Near-patient testing

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Grieve et al, 1999312599 patients of all ages with type 1 or type 2 diabetes
UK
Near-patient testing by nurse of HbA1c, lipids and creatinine
versus
conventional laboratory testing
  1. HbA1c
  2. Number of management changes
  3. Patient satisfaction
  4. Patient perceived frequency of hypoglycaemia
  5. Health service professionals’ views
  6. Quality of results
  1. No statistically significant differences in metabolic control between the groups.
  2. Number of changes in management was increased with near-patient testing (total of all patients in the study OR 1.52, 95% CI 1.02 to 2.26). When split into poorly managed and well managed: in the poorly managed group there was an increase in management changes with near-patient testing (OR 1.75, 95% CI 1.12 to 2.72), but in the patients with good glycaemic control there was no statistically significant change in number of management changes (OR 0.918, 95% CI 0.35 to 2.44). There was little evidence that management changes were made due to information regarding triglycerides and creatinine levels
  3. No statistically significant difference in the median total treatment satisfaction with the different testing methods. However, two of the individual parameters which did show a statistically significant difference between the two clinics was satisfaction with the test information given by the staff (75% vs. 60% recorded at least a satisfaction level of 4, p = 0.004) and satisfaction with the way in which the patient was treated by the staff (p = 0.04)
    At both hospitals there was strong agreement among patients that the immediate feedback of HbA1c is important because it allows patients to discus their results with the doctors at the clinic
  4. The patients who attended the near-patient testing clinic had a higher perceived frequency of hypoglycaemia than their counterparts (p = 0.005)
  5. The clinicians had a positive attitude to near-patient testing for HbA1c
  6. The quality control of results for abnormal samples for the isophane equipment had a coefficient of variation less than 6%, and the internal quality control for these samples compared favourably with the standard maintained at the central laboratory. For normal samples the quality of the near-patient testing was comparable to central laboratory testing of HbA1c, lipids and glucose. However, for creatinine samples measured on the Spotchem machines the coefficients of variation were very high
Patents were not randomised. The different treatment groups were at two different hospitalsControlled trialIIa
Cagliero et al, 1999313113 adults with type 1 diabetes
Mean age 49 ± 16 years
USA
HbA1c levels determined at the time of the visit with benchtop analyser, so results available at consultation
versus
HbA1c measured by usual laboratory results not available in the consultation
Trial length: 12 months
Change in HbA1c from start of the studyChange in HbA1c from start of the study: 0.34 ± 1.06% vs. 0.24 ± 1.03% (NS)Study looked at type 1 diabetes and type 2 diabetes: this has been split to report just type 1 diabetes hereRCTIb
Holman et al, 1987314146 adults with type 1 diabetes and 54 with type 2 diabetes
Mean age 47.9 ± 17.3 years
USA
Patients given equipment to take blood sample and post to laboratory to be analysed so the result was available by the next clinic visit
Trial length: five 3-month periods
  1. Number of samples that were feasible for analysis
  2. Mean HbA1c
  1. Number of samples that were feasible for analysis: 1984 Jun–Aug 145/209, 1984 Sep–Nov 149/218, 1984/5 Dec–Feb 166/214, 1985 Mar–May 155/199, 1985 Jun–Aug 151/206
  2. Mean HbA1c: 1984 Jun–Aug 10.8 ± 2.3%, 1984 Sep–Nov 10.2 ± 2.2%, 1984/5 Dec–Feb 9.8 ± 2.2% (compared with first reading in 1984 Jun–Aug p < 0.001), 1985 Mar–May 10.1 ± 1.9% (p < 0.05), 1985 Jun–Aug 10.1 ± 2.2% (p < 0.05)
Non-controlled intervention studyIII

From: Evidence tables

Cover of Type 1 Diabetes
Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People.
NICE Clinical Guidelines, No. 15.2.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2004 Sep.
Copyright © 2004, National Collaborating Centre for Women’s and Children’s Health.

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