Artificial pancreas smartphone app proves safe, effective
A pilot FDA-approved clinical trial has demonstrated the safety and efficacy of the interoperable Artificial Pancreas System, a new smartphone-based application platform.
The iAPS app, which runs on an unlocked smartphone, is able to interface wirelessly with leading continuous glucose monitors, insulin pump devices and decision-making algorithms, according to researchers who presented results of the study in the journal Diabetes Technology & Therapeutics (DTT).
The system was “safe and effective in regulating glucose levels under challenging conditions and is suitable for use in unconstrained environments,” concludes the study, which notes that artificial pancreas systems “close the loop” between a continuous glucose monitor and an insulin pump with an algorithm that adjusts insulin dose to control blood glucose in patients with type 1 diabetes.
The performance of the iAPS app was evaluated in a pilot clinical feasibility study of six participants with type 1 diabetes, which was conducted in April 2018 at the Sansum Diabetes Research Institute in Santa Barbara, Calif. Harvard University’s John A. Paulson School of Engineering of Applied Sciences was responsible for the design of control algorithms and the system.
Because the app and the remote system have built-in cybersecurity controls to protect and safeguard the user and to maintain the confidentiality and integrity of information, it is able to run on an unlocked smartphone.
The authors point out the fact that because the “current diabetes technology ecosystem is heterogeneous, a major concern in an artificial pancreas system is interoperability.”
However, iAPS provides wireless integration with Dexcom G5 and G6 continuous glucose monitors, as well as two different insulin pumps—a modified Tandem t:slim insulin pump and an OmniPod insulin pump with a modified Personal Diabetes Manager.
“Interoperability is so important with artificial pancreas systems, such that patients and their providers will have a choice for ongoing care of the best CGM and algorithm that fit each patient’s needs,” said Satish Garg, MD, editor in chief of Diabetes Technology & Therapeutics and professor of medicine and pediatrics at the University of Colorado Denver-Aurora.
“The iAPS modular system with its features, such as a client app, which can run on commercial off-the-shelf smartphones, distribution of the app through a private channel on Google Play, wireless connectivity, interoperability with multiple insulin pumps and CGM, interface with algorithms and remote monitoring, makes this closed-loop platform suitable for use in clinical trials within existing regulatory frameworks throughout the world,” state the study’s authors.
Going forward, they add that “future work will focus on further refinement of the system, particularly around user acceptance and its evaluation in real-life unconstrained outpatient environments.”
In related news, the National Institutes of Health is funding the first artificial pancreas study in the U.S. for pregnant women conducted by a multi-institutional team, including the Harvard John A. Paulson School of Engineering and Applied Sciences as well as a clinical research consortium made up of specialists from the Icahn School of Medicine at Mount Sinai, the Mayo Clinic, and the Sansum Diabetes Research Institute.
The team will develop and evaluate a pregnancy-specific artificial pancreas in a sequence of in-clinic and transitional environment clinical trials. The study is currently enrolling pregnant women with type 1 diabetes and will follow their glycemic outcomes throughout pregnancy and into the post-partum period.
“This work will bring our previous advancements in artificial pancreas technology to the next level, and will be the first project of its kind in the United States,” says Eyal Dassau, principal investigator and director of the Biomedical Systems Engineering Research Group at the Harvard John A. Paulson School of Engineering and Applied Sciences.
“Women with type 1 diabetes experience significant insulin reactions as they try to manage their glucose within a narrow target range throughout pregnancy. There has been no artificial pancreas trial involving pregnant women with type 1 diabetes in the U.S.,” adds Yogish Kudva, MD, professor of endocrinology at the Mayo Clinic in Rochester, Minn. “We are excited that we will adapting automated insulin delivery to relieve the burden on pregnant women with type 1 diabetes and their families.”