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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed Loop Control- MD-Logic | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MD-logic artificial pancreas system | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider children's Medical center | Petah Tikva | 49202 | Israel |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| day 2 |
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |