The quality of instruments for SMBG seems to have improved during recent years, although there are still analytical problems. A standardized evaluation protocol is necessary and should be regularly revised taking into account the development of new technology and the needs of the patients.

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Introduction Scope of the guidance Disclaimer Methodology I. Pre-sampling General considerations on appropriate mode of communication with the patient Patient position Step 1. Patient identification (1C) Step 2. Verify patient is fasting and properly prepared (1B) Step 3. Obtain supplies required for venous blood collection (2C) Step 4. Labeling and/or identifying tubes (1C) II. Sampling Step 5. Put on gloves (1C) Step 6. Apply tourniquet (1A) Step 7. Select venepuncture site (1B) Step 8. Clean sampling site (1B) Step 9. Puncture the vein (1A) Step 10. Drawing blood into the first tube (1A) Step 11. Release the tourniquet (1A) Step 12. Gently invert the tubes once immediately after collection (1B) Step 13. Draw additional tubes following the recommended order of draw (1B) Step 14. Remove the needle from the vein and ensure the safety mechanism is activated (1A) Step 15. Dispose of the needle (1A) Step 16. Bandage the puncture site (1C) Step 17. Tell the patient to apply gentle pressure and do not bend the arm (1C) Step 18. Invert all tubes at least 4 more times (1B) Step 19. Remove gloves (1A) III. Post sampling Step 20. Advise the patient to rest for 5 min (1B) IV. Implementation of the guidelines Potential barriers and challenges Framework for a successful implementation of this recommendation Conclusions References

Background: External quality assessment schemes (EQAS) are conducted to evaluate user performance (participant assessment) and to assess different methods and instruments (method assessment). The quality of control materials is crucial to achieving these goals. Inconsistencies in between-lot variations detected by use of different control and sample materials may affect EQAS outcomes. Methods: For the Accu-Chek Sensor, Precision Xtra, Ascensia Elite, and HemoCue 201 glucometers, 3 different lots of glucose strips were used with each instrument. Method assessment results from analysis of capillary blood and 3 control materials were used to calculate between-lot differences. A simulation study was performed to evaluate the effect of between-lot variation on participant assessment results. Results: With the Precision Xtra, the results obtained with EQA control material mirrored those obtained with capillary blood, but for the other instruments, we found between-lot differences of as much as 1.3 mmol/L, which were substantially greater than those found with capillary blood and of clinical importance at decision limits. The simulation study showed an effect on participant assessment results related to the target values, with the percentage of poor results decreasing (38%, 10%, and 4%) with the use of common, method-specific, and lot-specific target values, respectively. Conclusions: Between-lot variation may influence participant EQA results for participant and method assessments. The clinical relevance of between-lot variation

Little attention has been given and few studies have been published focusing on how to optimize self-monitoring of blood glucose (SMBG) use to monitor daily therapy for persons with type 1 diabetes mellitus. This study was designed to evaluate the effect on glycated hemoglobin (A1C) of a structured intervention focused on SMBG in type 1 diabetes patients with insufficient metabolic control (A1C ≥ 8%) using a randomized clinical trial design. Method:One hundred fifty-nine outpatients with type 1 diabetes on multiple injection therapy with insulin and A1C ≥8% were recruited and randomized to one group receiving a focused, structured 9-month SMBG intervention (n = 59) and another group receiving regular care based on guidelines (n = 64). Results:Glycated hemoglobin values (mean % ± standard deviation) at study start was similar: 8.65 ± 0.10 in the intervention group and 8.61 ± 0.09 in the control group. The two groups were comparable (age, gender, body mass index, complication rate, and treatment modality) at study start and had mean diabetes duration and SMBG experience of 19 and 20 years, respectively. At study end, there was decrease in A1C in the intervention group (p < .05), and the A1C was 0.6% lower compared with the control group (p < .05). No increase in the number of minor or major hypoglycemia episodes was observed in the intervention group during the study period. Conclusions:A simple, structured, focused SMBG intervention improved metabolic control in patients with longstanding diabetes type 1 and A1C ≥ 8%. The intervention was based on general recommendations, realistic in format, and can be applied in a regular outpatient setting.