Four NIH-backed artificial pancreas pivotal trials are slated to begin soon

February 13, 2017 – 8:00 AM | By Andrea Gonzalez | No comments yet

By Stacy Lawrence, Staff Writer

Intensive efforts to improve artificial pancreas technology continue apace even as Medtronic plc prepares to launch the first FDA-approved iteration by this summer. The National Institutes of Health (NIH) is highlighting four pivotal trials that it’s funding, which are slated to start over the next few years.

Two of the trials involve Medtronic: one for a next-generation iteration from the Dublin, Ireland-based company and the other using existing Medtronic insulin pump/continuous glucose monitor (CGM) equipment in combination with a novel algorithm.

Another of the NIH-backed pivotal artificial pancreas trials relies upon an assemblage of software and equipment from various companies including Dexcom Inc., Typezero Technologies LLC, Tandem Diabetes Care Inc. and Roche Diagnostic Ltd., while the final one, a dual-hormone device, comes from public benefit corporation Beta Bionics out of research at Boston University and the Massachusetts General Hospital.

The pivotal trials aim to push into territories not yet addressed including automatic insulin boluses, nighttime use as well as adolescent and young adult use. These efforts aren’t alone. Last fall, Bigfoot Biomedical Inc. raised $35.5 million series A funds to back its first clinical trial for an artificial pancreas device; the Milpitas, Calif.-based company is developing its Smartloop .

MEDTRONIC’S SLOW LAUNCH

Medtronic has pushed back a previously stated spring launch to a slightly softer spring/summer time frame for its Minimed 670G, which last year became the first FDA-approved hybrid closed loop system. That launch will follow an initial customer training phase in the spring.

“Since the earlier-than-expected approval of the system, we’ve been working diligently to ensure payer coverage, market and manufacturing readiness and appropriate training of employees, clinicians and diabetes educators on the new system,” Alejandro Galindo, president of intensive insulin management in the Medtronic Diabetes Group, told Medical Device Daily.

He continued, “Overall, the reception by payers has been positive towards our system with many major payers confirming coverage under existing policies … The feedback from clinicians and patients who participated in the clinical trial has been very positive, so we anticipate the system will be well-received.”

There are limitations with the 670G, which the NIH highlighted. The first hybrid Medtronic system offers automated insulin pump adjustments based on CGM readings, but it requires user insulin adjustment at mealtimes. The agency noted that, “A fully automated system will sense rising glucose levels, including at mealtimes, and adjust insulin automatically.”

The FDA approval came sooner than expected last September, which Medtronic has said resulted in the long lag-time between approval and launch. It expects weaker sales until the launch of the 670G as customers await it, despite the fact that Medtronic is offering a priority upgrade program to the new device.

BOLUS, NIGHTTIME AND BIHORMONAL TESTING

Up next, Medtronic is focused on making automated insulin boluses, at meals and other times, a reality.

“We are committed to developing a fully automated, closed loop system with a phased approach. Our next challenge will be to advance our algorithm in a way that will enable automated correction boluses. Once this challenge is addressed, we will focus our efforts on automating meal-time boluses. The timing for development will be dependent upon on multiple variables,” Galindo said.

That’s precisely the focus of one of the pivotal trials being backed by the NIH. It will compare results in more than 100 adolescents and young adults with type 1 diabetes, aged 14 to 30; the subjects will use both the approved 670G and a next-gen 690G back-to-back for 12 weeks each in a crossover study design after an initial two week assessment.

The 690G incorporates a software upgrade that’s intended “to further improve glucose control, particularly around mealtime,” the researchers said in a study description posted late last month on the trial. The new software is known as Fuzzy Logic, or Md-Logic, which it gained access to through a 2015 partnership with Dreamed Diabetes. At that time, Medtronic also made a $2 million investment in the Israeli start-up, which provides it with the software necessary to create a fully automated artificial pancreas.

This trial is expected to start this December and to have complete primary endpoint data in December 2019. The primary endpoint will be based on a comparison of the percent of time that CGM readings are above 180mg/dL from 7 a.m. to 11 p.m. Nighttime monitoring and adjustments present a separate challenge.

Another Medtronic-related artificial pancreas pivotal trial backed by the NIH is of a system known as Florencem; it is based on a version of the marketed 640G insulin pump that has been augmented with a next-generation sensor. Rather than rely upon a dedicated receiver, like the 670G, the insulin pump and Medtronic Enlite 3 CGM communicate wirelessly with an Android smartphone running the Cambridge model predictive algorithm, which is from the U.K.-based University of Cambridge.

That 150-person, 12-month trial is specifically in children aged 6 to 18; it already started last month and is slated to have final data by June 2018. The primary measure of the trial will compare glycated haemoglobin (HbA1c) at 12 months, with measures along the way consisting of a starting baseline and again at three, six and nine months. The randomized trial will include a control group of patients who are using an insulin pump only. And, unlike the other trial, will include nighttime and daytime data.

Another pivotal trial is already ongoing for smartphone-connected automated insulin delivery system Incontrol. The system incorporates software and parts from various diabetes players including Typezero and Dexcom. The 240-patient trial will be in type 1 diabetes patients age 14 and older over a six month period in the U.S. and Europe; a related six-month study of 180 patients will be in the U.S. only, and test an alternative algorithm with the system.

Finally, there’s the bionic pancreas trial from public benefit company Beta Bionics. It’s not slated to start until mid-2018. The 480-patient trial in type 1 diabetes patients aged 8 and older and will follow them for six months.

It’s an ambitious effort to test a bihormonal system that automatically delivers both insulin and its counteracting hormone glucagon. Dual-hormone automated delivery could offer the most sophisticated approach to keeping blood glucose levels more stable over longer periods of time, thereby potentially reducing the incidence of common and debilitating diabetic complications.

 

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