Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2008-11-30
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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insulin and glucose infusion
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
glucose and insulin infusions
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
Interventions
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glucose and insulin infusions
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
Eligibility Criteria
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Inclusion Criteria
* glucose at time of study \> 150 mg/dl
Exclusion Criteria
* renal or hepatic disease
* corticosteroids
* poor intravenous access
* anemia
* electrolyte abnormality
21 Years
85 Years
ALL
No
Sponsors
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Admetsys Corporation
INDUSTRY
Responsible Party
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Timothy Valk MD
Chief Scientist
Principal Investigators
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Timothy W Valk, MD
Role: PRINCIPAL_INVESTIGATOR
Admetsys Corporation
Locations
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3113 Lawton Road
Orlando, Florida, United States
Countries
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References
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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.
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.
Other Identifiers
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IBIS-1
Identifier Type: -
Identifier Source: org_study_id
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