Insulin pumps of the size carry a streaky wooden case in between many people with type 1 diabetes in the body. / romaset, stock.adobe.com
Charlottesville – A Hybrid Artificial Pancreas That Automatically Adjusts the Basal Insulin Dose to the Continuously Determined Blood Sugar, in a Randomized Study in the New England Journal of Medicine (201
, which continuously adjusts insulin infusion into the measured insulin level. All currently tested "Closed-Loop" systems, as well as last year in the United States and Europe, the MiniMed 670G from the manufacturer's Medtronic, "hybrid". It controls only the basal insulin infusion. After meals, insulin needed to be injected by patients themselves.
Diabetologists have long considered whether this insulin dosage should actually overload the algorithms of one's calculator. Namely, errors in dosage can end in a fatal way. An overdose threatens a hypoglycemia that could last for long periods unnoticed. Otherwise, in the event of a pump failure, it may lead to hyperglycemia with ketoacidosis.
These concerns could be largely eradicated. In clinical studies, the pumps have proven. These algorithms can be adapted to the needs of Type-1 diabetics. It provides special "safety modules" for hypoglycemia, an automated bolus donation to correct blood sugar levels or programs to intensify the nighttime basal insulin intake that await patients with normal blood sugar values in the morning. Because of the distinction between manufacturers 'and manufacturers' algorithms, the results of the clinical studies could not be transferred to other systems.
The DCLP3 study ("Clinical Acceptance of the Artificial Pancreas") is framed in the iDCL study (" International Diabetes Closed Loop ”) is yet to investigate an artificial pancreas that has been developed by researchers at the University of Virginia. The study is funded by the US National Institute of Diabetes and Digestive and Kidney Diseases, also with public funds.
In the study, seven patients enrolled 168 patients aged 14 to 71 years, For years undergoing a type-1 diabetes that was controlled with HbA1c values of 5.4 to 10.6% more or less. Most patients use ready-to-use insulin pumps and / or continuously measuring glucose sensors, so an artificial pancreas does not mean a large conversion.
the patients who themselves set the insulin dose for the basal insulin. The target of the treatment was a glucose level between 70 and 180 mg per deciliter (3.9 to 10.0 mmol / l).
Blood sugar targets were reached with artificial pancreas for a long time
As the team at Boris Kovatchev of the University of Virginia in Charlottesville reported that patients using the artificial pancreas could increase the proportion of time they find themselves in the target corridor of bloodsuckers in the 6-month study of 61 at 71%. In the control group, there was no improvement at this primary endpoint of the study. Patients remained unchanged in 59% of continuous measurements in the blood sugar target corridor.
The difference of 11 percentage points was highly significant with a 95 -% confidence interval of 9 to 14 percentage points. 11 percentage points correspond to a daily duration of 2.6 hours, of which 2.4 hours show a hyperglycemia and 13 minutes to a hypoglycemia. Also, at both secondary endpoints these differences were significant.
The HbA1c value improved with the artificial pancreas of 7.40 to 7.06%, while remaining in the control group. The difference of 0.33 percentage points (0.13 to 0.53) was equally significant.
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Up to one ketoacidosis episode by failing Insulin pumps (appearing in the artificial pancreas group) have no serious complications. According to Kovatchev, no serious hypoglycemia has occurred in any case.
The use of artificial pancreas has therefore proved to be safe (at least for a patient group that has had some experience in dealing with pump and continuous blood sugar measurement59). the artificial pancreas that protects patients better from the late complications of diabetes does not yet read for over half a year. After a recent study published in Diabetes Care (2019; 42: 400-405), a shortening of the time span in the glucose target range was 10% long-term with a 64% increased risk of progression and retinopathy. a 40% increased risk associated with the development of a microalbuminuria. © rme / aerzteblatt.de