Abstract
BackgroundScientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking. If three-monthly control in general practice could be reduced to six-monthly control in some patients, this would on the one hand reduce the use of medical services including involvement of practice nurses, and thus reduce costs, and on the other hand alleviate the burden of people with type 2 diabetes. The goal of this study is to make primary diabetes care as efficient as possible for patients and health care providers. Therefore, we want to determine whether six-monthly monitoring of well-controlled type 2 diabetes patients in primary care leads to equivalent cardiometabolic control compared to the generally recommended three-monthly monitoring.Methods and designThe study is a randomised controlled patient-preference equivalence trial. Participants are asked if they prefer three-monthly (usual care) or six-monthly diabetes monitoring. If they do not have a preference, they are randomised to a three-monthly or six-monthly monitoring group. Patients are eligible for the study if they are between 40 and 80 years old, diagnosed with type 2 diabetes more than one year ago, treated by a general practitioner, not on insulin treatment, and with HbA1c ≤7.5%, systolic blood pressure ≤145 mmHg and total cholesterol ≤5.2 mmol/l. The intervention group (six-monthly monitoring) will receive the same treatment with the same treatment targets as the control group (three-monthly monitoring). The intervention period will last one and a half year. After the intervention, the three-monthly and six-monthly monitoring groups are compared on equivalence of cardiometabolic control. Secondary outcome measures are HbA1c, blood pressure, cholesterol level, Body Mass Index, smoking behaviour, physical activity, loss of work due to illness, health status, diabetes-specific distress, satisfaction with treatment and adherence to medications. We will use intention-to-treat analysis with repeated measures. For outcomes that have only baseline and final measurements, we will use ANCOVA. Depending on the results, a cost-minimisation analysis or an incremental cost-effectiveness analysis will be done.DiscussionThis study will provide valuable information on the most efficient control frequency of well-controlled type 2 diabetes patients in primary care.Trial registrationCurrent Controlled Trials ISRCTN93201802
Highlights
Scientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking
Three quarterly controls are done by the practice nurse and the general practitioner is advised to perform the annual check-up
Study population Patients are eligible for the study if they are 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 overall well-controlled, defined as having HbA1c ≤7.5% and systolic blood pressure ≤145 mmHg and total cholesterol ≤5.2 mmol/l
Summary
Scientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking. We want to determine whether six-monthly monitoring of well-controlled type 2 diabetes patients in primary care leads to equivalent cardiometabolic control compared to the generally recommended three-monthly monitoring. The number of type 2 diabetes patients is still increasing [1], and their use of health care facilities. The current guideline on type 2 diabetes in primary care in the Netherlands advises to monitor type 2 diabetes patients four times a year [3], but this advice is not evidence-based. Comparing 15 diabetes guidelines in 13 countries, the advised frequency of monitoring HbA1c ranged from one to four times a year and monitoring blood pressure ranged from one to six times a year [4]. It is obvious that the workload for healthcare professionals will differ significantly, depending on the guideline that is followed
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call