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

Diabetes Type 1 Clinical Trial

— MD-Logic- Cont  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01501032
• Other study ID #: rmc006385ctil
• Status: Withdrawn
• Phase: Phase 1
• First received: December 14, 2011
• Last updated: March 18, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Type 1

Intervention

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

Locations

Country	Name	City	State
Israel	Schneider children's Medical center	Petah-tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit		Day 1	No
Primary	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	No
Primary	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	No
Primary	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	Yes
Primary	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	Yes
Primary	Overall frequency of hyperglycemia	Success defined as no subjects with diabetic ketoacidosis (DKA).	Day 3	Yes
Primary	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	Yes
Secondary	Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit		Day 1	No
Secondary	Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit		Day 1	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes