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The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery
The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin and glucose infusion | Experimental | trial of experimental technique in outpatient setting; the group under study will be comprised of type 1 and type 2 diabetic individuals ; they will have automated treatment using algorithm which regulates balancing infusions of glucose and/or insulin intravenously without manual intervention; blood glucose target of 80-180 mg/dl will be guide for the automated system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucose and insulin infusions | Device | combined algorithm directed glucose and insulin infusion with 5 minute blood glucose measurements to direct glucose control; regular insulin and glucose are infused intravenously as adjusted by the algorithm without manual intervention in the group of diabetic individuals under study to adjust the glucose level to a target range of 80-180 mg/dl |
| Measure | Description | Time Frame |
|---|---|---|
| glucose control in target range | blood glucose measurements in target range (80-125 mg/dl) | data will be evaluated within 6 months after completion of all 40 studies |
| Measure | Description | Time Frame |
|---|---|---|
| hypoglycemia | blood glucose <70 mg/dl | data will be evaluated within 6 months after all 40 studies are completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy W Valk, MD | Admetsys Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3113 Lawton Road | Orlando | Florida | 32803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30678470 | Result | Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Preliminary Study. J Diabetes Sci Technol. 2019 Sep;13(5):935-940. doi: 10.1177/1932296818821349. Epub 2019 Jan 24. | |
| 30854885 | Result | Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Advancing the Development. J Diabetes Sci Technol. 2019 Sep;13(5):941-948. doi: 10.1177/1932296819832876. Epub 2019 Mar 10. |
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with publication the data will be shared
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Insulin and glucose infusion in closed loop control; intervention is glucose control with insulin and glucose infusion
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