Novel automated insulin delivery system improves blood sugar in kids with type 1 diabetes: Study
USA: The use of a modified Control-IQ Automated insulin delivery system is safe and improved blood sugar control in children (2-5 years) with type 1 diabetes (T1D), according to results from a brief pilot study.
The findings of the study are published in the journal Diabetes Technology & Therapeutics.
Glycemic targets for young children (<6 years) with T1D have been traditionally set higher than older children and adolescents owing to the concerns of hypoglycemia. Due to this, blood sugar control becomes challenging in such children population and there is limited data on the use of closed-loop systems in this age range.
Against the above background, Laya Ekhlaspour, Stanford Diabetes Research Center, Stanford, California, USA, and colleagues aimed to evaluate the safety and efficacy of a modified version of the Tandem t:slim X2 Control-IQ system in young children with T1D, 2 to 5 years old, first under constant study team supervision and then for a brief period at home in their usual environment.
To examine that safety, they studied the use of Control-IQ system during 48 hours in an outpatient supervised hotel (SH) setting followed by 3 days of home use.
Meals and snacks were not restricted and boluses were estimated per parents' usual routine. At least 30 min of daily exercise was required during the SH phase. All participants were remotely monitored by study staff while on closed-loop in addition to monitoring by at least one parent throughout the study.
Key findings of the study include:
- Twelve participants diagnosed with T1D for at least 3 months with mean age 4.7 ± 1.0 years (range 2.0–5.8 years) and hemoglobin A1c of 7.3% ± 0.8% were enrolled at three sites.
- With use of Control-IQ, the percentage of participants meeting our prespecified goals of less than 6% time below 70 mg/dL and less than 40% time above 180 mg/dL increased from 33% to 83%.
- Control-IQ use significantly improved percent time in range (70–180 mg/dL) compared to baseline (71.3 ± 12.5 vs. 63.7 ± 15.1).
- All participants completed the study with no adverse events.
"Our findings show that, the modified investigational version of the Tandem t:slim X2 with Control-IQ System significantly improved glycemic control without an increase in hypoglycemia in toddlers and preschool-aged children with T1D," concluded the authors. "Larger clinical trials of longer duration are required to expand on experience with this system for this age group."
Reference:
The study titled, "Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers," is published in the journal Diabetes Technology & Therapeutics.
DOI: https://www.liebertpub.com/doi/10.1089/dia.2020.0507
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