NCT02651181

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

Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes -Single-arm, Single-center, in Clinic Study-The DREAMED Trail

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp. The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark. The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.

Detailed description

Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp. The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark. The primary objective of the study is to characterize the overall management of the glycemic control using this system including Safety. The data collected in this study will be used to confirm/develop the HLCL System further. Secondary objectives of this study include evaluation of the HLCL system in a monitored setting (camp) with the following stresses:Exercise, high carbohydrate and high fat meals 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 to 10 subjects will be enrolled (age 18-40). A minimum of 6 days run-in period with 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 a camp setting during which the HLCL feature will be studied.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	HLCL- Hybrid Logic Closed Loop System	All subjects wearing the HLCL System and using it with the closed loop algorithm

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2016-01-08
• Last updated: 2020-01-02

Locations

1 site across 1 country: Israel