February 02, 2021
2 min read
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Disclosure:
Wadwa reports that he has received consulting fees from Tandem Diabetes Care and that the study was supported by a research grant from Tandem Diabetes Care. In the study you will find all relevant financial information from all other authors.
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A modified version of an FDA-cleared closed-loop insulin delivery system may be effective for children 2 to 5 years of age 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 ages 6 and up. The study evaluated the device and algorithm used with the Dexcom G6 continuous glucose monitor as an artificial pancreas system.
A group of children aged 2 to 5 years spent more time in reach and less time in hyperglycemia with a modified version of the Tandem Diabetes Care t: Slim X2 insulin pump with Control-IQ technology.
“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 on the University of Colorado’s Anschutz Medical Campus, said Healio. “However, larger and longer studies are needed to provide more data on the safety and effectiveness of Control-IQ technology in young children under 6 years of age with type 1 diabetes.”
R. Paul Wadwa
Wadwa and colleagues conducted a brief pilot study of the X2 insulin pump with Control-IQ technology in children 2 to 5 years of age who had type 1 diabetes for at least 3 months, who had used an insulin pump and a Dexcom glucose monitor a daily insulin dose of at least 5 U. At the start of the study, parents or legal guardians of the participants were trained on the Tandem t: slim X2 insulin pump with Control-IQ and Dexcom G6 CGM. A study glucose meter and a blood ketone meter were also provided.
Participants began the study with a 48-hour stay in a supervised hotel with a doctor and medical staff. The parents or legal guardians were 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 had expired, the participants used the Control-IQ system at home for 72 hours under parental supervision and remote monitoring of the study staff. At the end of the study, the parents completed a questionnaire on the acceptance of the technology. The researchers also analyzed CGM trends during the study and checked blood ketone levels at the beginning and end of the monitored hotel period.
The study included 12 participants with four each from Stanford University, the University of Virginia, and the Barbara Davis Center for Diabetes. At baseline, 33% of participants achieved the primary result less than 6% of the time in the hypoglycemic range of less than 70 mg / dL and less than 40% of their time in the hyperglycemic range of more than 180 mg / dL. After using Control-IQ, 83% of participants achieved the primary result. The study population also had temporal improvements in control IQ from baseline (71.3% versus 61.7%, P = 0.016) and a significant reduction in time in hyperglycemia (34.1% versus 25.7%, P = 0.042)). The percent time at hypoglycaemia was similar for Control-IQ compared to baseline.
During the monitored hotel stay, the participants stayed in the closed loop 98.4% of the time. The number stayed high during the home portion of the study, using closed-loop control 97.5% of the time. The results of the questionnaire showed that parents responded positively to the Control-IQ system, which gave it high scores for ease of use and usefulness, while also reporting a minimal burden on its use. There were no major hypoglycemic events or diabetic ketoacidosis episodes during the study.
After the short study showed positive results, the researchers are now planning a larger study to see if the results are replicated.
“We need a larger, long-term outpatient study of Control-IQ technology in young children under 6 years of age with type 1 diabetes,” said Wadwa. “One such study was funded by the National Institute for Diabetes and Digestive and Kidney Diseases with U01, and we hope this study will begin in early 2021.”
For more informations:
R. Paul Wadwa, MDcan be reached at paulwadwa@cuanschutz.edu.
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