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Trial record 38 of 751 for:    Area Under Curve AND meal

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
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

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:

  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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Area under the curve above 180 mg/dl (10 mmol/l) [ Time Frame: 4 hours postprandial ]

Secondary Outcome Measures :
  1. Time within range of 70-180 mg/dl over 4 hours from the beginning of the meal [ Time Frame: 4 hours postprandial ]
  2. The incremental glucose rise from premeal to peak postprandial level [ Time Frame: 4 hours postprandial ]
  3. Number of hypoglycemic events below 70 mg/dl (3.9 mmol/l) [ Time Frame: 4 hours postprandial ]
  4. The percentage of subjects who reached the desired glucose target (70-180 mg/dl) 4 hours postprandial. [ Time Frame: 4 hours postprandial ]
  5. Percentage of time spent below 70 mg/dl (3.9mmol/l) [ Time Frame: 4 hours postprandial ]
  6. Percentage of time spent above 180, 250, (10, 13.9 mmol/l) [ Time Frame: 4 hours postprandial ]


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Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Israel
Schneider Children's Medical Center
Petah-Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01901913     History of Changes
Other Study ID Numbers: rmc007418ctil
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: November 2014
Keywords provided by Rabin Medical Center:
Type 1 Diabetes
Artificial pancreas
Closed loop
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents