Modelling fluctuations in blood glucose levels based on food intake and physical activity in patients with Diabetes Mellitus Type 2

Type 2 diabetes mellitus (T2DM) is a highly prevalent disease, causing
significant morbidity and mortality worldwide. Poor regulation of blood glucose
can lead to debilitating micro- and macrovascular complications such as
nephropathy, cardiovascular disease and amputations. Therefore, preventing
complications is an important treatment goal in T2DM. To aid patients with
T2DM, a coaching system can be developed to e.g. stimulate them in performing
certain physical activities or advise them to eat different compositions of
food to keep blood glucose levels within the desired range. Before we can
implement such a system, we need to have a clear understanding of the magnitude
of the effect these lifestyle changes have on blood glucose levels prior to
applying them. Therefore, this pilot study is designed to investigate if we can
model and predict changes of blood glucose levels when small changes in dietary
intake and/or physical activity are applied in patients with T2DM.

The primary objective is to investigate if models are able to predict changes
in blood glucose levels in patients with T2DM when small changes in dietary
intake and/or physical activity are applied.

This is a prospective pilot study in the outpatient setting. Patients with T2DM
from the outpatient clinic of internal medicine in the ZGT hospital Almelo,
will be recruited.

During a two-week period, participants will be asked to follow a protocol
during a controlled period 4h pre-prandial until 4h post-prandial of dinner in
which standardized low fat and carbohydrate dinner meals are administered and
on certain days with a normal amount of carbohydrates and/or fats. Furthermore,
participants are requested to eat a predetermined snack and a dessert 2h
pre-prandial of dinner and directly after dinner respectively. Finally,
participants are also asked or not to perform a physical activity 1 hour
post-prandial of dinner, which is a 30-minute normal paced walk. Each
participant will receive each change in dietary intake (dinner) and physical
activity (30-minute walk) in duplo. The order of administration of the
meals/physical activities is random for each participant.

There are no direct benefits for the patients to be included. Participation in
the pilot study is on a voluntary base. Patients will not receive any financial
support or priority for treatment of other diseases in the clinic during this
pilot study, besides that the meals of interest will be provided for them by
the University of Twente.
Patients will be asked to keep a lifestyle diary. During their visit, weight,
height, and walking speed will be assessed. The exercise is not designed to be
a strenuous amount as it is a normal paced walk. The applied dietary changes
are well within the normal range of intake to affect blood glucose for the
patients, so hypo- and hyperglycaemic events are not expected. Furthermore, no
invasive measurements will be executed and therefore risks of participation in
this pilot study are minimal.