Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Proof of Concept Study for the Identification of Patient-specific Parameters for Bolus Calculators in Type 1 Diabetic Patients

Conditions
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Type1 Diabetes Mellitus

Intervention / Treatment
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* Other: Gathering data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Patient followed at the endocrinology department of UZ Leuven Type 1 diabetes Treated with subcutaneous insulin pump (CSII) for more than 12 weeks Using a continuous glucose monitor (CGM) for more than 12 weeks No known diabetic gastroparesis C-peptide negative HbA1c between 6-10% Using, or willing to use, the bolus calculator Exclusion Criteria: Type 2 diabetes, patients with secondary diabetes Patients treated with multiple daily insulin injections or begin of treatment with CSII less than 12 weeks before inclusion Known diabetic gastroparesis C-peptide positive HbA1c < 6% or > 10% Not using or not willing to use the bolus calculator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: proof-of-concept, open label, single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>We will gather data from this group of patients. | Other: Gathering data<br>* Gathering data about sleep, heart rate, carbohydrate intake, insulin pump, continuous glucose sensor, meals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accepting mathematical model | The primary outcome measure will be to accept or reject the mathematical model by calculating mean-squared error differences with the data. | three weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, insulin pump, bolus calculator, continuous glucose monitoring, carbohydrate to insulin ratio, insulin sensitivity factor