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

NCT ID: NCT01501032

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-12-31

Brief 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. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal 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.

Conditions

Diabetes Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MD-logic artificial pancreas system

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Phillip, Prof

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Schneider children's Medical center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

rmc006385ctil

Identifier Type: -

Identifier Source: org_study_id