Michael Barbella, Managing Editor06.12.23
Tandem Diabetes Care Inc. is sharing positive results from a meta-analysis of three randomized controlled trials of its Control-IQ advanced hybrid closed-loop technology.
Results demonstrate the positive clinical impact of the system’s automatic correction bolusing on glucose control across a wide range of ages and demographics of people living with type 1 diabetes. Those with the highest baseline blood sugar levels experienced the greatest benefit from the auto-bolus feature of the Control-IQ algorithm. Automatic correction bolusing is an automated insulin dosing feature that is only commercially available in the t:slim X2 insulin pump with Control-IQ technology. All participants were using a Dexcom G6 Continuous Glucose Monitoring (CGM) System.
“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, M.D., Ph.D., executive director of the Jaeb Center for Health Research. “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.”
The analysis showed an average increase in time in range* of 2.8 hours and a reduction in hemoglobin A1c compared to control groups in people ages 2 to 72 years old.** Improvements in time in range for subjects using Control-IQ technology (n=256) were immediate, sustained, and observed across the spectrum of patient characteristics including age, race-ethnicity, parental education, family income, baseline glycated hemoglobin level, virtual vs. in-person training format, and pre-study insulin delivery method. The majority of the control group (n=113) used an insulin pump (91%), some with predictive low glucose suspend technology.
“All subgroups in these studies, regardless of age, ethnicity, education, or previous pump experience, benefited from Control-IQ technology,” said Boris Kovatchev, Ph.D., director of the Center for Diabetes Technology at the University of Virginia. “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.”
“With three randomized, controlled trials completed, Control-IQ technology has the most robust data set supporting its benefits compared to any other automated insulin delivery system available today,” Tandem Diabetes Care Vice President/Medical Director Jordan Pinsker, M.D., said.
Additional Data Highlights
Glycemic Control at Three Months
** The algorithm used in the study for ages 2-5 was identical to the commercial version of Control-IQ technology, except for the ability to enter a lower body weight and total daily insulin value at system initialization.
Based in San Diego, Calif., Tandem Diabetes Care Inc. creates new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience. The company’s human-centered approach to design, development, and support delivers products and services for people who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Control-IQ technology.
Publication Reference
Beck RW, Kanapka, LG, Breton, MD, et al. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023;25(5):1-14. DOI: 10.1089/dia.2022.0558
Results from the Protocol 3 study (DCLP3) of the International Diabetes Closed Loop (iDCL) trial evaluating the use of Control-IQ technology in ages 14 and up, from the Protocol 5 study (DCLP5) of the iDCL trial studying use in ages 6 to 13, and from the Pediatric Artificial Pancreas (PEDAP) Clinical Trial were published by the New England Journal of Medicine in October 2019, August 2020, and March 2023, respectively.
The three studies included in this meta-analysis were funded by the National Institute of Diabetes and Digestive and Kidney Diseases and PEDAP. Product support for all was provided by Tandem Diabetes Care and Dexcom Inc.
Results demonstrate the positive clinical impact of the system’s automatic correction bolusing on glucose control across a wide range of ages and demographics of people living with type 1 diabetes. Those with the highest baseline blood sugar levels experienced the greatest benefit from the auto-bolus feature of the Control-IQ algorithm. Automatic correction bolusing is an automated insulin dosing feature that is only commercially available in the t:slim X2 insulin pump with Control-IQ technology. All participants were using a Dexcom G6 Continuous Glucose Monitoring (CGM) System.
“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, M.D., Ph.D., executive director of the Jaeb Center for Health Research. “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.”
The analysis showed an average increase in time in range* of 2.8 hours and a reduction in hemoglobin A1c compared to control groups in people ages 2 to 72 years old.** Improvements in time in range for subjects using Control-IQ technology (n=256) were immediate, sustained, and observed across the spectrum of patient characteristics including age, race-ethnicity, parental education, family income, baseline glycated hemoglobin level, virtual vs. in-person training format, and pre-study insulin delivery method. The majority of the control group (n=113) used an insulin pump (91%), some with predictive low glucose suspend technology.
“All subgroups in these studies, regardless of age, ethnicity, education, or previous pump experience, benefited from Control-IQ technology,” said Boris Kovatchev, Ph.D., director of the Center for Diabetes Technology at the University of Virginia. “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.”
“With three randomized, controlled trials completed, Control-IQ technology has the most robust data set supporting its benefits compared to any other automated insulin delivery system available today,” Tandem Diabetes Care Vice President/Medical Director Jordan Pinsker, M.D., said.
Additional Data Highlights
Glycemic Control at Three Months
- Mean time in range with Control-IQ technology increased from 57% at baseline to 70% during follow-up compared to 56% to 57% in the control group, for a mean adjusted difference of 11.5%.
- Hemoglobin A1c decreased from 7.5% at baseline to 7% for the Control-IQ technology group, with an adjusted improvement of 0.38% compared to the control group.
- Substantial daytime and nighttime reductions in hyperglycemia (>250 mg/dL) and mean glucose were seen with Control-IQ technology compared with the control group. The greatest difference in mean glucose was between 4 a.m. and 8 a.m.
- Time spent in hypoglycemia (<70 mg/dL) was low at baseline, but reductions in time <70 mg/dL and <54 mg/dL were still observed with Control-IQ technology compared with the control group.
- The rate of severe hypoglycemia events was exceedingly low (~2 per 100 person-years) and similar between Control-IQ technology and the control group.
- Fewer user-initiated boluses (meal and correction) were associated with people age 14 to 24 years and those with a baseline hemoglobin A1c of 8% or higher. Fifty percent or more of the total number of daily boluses for these two groups were automated.
- The median time the system was in active closed loop was 93%.
- Results were observed regardless of pre-study experience with an insulin pump.
** The algorithm used in the study for ages 2-5 was identical to the commercial version of Control-IQ technology, except for the ability to enter a lower body weight and total daily insulin value at system initialization.
Based in San Diego, Calif., Tandem Diabetes Care Inc. creates new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience. The company’s human-centered approach to design, development, and support delivers products and services for people who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Control-IQ technology.
Publication Reference
Beck RW, Kanapka, LG, Breton, MD, et al. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023;25(5):1-14. DOI: 10.1089/dia.2022.0558
Results from the Protocol 3 study (DCLP3) of the International Diabetes Closed Loop (iDCL) trial evaluating the use of Control-IQ technology in ages 14 and up, from the Protocol 5 study (DCLP5) of the iDCL trial studying use in ages 6 to 13, and from the Pediatric Artificial Pancreas (PEDAP) Clinical Trial were published by the New England Journal of Medicine in October 2019, August 2020, and March 2023, respectively.
The three studies included in this meta-analysis were funded by the National Institute of Diabetes and Digestive and Kidney Diseases and PEDAP. Product support for all was provided by Tandem Diabetes Care and Dexcom Inc.