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Artificial Pancreas Controls Type 1 Diabetes Better Than Insulin Pump Alone

Diabetes word cloud

(Diabetes Care, Flickr)

4 Oct. 2018. A clinical trial shows a closed-loop algorithm-controlled artificial pancreas system helps people with type 1 diabetes better control their blood sugar levels than a glucose sensor and insulin pump system alone. These findings appear in yesterday’s issue of the journal The Lancet, and are reported in this week’s annual meeting of the European Association for the Study of Diabetes in Berlin.

A team led by University of Cambridge pediatrics researcher Roman Hovorka assessed the closed-loop artificial pancreas system against one of the system’s components acting on its own, an insulin pump with a sensor that alerts users of blood glucose levels trending too high or low. Participants in the trial were people with type 1 diabetes, an inherited autoimmune disorder where beta cells in the pancreas do not produce insulin. Type 1 diabetes is diagnosed primarily in children or young adults, where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells. From 5 to 10 percent of people diabetes have the type 1 form.

Insulin pumps are designed for people with type 1 diabetes to provide insulin when needed, and recent systems on the market include sophisticated sensors and controls to help the individual administer the right amounts of insulin into the blood stream under the skin at the right time. The artificial pancreas takes the technology one step further, adding a control technology for automatically dispensing the right dose of insulin when needed, without human intervention.

Hovorka’s research group at Cambridge designed an artificial pancreas system called Florence, starting with a smart sensor-based insulin pump. Added to the insulin pump is a control module built into an Android smartphone with software that reads the person’s glucose levels and uses an algorithm to calculate the amount of insulin needed. The software then sends instructions to the insulin pump to dispense that amount of insulin. The artificial pancreas works day and night, even when the user is sleeping.

The clinical trial, funded in part by the type 1 diabetes advocacy group JDRF, recruited people with type 1 diabetes older than age 6 in the U.K. and U.S. whose blood glucose levels were not well controlled. All of the 86 participants were fitted with a Medtronic 640G insulin pump that includes built-in sensors and glucose meter. Half of the group was also randomly assigned to receive a Florence artificial pancreas system to work with the insulin pump. Participants were tracked by phone and e-mail for the next 12 weeks, while they went about their daily lives.

The results show more participants with the artificial pancreas (65%) kept their blood sugar levels within safe target ranges than their counterparts with insulin pumps (54%). In addition, artificial pancreas recipients experienced greater reductions in blood sugar levels than insulin pump users, and reported less amount of time in conditions with blood sugar levels at potentially dangerous high or low levels. Daily insulin doses were about the same between the two groups and body weight changes were also about the same.

One serious adverse effect occurred in a participant with the artificial pancreas system, a case of diabetic ketoacidosis, attributed to a failure of the infusion mechanism. Two participants in each group also experienced hyperglycemia, or elevated blood sugar level episodes considered significant, with 13 other adverse events reported among users of the artificial pancreas and 3 events among insulin pump wearers.

Daniel Finan, research director at JDRF, says in an organization statement that, “this study demonstrates that people with diabetes who have sub-optimal control can benefit greatly from such technology.”

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