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The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose levels by delivery of insulin operable in clinical trial settings. The safety of the system was proved in previous inpatient and outpatient trials in large number of patients. In the current study we aim to optimize post-prandial closed-loop glycemic control by developing an automated MD-bolus calculator and to evaluate its safety and efficacy in controlling postprandial blood glucose when used together with the MD-Logic artificial pancreas system in type 1 diabetes patients.
The study will consist of a pilot study with two segments and a main study segment. The aim of each segment is detailed below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MD-bolus calculator for pre meal bolus | Experimental | closed loop session with MD-bolus calculator for pre-meal bolus. |
|
| No MD-bolus calculator for pre-meal bolus | Active Comparator | closed loop session without MD-bolus calculator for pre-meal bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MD-bolus calculator for pre-meal bolus | Device |
| ||
| No MD-bolus calculator for pre-meal bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve above 180 mg/dl (10 mmol/l) | 4 hours postprandial |
| Measure | Description | Time Frame |
|---|---|---|
| Time within range of 70-180 mg/dl over 4 hours from the beginning of the meal | 4 hours postprandial | |
| The incremental glucose rise from premeal to peak postprandial level | 4 hours postprandial | |
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Inclusion Criteria:
Diabetes type 1
Age 14-25 years
->1yr since diagnosis
Insulin infusion pump therapy for at least 3 months
HbA1c at inclusion ≤10%
BMI < 95th percentile for age and sex
Patients willing to follow study instructions
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center | Petah Tikva | 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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| Device |
|
| Number of hypoglycemic events below 70 mg/dl (3.9 mmol/l) |
| 4 hours postprandial |
| The percentage of subjects who reached the desired glucose target (70-180 mg/dl) 4 hours postprandial. | 4 hours postprandial |
| Percentage of time spent below 70 mg/dl (3.9mmol/l) | 4 hours postprandial |
| Percentage of time spent above 180, 250, (10, 13.9 mmol/l) | 4 hours postprandial |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |