Charles Sternberg, Associate Editor09.02.22
Medtronic plc, a global leader in healthcare technology, has announced results from the Medtronic ADAPT study published in The Lancet Diabetes & Endocrinology, the first multi-national randomized controlled study evaluating the performance of MiniMed 780G system1 versus standard of care (multiple daily injections (MDI) + continuous glucose monitoring (CGM)) in individuals with type 1 diabetes not currently meeting glycemic targets.
At study initiation, half of the participants were randomized to stay on standard of care, and the rest transitioned directly to the MiniMed 780G system. Study results showed improvement in glycemic targets for those that transitioned to the MiniMed 780G system with a significant and sustained 1.4% HbA1C reduction at six months. Those using the Medtronic system also saw a 27.6% absolute increase in Time in Range (6.6 more hours/day in target range) compared to those on standard of care without increased in time in hypoglycemia. This improvement was even greater overnight when the algorithm was in full control.
"The ADAPT study illustrates that insulin pump therapy with advanced algorithms, like that of the MiniMed 780G system, can produce significantly improved clinical results versus the current standard of care," said Ohad Cohen, M.D., senior global medical affairs director, Medtronic Diabetes. "Studies like this can change how health care systems define standard of care and expand options for people living with diabetes to begin using insulin pumps sooner to improve their glycemic control and help reduce the burden of diabetes."
When comparing A1C results at 6 months, 27.8% of individuals using the MiniMed 780G system in the study achieved an HbA1c below 7%, while no individuals that remained on MDI +isCGM achieved that desired result.
In terms of customer experience, participants using the MiniMed 780G system spent 95.8% of the time in SmartGuard (advanced hybrid closed-loop) and experienced few system exits (only 0.9 SmartGuard exits/week. Additionally, the sensor was being used 92.2% of the time (vs. 87.3% in the standard of care group). The ADAPT study also showed that those that transitioned to the MiniMed 780G system experienced a significant increase in treatment satisfaction2 and reduction in fear of hypoglycemia3.
Overall, results showed that the use of the MiniMed 780G system, even when paired with the Guardian sensor 3 which requires two fingerstick calibrations per day, had significant improvement across all glycemic metrics compared to standard of care and supports the use at early stages in the treatment pathway given the potential benefits of complication avoidance4, treatment satisfaction improvements, and reduced fear of hypoglycemia.
The MiniMed 780G system is now available in over 60 countries around the world and is currently being reviewed by the Food and Drug Administration (FDA) for approval in the U.S.
References:
1 MiniMed 780G System and Guardian™ 4 sensors are CE Marked only and not commercially available or approved in the U.S.
2 Patient reported outcomes within the ADAPT Study: Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Fear of Hypoglycemia (FHS) Survey
3 Mean DTSQs score for AHCL vs MDI+isCGM arm (6.1 ± 7.55 vs 0.2 ± 6.84, p=0.0003), and HFS scores for AHCL vs MDI+isCGM (-10.2 ± 15.51 vs -2.7 ± 13.08, p = 0.0409)
4 The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin dependent diabetes mellitus(opens new window) NIH external link. New England Journal of Medicine. 1993;329(14):977–986.
5 Carlson, A.L. et al. Safety and glycemic outcomes during the MiniMed™ Advanced Hybrid Closed-Loop system pivotal trial in adolescents and adults with type 1 diabetes. Diab Tech Ther 2021; in press.
6 Collyns.O. et al. Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes(opens new window). Diab Care 2021, 44: 969-975
About the Study
The study evaluated 82 individuals who were using MDI and an intermittently scanned continuous glucose monitor (isCGM) to manage their diabetes prior to trial initiation. On average, individuals enrolled were scanning their isCGM frequently (~9 scans/day) yet had suboptimal HbA1C above 8% at baseline.At study initiation, half of the participants were randomized to stay on standard of care, and the rest transitioned directly to the MiniMed 780G system. Study results showed improvement in glycemic targets for those that transitioned to the MiniMed 780G system with a significant and sustained 1.4% HbA1C reduction at six months. Those using the Medtronic system also saw a 27.6% absolute increase in Time in Range (6.6 more hours/day in target range) compared to those on standard of care without increased in time in hypoglycemia. This improvement was even greater overnight when the algorithm was in full control.
"The ADAPT study illustrates that insulin pump therapy with advanced algorithms, like that of the MiniMed 780G system, can produce significantly improved clinical results versus the current standard of care," said Ohad Cohen, M.D., senior global medical affairs director, Medtronic Diabetes. "Studies like this can change how health care systems define standard of care and expand options for people living with diabetes to begin using insulin pumps sooner to improve their glycemic control and help reduce the burden of diabetes."
When comparing A1C results at 6 months, 27.8% of individuals using the MiniMed 780G system in the study achieved an HbA1c below 7%, while no individuals that remained on MDI +isCGM achieved that desired result.
In terms of customer experience, participants using the MiniMed 780G system spent 95.8% of the time in SmartGuard (advanced hybrid closed-loop) and experienced few system exits (only 0.9 SmartGuard exits/week. Additionally, the sensor was being used 92.2% of the time (vs. 87.3% in the standard of care group). The ADAPT study also showed that those that transitioned to the MiniMed 780G system experienced a significant increase in treatment satisfaction2 and reduction in fear of hypoglycemia3.
Overall, results showed that the use of the MiniMed 780G system, even when paired with the Guardian sensor 3 which requires two fingerstick calibrations per day, had significant improvement across all glycemic metrics compared to standard of care and supports the use at early stages in the treatment pathway given the potential benefits of complication avoidance4, treatment satisfaction improvements, and reduced fear of hypoglycemia.
The MiniMed 780G system is now available in over 60 countries around the world and is currently being reviewed by the Food and Drug Administration (FDA) for approval in the U.S.
References:
1 MiniMed 780G System and Guardian™ 4 sensors are CE Marked only and not commercially available or approved in the U.S.
2 Patient reported outcomes within the ADAPT Study: Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Fear of Hypoglycemia (FHS) Survey
3 Mean DTSQs score for AHCL vs MDI+isCGM arm (6.1 ± 7.55 vs 0.2 ± 6.84, p=0.0003), and HFS scores for AHCL vs MDI+isCGM (-10.2 ± 15.51 vs -2.7 ± 13.08, p = 0.0409)
4 The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin dependent diabetes mellitus(opens new window) NIH external link. New England Journal of Medicine. 1993;329(14):977–986.
5 Carlson, A.L. et al. Safety and glycemic outcomes during the MiniMed™ Advanced Hybrid Closed-Loop system pivotal trial in adolescents and adults with type 1 diabetes. Diab Tech Ther 2021; in press.
6 Collyns.O. et al. Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes(opens new window). Diab Care 2021, 44: 969-975