Out-patient determination of glycosylated haemoglobin in the monitoring and control of diabetes mellitus: systematic review of the literature

To compare out-patient determination of HbA(1c) with lab figures, by measuring metabolic control, quality of life and hypoglycaemia episodes, in adults with type-1 or -2 diabetes mellitus. Systematic review. MEDLINE (1966-August 2006), EMBASE (2000-August 2006), bases held by the Center for Reviews and Dissemination (DARE, INAHTA, NHS-EED), Cochrane Library (number 3, 2006), European Medication Agency, Food and Drug Administration and the European Network of Emerging Technologies. A manual search was made in Point of Care and in the register of trials, (ClinicalTrials.gov). Inclusion criteria were studies with type-1 or -2 diabetics who used portable out-patient devices and with comparison with lab references. Studies of minors, of any other kind of diabetes, of patients without a portable device and where the comparator did not include reference methods were excluded. Those that a priori met the criteria were recovered fully. A quality analysis was run according to the CASPe programme criteria and data were extracted with specific formulae. As meta-analysis was not possible, a qualitative synthesis was made. Twenty publications were selected. The values of most devices correlated well (R(2)=0.85 and R(2)=0.059; P< .001). Some studies described increase in glycaemia control, with drop in HbA(1c) of 0.1%-1.5% (P< .01); therapy control was more intense (95% CI, 0.95-1.52) and visits to the doctor decreased. Out-patient evaluations are rapid and comfortable, increasing patients' metabolic control. However, they possess certain limitations.