Status
Conditions
Treatments
About
The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose levels by delivery of insulin operable in clinical trial settings. The safety of the system was proved in previous inpatient and outpatient trials in large number of patients. In the current study we aim to optimize post-prandial closed-loop glycemic control by developing an automated MD-bolus calculator and to evaluate its safety and efficacy in controlling postprandial blood glucose when used together with the MD-Logic artificial pancreas system in type 1 diabetes patients.
The study will consist of a pilot study with two segments and a main study segment. The aim of each segment is detailed below:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Diabetes type 1
Age 14-25 years
->1yr since diagnosis
Insulin infusion pump therapy for at least 3 months
HbA1c at inclusion ≤10%
BMI < 95th percentile for age and sex
Patients willing to follow study instructions
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
26 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal