November 9, 2017
Regarding Trina Health and Artificial Pancreas Treatment:
Diabetes is a complex disease wherein the burden of care rests squarely with the
patient and family caregivers 24/7. As a staunch advocate for the diabetes patient
community, the American Diabetes Association (ADA) is most concerned that people
with diabetes are particularly vulnerable to being persuaded to seek Artificial Pancreas
Treatment (APT), an expensive, long-term treatment protocol currently lacking sufficient
clinical evidence of effectiveness.
Trina Health uses the Bionica drug infusion pump in what it calls APT to deliver pulses
of insulin intravenously to patients for one-hour periods, three times in a day, every one
or two weeks. The Bionica pump was FDA-cleared as being substantially similar to
other drug infusion pumps already on the market when it received the clearance in
1988. This clearance is not the same as the approval that insulin pumps receive for
therapeutic treatment of diabetes. Devices approved for diabetes treatment by the FDA
deliver insulin subcutaneously, 24 hours a day with boluses of insulin corresponding to
food eaten throughout the day.
The ADA does not recognize APT or other pulsed insulin treatment (PIT) in its
Standards of Medical Care for Diabetes (Standards). The Standards are produced
annually by the ADA’s Professional Practice Committee (PPC), a multidisciplinary team
of 12 leading experts from around the world in the field of diabetes care, and approved
by the ADA’s Board of Directors. The PPC conducts a comprehensive annual review of
new research in diabetes care for potential inclusion in the annual Standards. At this
time, the PPC has not seen sufficient clinical evidence supporting the efficacy of PIT in
managing blood glucose levels in people with diabetes. The PPC relies on an evidencebased grading system that prioritizes well-controlled clinical trials for evidence that a
treatment is effective. At this time, the ADA is unaware of any randomized, controlled
clinical trials showing that PIT is effective at controlling blood glucose levels.
The ADA also relies on a report from the Centers for Medicare and Medicaid Services
(CMS) that found insufficient evidence for the effectiveness of PIT therapy in treating
diabetes, and CMS has denied coverage for the use of this therapy in treating diabetes.
The ADA’s opinion is that the information publicly available at this time is insufficient to
recommend APT for people with diabetes.