Type1 Diabetes Mellitus Clinical Trial
Official title:
Proof of Concept Study for the Identification of Patient-specific Parameters for Bolus Calculators in Type 1 Diabetic Patients
The adoption of bolus calculators has been limited by the slow speed of the current trial and
error approach. The goal of this project is to automate the determination of patient specific
insulin pump parameters based on current automatic electronic logbooks of glucose
measurements, carbohydrate intake, and insulin usage, by means of a mathematical model. More
specifically, the investigators are interested in computing the carbohydrate to insulin ratio
(CIR) and insulin sensitivity factor (ISF), which are the main parameters of bolus
calculators.
The present study is a proof-of-concept, open label, single arm clinical trial to validate
the new method and refine both the mathematical model and the numerical techniques in
well-regulated and disciplined type 1 diabetic subject.
The study is a "trial" of the selected underlying mathematical model and the associated
algorithms to simulate the glucose values of a patient with uncertain meal-data.
After signing informed consent and checking eligibility criteria participants will receive
uniform education related to self-monitoring of blood glucose and continuous glucose
monitoring (CGM) using the CGM sensor as well as on the bolus calculator (BC). The study will
take three weeks (or three sensors) per patient.
Patients should live a close to normal life and should participate in their normal daily
activities. During the study, patients must consequently keep using the BC of their insulin
pump, record in the insulin pump when they eat extra food outside their regular meals and
when they inject extra insulin without the use of their insulin pump. Faulty 'meal markers'
have to be noted in a booklet and patients will also have to take pictures of their plate for
each meal or record their meals in detail in a booklet. Patients should also consequently
shut off insulin delivery when they disconnect their insulin pump and write it down in a
booklet. The patients will be asked to wear an activity tracker (i.e. Fitbit), this data will
help in the refinement of the model and will be used for research later in the same project.
During the study, patients must skip a total of three meals: breakfast, lunch and dinner (not
on the same day, but within the three weeks). This gives the investigators a period of
measurements in which they know that there are no significant amounts of unpredictable
carbohydrates in the blood. Patients can give correction insulin or take extra fast
carbohydrates to correct the glycaemia when needed and record this in the insulin pump or in
a booklet. The fast rescue carbohydrates should be in the form of Dextro energy tablets
(provided by the study team).
After the three weeks, patients will come back to the hospital where the study team will
download data from the insulin pump, CGM sensor, and activity tracker. The booklet and
photographs of the meals will be handed over to the study team. This is the end of the study
for the patient. The collected patient data will further be used to assess the model fit of
the chosen mathematical model as in, i.e. the investigators evaluate how well the model is
able to reproduce the collected data.
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