Prevention of Hypoglycemia After Exercise Using Closed Loop System in Children and Adolescents With Type 1 Diabetes

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Type 1 Diabetes Mellitus
Interventions
DEVICE

DreaMed Substance Administration Device

"2 exercise days under DreaMed MD-AID control with afternoon exercise (in the time between 16:30 and 19:30).~New infusion set and two continuous glucose sensors (one for back-up) will be inserted in the subcutaneous tissue of the arm and then calibrated the day before each visit from 3 to 6.~The continuous glucose sensor continuously will measure interstitial glucose levels and these values will be sent by the Minilink™ via wireless, low-powered, radio frequency to the Paradigm Veo every 5 minutes for up to 6 days.~The DreaMed MD-AID uses a vendor-supplied and self-developed (communication module) communication application programming interface (API) in order to retrieve glucose / insulin data from the Paradigm Veo and set insulin treatment according to the algorithm decision."

DEVICE

Sensor Augmented Pump (SAP)

"2 exercise days under Sensor Augmented Pump with afternoon exercise (in the time between 16:30 and 19:30).~New infusion set and two continuous glucose sensors (one for back-up) will be inserted in the subcutaneous tissue of the arm and then calibrated the day before each visit from 3 to 6.~The continuous glucose sensor continuously will measure interstitial glucose levels and these values will be sent by the Minilink™ via wireless, low-powered, radio frequency to the Paradigm Veo every 5 minutes for up to 6 days.~During the exercise the group will turn off the insulin pump and lower their basal insulin for 20% for the next 4 hours after the exercise"

Trial Locations (1)

1000

University of Ljubljana, Faculty of Medicine, Ljubljana

All Listed Sponsors
lead

University of Ljubljana, Faculty of Medicine

OTHER

NCT02657083 - Prevention of Hypoglycemia After Exercise Using Closed Loop System in Children and Adolescents With Type 1 Diabetes | Biotech Hunter | Biotech Hunter