Key takeaways:
- Youngsters aged 5 years and youthful utilizing automated insulin supply had an identical drop in HbA1c as kids aged 6 to 10 years.
- Imply time under vary with glucose lower than 54 mg/dL was lower than 1%.
CHICAGO — Youngsters aged 5 years and youthful with kind 1 diabetes have comparable reductions in HbA1c at 6 months with use of an automatic insulin supply system as kids aged 6 to 10 years, researchers reported.
Healio beforehand reported that the FDA in June 2020 granted an expanded indication for the t:slim X2 insulin pump with Management-IQ expertise (Tandem Diabetes Care) for use in kids aged 6 to 14 years with kind 1 diabetes. The system has not been authorised by the FDA or the European Medicines Company to be used amongst kids aged 5 years and youthful. Nonetheless, Valentino Cherubini, MD, chief of the division of pediatric diabetes within the division of ladies’s and youngsters’s well being at Azienda Ospedaliero Universitaria delle Marche in Italy, mentioned there’s curiosity among the many dad and mom of younger kids with kind 1 diabetes to make use of the expertise.
Youngsters aged 5 years and youthful expertise comparable advantages with automated insulin supply use as kids aged 6 to 10 years. Picture: Adobe Inventory
“Regardless of the Management-IQ being off-label for kids underneath 6 years of age, many dad and mom are requesting its use on this age group,” Cherubini mentioned throughout a presentation on the American Diabetes Affiliation Scientific Periods. “A number of pediatric facilities in Italy have began utilizing this expertise in kids underneath 6 years after acquiring signed knowledgeable consent from the dad and mom.”
Researchers enrolled 253 kids aged 10 years or youthful with kind 1 diabetes for at the very least 6 months who beforehand used steady glucose monitoring for no less than 30 days. All individuals obtained the Tandem t:slim X2 insulin pump with Management-IQ automated insulin supply system. HbA1c and CGM measures have been collected each 6 months from baseline to 18 months. Researchers in contrast outcomes amongst kids aged 5 years and youthful with these aged 6 to 10 years. Major outcomes included time in vary with glucose of 70 mg/dL to 180 mg/dL, time in tight vary with glucose of 70 mg/dL to 140 mg/dL and HbA1c.
At baseline, kids aged 5 years and youthful had the next imply HbA1c than these aged 6 to 10 years (P = .02). No vital distinction was noticed in time in vary and time in tight vary at baseline.
From baseline to six months, each teams mixed had a 4.98 proportion level enhance in time in vary, a 5.01 proportion level enhance in time in tight vary and a 1.31 proportion level decline in HbA1c. Youngsters aged 6 to 10 years had a considerably larger enhance in each time in vary and time in tight vary in contrast with kids aged 5 years and youthful. HbA1c change was comparable in each teams from baseline to six months.
Cherubini added {that a} considerably larger enhance in time in vary and time in tight vary, and a considerably bigger lower in HbA1c, have been noticed with shorter time between kind 1 diabetes analysis and automatic insulin supply initiation.
There was one case of diabetic ketoacidosis between 12 and 18 months within the research, occurring in a participant within the aged 5 years and youthful group. One extreme hypoglycemia occasion in a baby aged 6 to 10 years occurred between 12 and 18 months. Imply time under vary with a glucose of lower than 54 mg/dL was lower than 1% in each age teams after 18 months, Cherubini mentioned.
“Management-IQ expertise demonstrated comparable advantages for kids aged underneath 6 [years] in comparison with these aged 6 to 10 [years],” Cherubini mentioned. “Given the challenges related to glycemic management in youthful kids, it’s essential to undertake superior expertise techniques to boost outcomes at a youthful age.”
Sources/Disclosures
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Cherubini V, et al. Summary 131-OR. Offered at: American Diabetes Affiliation Scientific Periods; June 20-23, 2025; Chicago.
Disclosures:
Cherubini reviews advising for Sanofi; serving as a board member for Merck and Sanofi; consulting for Movi, Novo Nordisk and Sanofi; and receiving analysis help from AstraZeneca, Eli Lilly and Medtronic.
