Hybrid closed-loop system lowers severe hypoglycemia, DKA rates in type 1 diabetes
Click Here to Manage Email Alerts
Key takeaways:
- Use of a hybrid closed-loop insulin delivery system leads to fewer adverse events compared with historical data.
- Quality of life improvements also were observed with hybrid closed-loop insulin.
Children and adults using a hybrid closed-loop insulin delivery system had fewer cases of severe hypoglycemia and diabetic ketoacidosis than what was previously observed in historical data, according to study findings.
In the Control-IQ Observational study, researchers obtained 1 year of real-world outpatient data from people with type 1 diabetes aged 6 years and older who were using the t:slim X2 insulin pump with Control-IQ technology (Tandem Diabetes Care). At 1 year, adults using the system had a time in range of 70.1%, and the device provided improvements in several self-reported quality of life measures.
“We conclude that use of the Tandem t:slim X2 insulin pump with Control-IQ technology is safe and effective in individuals with type 1 diabetes,” Eliah Aronoff-Spencer, MD, PhD, assistant professor of medicine at University of California, San Diego, and colleagues wrote in a study published in Diabetes Technology & Therapeutics.
Researchers enrolled children and adults aged 6 years and older diagnosed with type 1 diabetes who were prescribed the t:slim X2 insulin pump with Control-IQ technology from August 2020 to March 2022. All participants used the Dexcom G6 continuous glucose monitoring system and had to upload insulin pump data every 3 months. Demographic data were obtained through a baseline survey. Severe hypoglycemia and DKA events were collected through monthly surveys. Event rates were compared with historical data from the T1D Exchange. The Diabetes Impact and Device Satisfaction scale, the DAWN2 Impact of Diabetes Profile scale, and quality of sleep were measured at baseline, 3 months, 6 months and 12 months.
There were 3,157 people with type 1 diabetes who began the monthly surveys (median age, 29 years; 55.7% female; 69.4% adults aged 18 years and older) and 2,998 people completed the study. For severe hypoglycemia, adults using the hybrid closed-loop system had lower rates compared with historical data (9.77 vs. 29.49 events per 100 patient-years; P < .01). Children using the hybrid closed-loop system also had lower severe hypoglycemia rates than controls (9.31 vs. 19.31 events per 100-patient years; P < .01).
Adults in the hybrid closed-loop group had fewer DKA events compared with the historical rate (1.46 vs. 9.81 events per 100 patient-years; P < .01). Similarly, children using the t:slim X2 insulin pump with Control-IQ had fewer DKA events than the historical control group (1.93 vs. 12.81 per 100 patient-years; P < .01).
Median time in range with glucose between 70 mg/dL and 180 mg/dL was 70.1% for adults, 60.9% for adolescents aged 14 to 17 years and 61.2% for children aged 6 to 13 years. The researchers said time in hypoglycemia was very low in all age groups during the study.
On the Diabetes Impact and Device Satisfaction scale, median device satisfaction scores increased from 7.29 at baseline to 9.14 at 12 months (P < .01). Median diabetes impact scores decreased from 4.75 at baseline to 2.75 at 12 months (P < .01). DAWN2 Impact of Diabetes Profile scores decreased from 4.86 at baseline to 4.67 at 12 months (P < .01), indicating diabetes had a lower impact on a person’s quality of life. Sleep quality improved from a score of 3 out of 5 at baseline to 4 out of 5 at 12 months (P < .01).
“Recognizing the rapid pace of innovation and technological change in advanced hybrid-closed loop devices, future postmarket studies may need to follow the model of the Control-IQ Observational study with virtual visits to ensure timely completion and improve access to allow for broad participation,” the researchers wrote.
Collapse
Click Here to Manage Email Alerts