By William Elliott, MD, FACP, and James Chan, PharmD, PhD
The FDA has approved the first insulin pump with meal detection technology. The MiniMed 780G System is an advanced hybrid closed loop (AHCL) system (combined insulin delivery with continuous glucose monitoring).
INDICATIONS
Manage type 1 diabetes (patients age 7 years and older).
DOSAGE
Dose is individualized based on insulin requirement.
POTENTIAL ADVANTAGES
This is the only HCL system with meal detection technology (Guardian 4 sensor) that provides automatic adjustments and corrections to glucose levels every five minutes for both basal and mealtime insulin requirements.1 Glycemic control improves in patients who are not controlled on multiple daily injections and intermittent scanned continuous glucose monitoring.2 The AHCL system will adjust insulin delivery if needed when the entry for carb count is underestimated or missed.3 There are multiple personalized targets: 100 mg/dL, 110 mg/dL, or 120 mg/dL.
POTENTIAL DISADVANTAGES
This requires the user to wear the pump as well as the sensor, which may be a burden for some patients. It is not a tubeless and wireless device. It is not a fully closed-loop system and still requires entering a carb count into the pump before eating.1
COMMENTS
The efficacy of the AHCL system was compared to conventional insulin therapy in adults with T1D in an open-label, randomized, controlled study conducted in Europe.2 Subjects struggling to achieve glucose targets with conventional treatment were randomized to AHCL (n = 41) or multiple daily injections of insulin, plus intermittently scanned continuous glucose monitoring (IS-CGM; n = 41). The primary outcome was the between-group difference in mean change in HbA1c from baseline to six months. Secondary endpoints included time spent in hyperglycemic range (> 250 mg/dL or < 180 mg/dL), percent time spent in euglycemic range (70 mg/dL to 180 mg/dL), and time in hypoglycemic ranges (less than 54 mg/dL and < 70 mg/dL). At six months, HbA1c decreased by a mean -1.54% from a baseline of 9.07% for the AHCL group compared to -0.20% from a baseline of 9% for IS-CGM, a treatment effect of -1.42 (95% CI, -1.74 to -1.17; P = 0.0001). Times in euglycemic range were 71% vs. 44%, respectively. Times in range greater than 250 mg/dL and > 180 mg/dL were 6.6% and 27% vs. 23% and 54%, respectively. Users achieving HbA1c < 7% were 28% for the AHCL system compared to 0% for conventional therapy. Treatment satisfaction scores were higher in the AHCL group. No severe hypoglycemic or diabetic ketoacidosis event occurred in either treatment arm.
CLINICAL IMPLICATIONS
This device showed a benefit in patients trying to achieve glycemic control with conventional multidose injection therapy (i.e., baseline HbA1c of 9%). It is unclear how much of an advantage the automatic adjustment provides, as it was not compared to another insulin pump without this feature.
REFERENCES
1. Medtronic. FDA approves Medtronic MiniMed™ 780G System.
2. Choudhary P, Kolassa R, Keuthage W, et al. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): A randomised controlled study. Lancet Diabetes Endocrinol 2022;10:720-731.
3. Medtronic. MiniMed 780G system.
The FDA has approved the first insulin pump with meal detection technology.
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