At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prevention of Hypoglycemia After Exercise Using DreaMed Substance Administration Device in Children and Adolescents With Type 1 Diabetes (The PHYSI-DREAM Study)
In Brief
A clinical study evaluating DreaMed Substance Administration Device and Sensor Augmented Pump (SAP) for Type 1 Diabetes Mellitus. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The Study will compare treatment with Closed Loop (CL) system - DreaMed MD-AID to the standard treatment without computer algorithm decisions - SAP therapy in 20 children and adolescents with Type 1 Diabetes (T1D) during and after afternoon physical activity. The aims of the study are: * to demonstrate that the use of DreaMed MD-AID is safe during physical activity * to investigate the risk of hypoglycemia among children and adolescents with T1D after afternoon exercise during closed-loop control.
Study Details
Timeline
Interventions
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.
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