Less than 20% of children with type 1 diabetes attain the target glycated hemoglobin level of less than 7% recommended by the American Diabetes Association — can the artificial pancreas help?
An artificial pancreas, called a closed-loop system of insulin delivery or an automated insulin delivery system, might improve outcomes and quality of life in children with type 1 diabetes. The patients’ current systems require the patients to alert the system when an insulin bolus dose was needed at mealtimes. MiniMed670G, Medtronic, a single closed-loop system, was approved in the United States for ages 6-13. Still, studies on its safety and efficacy have been limited to single-group studies and no randomization. The FDA recently approved a t:slim x2 insulin pump with Control-IQ Technology for ages 14 years of age or older based on the six-month randomized trial composed of 168 adolescents and adults with type 1 diabetes.
A randomized trial involving children with type 1 diabetes age range 6-13 was conducted to assess the closed loop system’s efficacy and safety in this specific age group. Parent or guardian consent was obtained from each patient before the multicenter, randomized, open-label, parallel-group trial was started. Patients were gathered from four pediatric diabetes centers in the United States. The trial design was particular to details such as the previously mentioned age range, a diagnosis of diabetes one year before enrollment, insulin treatment for at least six months, and bodyweight of 25-140 kg with a total daily insulin dose of ten units. A 2-4 week run-in phase was required based on whether the patient was already using an insulin pump or glucose monitor daily for up to 2 weeks.
Patients were excused from the run-in phase who were already using an insulin pump or Dexcom continuous glucose monitor. After the patients completed the run-in phase, they were randomly assigned to a 3:1 ratio closed-loop group or the control group. The t: slim X2 insulin pump with control IQ-Technology and the Dexcom G6 were the closed-loop system used. The control group patients used Dexcom G6 sensors. The patients who had been using an insulin pump before the trial continued to use their pumps. Before the test, those who received insulin injections were provided with a t:slim x2 pump with predictive low glucose suspend feature.
Trial visits at weeks 2, 8, and 16 were done with patients from both groups, while at weeks 1,4,6,10,12, and 14 patients were contacted by telephone. Some adverse events to monitor for include: severe hypoglycemia, diabetic ketoacidosis, and hyperglycemia with ketonemia. The percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter was the primary outcome.
Statistical analyses were performed on an intention-to-treat basis. All the patients were included in the primary and all secondary analyses unless otherwise noted. A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group throughout the 16-week trial. It was concluded the glucose level was in the target range for a more significant percentage of time with the use of a closed-loop system than with the help of a sensor-augmented insulin pump. The benefits were evident within the first month and more prominent overnight than during the day using the closed-loop system. The trial’s strengths were the enrollment of patients with no restriction based on the glycated hemoglobin level, prior severe hypoglycemia, diabetic ketoacidosis, and high adherence to each assigned device, a majority of 100%. Further studies will be needed to explore whether the closed-loop system’s effectiveness in the current trial would be similar in groups with lower socioeconomic status and less tech-savvy individuals.
Practice Pearls:
- An artificial pancreas is a closed-loop system of insulin delivery.
- Less than 20% of children with type 1 diabetes attain the target glycated hemoglobin level of less than 7% recommended by the American Diabetes Association.
- The glucose level was in the target range for a more significant percentage of time using a closed-loop system than with the help of a sensor-augmented insulin pump.
References for “Children with Type 1 Diabetes and the Artificial Pancreas”:
Rodolfo J. Galindo, Grazia Aleppo: Continuous glucose monitoring: The achievement of 100 years of innovation in diabetes technology. Published: October 12, 2020, https://ift.tt/3qKbsl9
N.Tubiana-Rufi et al., Practical implementation of automated closed-loop insulin delivery: A French position statement. November 2, 2020. https://ift.tt/3gmbs5X
Andrea Scaramuzza, Claudio Cavalli, Ivana Rabbone, Control-IQ technology enhanced by educative path in diabetes children Published: October 28, 2020, https://ift.tt/39R9edx
Jonnessia Winslow, PharmD Candidate, South College School of Pharmacy
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