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NEJM: Better sugar control, bionic pancreas is expected to be an effective treatment for type 1 diabetes

 Last Update: 2022-11-01
 Source: Internet
 Author: User

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Type 1 diabetes is a metabolic disorder syndrome characterized by hyperglycemia
caused by absolute insufficiency of insulin.
The routine operation of currently available semi-automated insulin delivery systems is still not convenient and requires individualized insulin regimens and reference to carbohydrate doses
in the patient's diet.
In contrast, the Bionic Pancreas device is simpler and more efficient, requiring only initial dose settings based on body weight, and its algorithm can automatically adjust the insulin dose
according to the user's needs over time.

Recently, the New England Journal of Medicine (NEJM) published the results of a multicenter randomized trial evaluating the effectiveness and safety
of bionic pancreatic devices (insulin infusion only, no glucagon) in adults with type 1 diabetes and children 6 years of age and older.
Clinical trials have shown that patients using the bionic pancreas have a greater decline in glycosylated hemoglobin (HbA_1c) levels and longer
time to reach blood glucose levels than standard care.

"Bionic pancreatic technology is able to manage blood sugar
better in patients of all ages than currently available insulin delivery devices.
This is a quantum leap forward in artificial pancreas technology, reducing the investment
of medical staff and patients in blood sugar management.
One of the principal investigators, Dr.
Nelly Mauras, a pediatric endocrinologist and diabetologist from Mayo Clinic, one of the world's leading medical institutions, said
.

Screenshot source: The New England Journal of Medicine

The trial was conducted in 16 centers in the United States, and the subjects were patients aged 6~79 years old who had taken insulin for at least 1 year
.
326 patients were randomized in a 2:1 ratio to receive bionic pancreatic treatment with insulin aspartate or insulin lipro infusion (219 patients) or standard care (107 patients) for 13 weeks
.

The primary outcome of this trial was glycosylated haemoglobin level at 13 weeks, which is an important measure
of long-term glycaemic control.
Key secondary outcomes were the percentage of
time when blood glucose levels were below 54 mg/dL as assessed by continuous glucose monitoring.

The results showed that glycated hemoglobin levels decreased from 7.
9% to 7.
3% in patients using the bionic pancreas, while glycosylated hemoglobin levels did not improve in patients in the standard of care control group (7.
7% before and after the trial).

There was no significant difference
between the two groups in the percentage of time patients spent continuously monitoring blood glucose below 54 mg/dL.

▲ HbA 1c level comparison at week₁₃ (Image source: Reference [1])

In addition, compared with the control group, the percentage of time when the blood glucose level remained within the target range (70 mg/dL ~ 180 mg/dL) in the bionic pancreas group was 11% higher, which was equivalent to an increase of 2.
6 hours in the daily blood glucose compliance time of the bionic pancreas group.

The results were similar in adolescent and adult participants, with the bionic pancreas having the most pronounced
improvement in blood sugar control among participants with higher blood sugar levels at the start of the study.
▲ Comparison of primary and secondary efficacy outcomes at week 13 (Image source: Reference [1])
In terms of safety, the incidence of severe hypoglycemia was 17.
7 times/100 participant-years in the bionic pancreas group and 10.
8 times/100 participant-years
in the standard care group.
No diabetic ketoacidosis
occurred in either group.

Overall, in this 13-week randomized trial covering adults and children with type 1 diabetes, the use of bionic pancreas reduced glycosylated hemoglobin levels
more dramatically than standard treatment.
In addition, the use of bionic pancreas in the treatment of type 1 diabetes has shown good tolerability and safety
.

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