New data shows that Insulet’s Omnipod 5 automated insulin delivery system improves glycemic control in people with type 1 diabetes under 2 years of age.

The Omnipod 5 system consists of a tube-free insulin-filled “Pod” with a Dexcom G6 continuous blood glucose monitor and an algorithm built into the Pod that connects the two devices via a smartphone app to analyze semi-automated insulin delivery. It is currently under review by the US Food and Drug Administration. The company is expected to launch the limited edition in the second half of 2021.

Results from a pivotal trial in children aged 2 to 5.9 years with type 1 diabetes were presented in the 81st Scientific Session of the American Diabetes Association (ADA). Follow-up data at 6 months were also presented in another pivotal study of 112 children aged 6–13.9 years and 129 adults aged 14–70 years. Those three-month key data were reported earlier this year at the Endocrine Society’s annual meeting and then published online June 7 in the journal Diabetes Care. Another study presented at the ADA looked at quality of life in children using the Omnipod 5 and their caregivers.

If approved by the US Food and Drug Administration, the Omnipod 5 will be the third automated insulin delivery system marketed – also known as an artificial pancreas or hybrid closed-loop system. closed-loop) – in the United States. This will be the second method approved for children under 2 years of age and the first to deliver insulin by subcutaneous injection without the need for a tube.

The “No Tubing” feature will appeal to parents with young children

When asked for comment, pediatric endocrinologist Laura M. Jacobsen, University of Florida, Gainesville, told Medscape Medical News: “I think, if it is widely distributed in the market, the big advantage of Omnipod 5 is that it is the only automatic tubeless insulin delivery system in the US.”

“Automated delivery systems are great at helping patients reach their target range of time, especially overnight. And the fact that this is happening at a young age, where it can be very difficult to get there, and so this system is amazing.”

Another difference between the Omnipod 5 and other systems is its ability to target glucose (between 110 and 150 mg/dL), although newer versions of the existing hybrid closed-loop system are also expected. will include that feature. “They are all slightly different in how the algorithms work, but I think the end result is similar,” says Jacobsen.

However, she says, the tube-free feature can be especially helpful for some very active young children. “A lot of young children use a pump and you can make it work for a lot of kids, but for some kids it’s going to get stuck. I think this really helps parents do it. Many of them don’t want to try the tube once they see the Omnipod and can feel a little more confident trying out a pump.”

Overall, Jacobsen, who does not disclose financials to Insulet, Dexcom or any of their competitors, said: “I think any addition to the technology sector improves the quality of life. Living for people with type 1 diabetes is important and people need to make choices.”

Overall data show benefit in “difficult to manage” Preschoolers

Overall 3-month data for Omnipod 5 in children aged 2-5.9 years with type 1 diabetes were presented June 26 by pediatric endocrinologist Jennifer Sherr, MD, PhD, School of Medicine Yale, New Haven, Connecticut.

“As a pediatric endocrinologist, I can attest how difficult it is to manage this age group, given the irregular diet and erratic physical activity. Often, caregivers may fear these children have hypoglycemia because these young people are unable to speak or have low self-treatment.”

A total of 80 children attended 10 institutions across the US. There was a single standard therapy period of 14 days (initial), followed by 3 months of auto-insulin during which the child’s eating and exercise were unrestricted.

At 3 months, mean HbA1c had decreased from 7.4% at baseline to 6.9%, a significant difference (P < 0.05). The rate of achieving the target HbA1c below 7% was 54% at 3 months compared with 31% at baseline. The reduction was even greater in the group of 25 people with baseline HbA1c of 8% or higher, although the reduction was significant even in the group of 55 people who started with a lower A1c (–1.06 vs. 0.31 percentage points; both P < 0.05).

Time for blood glucose to be in target range increased from 57.2% at baseline to 68.1% at 3 months (P < 0.05).

These young adults are spending an average of 2.6 more hours/day, Sherr commented, noting that the difference became apparent soon after the start of the study and was maintained over the course of 3 months.

Sherr notes that the improvement in blood glucose time within this 10.9% target range with the Omnipod 5 is similar to the improvements in the previously reported pivotal study of older children and adults. The data from that study showed that the improvement in glycemic time was within the target range from a 15.6% increase in the 6-13.9-year-old group to 8.0% in the 26-49-year-old group. Interestingly, she noted that improvements in blood sugar time to target range were seen even in the oldest group, ages 50-70, who rose from baseline. went as high as 69.9% to 79.1% with the Omnipod 5 after 3 months.

In her current study, in the youngest age group, the improvement in blood glucose time within the target range was achieved primarily by reducing the time above normal, from less than 2.4 hours/ days above 180 mg/dL, while periods below 70 mg/dL were reduced to 4 minutes/day. Blood glucose time within the target range overnight improved 1.4 hours/night, with most improvement in reducing hyperglycemia.

The rate of response to the combined goals for less than 4% of the time and over 60% of the time blood glucose is in the target range increased from 29% to 65%.

There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the 3-month study period.

Another important related indicator, parent/caregiver sleep quality, also improved. The percentage of reporting overall sleep quality as “very good” or “fairly good” increased from 65% at baseline to 90% with the Omnipod 5, while “very bad” sleep quality dropped from 8.8 % down to 0%.

All 80 patients completed the study and opted to continue the trial over a 12-month period.

Ongoing Benefits in Older Children and Adults

In a promotional poster introduced on June 25, Anders L. Carlson, MD, medical director at the International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, presented additional tracking data for Major studies reported 3 months earlier, 108 older children and 109 adults compared with the original study.

HbA1c remained lower at 6 months from baseline for both children and adults (P < 0.001). In children, HbA1c levels were not significantly different at the end of 6 months versus 3 months, while in adults the reduction was further 0.1 percentage points (P < 0.01).

There was an episode of diabetic ketoacidosis and no episodes of severe hypoglycemia for 3 months. Carlson and colleagues conclude: “The continued reduction in HbA1c demonstrates the potential long-term benefits of the Omnipod 5 System.”

Reducing depression caused by diabetes (Diabetes Distress), don’t forget the quality of your parents’ life

Meanwhile, psychologist Korey K. Hood, PhD, Stanford University, California, presented quality-of-life data at the meeting for 83 children aged 6-11.9 years and 42 adolescents 12-17.9 years old using the Omnipod 5 from the larger study population and their parents.

Significant improvements were seen for both adolescents and caregivers in the Diabetes Problem Areas scores (Problem Areas in Diabetes score), a measure of diabetic depression. Less severe changes on the Hypoglycemic Belief Scale (Hypoglycemia confidence scale), although the improvements were significant for caregivers of young children.

“We know this is a group that is really concerned about hypoglycemia in a lot of situations, not just during sleep but at school and outside of the home. So to boost their confidence to this extent, I think is a pretty important finding,” Hood commented.

There was no significant cross-group improvement trend in the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index), but overall sleep quality improved significantly in parents with young children. And in the World Health Organization 5 quality of life survey-5, caregivers of young children made significant improvements once again.

“Reducing diabetic depression and improving quality of life are key benefits of using the Omnipod 5 system,” says Hood. [phân phối insulin tự động] complement the glycemic benefits achieved”.

ADA 2021. Presented June 26, 2021. Abstracts 70-OR, 71-OR.

Source: https://www.medscape.com/viewarticle/953826#vp_1

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Translator: ToanTran