Nocturnal Insulin-Glucose in Hospital: Tight Control (NIGHT CONTROL)

Corporacion Parc Tauli

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02160184

NIGHT CONTROL

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

experimental

Experimental group

Description:

Night under closed loop system

Treatment:

Device: Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)