Clinical trial NCT01501032: Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes
Official title: Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Diabetes Type 1
Keywords: Diabetes Type 1
Artificial Pancreas
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit
timeFrame: Day 1
measure: Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus
timeFrame: Day 1
measure: 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
timeFrame: Day 2
measure: Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise
timeFrame: Day 3
measure: Overall frequency of hypoglycemia
timeFrame: day 3
measure: Overall frequency of hyperglycemia
timeFrame: Day 3
measure: 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
timeFrame: day 2
Secondary outcomes:
measure: Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit
timeFrame: Day 1
measure: Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit
timeFrame: Day 1
measure: Percent of blood glucose values >400 mg/dL during the first admission visit
timeFrame: Day 1
measure: Percent of blood glucose values <=60 mg/dL during the first admission visit
timeFrame: Day 1
measure: Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus
timeFrame: Day 1
measure: Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus
timeFrame: Day 1
measure: 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
timeFrame: Day 2
Other outcomes:
Locations:
city: Petah-tikva
country: Israel
facility: Schneider children's Medical center
Study officials:
affiliation: Rabin Medical Center
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References: