ADA News: how close are we to the Type 1 bionic era? – by Emily Burns

Emily BurnsWe can always count on the ADA for the latest on new technology in diabetes, particularly for people with Type 1, and this year was no exception.

New results on the artificial pancreas

 The International Diabetes Closed Loop (iDCL) trial team were on hand to give us a sneak preview of results from their research testing two new technologies against each other.

First, the sensor augmented pump. This is considered a ‘hybrid’ artificial pancreas: an insulin pump worn with a continuous glucose monitor (CGM) – a sensor that sits under the skin, reads blood glucose levels in real time and provides information about their direction of travel. The pump provides low levels of background insulin to help keep blood glucose levels stable, but the wearer still adds extra insulin for meal times. It isn’t a full artificial pancreas because it doesn’t have an algorithm to ‘close the loop’ between the pump and CGM, allowing the two devices to work together.

That’s where the fully closed-loop artificial pancreas system comes in. In the case of the iDCL trial, this was a t:slim X2 pump and a Dexcom G6 CGM connected together by the Control-IQ algorithm.

This special algorithm calculates the insulin you need for meals, has a hypo safety system (where it stops delivering insulin if blood glucose levels start to drop), and manages blood glucose levels at night more closely, so that the wearer doesn’t wake up with high blood sugars in the morning.

They tested the two systems in 168 people who were 14 years or older. If they hadn’t used a CGM or pump before, they took part in a ‘run-in’ phase, wearing the technology for at least 200 hours before the trial could start. 112 people wore the artificial pancreas and 56 wore the sensor-augmented pump for six months, and everyone made it to the end of the trial.

The largest benefits were seen for those wearing the artificial pancreas: average HbA1c dropped from 7.4% to 7%, they spent roughly 2.5 hours more with blood sugars in a safe range, and there was a 10% reduction in high blood glucose levels (or hypers) – all without increasing any hypos.

This research isn’t yet published, but there’s more on the news here

All about the kids

Children with Type 1 are a group who could really benefit from technology like the artificial pancreas or CGM, but artificial pancreas trials in children are particularly challenging. Children need smaller amounts of insulin, have less space on their body to wear a device, the special algorithms often need to be adapted, and there’s the crucial safety issue.

The Freelife Kid AP study was testing the same closed-loop system described above in young children aged 6-12 years.

The Freelife team wanted to see if 18 weeks of home use could reduce hypos and hypers, increase the amount of time spent with blood sugars within a safe range, reduce blood glucose variability and improve quality of life. They were comparing results from children wearing the device 24 hours a day to children only wearing it at night.

The full trial will involve 120 children, but we were shown some early results involving the first 30. It looks like the full-time tech led to larger improvements: children wearing the device 24 hours a day saw their time spent with blood sugars in a safe range increase from 60% to 72% of each day. And their time spent in hyper dropped, whilst their time spent in hypo stayed the same.

We’re looking forward to seeing the full results…

Another trial to keep an eye on is SENCE (Strategies to Enhance New CGM use in Early Childhood), testing the effects of CGM in children and looking at whether CGM training as a family could improve the benefits.

143 very young (aged 2-7 years) children are involved, divided into three groups: standard blood glucose monitor, CGM or CGM plus family training.

At the end, they didn’t see any improvements in time spent with blood sugars in a safe range across the three groups, which was surprising. But children using CGM spent less time with hypers or hypos, and children using CGM plus family training reported feeling less worried about their diabetes and were more satisfied with the tech.

This research isn’t yet published, but you can read the press release here.

 Getting the most out of CGM

With a large number of children and adults with Type 1 in the US already using CGM, an international group of scientists, healthcare professionals and people with diabetes have come together to recommend new ‘Time-in-Range’ goals for people using CGM – as an alternative to HbA1c measurements.

The group hope that clear, easy-to-understand targets for Time-in-Range will help to improve the health of people with diabetes, emphasising that it’s important that both healthcare professionals and people with diabetes understand and use the guidelines.

While the group highlighted that individual goals should be personalised, they advised on people with Type 1 and Type 2 diabetes spending 70% of their time within a target range of 70-180 mg/dL (or 3.9-10 mmol/L). And a different target range of 63-140 mg/dL (or 3.5-7.8 mmol/L) during pregnancy.

Figure from the new consensus paper

The new recommendations on Time-in-Range were published in Diabetes Care.

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