NCT02692547

Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.

Detailed description

This study is a single-arm, single-center, in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy. Run-in Period A total of up 10 subjects will be enrolled (age 18-25). A minimum of 6 days run-in period with the 640G (sensor augmented pump) will be used to collect sensors and insulin data and to allow the subject to become familiar. Study Period - Camp Following the run-in period subjects will participate in a 5 day, 4 night study period in an camp setting during which the CL feature will be studied. Subjects will receive 3 meals each day, one night they receive a high fat dinner, one morning they will receive breakfast high in carbohydrates. Subjects will be asked to exercise for up to 60 minutes on one day during their study period. Subjects will be asked to take a minimum of 5 fingersticks a day (before each meal, morning and before bedtime)

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Hybrid-logic closed loop system	All patients get to wear the pump

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2016-02-26
• Last updated: 2018-01-19