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

NCT02657083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-09-21

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • University of Ljubljana, Faculty of Medicine

    lead OTHER

Principal Investigators

  • Tadej Battelino, Prof, MD · University of Ljubljana, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657083 on ClinicalTrials.gov