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)

Diabetes Obes Metab. 2014 Sep;16(9):841-9. doi: 10.1111/dom.12288. Epub 2014 Apr 9.

Abstract

Aim: 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.

Keywords: diabetes mellitus; primary care; randomised trial.

Publication types

  • Multicenter Study
  • Pragmatic Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Blood Pressure
  • Cholesterol / blood*
  • Cost-Benefit Analysis
  • Diabetes Mellitus, Type 2 / blood*
  • Diabetes Mellitus, Type 2 / economics
  • Diabetes Mellitus, Type 2 / epidemiology
  • Female
  • Follow-Up Studies
  • Glycated Hemoglobin A / metabolism*
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Male
  • Middle Aged
  • Monitoring, Physiologic* / economics
  • Monitoring, Physiologic* / methods
  • Monitoring, Physiologic* / standards
  • Netherlands / epidemiology
  • Patient Preference / statistics & numerical data*
  • Primary Health Care*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome

Substances

  • Glycated Hemoglobin A
  • hemoglobin A1c protein, human
  • Cholesterol