Spremljanje urejenosti glikemije diabetičnih bolnikov z dvema metodama določanja glikiranega hemoglobina v krvi

Kralj, Urška (author), Osredkar, Joško (mentor), Krivec, Štefka (comentor)

Nadzor nad glikemijo je temelj urejanja sladkorne bolezni ter s tem povezanega zmanjševanja tveganja za kronične zaplete. Eden pomembnih kazalnikov glikemičnega statusa je HbA1c v krvi. Njegova vrednost predstavlja oceno glikemije v obdobju preteklih treh mesecev. V magistrskem delu smo se osredotočili na 102 bolnika Diabetološke ambulante Splošne bolnišnice Celje. Bolnikom smo po odvzemu venske krvi v epruveto z dodanim antikoagulantom K2EDTA izmerili HbA1c z dvema imunokemijskima metodama, in sicer najprej na biokemijskem analizatorju Cobas c501 proizvajalca Roche Diagnostics na Oddelku za laboratorijsko medicino Splošne bolnišnice Celje in nato na POC (Point of care; ob preiskovancu) aparatu DCA Vantage proizvajalca Siemens Healthineers v Diagnostičnem laboratoriju ZSZD Nazarje. Statistično smo ovrednotili natančnost oz. ponovljivost metode za HbA1c na aparatu DCA Vantage, ki je glede na rezultate proizvajalca kontrolnega materiala (Siemens Healthineers) podal primerljiv izračun koeficienta variacije CV (Coefficient of Variation). Iz tega je razvidno, da je POC aparat v ZSZD Nazarje ustrezno natančen oz. so rezultati analiz z njim ponovljivi ter je tako primeren za spremljanje glikemičnega statusa sladkornih bolnikov v Diabetološki ambulanti. Statistično smo ovrednotili primerljivost metod z linearno regresijo Passing-Bablok ter preučili odstopanja med metodama. Ugotovili smo, da je med meritvami HbA1c v Splošni bolnišnici Celje in ZSZD Nazarje zelo visoka korelacija. Statistično smo ovrednotili primerljivost metod z Bland-Altmanovim diagramom ujemanja med dvema metodama. Ugotovili smo, da sta metodi dovolj skladni, da ju lahko uporabimo izmenično. V študiji DCCT (Diabetes Control and Complications Trial) pomeni ugodni glikemični status dobro urejena sladkorna bolezen s HbA1c ≤ 7,0 % in glukozo v serumu ali plazmi od 4 do 7 mmol/L na tešče in < 10 mmol/L po obroku. Delež bolnikov, ki so dosegli glikemični cilj, je bil 30,4 % (HbA1c je ≤ 7,0 % oz. 53 mmol/mol), delež bolnikov, ki ga niso dosegli, pa 69,6 % (HbA1c je ≥ 7,1 % oz. 54 mmol/mol). Sočasno smo pri bolnikih poleg določitev HbA1c spremljali dodatne serumske preiskave, ki se najpogosteje določajo pri sladkornih bolnikih: glukozo, kreatinin z oGF, holesterol, trigliceride, HDL-holesterol ter LDL-holesterol. Z dodatnimi preiskavami smo poskušali dobiti širši vpogled v pojavnost zapletov glede na dosežen glikemični status bolnikov in dejavnike tveganja. Z neparametričnim statističnim testom Mann-Whitney smo primerjali dodatne serumske preiskave pri skupini bolnikov, ki dosegajo glikemični cilj, in tisti, ki ga ne dosegajo.

• Language: Slovenian
• Keywords: Glikemični status, glikiran hemoglobin (HbA1c), hiperglikemija – povečana koncentracija glukoze, POCT – Testiranje ob preiskovancu, sladkorna bolezen.
• Work type: Master's thesis/paper
• Typology: 2.09 - Master's Thesis
• Organization: FFA - Faculty of Pharmacy
• Publisher: [U. Kralj]
• Year: 2026
• PID: 20.500.12556/RUL-182090
• UDC: 577.1:616.379-008.64:616-074(043.2)
• COBISS.SI-ID: 276734467
• Publication date in RUL: 24.04.2026

Secondary language

• Language: English
• Title: Monitoring glycemic control of diabetic patients with two methods for determining glycated hemoglobin in the blood

Abstract

Glycemic control is the cornerstone of diabetes management and the associated reduction in the risk of chronic complications. One important indicator of glycemic status is HbA1c in the blood. Its value represents an assessment of glycemia over the past three months. In the master's thesis, we focused on 102 patients of the Diabetes Outpatient Clinic of the Celje General Hospital. After venous blood was collected in a tube with the added anticoagulant K2EDTA, we measured HbA1c in the patients using two immunochemical methods, first on the biochemical analyzer Cobas c501 manufactured by Roche Diagnostics at the Department of Laboratory Medicine of the Celje General Hospital and then on the POC (Point of care; at the patient) DCA Vantage device manufactured by Siemens Healthineers in the Diagnostic Laboratory of the ZSZD Nazarje. We statistically evaluated the accuracy or repeatability of the method for HbA1c on the DCA Vantage device, which, according to the results of the control material manufacturer (Siemens Healthineers), provided a comparable calculation of the coefficient of variation (CV). This shows that the POC device in the ZSZD Nazarje is appropriately accurate or that the results of the analyses are reproducible and is thus suitable for monitoring the glycemic status of diabetic patients in the Diabetes Outpatient Clinic. We statistically evaluated the comparability of the methods using the linear regression Passing-Bablok and examined the deviations between the methods. We found that there is a very high correlation between HbA1c measurements at the Celje General Hospital and the ZSZD Nazarje. We statistically evaluated the comparability of the methods using the Bland-Altman correlation diagram between the two methods. We found that the two methods are consistent enough to be used interchangeably. In the Diabetes Control and Complications Trial (DCCT), favorable glycemic status is defined as well-controlled diabetes with HbA1c ≤ 7.0% and fasting serum or plasma glucose of 4 to 7 mmol/L and < 10 mmol/L after a meal. The proportion of patients who achieved the glycemic goal was 30.4% (HbA1c ≤ 7.0% or 53 mmol/mol), while the proportion of patients who did not achieve it was 69.6% (HbA1c ≥ 7.1% or 54 mmol/mol). At the same time, in addition to HbA1c determinations, we monitored additional serum tests in patients that are most often determined in diabetic patients: glucose, creatinine with oGF, cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol. With additional tests, we tried to gain a broader insight into the incidence of complications according to the achieved glycemic status of the patients and risk factors. Using the non-parametric Mann-Whitney statistical test, we compared additional serum tests in the group of patients who achieve the glycemic goal and those who do not.

• Keywords: Diabetes mellitus, Glycated hemoglobin (HbA1c), Glycemic status, Hyperglycemia – increased glucose concentration, POCT – Point of care testing.