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

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• Status: Withdrawn
• Conditions: Diabetes Type 1
• Intervention / Treatment: Device: MD-logic artificial pancreas system

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: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 63 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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		Day 1
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.	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	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	Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL.	Day 3
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.	day 3
Overall frequency of hyperglycemia	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	Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL	day 2

Secondary Outcome Measures

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		Day 1
Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit		Day 1
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.	Day 1
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	Day 1
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	Day 1
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	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	Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL	Day 2

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: December 25, 2011
• First Posted (Estimate): December 29, 2011

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Diabetes Type 1; Artificial Pancreas
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: rmc006385ctil