Artificial pancreas may be safe for young children with type 1 diabetes
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A modified version of an FDA-approved close-loop insulin delivery system may be effective for children aged 2 to 5 years with type 1 diabetes, according to study data published in Diabetes Technology & Therapeutics.
In June, the FDA approved the use of the Tandem Diabetes Care t:slim X2 insulin pump with Control-IQ technology for children aged 6 years and older. The study assessed the device and algorithm used with the Dexcom G6 continuous glucose monitor as an artificial pancreas system.
“A modified version of Control-IQ technology appears to be safe in young children aged 2 to 5 years with type 1 diabetes,” R. Paul Wadwa, MD, professor of pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, told Healio. “But larger and longer studies are needed to provide more data on safety and efficacy of Control-IQ technology in young children under 6 years of age with type 1 diabetes.”
Wadwa and colleagues conducted a brief pilot study on the X2 insulin pump with Control-IQ technology in children aged 2 to 5 years who had type 1 diabetes for at least 3 months, were users of an insulin pump and a Dexcom continuous glucose monitor, and had a daily insulin dose of at least 5 U. Parents or guardians of the participants were trained on the Tandem t:slim X2 insulin pump with Control-IQ and the Dexcom G6 CGM at the start of the study. A study glucose meter and blood ketone meter were also provided.
Participants began the study with a 48-hour stay at a supervised hotel staffed with a physician and medical personnel. The parent or guardian was responsible for using the system during the stay. There were no dietary restrictions, and planned group activities, including daily exercise, took place. After the 48-hour period concluded, participants used the Control-IQ system at home for 72 hours under parental supervision and remote study staff monitoring. Parents completed a technology acceptance questionnaire at the end of the study. Researchers also analyzed CGM trends during the study and checked blood ketone levels at the beginning and end of the supervised hotel period.
The study included 12 participants, with four each at Stanford University, University of Virginia and the Barbara Davis Center for Diabetes. At baseline, 33% of participants achieved the primary outcome of less than 6% of time in hypoglycemic range of less than 70 mg/dL and less than 40% of their time in the hyperglycemic range of greater than 180 mg/dL. After using Control-IQ, 83% of participants achieved the primary outcome. The study population also had improvements in time in range on Control-IQ vs. baseline (71.3% vs. 61.7%, P = .016) and a significant reduction in time in hyperglycemia (34.1% vs. 25.7%, P = .042). The percent time in hypoglycemia was similar on Control-IQ compared with baseline.
During the supervised hotel stay, participants remained in closed loop 98.4% of the time. The number remained high during the at-home portion of the study, with closed loop used 97.5% of the time. Results from the questionnaire showed parents had a favorable response to the Control-IQ system, giving it high scores for ease of use and usefulness, while also reporting a minimal burden with its use. There were no severe hypoglycemia events or diabetic ketoacidosis episodes during the study.
After the brief study showed favorable findings, researchers are now planning for a larger study to see whether the findings are replicated.
“We need a larger outpatient study of Control-IQ technology in young children under 6 years of age with type 1 diabetes carried out over a longer period of time,” Wadwa said. “Such a study has received U01 funding from the National Institute of Diabetes and Digestive and Kidney Diseases, and we hope that this study will begin in early 2021.”
For more information:
R. Paul Wadwa, MD, can be reached at paulwadwa@cuanschutz.edu.
Perspective
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Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
Hybrid-closed loop insulin pump technology is growing quickly with three FDA-approved options in the U.S. These include the Tandem Control IQ, Medtronic 670G and Medtronic 770G. Omnipod 5 is also expected later in 2021. Control IQ was originally approved for ages 14 years and older and then gained FDA approval for ages 6 years and over after a clinical trial showed positive results in 6- to 13-year-olds. One of the barriers to using Control IQ in younger kids is the minimum daily insulin requirement of 10 units as well as a minimum weight of 55 pounds. The Medtronic 670G is approved for ages 7 years and up. The Medtronic 770G, which became available late 2020, is approved for ages 2 years and up. Both the 670G and 770G require a minimum of eight units of insulin per day but have no minimum weight requirement.
In this study by Wadwa and colleagues, a modified version of Control IQ was used in children aged 2 to 5 years old. The algorithm required a minimum of five units of insulin per day.
There were some impressive results: Time in range and time above range were significantly improved. Since Control IQ works with Dexcom G6, there are no required calibrations. Although this was a small study of 12 participants who wore the pump for only 5 days, this sets the stage for an upcoming larger clinical trial in this age group. It is great to see the hybrid closed-loop technology advance, which is making it easier for people with diabetes to manage their glucose levels. It is especially important for younger children, who are at greater risk for hypoglycemia and can be particularly challenging for their parents and caregivers.
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