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ORLANDO – An automated closed-loop system for continuous monitoring of blood glucose and insulin administration – for example an "artificial pancreas" – improved glycemic control in the randomized trial ANGIE02 in patients Type 2 diabetics hospitalized.
The time in the target range of 100 to 180 mg / dL was 65.8% with the system versus 41.5% with conventional subcutaneous insulin therapy (P<0.001), Roman Hovorka, PhD, from the University of Cambridge, England, and his colleagues reported here at the meeting of the American Diabetes Association.
The approach did not increase the total daily dose of insulin (44.4 vs 40.2 U, P= 0.50) or hypoglycemia, with a glucose duration similar to 54 mg / dL between groups (P= 0.80), and no cases of severe hypoglycemia or clinically significant hyperglycemia with ketonemia.
"The advantage of a closed-circuit system is the instantaneous and precise modulation of insulin administration by glucose, with its continuous adaptation to changing insulin requirements during the day and between days, "writes the group in an article published simultaneously. New England Journal of Medicine.
Another benefit was the lack of involvement of staff members.
"People spend a lot of time – nurses, doctors – trying to get the right amount of blood sugar and it's really hard to do in a chaotic environment where people pass tests and are not there to prepare their meal. they have to change to IV fluids, et cetera, "commented John Buse, MD, PhD, of the University of North Carolina at Chapel Hill." It's a mess to take care of diabetes at home. # 39; hospital. "
In addition, "severe hypoglycaemia at the hospital can prevent you from receiving hospitalization, which has consequences for hospitals," he said. MedPage today.
Steven Russell, MD, PhD, of Massachussets General Hospital in Boston, whose group is working on a similar "bionic pancreas," noted that hypoglycemia seen with previous attempts to improve control has hindered progress despite widespread consensus hyperglycemia in patients with type 2 diabetes contributes to morbidity.
"Having an automated way to regulate glucose is clearly a good idea and what was needed, it was proof of principle with the current closed systems in hospitals," he said. However, "the particular system they use is not something you would market," he warned, noting that the glucose monitor used is no longer on the market.
The open trial included 136 adults with type 2 diabetes who were not seriously ill but required subcutaneous insulin therapy during treatment in the general services of two tertiary hospitals in Europe. Participants were randomized to the closed-circuit insulin administration or conventional subcutaneous insulin therapy strategy of the center for a period of up to 15 days or up to 15 days. the exit.
The closed loop system used a Freestyle Navigator II Continuous Glucose meter communicating via Bluetooth with a tablet connected to the Dana Diabecare R pump (on the market in Europe but not in the US) for fast-acting insulin delivery. . He used a predictive control algorithm but no mealtime insulin bolus nor timing or carbohydrate intake of meals. The usual care group had masked the continuous readings from the glucose monitor.
Single episodes of hypoglycemia with a capillary glucose measurement below 63 mg / dL, confirmed by place-of-care measurements, occurred in three closed-loop patients, compared to nine episodes in eight patients in the control group , oral carbohydrates to treat it. Two closed-circuit patients received additional insulin to measure sensor glucose at over 434 mg / dL for more than one hour.
Adverse events related to the interventions included skin irritation due to sensor adhesive or bruising at the cannula insertion site in three closed-group and two control groups. The closed-loop system had two sensor failures and one pump check error.
Russell also warned that, although the trial did not show a significant increase in duration hypoglycemia, the absolute amount of hypoglycemia was significantly higher and may have become significantly more important in a larger study with a wider variety of patients.
The limitations included an imbalance between the groups, with greater availability of sensor glucose measurements and longer test duration in the closed-loop group, possibly due to greater burden of coexisting diseases in this group.
The study was supported by Diabetes UK, the Swiss National Fund for Scientific Research, the European Foundation for the Study of Diabetes, JDRF, the National Center for Biomedical Research of the National Institute of Health Research and a Wellcome Strategic Award.
Abbott Diabetes Care updated the continuous glucose monitoring devices and sensors used in the test and provided details of a communication protocol to facilitate real-time connectivity to the insulin pump.
Hovorka revealed non-financial support from Abbott Diabetes Care and relations with Diabetes UK, the Biomedical Research Center of the National Institute of Health Research, a Wellcome Strategic Award, Eli Lilly, Novo Nordisk, BBraun and Medtronic.
Hovorka also disclosed patents on the security layer of the closed-loop hybrid system used in the study, a closed-circuit insulin delivery overnight with a predictive control model and a model of the same. glucose measurement error. and a closed-loop system based on a model used in the study.
Russell has disclosed relationships with many sensor and pump companies, but not those with devices used in the test.
2018-06-25T17: 45: 00-0400
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