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This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will participate in four consecutive over nights under closed-loop with MDLAP, and four additional over nights under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days between arms.
In the last two decades, remarkable technological progress has been made with the development of continuous glucose sensors, miniature devices, implantable pumps and sensors and wireless communications, interest in the closed-loop insulin delivery was revived.
Control trails that evaluate the clinical benefits of continuous glucose sensor have shown improved HbA1c with no significant increase in sever hypoglycemia, trend towards lower hypoglycemic episodes although not significant and no significant change in sever hypoglycemia. One of the main drawbacks of continuous glucose sensor is noncompliant of the patient, the flow of information and the need to act accordingly makes this devise a burden for some patients. Theoretically subcutaneous insulin pumps and glucose sensors attached to an artificial pancreas in a closed-loop system can mimic the activity of functioning pancreatic beta cells, with strict control of blood glucose levels. Such a system may also offer an opportunity to free the patients from the daily burden of dealing with their diabetes.
Study Objectives are to determine the safety and efficacy of using the MDLAP system to automatically control overnight blood glucose in type 1 diabetic patients. Overnight glucose control time defined as the time range between bedtime (21:00-23:00 PM) and awaking time (7:00 AM).
This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; 75 eligible patients will be enrolled.Each subject will participate in four consecutive over nights under closed-loop with MDLAP, and four additional over nights under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days between arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MD-Logic Artificial Pancreas (MDLAP) system | Experimental | four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system |
|
| Standard treatment with sensor augmented pump therapy | Active Comparator | four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MD-Logic Artificial Pancreas (MDLAP) system | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| time sensor glucose level spent below 70mg/dl | final visit (day 44) | |
| The percentage of nights mean overnight sensor glucose levels was within90-140 mg/dl | At final visit (day 44) |
| Measure | Description | Time Frame |
|---|---|---|
| The time sensor glucose level spent within 70-140 mg/dl | At final visit (day 44) | |
| The number and frequency of hypoglycemic events below 63, 79 mg/dl | At final visit (day 44) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, MD | Schneider Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes -Zentrum fuer kinder und jugendliche | Hanover | Germany | ||||
| Schneider Children's Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23944875 | Derived | Nimri R, Muller I, Atlas E, Miller S, Kordonouri O, Bratina N, Tsioli C, Stefanija MA, Danne T, Battelino T, Phillip M. Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis. Pediatr Diabetes. 2014 Mar;15(2):91-9. doi: 10.1111/pedi.12071. Epub 2013 Aug 15. |
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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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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| sensor augmented pump therapy | Procedure |
|
|
| The time sensor glucose level spent above 140, 180 mg/dl |
| At final visit (day 44) |
| The area under the curve <63, <70, >140, >180 mg/dl | At final visit (day 44) |
| Glucose variability | glucose variability measured as the standard deviation from the mean glucose | At final visit (day 44) |
| The total insulin dose during the overnight period | At the final visit (day 44) |
| Artificial pancreas technical performance defined as total frequency of technical failures | at final visit (day 44) |
| Artificial pancreas technical performance defined as total frequency of lost or inaccurate sensor records | At final vist (day 44) |
| Percentage of time of active closed loop control | percentage of time that the MDLAP system worked without any technical problem | At final visit (day 44) |
| Fear of Hypoglycemia questionnaire | At final visit (day 44) |
| Acceptance questionnaire | At final visit (day 44) |
| Artificial Pancreas Satisfaction Questionnaire | At final visit (day 44) |
| Petah Tikva |
| 49202 |
| Israel |
| University Children's Hospital | Slovenia | Slovenia |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |