Type1 Diabetes Mellitus Clinical Trial
— POC-IDENTITY-1Official title:
Proof of Concept Study for the Identification of Patient-specific Parameters for Bolus Calculators in Type 1 Diabetic Patients
Verified date | August 2018 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | July 12, 2018 |
Est. primary completion date | July 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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