NCT02463097

Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes

Safety Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe as part of the overall system.

Detailed description

The study will proceed as follows: Run-in Period: A total of up to 150 subjects (age 14 - 75) will be enrolled at up to 10 investigational centers (9 in the US, 1 in the Europe, Middle East and Africa (EMEA) region) in order to reach 100 subjects who will complete the HCL study. The 2-week run-in period will be used to allow subjects to become familiar with new study devices. During the two week run-in period subjects will be using the Study Pump (670G) with the Sensor Augmented Pump function only activated (i.e. SmartGuard OFF and HCL OFF). Study Period - At Home: Following the two week run-in period using the Study Pump (670G), all subjects will participate in a 3-month study period. Subjects will be required to have a companion with them during the night for the duration of the study period. Companions will need to be under the same roof, but not necessarily in the same bedroom. During the Hotel stay where subjects are monitored closely, the presence of a companion is not necessary. Study Period - Hotel Study Subjects will participate in a Hotel study (6 days, 5 nights), with the remainder of the study period to be spent at home. All subjects will undergo daytime and nighttime Frequent Sample Testing (FST) for approximately 24 hours during the Hotel study with YSI or i-STAT® used as a reference value. With respect to meals, subjects will be allowed to eat as they normally do. Continued Access Program Subjects will be given the opportunity to extend use of their study devices for a period of 3 years. If subjects choose to participate in the continuation period, they will retain the study devices at the end of study period visit or receive them back in the event they have been returned to study staff already. During the continuation period, subjects will come in for office visits every 3 months. At each of the quarterly visits, subjects will be asked about the occurrence of adverse events and device complaints.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Insulin Pump	Closed Loop Algorithm

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-03-01
• Completion: 2018-10-01
• First posted: 2015-06-04
• Last updated: 2019-04-16
• Results posted: 2017-04-18

Locations

10 sites across 2 countries: United States, Israel