CEP 304
Research type
Research Study
Full title
Multi-center, Randomized, Parallel, Adaptive, Controlled Trial in Adult and Pediatric Patients with Type 1 Diabetes Using Hybrid Closed Loop System and Control (CSII, MDI and SAP) at Home
IRAS ID
252064
Contact name
Mark Evans
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
This study involves subjects with Type 1 diabetes who have been recommended to get a device system called Medtronic Hybrid Closed Loop,(HCL) which is the control mechanism in the 670G insulin pump for Diabetes management. This device system consists of an insulin pump, a Medtronic glucose sensor, an insertion device for the sensor and glucose meter. The system is designed to translate sensor information and direct the pump to provide the needed dosage of insulin automatically and continuously.
This is a study of a device system that has CE mark and has been authorised for use in Europe for patients who are 7 years of age or older. The 670G system has not been approved anywhere for patients who are younger than 7 years of age.The glucose levels that are detected by the sensor are sent to the pump every 5 minutes via a transmitter that is attached to the sensor. The controller algorithm (software) in the 670G insulin pump decides how much insulin needs to be delivered to keep the glucose levels in a safe range.
The purpose of this study is to evaluate how safe the Hybrid Closed Loop system (HCL) is and how well it works. The HCL system is built into the 670G insulin pump, in adult and pediatric patients with type 1 diabetes in a home setting.REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0361
Date of REC Opinion
9 Jan 2019
REC opinion
Further Information Favourable Opinion