| Objective:Diabetes mellitus is a group of metabolic diseases characterized by high blood glucose levels,which may lead to microvascular disease,resulting in blindness,kidney failure,and nerve damage.One important goal of diabetes treatment is to keep the blood glucose levels near the normal range.Home blood glucose testing by pricking fingertip is an important part of controlling blood glucose.But frequent finger punctures bring great pain and big pressure to diabetics.Therefore,many researchers and manufacturers devote to invent non-invasive glucose meters.This research aims to monitor blood glucose with the sample of saliva,which is a totally non-invasive method and can provide more intensive control of blood glucose in patients with diabetes.Methods:1.A new chromogen was synthesised according to Trinder's paper,with which a highly sensitive assay was established to analyze saliva glucose.2.Saliva was collected with or without stimulation.Collected saliva volume,saliva glucose and its correlation with blood glucose were compared in 10 patients between two methods to make sure which one was better.3.Blood glucose was determined with routine commercial reagent kits,and saliva glucose was determined by the established highly sensitive assay.The correlation between blood glucose and saliva glucose was analyzed by linear regression.66 patients with diabetes was studied to explore the population correlation coefficient,30 patients to explore the individual correlation coefficient,and the stability of individual correlation coefficient was also evaluated.4.A highly sensitive test strip method was established for home saliva glucose testing, and it was compared with the established automatic assay.Results:1.The established saliva glucose assay is far more sensitive than traditional blood glucose assay due to the new chromogen(TBHBA),elevated sample/reagent ratio and increased enzyme concentration,which meets the demands for determination of saliva glucose.2.The saliva glucose of patients with diabetes ranges from 12.3 mg/L to 46.2mg/L (22.7±6.8 mg/L),while that of healthy control is from 4.6 mg/L to 12.6mg/L(8.6±1.9 mg/L).The statistic shows that they have significant difference.The population correlation coefficient is 0.87,which suggests that there was a good correlation between the saliva glucose and blood glucose.3.The individual correlation coefficients varies.The higher the individual correlation coefficient is,the nearer the evaluated blood glucose with saliva glucose is to the actual blood glucose.A follow-up observation of three months shows that the individual correlation coefficient s are stable(CV＜5%).4.Lyophilization is the best way to prepare test strip for determination of saliva glucose.The suitable excipient was 10g/L albumin.5.The linear range of prepared test strip is 0.03mmol/L～0.22mmol/L,which covers the range of saliva glucose of both healthy people and diabetics.There is a good correlation between the results of test strips and that of biochemical analyzer.Conclusion:1.A new chromogen was synthesised according to Trinder's paper,with which a highly sensitive assay was established to analyze saliva glucose.2.There is a good correlation between the saliva glucose and blood glucose.3.Individual correlation coefficient is superior to population correlation coefficient in monitoring blood glucose with saliva.4.The established method of test strip for determination of saliva glucose meets the demand of monitoring blood glucose non-invasively at home. |
