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A meta-analysis of trials examining use of the t:slim X2 insulin pump with Control-IQ technology, results of the study indicate use of the hybrid closed loop technology was associated with improvements in glycemic control, regardless of patient age, race, or previous CGM use.
A new study suggests leveraging Control-IQ technology through use of the t:slim X2 insulin pump could improve time in target glucose range among people with type 1 diabetes by nearly 3 hours per day.
A meta-analysis of 3 randomized clinical trials examining use of the insulin pump in conjunction with the Dexcom G6 continuous glucose monitoring (CGM) system, results of the study indicate use of Control-IQ advanced hybrid closed-loop technology was associated with statistically significant in mean glucose, hyperglycemia metrics, hypoglycemic metrics, and HbA1c in addition to the aforementioned time in range improvements.1
“Control-IQ technology delivered the most robust improvements in those entering the study with the highest hemoglobin A1c and lowest time in range,” said Roy W. Beck, MD, PhD, executive director of the Jaeb Center for Health Research.2 “The high number of automatic boluses given by the system in this group likely reflect previously missed meal boluses or lack of manual correction boluses when on conventional therapy and demonstrates the substantial impact Control-IQ technology’s auto-bolusing feature can have for people struggling on a standard pump or multiple daily injections.”
Few fields have been able to witness the sheer level of advancement observed within diabetes technology in the last several decades. Once likened to science fiction by some, the diabetes community has since embraced the technology and been the recipient of its benefits. Among the titans of the space is Tandem Diabetes Care with their t:slim X2 insulin pump with Control-IQ technology.
Approved by the US Food and Drug Administration in 2018, the advanced hybrid closed loop system is used with the Dexcom G6 CGM system.3 Since the initial approval, the device received a subsequent approval for use in people as young as 6 years old in 2020.4
Citing the publishing of the PEDAP trial in March 2023, Beck and a team of colleagues launched the current study with the intent of providing clinicians and researchers with an overview of the effects of the advanced hybrid closed loop system across age groups using data from the DCLP3, DCLP5, and PEDAP trials, which examined use in patients aged 14-72 years, 6-13 years, and 2-5 years, respectively. A meta-analysis of the 3 trials, investigators obtained data related to a cohort of 369 individuals for inclusion in the current study.1
Of the 369 individuals included, 256 were randomized to the t:slim X2 insulin pump with Dexcom G6 CGM and 113 were randomized to the control group. Investigators pointed out 54% of the overall cohort was less than 14 years of age and the cohort was 50% male.1
The primary outcome of interest for the study was the difference in time in range of 70-180 mg/dL. Secondary outcomes of interest included mean glucose, hyperglycemia metrics, hypoglycemic metrics, and HbA1c.1
Upon analysis, results indicated the mean time in range improved from 57% (SD, 17) at baseline to 70% (SD, 11) at the end of the trial in the Control-IQ group and from 56% (SD, 15) at baseline to 57% (SD, 14) in the control group, which correlates to an adjusted difference of 11.5% (95% confidence interval [CI], 9.7 to 13.2; P <.001) and representative of 2.8 hours per day in favor of the Control-IQ arm. Further analysis demonstrated use of Control-IQ technology was associated with a reduction in time below 70 mg/dL and time below 54 mg/dL relative to the control group, with adjusted mean differences of -0.7% (95% CI, -0.9 to -0.4; P <.001) and -0.10% (95% CI, -0.18 to -0.03; P=.006), respectively.1
When examining changes in HbA1c, results suggested the mean HbA1c decreased from 7.5% (SD, 1.0) at baseline to 7.0% (SD, 0.8) at the end of the trial among the Control-IQ group compared to 7.6% (SD, 0.9) at baseline and 7.5% (SD, 0.9) at the end of the trial among the control group. Investigators pointed out a statistically significant, similar beneficial effect on time in range was observed across the full age range included, irrespective of race-ethnicity, household income, prestudy continuous glucose monitor use, or prestudy insulin delivery method.1
“All subgroups in these studies, regardless of age, ethnicity, education, or previous pump experience, benefited from Control-IQ technology,” said Boris Kovatchev, PhD, director of the Center for Diabetes Technology at the University of Virginia.2 “It is clear from these results, which are consistent with real-life data from thousands of current Control-IQ technology users, that this technology should be considered as an option for anyone living with type 1 diabetes.”