Type 1 Diabetes
Conditions
Brief summary
The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.
Interventions
DEVICEArtificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)
Sponsors
Corporacion Parc Tauli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 Diabetes * Diabetes duration \> 3 years * Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year * A1c 6-9% * No ketoacidosis during the previous 12 months * Glomerular Filtration Rate (GFR) \> 60 ml/kg/min m2 * Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice
Exclusion criteria
* Gastroparesis * Hypoglycemia unawareness * Uncorrected visual impairment * Deafness * BMI\> 35 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit. | During the closed-loop period for each patient: 12 hours |
Countries
Spain
Outcome results
None listed