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Feasibility and Safety of Hybrid Closed-Loop Insulin Delivery in Young Children

Jul 23, 2019
 
Editor: Steve Freed, R.PH., CDE

Author: Onyi Ibeji, PharmD. Candidate, LECOM School of Pharmacy

Can young children benefit from a hybrid closed-loop insulin delivery system?

A hybrid closed-loop insulin delivery system is a system that can be set to automatically maintain blood glucose levels by adjusting basal insulin delivery every five minutes. Insulin delivery has constantly evolved in the quest to make it easier, to make it less painful, and to have better results and control for patients with diabetes. In general, insulin delivery is challenging, and it is even more difficult for families with young children in need of insulin. A previous study indicated that the use of a hybrid closed-loop system can improve HbA1c in adolescents. This study tried to find out if the use of a hybrid closed-loop insulin delivery system both during the day and at night would be beneficial and safe in young children with type 1 diabetes. Establishing its feasibility and safety may further help reduce the stress on the children and their families, and enable better glycemic control.

This study was an open label, multicenter, multinational, randomized trial study which included children who have lived with type 1 diabetes for at least 6 months and who were already on insulin pump therapy for at least three months. It excluded those whose total daily insulin dose is greater than or equal to 2.0 units/kg/day. It compared hybrid closed-loop glucose control using diluted insulin (U20) vs standard insulin strength (U100) in free living settings for 3 weeks. The participants’ age range was children between 1 – 7 years old, who were then enrolled into two randomized intervention periods. Each participant received either the diluted insulin aspart first, followed by a standard insulin aspart via hybrid closed-loop insulin delivery system; or each participant received insulin in reverse order, but each person received both standard and diluted insulin separated by 1 to 4 weeks washout period between each. The primary end point was evaluated by continuous glucose monitoring bearing in mind a target range between 3.9 and 10.0 mmol/L during the intervention periods. Secondary end points assessed mean sensor glucose concentrations, glucose variability, time spent at various glucose levels and total insulin delivery. The statistical analysis data was collected using the intention to-treat principle. A linear mixed model; rank normal transformation analyses; gstat software; and SAS software were used to analyze the data collected and calculate outcomes.

Out of the 24 randomized participants recruited, one person withdrew from the study due to technical issues with the delivery system and 23 participants finished the trial study. The results were calculated based on the primary and secondary endpoint criteria. There were no differences found between the diluted vs standard insulin interventions in the following areas: the proportion of time sensor glucose (P = 0.16), the mean glucose levels (p = 0.14) or glucose variability, relative burden of hypoglycemia (p = 0.71), total daily insulin delivery (p = 0.76) and basal-to-bolus insulin ratios (p = 0.10). A statistically significant reduction of bolus insulin delivery was observed with diluted insulin (p = 0.006).

Another retrospective observational study compared the coefficient of variation of insulin delivery for young children and adults at nighttime and found a 10.7% points higher variation in young children (95% CI 2.9 -18.4, P = 0.003). Similar variation was observed during daytime insulin delivery (95% CI 2 -10.9, P = 0.02).

The study found that it is safe and practically possible to use hybrid closed-loop insulin delivery system in very young children with type 1 diabetes. This delivery system can be used in free living settings during the day and night. Comparing diluted insulin vs standard strength insulin during closed loop insulin delivery, the study found that the diluted insulin does not have any extra benefit.

The retrospective observational study acknowledged that the management of diabetes is complicated especially in young children due to increased variability of insulin needs in this population. Therefore, this study also supports the use of closed-loop insulin delivery in young children.

Practice Pearls:

  • The use of a hybrid insulin delivery system would be beneficial and help families with young children manage their type 1 diabetes.
  • Diluted insulin has no additional benefits when used in hybrid closed-loop insulin delivery.
  • Higher variability of insulin requirement in young children supports the use of hybrid closed-loop insulin delivery.

 

References

Tauschmann, Allen, et al. “Home use of day-and-night hybrid closed-loop insulin delivery in very young children: A multicenter, 3-week, randomized trial.” Diabetes Care 2019; 42:594–600 https://doi.org/10.2337/dc18-1881 

Dovc, Boughton, et al. “Young children have higher variability of insulin requirements: Observations during hybrid closed-loop insulin delivery.” Diabetes Care 2019; 42:1344–1347 https://doi.org/10.2337/dc18-2625

 

Onyi Ibeji, PharmD. Candidate, LECOM School of Pharmacy