Closed-loop insulin delivery improves metrics for young children with type 1 diabetes
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Young children with type 1 diabetes who used an advanced hybrid closed-loop insulin delivery system had a reduction in HbA1c and improvement in time in range from baseline to 12 weeks, according to study data.
In a single-arm clinical trial, children aged 2 to 6 years with type 1 diabetes in Finland used the MiniMed 780G (Medtronic) advanced hybrid closed-loop system for 12 weeks. The cohort had improvements in multiple glycemic control measures at 12 weeks with no reports of diabetic ketoacidosis or serious hypoglycemia.
“Hybrid closed-loop systems seem to help young children with type 1 diabetes to reach better glycemic control and ease the burden of diabetes from families,” Anna-Kaisa Tuomaala, MD, PhD, a pediatric endocrinologist at the Children’s Hospital, Pediatric Research Center at Helsinki University Hospital and the University of Helsinki, told Healio. “We should work for approval of hybrid closed-loop systems for young children.”
Tuomaala and colleagues enrolled 35 children with type 1 diabetes for at least 6 months who received at least 8 U insulin daily, had a baseline HbA1c of less than 10% and were capable of using an insulin pump and continuous glucose monitor (51% boys; mean age, 4.3 years). All participants used the MiniMed 780G hybrid closed-loop system for 12 weeks. CGM measures and insulin doses were downloaded. Clinicians and diabetes nurses frequently contacted caregivers to obtain safety data. HbA1c, height and weight were measured during the run-in phase and at 12 weeks. The Problem Areas in Diabetes Revised for Parents (PAID-PR) survey was administered at baseline and 12 weeks to obtain diabetes distress from caregivers. Outcomes were reported using standardized mean difference values.
The findings were published in Diabetes Technology & Therapeutics.
At 12 weeks, the cohort had improvements in most glycemic parameters. Children had reductions in HbA1c (standardized mean difference [SMD] = –0.46), mean sensor glucose values (SMD = –0.77) and time above range (SMD = –0.9) and an increase in time in range (SMD = 0.89) from baseline to 12 weeks. Mean sensor glucose standard deviation (standardized mean difference = –0.7; P = .0002) and glycemia risk index values (SMD = 0.93; P < .00001) also decreased from baseline to 12 weeks Mean sensor glucose coefficient of variation and time below range did not differ from baseline to 12 weeks. No DKA or serious hypoglycemia events were reported.
Researchers compared data from 12 children with a lower glucose target of 5.5 mmol/L to 6.1 mmol/L with less than 2.5 hours of active insulin time to 23 children with a glucose target of 6.7 mmol/L or more than 2.5 hours of active insulin time. The group with the lower target level had a lower time below range compared with the higher target level group (2.2% vs. 3.8%; P = .03). No other differences between the two groups were observed.
Parental diabetes distress score decreased from baseline to 12 weeks (SMD = 0.52; P = .006). Parental diabetes distress was not correlated with glycemic markers at either time period.
“The automated hybrid closed-loop system MiniMed 780G improved glycemic control safely in a 12-week study period in toddlers and preschoolers, simultaneously diminishing parental diabetes distress and offering hope for the treatment of type 1 diabetes in this vulnerable population,” the researchers concluded.
For more information:
Anna-Kaisa Tuomaala, MD, PhD, can be reached at anna-kaisa.tuomaala@hus.fi.
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