Status:
UNKNOWN
Assessing Detection Algorithms for Insulin Pump Malfunctions in Type 1 Diabetes
Lead Sponsor:
University of Padova
Collaborating Sponsors:
Azienda Ospedaliera di Padova
Conditions:
Diabetes Mellitus, Type I
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test the effectiveness of fault-detection algorithms in detecting malfunctioning of the insulin infusion system in an artificial pancreas (also known as Automated...
Detailed Description
In individuals with type 1 diabetes, adjusting insulin doses to accommodate the ever-changing conditions of daily life is crucial for achieving satisfactory metabolic control. To address this challeng...
Eligibility Criteria
Inclusion
- Age between 18 (included) and 70 years
- At least 1 year from the diagnosis of type 1 diabetes mellitus
- Body mass index (BMI) less than 30 kg/m²
- Treated with automated insulin delivery system (AID) for at least 3 months
- Using carbohydrate counting to calculate meal bolus
- Glycated hemoglobin \< 10%
- If treated with antihypertensive, thyroid, antidepressant or lipid-lowering drugs, the therapy must be stable for at least 1 month before enrolment and remain stable for the entire duration of the study
- Awareness of the study design and purpose
- Willingness to undergo the study procedures
- Signing the informed consent
Exclusion
- Pregnancy or breastfeeding; pregnancy planning (effective contraception is required in women of childbearing age)
- Hematocrit less than 36% in females and less than 38% in males
- Presence of ischemic heart disease or congestive heart failure or history of a cerebrovascular event
- Therapy with a drug that significantly affects glucose metabolism (e.g. steroids)
- Uncontrolled hypertension
- Allergy or adverse reaction to insulin
- Known adrenal problems, pancreatic cancer, or insulinoma
- Any comorbid condition affecting glucose metabolism as judged by the investigator
- Current alcohol abuse, substance abuse, or serious mental illness, as judged by the investigator
- Unstable proliferative retinopathy according to fundus examination within the last year
- Known hemorrhagic diathesis or dyscrasia
- Blood donation in the last 3 months
- Renal failure with creatinine \> 150 μmol/L
- Impaired hepatic function based on plasma AST/ALT levels \> 2 times the upper limits of normal values
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06147583
Start Date
December 1 2023
End Date
April 1 2024
Last Update
December 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera di Padova
Padua, PD, Italy, 35128