title: Effectiveness and cost-effectiveness of 3-monthly versus 6-monthly monitoring of well-controlled type 2 diabetes patients: a pragmatic randomised controlled patient-preference equivalence trial in primary care (EFFIMODI study).
abstract: OBJECTIVE
  To investigate effectiveness and cost-effectiveness of 6-monthly monitoring compared with 3-monthly monitoring of well-controlled type 2 diabetes patients in primary care.
  
  
  METHODS
  A pragmatic randomised controlled patient-preference equivalence trial was performed. From April 2009 to August 2010, 2215 patients from 233 general practitioners across the Netherlands were included. Patients were eligible if between 40- and 80-years-old, diagnosed with type 2 diabetes for more than a year, treated by their general practitioner, not on insulin treatment and well-controlled during the last year (HbA1c ≤ 58 mmol/mol, systolic blood pressure ≤ 145 mmHg and total cholesterol ≤ 5.2 mmol/l). Patients without a strong preference for their monitoring frequency were randomised to 3-monthly or 6-monthly monitoring. Follow-up was 18 months. The primary outcome is the percentage of patients remaining under: HbA1c ≤ 58 mmol/mol, systolic blood pressure ≤ 145 mmHg and total cholesterol ≤ 5.2 mmol/l. Equivalence was assumed if the two-sided 95% confidence interval (CI) was between -5 and 5%. Cost-effectiveness was determined using a cost-minimisation analysis.
  
  
  RESULTS
  In the 3-monthly group 69.5% remained under good cardiometabolic control, versus 69.8% in the 6-monthly group (difference: 0.3%; 95%CI: -6.2-6.7%). All secondary outcomes were equivalent for 3-monthly and 6-monthly monitoring, except the systolic blood pressure target, physical activity and antihypertensive drug use. Six-monthly monitoring was €387 (£333) cheaper per patient compared to 3-monthly monitoring during the study period.
  
  
  CONCLUSIONS
  Patients with good cardiometabolic control and without preference for their monitoring frequency can visit the primary care physician less often. The cost-savings can be considerable.
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
authors.forename: P R
authors.initials: PR
authors.lastname: Wermeling
authors.forename: K J
authors.initials: KJ
authors.lastname: Gorter
authors.forename: R K
authors.initials: RK
authors.lastname: Stellato
authors.forename: G A
authors.initials: GA
authors.lastname: de Wit
authors.forename: J W J
authors.initials: JW
authors.lastname: Beulens
authors.forename: G E H M
authors.initials: GE
authors.lastname: Rutten
mesh_terms: D000368:Aged; D001794:Blood Pressure; D002784:Cholesterol / Q000097:blood*; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000191:economics / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000191:economics / Q000379:methods / Q000592:standards; D009426:Netherlands / Q000453:epidemiology; D057240:Patient Preference / Q000706:statistics & numerical data*; D011320:Primary Health Care; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002784:Cholesterol; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: diabetes mellitus; primary care; randomised trial