NCT01901913

MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 14 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose levels by delivery of insulin operable in clinical trial settings. The safety of the system was proved in previous inpatient and outpatient trials in large number of patients. In the current study we aim to optimize post-prandial closed-loop glycemic control by developing an automated MD-bolus calculator and to evaluate its safety and efficacy in controlling postprandial blood glucose when used together with the MD-Logic artificial pancreas system in type 1 diabetes patients. The study will consist of a pilot study with two segments and a main study segment. The aim of each segment is detailed below: 1. Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to evaluate the efficacy and safety of different pre-meal bolus dosing compared to full closed-loop operation with no meal announcement. 2. Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to test the optimal distribution of insulin delivery during the meal. 3. Main study - Segment 3 - Automatic bolus calculator In this main segment of the study we will use the results and conclusions from the previous two pilot segments to develop the MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this automated insulin bolus calculator will be tested in a randomized cross-over study that will compare postprandial glycemic control under MDLAP with and without the use of the MD-Bolus Calculator.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	MD-bolus calculator for pre-meal bolus
DEVICE	No MD-bolus calculator for pre-meal bolus

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-07-17
• Last updated: 2015-04-16

Locations

1 site across 1 country: Israel