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Diabetes Type 1Phase 1MD-Logic- ContNCT01501032

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

A Phase 1 study testing MD-logic artificial pancreas system in people with Diabetes Type 1, run by Rabin Medical Center at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Diabetes Type 1
What is being tested?
MD-logic artificial pancreas system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteIsrael
Study dates
Oct 2013to Dec 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Schneider children's Medical center

    Petah Tikva, 49202

Other trials in Israel

About this study

Official title: 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.

Read the 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.

Conditions
Diabetes Type 1
Being tested
MD-logic artificial pancreas system
Keywords
Diabetes Type 1, Artificial Pancreas
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MD-logic artificial pancreas systemDevice

    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

Study groups in NCT01501032
Study groupRoleWhat they receive
Closed Loop Control- MD-LogicExperimentalThe 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.
Receives: Device: MD-logic artificial pancreas system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit

    Measured: Day 1

  2. Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus

    Success is defined as >=40% subjects with a blood glucose in the 71-180 mg/dL range.

    Measured: Day 1

  3. 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

    Success is defined as >=50% subjects with a blood glucose in the 71-180 mg/dL range.

    Measured: Day 2

  4. Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise

    Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL.

    Measured: Day 3

  5. Overall frequency of hypoglycemia

    Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.

    Measured: day 3

  6. Overall frequency of hyperglycemia

    Success defined as no subjects with diabetic ketoacidosis (DKA).

    Measured: Day 3

  7. 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

    Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL

    Measured: day 2

Secondary outcomes (7)

  1. Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit

    Measured: Day 1

  2. Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit

    Measured: Day 1

  3. Percent of blood glucose values >400 mg/dL during the first admission visit

    Individual success is defined as no blood glucose values >400 mg/dL.

    Measured: Day 1

  4. Percent of blood glucose values <=60 mg/dL during the first admission visit

    No more than 33% of visits with blood glucose <=60 mg/dL

    Measured: Day 1

  5. Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus

    Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL

    Measured: Day 1

  6. Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus

    Success is defined as less than 15% of subjects have a nadir blood glucose <=60 mg/dL

    Measured: Day 1

  7. 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

    Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL

    Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2011 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01501032
Sponsor's protocol ID
rmc006385ctil
Acronym
MD-Logic- Cont
Status last verified
Mar 2015
First submitted
14 Dec 2011
Last updated
19 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MD-logic artificial pancreas system in people with Diabetes Type 1, run by Rabin Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01501032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.

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