Abstract Body

There have been major advancements in automated insulin delivery systems in the past several years, with hybrid closed-loop systems offering patients new means to manage their diabetes. Such systems rely on algorithms to modulate the insulin delivery, increasing or decreasing insulin delivery based upon programed target glucose, patient-entered carbohydrates and correction boluses that can be user or device initiated. The MiniMed^TM Advanced Hybrid Closed Loop (AHCL) system, or MiniMed^TM 780G, is a new iteration of pump therapy that has a target set point of either 100 mg/dL (5.6 mmol/L) or 120 mg/dL (6.7 mmol/L), along with automated corrections that can deliver boluses every 5 minutes as needed.

The MiniMed^TM 780G system has been studied for safety and efficacy in recent trials. The largest trial was a multi-site pivotal trial of 39 adolescents (age 14-21 years) and 118 adults (>22 years) during which patients with type 1 diabetes used either the 100 mg/dL or 120 mg/dL set point for approximately 45 days, and then crossed over to the other set point for another period of about 45 days. For the overall study group, time in range (70-180 mg/dL/ 3.9 mmol/L-10 mmol/L) increased from 68.8% to 74.5% (p = 0.001). For those using the set point of 100 mg/dL and an active insulin time of 2 hours, time in range increased to 78.8%. Auto Mode was in use for 95% of the time for both set points during the study. Of the total bolus insulin delivered during the study, approximately 22% of this was administered by the auto-correction function. Time in hypoglycemia was reduced in both adolescents and adults, and there were no DKA or severe hypoglycemia events.

Additional studies have compared the MiniMed^TM 780G system against both the first commercially available hybrid closed-loop system in the United States, the MiniMed^TM 670G, and to a system with predictive low glucose threshold suspend MiniMed^TM 640G. Both studies concluded the AHCL system provided improved glycemic control without increasing time in hypoglycemia.

The MiniMed^TM 780G has consistently demonstrated improved time in range without increasing time below range, and has been safe in the trials to date. The system also seemed to have improved user experience with patient-selected targets and fewer Auto Mode exits.

Abstract Body

In 2018-2020, two randomized controlled pivotal trials tested a new CLC system - Control-IQ® from Tandem Diabetes Care - based on an algorithm developed at the University of Virginia. Both studies were part of the International Diabetes Closed-Loop (iDCL) Trial sponsored by NIH/NIDDK.

NCT03563313 randomized 168 participants ages 14 years or older to Control-IQ vs. sensor-augmented pump (SAP) and met all primary and secondary outcomes. The time in range (TIR, 70-180mg/dL) increased in the Control-IQ group by 11%, compared to SAP, and the time below range (TBR) was reduced by 0.9%, without severe hypoglycemia.

NCT03844789 randomized 101 participants ages 6-13 and achieved similar outcomes: Control-IQ compared to SAP resulted in 11% increase in TIR, 0.4% reduction in TBR without severe hypoglycemia, and reduction of HbA1c by 0.4%.

Two papers in the New England Journal of Medicine presented the complete results, leading to FDA clearance of this system for use by children and adults ages 6 and up.

In February 2021, one-year real-life data became available for 9,451 users of Control-IQ with type 1 and type 2 diabetes. The median percent time in automated control was 94.2%; TIR increased from 63.6% at baseline 73.6% during Control-IQ use; TBR remained consistent at approximately 1%, and the Glucose Management Indicator (GMI) was reduced from 7.2 at baseline to 6.9.

We can therefore conclude that the outcomes of the two pivotal trials of this system were replicated during 1-year real-life use by thousands of children and adults with type 1 or type 2 diabetes.