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Closed-loop Glucose Control for Automated Management of Type 1 Diabetes

2014-08-27 03:25:32 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Type 1 Diabetes

Intervention

Closed-loop device, Open-loop continuous sub-cutaneous infusion of insulin

Location

Massachusetts General Hospital
Boston
Massachusetts
United States
02114

Status

Completed

Source

Boston University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:25:32-0400

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Head to tail array of covalently joined DNA sequences generated by concatenation. Concatenated DNA is attached end to end in contrast to CATENATED DNA which is attached loop to loop.

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