A register-based study describing time trends in risk factor control and serious hypoglycaemia together with the effects of starting continuous glucose monitoring in people with type 1 diabetes in Norway.

AIMS: To describe trends in risk factor control and serious hypoglycaemia in people with type 1 diabetes and to assess the effect of starting continuous glucose monitoring (CGM) in the real-world setting. METHODS: Two cross-sectional surveys including 5746 individuals in 2012 and 18,984 individuals in 2020 based on data recorded in the Norwegian Diabetes Register for Adults (NDR-A) and an analysis of a longitudinal cohort of 2057 individuals where data on CGM and HbA1c were available in the NDR-A in 2012 and 2020. RESULTS: In the cross-sectional surveys mean HbA1c decreased from 66 mmol/mol (99% CI 65, 66) (8.2%) in 2012 to 61 mmol/mol (99% CI 61, 61) (7.7%) in 2020 (p < 0.0001). The proportion reporting serious hypoglycaemia decreased from 16.9 to 6.2% in 2020 (p < 0.0001). Mean LDL-cholesterol decreased from 2.80 (99% CI 2.78, 2.83) to 2.63 (99% CI 2.61, 2.65) mmol/l in 2020 (p < 0.0001). Mean blood pressure increased slightly. In the CGM cohort, we found a 3 mmol/mol (0.3%) greater improvement in mean HbA1c and a greater reduction in serious hypoglycaemia (-12.3% vs. -6.2%) among individuals that had started using CGM between 2013 and 2020 when compared with individuals that had not started using CGM. CONCLUSIONS: Between 2012 and 2020, we found marked improvements in glycaemic control and a considerable decrease in the proportion of individuals reporting serious hypoglycaemia. The proportion of individuals using CGM increased substantially and individuals that had started using CGM by 2020 showed greater improvement in glycaemic control and less serious hypoglycaemia.

Diabetes risk assessments and HbA1c-measurements in community pharmacies.

OBJECTIVES: Due to a lack of clear symptoms, type 2 diabetes (T2D) can remain undetected for many years. The aim of the study was to explore if Norwegian community pharmacies could identify individuals with a high risk of developing T2D by offering a diabetes risk assessment service. This study also investigated if the service recruited individuals that the national guideline recommends for diabetes risk assessment, and the proportion of participants who had visited their GP at least once a year. METHODS: During the inclusion period (September 2016 to the middle of April 2017), pharmacy customers 45 years or older wishing to participate contacted the pharmacy staff. Included participants completed a diabetes risk test and participants with a high risk were offered an HbA1c measurement. At two months after intervention, all participants were followed up. KEY FINDINGS: Of the 245 participants, 27% had a high risk of developing T2D. Of these, 46%, 43% and 9% had HbA1c values corresponding to normal (<39 mmol/mol [5.7%]), prediabetes (39-47 mmol/mol [5.7-6.4%]) or above cut-off for diabetes (≥48 mmol/mol [≥6.5%]), respectively. A total of 86% of the participants were in at least one category that the guideline recommends for a diabetes risk assessment, and 88% had visited their GP at least once a year. CONCLUSIONS: Norwegian community pharmacies can identify individuals with a high risk of developing T2D by offering a diabetes risk assessment service. Individuals who sought out the service were within the relevant demographics for testing, and a high proportion visited their GP at least once a year.

Pharmacists' experience of a diabetes risk-assessment service and analytical quality control in community pharmacies - A focus-group study.

BACKGROUND: Healthcare services such as diabetes risk-assessment are increasingly common in community pharmacies. Knowledge of community pharmacists' experiences of such services could ease the implementation of a larger-scale service. OBJECTIVES: To explore Norwegian pharmacists' experience of a diabetes risk-assessment service, including analytical quality control, in a community-pharmacy setting. METHODS: Three focus-group interviews were conducted in Norway between August and September 2017. Systematic text condensation was used, an analytic approach well suited for thematic content analysis across interview data. Fourteen pharmacists took part, recruited from a project offering a diabetes risk-assessment service, including measurements of Glycated hemoglobin A1c (HbA1c), in Norwegian community pharmacies. RESULTS: The pharmacists emphasized the importance of using their knowledge and skills to promote good health. They considered offering this service as being compatible with their role as pharmacists. As communication is an essential part of their work, the pharmacists evaluated their communication skills as being good. Nevertheless, how to communicate the offering of this service was seen as a challenge, for instance recruiting participants and communicating in an understandable and professional way. Inclusion of the whole pharmacy staff as a team was experienced as an important success factor for implementation of a risk-assessment service. Analytical quality control was perceived as being a natural part of their job and a manageable task. CONCLUSIONS: Offering a diabetes risk-assessment service is in line with the way a selected group of Norwegian community pharmacists perceived their professional role. However, they were uncomfortable recruiting participants, and expressed the wish for more support from the pharmacy chain. Our results add performance of analytical quality control as part of the ongoing development involving expansion of pharmacists' professional role. Future implementation studies may also benefit from giving both the pharmacy staff and customers sufficient time to familiarize themselves with the new service before measuring effects.

Type 2 diabetes in general practice - a focus-group study. / Type 2-diabetes i fastlegepraksis ­ en fokusgruppestudie.

BACKGROUND: The National Diabetes Plan 2017-21 has implemented measures to improve diagnosis and follow-up of persons with type 2 diabetes by the primary health services. The objective of this study was to explore the experiences and thoughts of Norwegian general practitioners (GPs) with regard to diagnosis and follow-up of this patient group. MATERIAL AND METHOD: In this qualitative study, three focus-group interviews were conducted with a total of 17 GPs. The interviews were recorded, transcribed and analysed using systematic text condensation. RESULTS: The GPs reported having a busy daily schedule that rarely allowed for targeted identification of patients in the risk zone to be prioritised. They described a patient-centred diabetes care, in which motivating for lifestyle change was considered a necessary but demanding task. The doctors identified the need to find a balance between following the general clinical guidelines on the one hand and individually adapting the follow-up to each patient on the other. Furthermore, the participants reported being less updated on current medical knowledge than they wanted, due to time constraints. INTERPRETATION: The GPs in the study described a patient-centred diabetes care that was driven by clinical experience. The guidelines have an advisory, but not mandatory function. This approach enables personalised and adapted treatment, but could also be a contributory cause of the failure to provide sufficient follow-up as required by the national guidelines.

Performance and user-friendliness of the rapid antigen detection tests QuickVue Dipstick Strep A test and DIAQUICK Strep A Blue Dipstick for pharyngotonsillitis caused by Streptococcus pyogenes in primary health care.

Sensitivity and specificity of rapid antigen detection tests (RADTs) for detection of group A hemolytic streptococcus (GAS) vary. The purpose is to present the first SKUP (Scandinavian evaluation of laboratory equipment for point of care testing) evaluations concerning the assessment of the diagnostic performance and user-friendliness of two RADTs for detection of GAS when used under real-life conditions in primary health care. Throat samples were collected in duplicates at primary health care centers (PHCCs) from patients with symptoms of pharyngitis. The performance of QuickVue Dipstick Strep A test (307 samples) and DIAQUICK Strep A Blue Dipstick (348 samples) was evaluated using culture results at a clinical microbiology laboratory as comparison. The user-friendliness was evaluated using a questionnaire. The diagnostic sensitivity was 92% (90% confidence interval (CI) 87-96%) and 72% (90% CI 65-79%), while the diagnostic specificity was 86% (90% CI 81-90%) and 98% (90% CI 96-99%) for QuickVue Dipstick Strep A test and DIAQUICK Strep A Blue Dipstick, respectively. Both RADTs obtained acceptable assessments for user-friendliness and fulfilled SKUP's quality goal for user-friendliness. The diagnostic sensitivity for QuickVue Dipstick Strep A test and the diagnostic specificity for DIAQUICK Strep A Blue Dipstick in this objective and supplier-independent evaluation were higher compared with previous meta-analyses of RADTs. However, the diagnostic specificity for QuickVue Dipstick Strep A test and the diagnostic sensitivity for DIAQUICK Strep A Blue Dipstick were lower compared with previous meta-analyses of RADTs.

Quality of Warfarin Therapy and Quality of Life are Improved by Self-Management for Two Years.

BACKGROUND: Studies from several countries show that self-management of vitamin K antagonist (e.g., warfarin) therapy reduce the risk of complications compared with conventional management. OBJECTIVES: The aim of this study was to investigate the quality of warfarin management when patients were transferred from conventional management to self-management in Norway. In addition, quality of life (QoL) before and after 2 years of warfarin self-management was investigated. MATERIALS AND METHODS: The study was longitudinal with a retrospective and prospective design where 126 patients on conventional management of long-term warfarin therapy underwent a 21-week training program of warfarin self-management followed by 2 years of self-management. The outcomes of the study were time in therapeutic range (TTR), the variance of international normalized ratio (INR) values, extreme INR values (INR ≤ 1.5 and ≥ 5), complications, and QoL, comparing the 2-year period of the conventional management with the 2-year period with the self-management. RESULTS: The median TTR was higher during self-management compared with conventional management (78.1% vs. 65.9%, respectively, p < 0.001). In addition, self-management resulted in lower INR variance (0.22 vs. 0.33, p < 0.001), reduced percentage of extreme INR values (1.8% vs. 5.3%, p < 0.001), less complications (0% vs. 5.6%), and improved QoL (p < 0.001) compared with conventional management. CONCLUSION: We used five different measures and found improved quality of warfarin self-management 2 years after patients were transferred from the conventional management.

The EuBIVAS: Within- and Between-Subject Biological Variation Data for Electrolytes, Lipids, Urea, Uric Acid, Total Protein, Total Bilirubin, Direct Bilirubin, and Glucose.

BACKGROUND: The European Federation of Clinical Chemistry and Laboratory Medicine European Biological Variation Study (EuBIVAS) has been established to deliver rigorously determined data describing biological variation (BV) of clinically important measurands. Here, EuBIVAS-based BV estimates of serum electrolytes, lipids, urea, uric acid, total protein, total bilirubin, direct bilirubin, and glucose, as well as their associated analytical performance specifications (APSs), are presented. METHOD: Samples were drawn from 91 healthy individuals (38 male, 53 female; age range, 21-69 years) for 10 consecutive weeks at 6 European laboratories. Samples were stored at -80 °C before duplicate analysis of all samples on an ADVIA 2400 (Siemens Healthineers). Outlier and homogeneity analyses were performed, followed by CV-ANOVA on trend-corrected data, when relevant, to determine BV estimates with CIs. RESULTS: The within-subject BV (CVI) estimates of all measurands, except for urea and LDL cholesterol, were lower than estimates available in an online BV database, with differences being most pronounced for HDL cholesterol, glucose, and direct bilirubin. Significant differences in CVI for men and women/women <50 years of age were evident for uric acid, triglycerides, and urea. The CVA obtained for sodium and magnesium exceeded the EuBIVAS-based APS for imprecision. CONCLUSIONS: The EuBIVAS, which is fully compliant with the recently published Biological Variation Data Critical Appraisal Checklist, has produced well-characterized, high-quality BV estimates utilizing a stringent experimental protocol. These new reference data deliver revised and more exacting APS and reference change values for commonly used clinically important measurands, thus having direct relevance to diagnostics manufacturers, service providers, clinical users, and ultimately patients.

Risk assessment and HbA1c measurement in Norwegian community pharmacies to identify people with undiagnosed type 2 diabetes - A feasibility study.

OBJECTIVES: Determine the feasibility of using a diabetes risk assessment tool followed by HbA1c-measurement in a community-pharmacy setting in Norway. METHODS: In this longitudinal study two pharmacists in each of three community pharmacies were trained to perform risk assessments, HbA1c-measurements and counselling. Pharmacy customers who were > 18 years old and could understand and speak Norwegian or English were recruited in the pharmacies during a two-months-period. Information about the service was presented in local newspapers, social media, leaflets and posters at the pharmacy. Customers wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. A HbA1c measurement was performed for individuals with a moderate to high risk of developing diabetes. If HbA1c ≥ 6.5% they were recommended to visit their general practitioner for follow-up. The pharmacies performed internal and external quality control of the HbA1c instrument. RESULTS: Of the 211 included participants 97 (46%) were > 50 years old. HbA1c was measured for the 47 participants (22%) with high risk. Thirty-two (15%) had HbA1c values < 5.7%, twelve (5.4%) had values between 5.7%-6.4%, and three (1.4%) had an HbA1c ≥ 6.5%. Two participants with HbA1 ≥ 6.5% were diagnosed with diabetes by their general practitioner. The third was lost to follow-up. Results from internal and external quality control for HbA1c were within set limits. CONCLUSION: The pharmacists were able to perform the risk assessment and measurement of HbA1c, and pharmacy customers were willing to participate. The HbA1c measurements fulfilled the requirements for analytical quality. Thus, it is feasible to implement this service in community pharmacies in Norway. In a large-scale study the inclusion criteria should be increased to 45 years in accordance with the population the risk test has been validated for.

The EuBIVAS Project: Within- and Between-Subject Biological Variation Data for Serum Creatinine Using Enzymatic and Alkaline Picrate Methods and Implications for Monitoring.

BACKGROUND: The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) European Biological Variation Study (EuBIVAS) has been established to deliver rigorously determined biological variation (BV) indices. EuBIVAS determined BV for serum creatinine using the enzymatic and alkaline picrate measurement methods. METHOD: In total, 91 healthy individuals (38 males, 53 females; age range, 21-69 years) were bled for 10 consecutive weeks at 6 European laboratories. An equivalent protocol was followed at each center. Sera were stored at -80 °C before analysis. Analyses for each patient were performed in duplicate within a single run on an ADVIA 2400 system (San Raffaele Hospital, Milan). The data were subjected to outlier and homogeneity analysis before performing CV-ANOVA to determine BV and analytical variation (CVA) estimates with confidence intervals (CI). RESULTS: The within-subject BV estimates [CVI (95% CI)] were similar for enzymatic [4.4% (4.2-4.7)] and alkaline picrate [4.7% (4.4-4.9)] methods and lower than the estimate presently available online (CVI = 5.9%). No significant male/female BV differences were found. Significant differences were observed in mean creatinine values between men and women and between Turkish individuals and those of other nationalities. Between-subject BV (CVG) estimates, stratified accordingly, produced CVG values similar to historical BV data. CVA was 1.1% for the enzymatic and 4.4% for alkaline picrate methods, indicating that alkaline picrate methods fail to fulfill analytical performance specifications for imprecision (CVAPS). CONCLUSIONS: The serum creatinine CVI obtained by EuBIVAS specifies a more stringent CVAPS than previously identified. The alkaline picrate method failed to meet this CVAPS, raising questions regarding its future use.

Intensive educational efforts combined with external quality assessment improve the preanalytical phase in general practitioner offices and nursing homes.

BACKGROUND: Errors in the preanalytical phase in clinical laboratories affect patient safety. The aim of this study was to evaluate the effect of intensive educational efforts together with external quality assessment (EQA) of the preanalytical phase from 2013 to 2015 to improve patient identification in primary health care in Norway. In addition, routines for venous and capillary blood sampling were investigated. METHODS: A preanalytical EQA was circulated in 2013 by the Norwegian Quality Improvement of Laboratory Examinations (Noklus) to general practitioner offices and nursing homes (n=2000) to obtain information about important issues to focus on before launching an intensive educational program with courses, posters and visits in 2013-2015. Preanalytical EQA surveys were further circulated in 2014 and 2015. RESULTS: The response rate varied between 42% and 55%. The percentages of participants asking for the patients' name and the Norwegian identification number increased from about 8% in 2013 to about 35% in 2015. The increase was similar for those participating in only one EQA survey and for those who participated in EQA surveys both in 2013 and 2015. Guidelines for venous and capillary blood sampling were not always followed. CONCLUSIONS: Educational efforts more than the preanalytical EQA influenced the actions and resulted in an increase in the percentages of participants that followed the guidelines for patient identification. Some aspects of blood sampling routines need improvement.

Biological Variation Estimates Obtained from 91 Healthy Study Participants for 9 Enzymes in Serum.

BACKGROUND: We sought to develop estimates of biological variation (BV) for 9 enzymes in blood serum as part of the European Biological Variation Study. METHODS: Ninety-one healthy study participants (38 male and 53 female, 21-69 years old) were phlebotomized in each of 10 consecutive weeks at 6 European laboratories. The same preanalytical sample-handling protocol was followed at each center before transport to San Raffaele Hospital, Milan, Italy, for analysis. Sera were stored at -80 °C before analysis in duplicate within a single run on an ADVIA 2400 Clinical Chemistry System (Siemens Healthcare) following a protocol designed to minimize analytical imprecision. Assay traceability was established using frozen sera with target values assigned by reference methods. The results were subjected to outlier analysis before CV-ANOVA to deliver valid BV estimates. Results for 9 enzymes were subsequently partitioned for graphical display allowing visual assessment of the effects of country of origin, sex, and age on BV estimates. RESULTS: We found no effect of country upon the observed variation, but overall sex-related differences were evident for alanine amino transferase (ALT), γ-glutamyl transferase (GGT), and creatine kinase (CK). The following estimates for within-subject BV (CVI) and between-subject BV (CVG), respectively, were obtained: ALT: 9.3%, 28.2%; aspartate aminotransferase: 9.5%, 20.3%; GGT: 8.9%, 41.7%; alkaline phosphatase : 5.3%, 24.9%; lactate dehydrogenase: 5.2%, 12.6%; CK: 14.5%, 31.5%; amylase: 6.8%, 30.4%; pancreatic α-amylase: 6.3%, 24.9%; and lipase (LIP): 7.7%, 23.8%. CONCLUSIONS: All CVI and some CVG estimates were lower than those reported in the online BV 2014 updated database. Analytical performance specifications derived from BV can be applied internationally.

The potential for deprescribing in care home residents with Type 2 diabetes.

Background Type 2 diabetes is a common diagnosis in care home residents that is associated with potentially inappropriate prescribing and thus risk of additional suffering. Previous studies found that diabetes medicines can be safely withdrawn in care home residents, encouraging further investigation of the potential for deprescribing amongst these patients. Objectives Describe comorbidities and medicine use in care home residents with Type 2 diabetes; identify number of potentially inappropriate medicines prescribed for these residents using a medicines optimisation tool; assess clinical applicability of the tool. Setting Thirty care homes for older people, East Anglia, UK. Method Data on diagnoses and medicines were extracted from medical records of 826 residents. Potentially inappropriate medicines were identified using the tool 'Optimising Safe and Appropriate Medicines Use'. Twenty percent of results were validated by a care home physician. Main outcome measure Number of potentially inappropriate medicines. Results The 106 residents with Type 2 diabetes had more comorbidities and prescriptions than those without. Over 90 % of residents with Type 2 diabetes had at least one potentially inappropriate medication. The most common was absence of valid indication. The physician unreservedly endorsed 39 % of the suggested deprescribing, and would consider discontinuing all but one of the remaining medicines following access to additional information. Conclusion UK care home residents with Type 2 diabetes had an increased burden of comorbidities and prescriptions. The majority of these patients were prescribed potentially inappropriate medicines. Validation by a care home physician supported the clinical applicability of the medicines optimisation tool.

Sample collections from healthy volunteers for biological variation estimates' update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine.

BACKGROUND: Biological variation (BV) data have many fundamental applications in laboratory medicine. At the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) the reliability and limitations of current BV data were discussed. The EFLM Working Group on Biological Variation is working to increase the quality of BV data by developing a European project to establish a biobank of samples from healthy subjects to be used to produce high quality BV data. METHODS: The project involved six European laboratories (Milan, Italy; Bergen, Norway; Madrid, Spain; Padua, Italy; Istanbul, Turkey; Assen, The Netherlands). Blood samples were collected from 97 volunteers (44 men, aged 20-60 years; 43 women, aged 20-50 years; 10 women, aged 55-69 years). Initial subject inclusion required that participants completed an enrolment questionnaire to verify their health status. The volunteers provided blood specimens once per week for 10 weeks. A short questionnaire was completed and some laboratory tests were performed at each sampling consisting of blood collected under controlled conditions to provide serum, K2EDTA-plasma and citrated-plasma samples. RESULTS: Samples from six out of the 97 enroled subjects were discarded as a consequence of abnormal laboratory measurements. A biobank of 18,000 aliquots was established consisting of 120 aliquots of serum, 40 of EDTA-plasma, and 40 of citrated-plasma from each subject. The samples were stored at -80 °C. CONCLUSIONS: A biobank of well-characterised samples collected under controlled conditions has been established delivering a European resource to enable production of contemporary BV data.

'I try not to bother the residents too much' - the use of capillary blood glucose measurements in nursing homes.

BACKGROUND: Capillary blood glucose measurements are regularly used for nursing home residents with diabetes. The usefulness of these measurements relies on clear indications for use, correct measurement techniques, proper documentation and clinical use of the resulting blood glucose values. The use of a regular, invasive procedure may also entail additional challenges in a population of older, multimorbid patients who often suffer from cognitive impairment or dementia. The aim of this study was to explore the perspectives of physicians, registered nurses and auxiliary nurses on the use, usefulness and potential challenges of using capillary blood glucose measurements in nursing homes, and the procedures for doing so. METHODS: This was a qualitative study that used three profession-specific focus group interviews. Interviews were transcribed in modified verbatim form and analysed in accordance with Malterud's principles of systematic text condensation. Five physicians, four registered nurses and three auxiliary nurses participated in the focus groups. RESULTS: All professional groups regarded capillary blood glucose measurements as a necessity in the management of diabetes, the physicians to ensure that the treatment is appropriate, and the nurses to be certain and assured about their caring decisions. Strict glycaemic control and excessive measurements were avoided in order to promote the well-being and safety of the residents. Sufficient knowledge of diabetes symptoms, equivalent practices for glucose measurement, and unambiguous documentation and communication of results were determined to be most helpful. However, all professional groups seldom involved the residents in managing their own measurements and stated that guidelines and training had been inconsistent or lacking. CONCLUSION: Inadequate procedures and training in diabetes care may compromise the rationale for capillary blood glucose measurements in nursing homes, and hence the residents' safety. These concerns should be addressed together with the possibility of involving and empowering residents by exploring their ability and wish to manage their own disease.

Self-management of warfarin therapy.

BACKGROUND: Clinical studies from other countries show that self-management of warfarin therapy may reduce the risk of mortality, thromboembolism and complications when compared to conventional therapy. The purpose of this study was to train patients in self-management and compare the results with conventional therapy in Norway. METHOD: A total of 23 patients who had previously been given conventional therapy by their GPs were instructed in how to measure INR (using the CoaguChek XS device) and administer warfarin dosage through a structured training programme over the course of 27 weeks. The participants continued with self-management for a further 28 weeks after the end of the training period. The time in the therapeutic range (TTR, measured as a percentage) was calculated and the TTR for conventional therapy and self-management were compared. RESULTS: No significant difference in average TTR was found when comparing conventional therapy (70% (95% confidence interval (CI) 62-78)) with the self-management period (75% (95% CI 69-81, p = 0.24)). The percentage of extreme INR values (< 1.5 or > 5.0) was higher during conventional therapy than during self-management (6.8% vs. 1.0%, p < 0.001). INTERPRETATION: No significant difference in TTR was found when comparing self-management and conventional warfarin therapy in our study, but for self-management there was a lower percentage of extreme INR values compared to conventional warfarin therapy.

Nursing home patients with diabetes: prevalence, drug treatment and glycemic control.

AIMS: Determine prevalence of diabetes, and describe use of blood glucose lowering (BGL) drugs and glycemic control in Norwegian nursing homes. METHODS: In this cross-sectional study we collected details of BGL drugs, capillary blood glucose measurements (CBGM) in the last four weeks and HbA1c measurements in the last 12 months from the medical records of patients with diabetes, within a population of 742 long-term care patients from 19 randomly selected nursing homes in Western Norway. Descriptive statistics were applied, and Pearson's chi-squared (P≤0.05) or non-overlapping 95% confidence intervals were interpreted as significant effects. RESULTS: 116 patients (16%) had diabetes, 100 of these gave informed consent and medical data were available. BGL treatment was as follows: (1) insulin only (32%), (2) insulin and oral antidiabetics (OADs) (15%), (3) OADs only (27%) and (4) no drugs (26%). Patients with cognitive impairment were less likely to receive medical treatment (P=0.04). CBGM and HbA1c measurements were performed for 73% and 77% of patients, respectively. Mean HbA1c was 7.3% (57 mmol/mol), 46% of patients had an HbA1c <7.0% (53 mmol/mol), and CBGM consistent with risk of hypoglycemia was found for 60% of these patients. CONCLUSIONS: Prevalence of diabetes and BGL treatment in Norwegian nursing homes is comparable to other European countries. Although special care seems to be taken when choosing treatment for patients with cognitive impairment, there are signs of overtreatment in the population as a whole. The strict glycemic control unveiled may negatively affect these frail patients' quality of life and increase the risk of early death.

Diagnosing diabetes mellitus: performance of hemoglobin A1c point-of-care instruments in general practice offices.

BACKGROUND: Hemoglobin A1c (Hb A1c) measurement by hospital laboratory instruments, but not by point-of-care (POC) instruments, has been recommended for use to diagnose diabetes mellitus. We evaluated results from 13 Hb A1c external quality assurance (EQA) surveys over a 6-year period in Norway, from both POC instruments used in general practice (GP) offices and instruments in hospital laboratories, against the analytical quality specifications recommended for use of Hb A1c to diagnose diabetes mellitus. METHODS: All GP offices (n = 1288) and hospital laboratories (n = 52) measuring Hb A1c in Norway participated in the EQA survey. The percentage of participants that performed measurements within the quality specifications was calculated. Pooled within-laboratory CVs were estimated for the Afinion, DCA 2000, DCA 2000+, DCA Vantage(TM), and Nycocard Hb A1c Reader instruments and for hospital laboratory instruments. RESULTS: Between 60% to 90% of Afinion and DCA users and hospital laboratories performed Hb A1c measurements within the quality specifications for both trueness (6.0%) and imprecision (CV ≤2.0%) at 2 levels in each EQA survey. The pooled within-laboratory CVs for the Afinion and DCA instruments and hospital laboratories were below the recommended limit of 2.0% for most of the surveys. CONCLUSIONS: A large proportion of GP offices using Afinion and DCA POC instruments to measure Hb A1c fulfill the analytical quality specifications for diagnosing diabetes mellitus, and these instruments demonstrate analytical quality comparable to that of hospital laboratory instruments. When GP offices participate in a stringent quality assurance program and generate Hb A1c measurements that meet analytical quality specifications, these measurements can be recommended for use to diagnose diabetes mellitus.