MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MD-bolus calculator for pre-meal bolus
No MD-bolus calculator for pre-meal bolus
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Artificial pancreas, Closed loop
Eligibility Criteria
Inclusion Criteria:
- Diabetes type 1
Age 14-25 years
->1yr since diagnosis
- Insulin infusion pump therapy for at least 3 months
- HbA1c at inclusion ≤10%
- BMI < 95th percentile for age and sex
- Patients willing to follow study instructions
Exclusion Criteria:
- Any condition that influence intestinal absorption or motility such as diabetic gastroparesis, celiac disease or malabsorptive states that could affect postprandial glucose absorption.
- any episode of diabetic ketoacidosis within the month prior to study entry and/or severe hypoglycaemia resulting in seizure or loss of consciousness in the month prior to enrolment
- any concomitant disease that may influence metabolic control
- participation in any other interventional study
- known or suspected allergy to trial products
- any significant diseases (such as preexisting seizures or epilepsy) or conditions including psychiatric disorders, eating disorder and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety
- Female subject who is pregnant or planning to become pregnant within the planned study duration.
Sites / Locations
- Schneider Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MD-bolus calculator for pre meal bolus
No MD-bolus calculator for pre-meal bolus
Arm Description
closed loop session with MD-bolus calculator for pre-meal bolus.
closed loop session without MD-bolus calculator for pre-meal bolus
Outcomes
Primary Outcome Measures
Area under the curve above 180 mg/dl (10 mmol/l)
Secondary Outcome Measures
Time within range of 70-180 mg/dl over 4 hours from the beginning of the meal
The incremental glucose rise from premeal to peak postprandial level
Number of hypoglycemic events below 70 mg/dl (3.9 mmol/l)
The percentage of subjects who reached the desired glucose target (70-180 mg/dl) 4 hours postprandial.
Percentage of time spent below 70 mg/dl (3.9mmol/l)
Percentage of time spent above 180, 250, (10, 13.9 mmol/l)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01901913
Brief Title
MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
Official Title
MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Artificial pancreas, Closed loop
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MD-bolus calculator for pre meal bolus
Arm Type
Experimental
Arm Description
closed loop session with MD-bolus calculator for pre-meal bolus.
Arm Title
No MD-bolus calculator for pre-meal bolus
Arm Type
Active Comparator
Arm Description
closed loop session without MD-bolus calculator for pre-meal bolus
Intervention Type
Device
Intervention Name(s)
MD-bolus calculator for pre-meal bolus
Intervention Type
Device
Intervention Name(s)
No MD-bolus calculator for pre-meal bolus
Primary Outcome Measure Information:
Title
Area under the curve above 180 mg/dl (10 mmol/l)
Time Frame
4 hours postprandial
Secondary Outcome Measure Information:
Title
Time within range of 70-180 mg/dl over 4 hours from the beginning of the meal
Time Frame
4 hours postprandial
Title
The incremental glucose rise from premeal to peak postprandial level
Time Frame
4 hours postprandial
Title
Number of hypoglycemic events below 70 mg/dl (3.9 mmol/l)
Time Frame
4 hours postprandial
Title
The percentage of subjects who reached the desired glucose target (70-180 mg/dl) 4 hours postprandial.
Time Frame
4 hours postprandial
Title
Percentage of time spent below 70 mg/dl (3.9mmol/l)
Time Frame
4 hours postprandial
Title
Percentage of time spent above 180, 250, (10, 13.9 mmol/l)
Time Frame
4 hours postprandial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes type 1
Age 14-25 years
->1yr since diagnosis
Insulin infusion pump therapy for at least 3 months
HbA1c at inclusion ≤10%
BMI < 95th percentile for age and sex
Patients willing to follow study instructions
Exclusion Criteria:
Any condition that influence intestinal absorption or motility such as diabetic gastroparesis, celiac disease or malabsorptive states that could affect postprandial glucose absorption.
any episode of diabetic ketoacidosis within the month prior to study entry and/or severe hypoglycaemia resulting in seizure or loss of consciousness in the month prior to enrolment
any concomitant disease that may influence metabolic control
participation in any other interventional study
known or suspected allergy to trial products
any significant diseases (such as preexisting seizures or epilepsy) or conditions including psychiatric disorders, eating disorder and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety
Female subject who is pregnant or planning to become pregnant within the planned study duration.
Facility Information:
Facility Name
Schneider Children's Medical Center
City
Petah-Tikva
ZIP/Postal Code
49202
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
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