New data suggests that Insulet’s Omnipod 5 automated insulin delivery system under review will improve glycemic control in people with type 1 diabetes as young as 2 years of age.
The Omnipod 5 system combines a “pod” for tubeless insulin delivery with the continuous glucose monitor Dexcom G6 and an algorithm integrated into the pod that connects the two devices via a smartphone app to make insulin delivery semi-automatically. It is currently under review by the US Food and Drug Administration. The company expects to launch it in limited editions in the second half of 2021.
Results from a pivotal study of the system in children aged 2 to 5.9 years with type 1 diabetes were presented during the 81st scientific meeting of the American Diabetes Association (ADA) virtual.
Follow-up data at 6 months were also provided for another pivotal study involving 112 children aged 6-13.9 years and 129 adults aged 14-70 years. These 3-month primary data were released at the Endocrine Society’s annual meeting earlier this year and then posted online in Diabetes Care on June 7th. Another study presented at ADA looked at the quality of life of children using the Omnipod 5 and their caregivers.
If approved by the US Food and Drug Administration, the Omnipod 5 would be the third commercially available automated insulin delivery system – also known as hybrid closed-loop or artificial pancreas systems – in the USA. It would be the second approved for children 2 years and older and the first to deliver insulin subcutaneously without a tube.
“No tubing” feature will be an attraction for parents of young children
When asked for comment, pediatric endocrinologist Laura M. Jacobsen, MD, of the University of Florida, Gainesville, told Medscape Medical News, “I think the big advantage of the Omnipod 5 is that [if approved it will be] the only tubeless automated insulin delivery system in the US. “
“The automated delivery systems were just wonderful for helping patients get time within reach, especially overnight.
Another difference between the Omnipod 5 and other systems is the ability to adjust glucose targets (from 110 to 150 mg / dL), although newer versions of the currently available hybrid closed-circuit systems are likely to include this feature as well. “They all differ slightly in how the algorithms work, but I think the end result is similar,” said Jacobsen.
But, she said, the tubeless feature could be especially helpful for some very active young children. “Lots of young kids use the peristaltic pumps, and you can get it to work with lots of kids, but some kids just won’t … the hose gets tangled. I think this really helps parents make the move. Lots of they don’t want to try the tube while they see the Omnipod and maybe feel a little more confident to try a pump. “
Overall, Jacobsen, who has not provided financial information about Insulet, Dexcom or any of their competitors, said, “I think any addition to the technology space to improve the quality of life for people with type 1 diabetes is important and people have choices to make.”
Critical data shows benefits for “difficult to manage” preschoolers
Important 3-month data for the Omnipod 5 in children 2 to 5.9 years of age with type 1 diabetes was obtained on June 26th by pediatric endocrinologist Jennifer Sherr, MD, PhD, Yale School of Medicine, New Haven , Connecticut.
“As a pediatric endocrinologist, I can testify that this age group is difficult to manage due to eating habits and irregular physical activity. Often caregivers have concerns about hypoglycemia because these teens are unable to verbalize lows or treat them themselves, ”she noted.
A total of 80 children were enrolled in 10 facilities in the United States. There was a single 14-day baseline of standard therapy, followed by 3 months of automated insulin delivery, during which the children were able to eat and move freely.
After 3 months, the mean A1c had dropped from 7.4% at baseline to 6.9%, a significant difference (P <0.05). The proportions that achieved the A1c target value of less than 7% were 54% after 3 months compared to 31% at the start of the study. The reduction was even greater in the 25 who started with a baseline A1c of 8% or more, although it was significant even in the 55 who started with a lower A1c (-1.06 vs -0.31 percentage points; both P <0.05).
The time in the field increased from 57.2% at baseline to 68.1% after 3 months (P <0.05).
“These teens spend an average of 2.6 hours more per day in range,” commented Sherr, noting that the difference became apparent shortly after the study began and was sustained through the 3 months.
Sherr found that this 10.9% improvement in range with Omnipod 5 was similar to the improvements seen in the previously reported pivotal study of older children and adults. The data from this study showed an improvement over time ranging from 15.6% in the 6 to 13.9 year olds to 8.0% in the 26 to 49 year olds. Interestingly, she found, improvements in range were seen even in the oldest group aged 50-70, which increased after 3 months from an already high baseline of 69.9% to 79.1% with the Omnipod 5.
In their current study, in the youngest age group, the improvement in time in the range was mainly achieved by reducing the time above the range from 2.4 hours / day to above 180 mg / dL, while the time below 70 mg / dL by. was decreased 4 minutes / day. Night time in the area improved by 1.4 hours / night, with most of the improvements reducing hyperglycemia.
The proportion that met the combined goals of less than 4% time below range and more than 60% time within range increased from 29% to 65%.
There were no episodes of severe hypoglycaemia or diabetic ketoacidosis during the 3-month study phase.
Another key related metric, parent / carer sleep quality, also improved. The percentage of overall sleep quality “very good” or “fairly good” increased from 65% at the beginning to 90% with the Omnipod 5, while the “very poor” sleep quality decreased from 8.8% to 0%.
All 80 patients completed the study and opted for a 12-month extension phase.
Ongoing benefit in older children and adults
In a recent poster presented on June 25, Anders L. Carlson, MD, medical director at the International Diabetes Center in Park Nicollet, Minneapolis, Minnesota, presented additional follow-up data on the previously reported 3-month pivotal study , including 108 older children and 109 adults from the original study.
A1c remained lower at 6 months in both children and adults than at baseline (P <0.001). In the children, the A1c values at the end of 6 versus 3 months were not significantly different, while in the adults there was an additional decrease of 0.1 percentage points (P <0.01).
There was one episode of diabetic ketoacidosis and no major hypoglycemic episodes in the 3-month extension. “The continued reduction in A1c shows the potential long-term benefits of the Omnipod 5 system,” concluded Carlson and colleagues.
Reduced diabetes symptoms, don’t forget the quality of life of the parents
Meanwhile, psychologist Korey K. Hood, PhD, of Stanford University, California, presented quality of life data from 83 children, ages 6-11.9 and 42 adolescents, ages 12-17.9, at the meeting using the Omnipod 5 from the larger study population, and their parents.
Significant improvements were noted for both adolescents and their carers in the Score Problem Areas in Diabetes, a measure of the emotional distress associated with diabetes. The changes on the hypoglycemic confidence scale were less dramatic, although the improvements were significant for the younger child caregivers.
“We know this is a group that is really concerned about hypoglycemia in many situations, not just while sleeping, but also at school and outside the home. So I think it’s pretty important to build your confidence to that extent, ”Hood said.
In the Pittsburgh Sleep Quality Index, there was no significant improvement trend between the groups, but overall sleep quality improved significantly in the parents of the younger children. And the World Health Organization-5 survey on quality of life again found significant improvements in young child carers.
“Reduced diabetes symptoms and improved quality of life are the main benefits of using the Omnipod 5 [automated insulin delivery] Systems that are complementary to the glycemic benefits obtained, “Hood said.
Jacobsen has not reported any relevant financial relationships. Sherr has reported being a consultant, advisor, and / or fellow with Bigfoot Biomedical, Cecelia Health, Insulet, Medtronic Diabetes, Eli Lilly, Lexicon, Sanofi, and the National Institute of Diabetes and Digestive and Kidney Diseases. Hood has reported that he is a consultant for Cecelia Health, Havas and Cercacor.
ADA 2021. Presented on June 26, 2021. Abstracts 70-OR, 71-OR.
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