Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes (MD-Logic- Cont)

March 18, 2015 updated by: Rabin Medical Center

Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients

The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic artificial pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise. During the the visits, meal boluses will be semi-automated, with manual meal announcement by the physician/nurse, automated bolus recommendation by the system, and automated delivery of the bolus following confirmation of the recommendation. Between-meal insulin dosing will be fully automated. Bolus confirmation by the physician/nurse will be requested by the closed loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah-tikva, Israel, 49202
        • Schneider Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 61 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months
  • Age 12 to 65 years
  • Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
  • For females, not currently known to be pregnant
  • Demonstration of proper mental status and cognition for the study
  • An understanding of and willingness to follow the protocol and sign the informed consent or assent

Exclusion Criteria:

  • Diabetic ketoacidosis in the past 6 months
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
  • History of a seizure disorder (except hypoglycemic seizure).
  • Coronary artery disease or heart failure.
  • Cystic fibrosis
  • Active infection
  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
  • A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
  • Current use of a beta blocker medication
  • Hematocrit <30%
  • Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Closed Loop Control- MD-Logic
The MD-Logic artificial pancreas system will be used in conjunction with continuous glucose monitoring and insulin pump delivery to manage the subject's blood glucose.
Device: MD-logic artificial pancreas system
The MD-logic artificial pancreas system is a closed loop control system using continuous glucose monitoring (CGM)and subcutaneous insulin pump infusion to mange glucose control in individuals with type 1 diabetes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit
Time Frame: Day 1
Day 1
Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus
Time Frame: Day 1
Success is defined as >=40% subjects with a blood glucose in the 71-180 mg/dL range.
Day 1
Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount
Time Frame: Day 2
Success is defined as >=50% subjects with a blood glucose in the 71-180 mg/dL range.
Day 2
Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise
Time Frame: Day 3
Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL.
Day 3
Overall frequency of hypoglycemia
Time Frame: day 3
Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.
day 3
Overall frequency of hyperglycemia
Time Frame: Day 3
Success defined as no subjects with diabetic ketoacidosis (DKA).
Day 3
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Time Frame: day 2
Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
day 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit
Time Frame: Day 1
Day 1
Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit
Time Frame: Day 1
Day 1
Percent of blood glucose values >400 mg/dL during the first admission visit
Time Frame: Day 1
Individual success is defined as no blood glucose values >400 mg/dL.
Day 1
Percent of blood glucose values <=60 mg/dL during the first admission visit
Time Frame: Day 1
No more than 33% of visits with blood glucose <=60 mg/dL
Day 1
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus
Time Frame: Day 1
Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
Day 1
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus
Time Frame: Day 1
Success is defined as less than 15% of subjects have a nadir blood glucose <=60 mg/dL
Day 1
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Time Frame: Day 2
Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • rmc006385ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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