Towards a more efficient diabetes control in primary care: six-monthly monitoring compared with three-monthly monitoring in type 2 diabetes - The EFFIMODI trial : design of a randomised controlled patient-preference equivalence trial in primary care.
BMC Family Practice, Vol. 11, p.35-. ISSN 1471-2296.
Background: Scientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking. If threemonthly
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 design: The 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.
Discussion: This study will provide valuable information on the most efficient control frequency of well-controlled
type 2 diabetes patients in primary care. Trial registration: Current Controlled Trials ISRCTN93201802