Performance of the GlucoMen® Day (WaveForm Cascade) Continuous Glucose Monitor (CGM) in daily practice

Diabetes therapy requires intensive self-management from patients with diabetes
type 1 including at least four times measurement of glucose concentrations and
injection of the blood glucose lowering hormone insulin. Each time, patients
need to determine their need for insulin, which depends mostly on the actual
blood sugar value, anticipated glucose trends, what the patient is going to eat
(to be more precise: the amount of carbohydrates in the food), to what extent
the patient has performed physical activities in the last couple of days, is
going to perform physical exercise in the coming couple of hours, as well as
the insulin boluses given recently. Next to these factors, (at least) two other
personal factors attenuate the amount of insulin needed: carbohydrate ratio and
insulin sensitivity; these factors are personal and can vary over the course of
days, and weeks.

Classically, capillary self-measurements with fingerpricks are used to measure
glucose concentrations. As this method is painful, prone to errors, time
consuming, and does not allow identification of the course of glucose
concentrations novel methods to measure glucose have been developed over the
last decades. In particular measurement of glucose concentrations in the
interstitial fluid has manifested as a viable alternative to capillary
measurements. At present, real-time continuous glucose monitoring (rt-CGM) and
flash glucose monitoring (FGM) are available as methods for interstitial
glucose measurements. Most rt-CGM and FGM methods use glucose oxidase based
techniques for measuring glucose, moreover fluorescence based are also
available. If used appropriately, with rt-CGM the user often only needs to
calibrate the sensor at some time points daily and being able to act and react
on alarms preset at certain cut-off points. In contrast, FGM users use a
factory-calibrated sensor, which with the currently available version in the
Netherlands needs scanning for obtaining the required information.

In recent years, the frequency of use of both FGM and rt-CGM has increased
markedly. Also, more device manufacturers have become active. With each
introduction of a newly developed device it is imperative to validate such
device and assess accuracy, both under strictly controlled circumstances and
during normal daily life activities. Recently, the GlucoMen® Day CGM (WaveForm
Cascade) Continuous Glucose Monitor (CGM) (in short: Menarini CGM, M-CGM) has
been introduced in Europe. The device is CEE certified, but has not been widely
introduced yet. Given the importance of reliable glucose measurements in type 1
diabetes management, it is of great importance and direct relevance for
end-users that real-life data concerning the performance of the M-CGM become
available.

In recent years, our research group has assessed the performance of a variety
of capillary blood glucose measurement devices, FGMs and rt-CGMs. Under
different conditions, the proposed study would comprise both assessments during
normal daily life circumstances and in a controlled outpatient setting. In
these Covid-19 times, it is proposed to choose another approach, without
personal in-clinic contacts to collect data. It is proposed to assess results
of the Nova hand-held capillary glucose meter (from now: Nova) with the M-CGM
and the measurement devices (FGM or rt-CGM) normally used by the study
participants. This allows a robust and real-life assessment of the performance
of the M-CGM.

The primary objective of this study is to establish the performance of the
M-CGM as
Compared to capillary measurements. As secondary outcomes we will compare the
performance of the M-CGM with current FGM and rt-CGM techniques.

This is a 14-day, prospective, observational study during real-life
circumstances.

A small needle is insered through the skin and a small probe remains for 14
days. No futher risks for the subjects