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Most guidelines advocate relaxed glycaemic control in older and especially frail people with type 2 Diabetes Mellitus (T2DM), but these recommendations have not yet been adopted in routine practice.

Research question:

1) how to implement a program to reduce glucose lowering medication in older T2DM patients in primary care.

2) is this reduction safe, does it improve quality of care and is it cost effective.

Study design:

Pilot phase followed by an open intervention study in primary care that is cluster randomized on the level of the GP with a follow up of two years.

Study population:

People with T2DM >= 70 years who have HbA1c levels that are below the guideline suggested set points and are using glucose lowering medication.

Intervention:

A glucose lowering medication reduction program in close communication with the patient.

Outcome measures:

The primary outcome is a combined safety outcome measure reflecting adverse events based on EMR registrations. Secondary outcome measures are Quality Of Life (Q5D-5L), Cognitive functioning measured with a short questionnaire (Mini-Cog), Health care and patient costs, routine blood and urine measurements and medication prescriptions.

Analysis:

Poisson univariate and multivariate regression analyses. Cost Effectiveness and Cost Utility analysis. We will perform the study in 62 GP practices in order to include 446 subjects

We shall study the implementation according to the Extended Normalisation Process Theory and the RE-AIM method using the NoMAD questionnaire and the RE-AIM toolkit.

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