MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
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|ClinicalTrials.gov Identifier: NCT01901913|
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : April 16, 2015
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:
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: MD-bolus calculator for pre-meal bolus Device: No MD-bolus calculator for pre-meal bolus||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: MD-bolus calculator for pre meal bolus
closed loop session with MD-bolus calculator for pre-meal bolus.
Device: MD-bolus calculator for pre-meal bolus
Active Comparator: No MD-bolus calculator for pre-meal bolus
closed loop session without MD-bolus calculator for pre-meal bolus
Device: No MD-bolus calculator for pre-meal bolus
- Area under the curve above 180 mg/dl (10 mmol/l) [ Time Frame: 4 hours postprandial ]
- Time within range of 70-180 mg/dl over 4 hours from the beginning of the meal [ Time Frame: 4 hours postprandial ]
- The incremental glucose rise from premeal to peak postprandial level [ Time Frame: 4 hours postprandial ]
- Number of hypoglycemic events below 70 mg/dl (3.9 mmol/l) [ Time Frame: 4 hours postprandial ]
- The percentage of subjects who reached the desired glucose target (70-180 mg/dl) 4 hours postprandial. [ Time Frame: 4 hours postprandial ]
- Percentage of time spent below 70 mg/dl (3.9mmol/l) [ Time Frame: 4 hours postprandial ]
- Percentage of time spent above 180, 250, (10, 13.9 mmol/l) [ Time Frame: 4 hours postprandial ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901913
|Schneider Children's Medical Center|
|Petah-Tikva, Israel, 49202|