moderate smartphone use appeared to correlate with better clinical outcomes, while excessive checking was linked to reduced performance. Future interventions should focus on managing smartphone use to enhance nursing students' clinical efficiency.

Significant disparities in access to diabetes screening persist, particularly among populations with limited healthcare access. We aimed to estimate the proportion of overweight-obese Peruvian adults who underwent blood glucose testing (BGT) in the past year and to analyse the socioeconomic and geographic inequalities associated with access to this preventive intervention. We conducted a cross-sectional study using data from the Demographic and Family Health Survey 2023. We included adults aged 35-70 years diagnosed with overweight or obesity, according to the United States Preventive Services Task Force screening recommendation. We used concentration curves (CC) and concentration indices (CI) to assess socioeconomic inequalities in BGT. BGT was ascertained using a self-reported question, while the wealth index was used as the variable to measure inequality. We also conducted a decomposition analysis to determine the relative contributions of covariates to socioeconomic inequalities in BGT. A total of 9499 individuals were included in the analysis. A pro-rich concentration of BGT uptake was observed in CC and CI (0.2090; p < 0.001). Notably, a 27-point prevalence difference was reported between the lowest and highest wealth index. The decomposition analysis showed that higher education (+64%) and rural areas (+10.6%) were the main contributors to this pro-rich concentration. In contrast, secondary education (-4.7%) and female gender (-3.4%) reduced this pro-rich concentration. The results underscore the need for targeted strategies, such as enhancing healthcare infrastructure and implementing localized screening initiatives, to close the gap and address the burden of undiagnosed diabetes in high-risk populations.

BackgroundLittle is known about the efficiency and effectiveness of the current level of diabetes screening activity in Ontario where there is universal access to health services. Our study aims were to: (i) determine how often Ontarians are screened for diabetes; (ii) estimate screening efficiency based on the number needed to screen (NNS) to diagnosis one diabetes case; (iii) examine the population effectiveness of screening as estimated by the number of undiagnosed diabetes cases.MethodsOntario respondents of the Canadian Community Health Survey who agreed to have their responses linked to health care data (n = 37,400) provided the cohort. The five-year probabilities of glucose testing and diabetes diagnoses were estimated using a Cox Proportional Hazards Model. We defined NNS as the ratio of diabetes tests to number of diabetes diagnoses over the study period. We estimated the number of undiagnosed diabetes by dividing the number not tested at the end of study period by the NNS.Results80% of women and 66% of men had a blood glucose test within 5 years. The efficiency of screening was estimated by a NNS of 14 among men and 22 among women. 127,100 cases of undiagnosed diabetes were estimated, representing 1.4% of the Ontario adult population. Increasing age, hypertension, immigrant and non-white ethnicity, and number of general practitioner visits were associated with an increased likelihood of having a glucose test (LR χ2 p < 0.001). Low income men were less likely to be tested.ConclusionsDiabetes screening was high in this population-based cohort of Ontarians. Screening efficiency varied considerably in the population. Undiagnosed diabetes continues to be prevalent and remains concentrated in the highest risk groups for diabetes, especially among men.

GDM prevalence was reported to be 2 -2.5% in the 16 th week, 2.5 -3% in the 24 th week, and 3% in the 32 nd week.In India, the prevalence of GDM ranged from < 4% to 18% (9).Various recommendations to screen tests for GDM were present, but no uniform standard has yet been established.This comparative study was conducted to assess the role of the glucose challenge test (GCT) and fasting blood glucose (FBG)/post-prandial blood glucose (PPBG) test to identify GDM in pregnant women attending the prenatal clinic outpatient department. MethodsType of study: A comparative observational study was conducted by collecting Highlights What is current knowledge?Recently, the trend of incidence of gestational diabetes mellitus (GDM) has been on the rise due to various causes.There has been no extensive national assessment research on GDM and its associated socioeconomic and geographic aspects. What is new here?The results imply that the glucose challenge test can be done as a 1-step rapid screening process with higher specificity for the early diagnosis of GDM to enable easy management, which helps to reduce the maternal and neonatal risk of diabetes mellitus at later stages.

Objectives: Diabetes ranks in the top four causes of death in Taiwan, and the prevalence of diabetes in adults is increasing year by year. Mortality among elderly people with diabetes is 2.5 times higher than that of the same age group. This study collected data on blood glucose records from 2,846 people undergoing medical examination for the elderly at a Medical Centre of Southern Taiwan in 2016. According to these data, a statistical analysis of the prevalence of diabetes was performed, then a follow-up health care plan was developed to assist patients with diabetics in controlling their blood sugar, further to avoid resulting in other lesions. Methods: Diagnostic criteria for diabetes in the elderly is 100mg/dl＜fasting glucose≦126mg/dl as pre-diabetes, and the fasting glucose ＞126mg/dl for diabetes. In this study, the Minitab V17 was used for basic statistical analysis, and based on the statistical level of α=0.05, Chi-square was used to test the relevant impact factors of diabetes (such as gender, waist circumference, BMI, etc.). Results: The entire elderly had the mean age of 72.1±6.4 years, of whom 50.46% were males with an average age of 72.8±6.6 years and women were 49.54% with an average age of 71.4±6.2 years. The average fasting blood glucose of these elderly was 108.5±23.6 mg/dl, with a male average of 109.4±23.4 mg/dl and a female average of 107.5±23.8 mg/dl. The proportion of prediabetes was 43.3% (1233 persons), and 13.9% (395 persons) were diabetic, both of which males were higher than females. The Chi-square test showed that the subjects had diabetes versus waist circumference and BMI with a statistically significant correlation. Conclusion: The fasting blood glucose test in the health examination can be as an indicator to diagnose whether it is a diabetic patient. In this study, 43.3% of the elderly in these analysis samples achieved pre-diabetic levels, thus it is necessary to develop a follow-up health care plan to help them control blood sugar and prevent the risk of transferring to other diseases.

BackgroundThe self-care of type 1 diabetes (T1D) includes undergoing procedures with needles several times daily, which may cause pain and fear. AimsThe aim was to identify the degree of perceived pain, affective reactions, fear, and emotional coping among children and adolescents with T1D. DesignA cross-sectional survey was performed. MethodsChildren and adolescents 7-18 years of age (n = 197) and their parents (n = 123) completed the Coloured Analogue Scale (CAS), the Facial Affective Scale (FAS), the Diabetes Fear of Injection Questionnaire (D-FISQ), and the Faces Emotional Coping Scale (FECS) in relation to needle procedures. ResultsThe higher the values of the CAS, FAS and D-FISQ scores, the lower values for coping were reported by children and adolescents regarding treatment with insulin pen or pump, blood glucose test, and venipuncture (p < .001). Patients reported strong negative affect regarding insulin injections (35%) and blood glucose tests (32%), as well as negative affect (48%, 69%) and substantial pain (27%, 50%) for inserting a pump needle and venipuncture, respectively. Parents reported significantly higher values than children on all scales and procedures except D-FISQ (blood glucose tests) and FECS (venipuncture). ConclusionsChildren and adolescents who perceive greater pain during needle-related procedures have poorer coping ability. Pediatric diabetes teams need to identify those in need of extra support to develop pain coping strategies.

IntroductionNeonatal hyperglycaemia is frequently treated with insulin, which may increase the risk of hypoglycaemia. Computer-determined dosage of insulin (CDD) with the STAR-GRYPHON program uses a computer model to predict an...