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

Primary Purpose

Diabetes Type 1

Status

Withdrawn

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

MD-logic artificial pancreas system

About this trial

This is an interventional treatment trial for Diabetes Type 1 focused on measuring Diabetes Type 1, Artificial Pancreas

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Schneider children's Medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Closed Loop Control- MD-Logic

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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.

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.

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.

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.

Overall frequency of hyperglycemia

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

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

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

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.

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

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

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

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

Full Information

NCT ID

NCT01501032

First Posted

December 14, 2011

Last Updated

March 18, 2015

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01501032

Brief Title

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

Acronym

MD-Logic- Cont

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Withdrawn

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rabin Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Type 1

Keywords

Diabetes Type 1, Artificial Pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Closed Loop Control- MD-Logic

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

MD-logic artificial pancreas system

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Day 1

Title

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

Description

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

Time Frame

Day 1

Title

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

Description

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

Time Frame

Day 2

Title

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

Description

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

Time Frame

Day 3

Title

Overall frequency of hypoglycemia

Description

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

Time Frame

day 3

Title

Overall frequency of hyperglycemia

Description

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

Time Frame

Day 3

Title

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

Description

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

Time Frame

day 2

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Description

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

Time Frame

Day 1

Title

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

Description

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

Time Frame

Day 1

Title

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

Description

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

Time Frame

Day 1

Title

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

Description

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

Time Frame

Day 1

Title

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

Description

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

Time Frame

Day 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moshe Phillip, Prof

Organizational Affiliation

Rabin Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Schneider children's Medical center

City

Petah-tikva

ZIP/Postal Code

49202

Country

Israel

12. IPD Sharing Statement

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

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