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

This study is not yet open for participant recruitment.
Verified March 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01501032
First received: December 14, 2011
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Type 1
 Device: MD-logic artificial pancreas system
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Success is defined as >=40% subjects with a blood glucose in the 71-180 mg/dL range.

  • 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 ] [ Designated as safety issue: No ]
    Success is defined as >=50% subjects with a blood glucose in the 71-180 mg/dL range.

  • Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL.

  • Overall frequency of hypoglycemia [ Time Frame: day 3 ] [ Designated as safety issue: Yes ]
    Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.

  • Overall frequency of hyperglycemia [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    Success defined as no subjects with diabetic ketoacidosis (DKA).

  • 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 ] [ Designated as safety issue: Yes ]
    Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percent of blood glucose values >400 mg/dL during the first admission visit [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Individual success is defined as no blood glucose values >400 mg/dL.

  • Percent of blood glucose values <=60 mg/dL during the first admission visit [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    No more than 33% of visits with blood glucose <=60 mg/dL

  • Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL

  • Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Success is defined as less than 15% of subjects have a nadir blood glucose <=60 mg/dL

  • 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 ] [ Designated as safety issue: Yes ]
    Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL


Estimated Enrollment: 25
Study Start Date: October 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501032

Contacts
Contact: Moshe Phillip, Prof 972-3-9253778 mosheph@clalit.org.il

Locations
Israel
Schneider children's Medical center Not yet recruiting
Petah-tikva, Israel, 49202
Sub-Investigator: Revital Nimri, MD            
Sub-Investigator: Eran Atlas, Eng            
Sub-Investigator: Tal Oron, MD            
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Prof Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01501032     History of Changes
Other Study ID Numbers: rmc006385ctil
Study First Received: December 14, 2011
Last Updated: March 5, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Diabetes Type 1
Artificial Pancreas

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013