Semi artificial pancreas (AP) from Medtronic was FDA approved in 2016. The quest for full automated insulin pump continues. Current study evaluated the adaptive artificial pancreas technology in 30 adults with type 1 diabetes over a 12 week period.
By the end of the study, adaptive AP lowered A1c down to 6.7% from 7.0%. Day-time and night-time hypoglycemia also improved significantly. Software adaptations were manually overwritten 10% of the time.
Overall these are great advances toward user-independent artificial-intelligence pancreas. There will be more to come on the subject.
Bihormonal bionic artificial pancreas
Artificial pancreas (AP) systems are best positioned for optimal treatment of type 1 diabetes (T1D) and are currently being tested in outpatient clinical trials. Our consortium developed and tested a novel adaptive AP in an outpatient, single-arm, uncontrolled multicenter clinical trial lasting 12 weeks.
Thirty adults with type 1 diabetes completed a continuous glucose monitor (CGM)–augmented 1-week sensor-augmented pump (SAP) period. After the AP was started, basal insulin delivery settings used by the AP for initialization were adapted weekly, and carbohydrate ratios were adapted every 4 weeks by an ALGORITHM running on a CLOUD-BASED server, with automatic data upload from devices. Adaptations were reviewed by expert study clinicians and patients.
The primary end point was change in A1c. Outcomes are reported adhering to consensus recommendations on reporting of AP trials.
Twenty-nine patients completed the trial. HbA1c, 7.0% at the start of AP use, improved to 6.7% after 12 weeks (−0.3%, p < 0.001).
Compared with the SAP run in, CGM time spent in the hypoglycemic range improved during the day from 5.0 to 1.9% (−3.1%, p < 0.001) and overnight from 4.1 to 1.1% (−3.1%, p < 0.001).
Whereas carbohydrate ratios were adapted to a larger extent initially with minimal changes thereafter, basal insulin was adapted throughout. Approximately 10% of adaptation recommendations were manually overridden.
There were no protocol-related serious adverse events.
Use of our novel adaptive AP yielded significant reductions in HbA1c and hypoglycemia.