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Sponsors and Collaborators: |
Boston University Massachusetts General Hospital Juvenile Diabetes Research Foundation |
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Information provided by: | Boston University |
ClinicalTrials.gov Identifier: | NCT00811317 |
We hypothesize that our integrated closed-loop glucose-control system can provide effective, tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the feasibility of closed-loop BG control.
Condition | Intervention |
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Type 1 Diabetes |
Device: Closed-loop device Device: Open-loop continuous sub-cutaneous infusion of insulin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Closed-loop Glucose Control for Automated Management of Type 1 Diabetes |
Estimated Enrollment: | 25 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Open-loop: Active Comparator
Type 1 diabetic subjects under open-loop (usual) control
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Device: Open-loop continuous sub-cutaneous infusion of insulin
Subject will regulate sub-cutaneous insulin infusion according to their usual practice and with their own insulin pump using information from self-monitoring blood glucose measurements
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Closed-loop: Experimental
Type 1 diabetic subjects under closed-loop blood glucose control
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Device: Closed-loop device
Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target
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This study investigates the utility of an integrated closed-loop glucose-control system for regulating BG in type
1 diabetic subjects. The closed-loop system utilizes sub-cutaneous infusion or insulin and glucagon under the control of a computer algorithm. The only inputs to the algorithm are the subject weight and BG values measured every five minutes. Subjects will undergo up to three 27 hour GCRC admissions during which they will consume three standardized meals. Subject may participate in up to two closed-loop visits (with different insulin lispro pharmacokinetic parameter settings in the control algorithm) and some subjects will participate in open-loop visits. During the closed-loop admission BG will be controlled by the closed-loop system. During the open-loop visit subjects will regulate their own BG in the usual function using their insulin pumps. A small group of non-diabetic subjects will undergo a single 27 hour GCRC admission during which they will eat the same standardized meals. During all admission BG will be measured every 5 minutes and blood will be collected for measurement of insulin and glucagon levels every 10 minutes. During the closed-loop admission of diabetic subjects and the single admission of non-diabetic subjects, three commercially available continuous glucose monitoring devices will be worn. The data from these devices will later be compared to reference BG data.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (type 1 diabetic subjects):
Inclusion Criteria (non-diabetic subjects):
Exclusion Criteria (all subjects):
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Study Director: | Steven J Russell, M.D., Ph.D. | Massachusetts General Hospital |
Principal Investigator: | Edward Damiano, Ph.D. | Boston University |
Responsible Party: | Boston University ( Edward Damiano ) |
Study ID Numbers: | 2007P-000101, H-27207, SPID#0813 |
Study First Received: | May 29, 2008 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00811317 History of Changes |
Health Authority: | United States: Food and Drug Administration |
diabetes glucose hyperglycemia hypoglycemia insulin glucagon counter-regulation closed-loop |
feedback control dual-infusion subcutaneous automated artificial pancreas intensive insulin therapy |
Metabolic Diseases Autoimmune Diseases Glucagon Diabetes Mellitus Endocrine System Diseases Diabetes Mellitus Type 1 Hypoglycemia Pancrelipase |
Insulin Hypoglycemic Agents Hyperglycemia Diabetes Mellitus, Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 Physiological Effects of Drugs |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |