SAFE-AP: Automatic Control of Blood Glucose Under Announced and Unannounced Exercise

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 1, 2018

Primary Completion Date

April 30, 2019

Study Completion Date

July 31, 2019

Conditions
Diabetes Mellitus, Type 1
Interventions
DEVICE

Closed-loop controller with exercise mitigation module

"Each subject will undergo three exercise tests, each one at 1-2 week intervals, thus completing the 3 experiments in about 6 weeks. The day of the experiment, the participant will do 3 sets of 15 minutes of cycloergometer at 70% of VO2max with 5 minutes of rest between them. On the first arm, participants will receive Sliding Mode Reference Conditioning (SMRC) Closed-loop insulin administration with a mitigation mode, based on subcutaneous continuous glucose monitoring (First arm, Closed-loop study with mitigation module).~Commercial insulin infusion systems and continuous glucose monitoring devices will be used."

DEVICE

Closed-loop controller without exercise mitigation module

"On the second arm, participants will receive Sliding Mode Reference Conditioning (SMRC) Closed-loop insulin administration without a mitigation mode, based on subcutaneous continuous glucose monitoring (Second arm, Closed-loop study without mitigation module).~Commercial insulin infusion systems and continuous glucose monitoring devices will be used."

DEVICE

Open-loop insulin infusion system

Standard subcutaneous insulin infusion based on the individual insulin sensibility. Commercial insulin infusion systems and continuous subcutaneous glucose monitoring devices will be used.

Trial Locations (1)

08036

Hospital Clínic de Barcelona, Barcelona

All Listed Sponsors
collaborator

Universitat Politècnica de València

OTHER

collaborator

Universitat de Girona

OTHER

lead

Hospital Clinic of Barcelona

OTHER

NCT03577158 - SAFE-AP: Automatic Control of Blood Glucose Under Announced and Unannounced Exercise | Biotech Hunter | Biotech Hunter