NCT01509157

MDRS for Prevention of Nocturnal Hypoglycemia

Prevention of Nocturnal Hypoglycemia in Children and Young Adults With Type 1 Diabetes Using a Remote Safety and Control Diabetes Management System

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 4 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

The investigators have developed a unique Remote \& Safety diabetes management system (MDRS) that offers real-time remote monitoring and control of glucose levels. The system allows the supervising personal to alarm the patient and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults.The aim of this feasibility study is to evaluate the efficacy of the MDRS system in preventing nocturnal hypoglycemia in children and young adults with type 1 diabetes.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	MDRS System (Remote & Safety diabetes management system)	Participants will be using the MDRS system combined with their regular Continuous Glucose Monitoring during nightime for 2 weeks. The MDRS will allow the supervising personal to get real time remote data of glucose level and to alarm the patients and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults
PROCEDURE	Continuous Glucose Monitoring	Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-02-01
• Completion: 2013-04-01
• First posted: 2012-01-12
• Last updated: 2013-07-16

Locations

1 site across 1 country: Israel