In insulin-treated T2D, automated insulin delivery reduced HbA1c without increasing hypoglycemic events vs. usual care at 13 wk
A manufacturer trial showed that automated insulin delivery is safe and effective for improving HbA1c levels in a range of patients with type 2 diabetes, but the technology will require attentiveness and problem solving to troubleshoot, an ACP Journal Club commentary said.
The 2IQP (Randomized Trial Evaluating the Efficacy and Safety of Control-IQ+ Technology in Adults with Type 2 Diabetes Using Basal Bolus Insulin Therapy) study was conducted by Tandem Diabetes Care among 319 patients at 21 centers in the U.S. and Canada. It found that patients randomized to an automated insulin device (AID) lowered their HbA1c level by 0.9 percentage point (compared to 0.3 percentage point in the control group). The mean percentage of time in the target glucose range increased from 48% to 64% in the AID group and from 51% to 52% in the control group.
The study was published by the New England Journal of Medicine on March 19. The following commentary by Darren Lau, MD, PhD, and Peter Senior, MBBS, PhD, was published in the ACP Journal Club section of Annals of Internal Medicine Aug. 5.
AID integrates CGM with insulin pump therapy (IPT) to partially automate insulin delivery. Control-IQ+ is an AID algorithm that adjusts basal infusion rates (to reduce hyperglycemia and hypoglycemia) and delivers correction boluses (to reduce hyperglycemia) with minimal user input. 2IQP is the largest trial of AID in patients with type 2 diabetes (T2D) receiving multiple daily insulin injections (96%) or IPT (4%), with most patients maximally managed on concomitant glucagon-like peptide-1 receptor agonists and/or sodium–glucose co-transporter-2 inhibitors. The trial included older patients (33% aged ≥65 y) and those from racial or ethnic minority groups (30%). Patients in the AID group were in automated insulin-delivery mode 93% of the time, showing usability for a wide range of patients.
2IQP showed that AID improved HbA1c levels without increasing hypoglycemia vs. usual care with CGM. The reduction appeared greater in patients with baseline HbA1c levels >8% and was similar in patients using fixed meal-time doses and those using doses adjusted for carbohydrate content. These subgroup results suggest that AID may benefit patients who might not be considered ideal candidates for IPT; that is, automated correction can compensate for inadequate meal-time insulin dosing in patients with poorer numeracy skills who use IPT.
Excess nonserious adverse events in the AID group were mostly hyperglycemia related to IPT-infusion set problems, which did not lead to hyperosmotic syndrome or ketoacidosis events. Consistent with other studies, AID increased weight vs. usual care with CGM (2.4 kg vs. 0.9 kg) despite lower total insulin doses, possibly due to reduced dietary restraint or less caloric loss from glucosuria.
The seminal 2IQP trial shows that AID is safe and effective for improving HbA1c levels in a range of patients with T2D receiving multiple daily insulin injections or IPT. Although AID can accommodate more variable insulin-dosing skills than IPT alone, it requires attentiveness and problem solving to troubleshoot and to maintain a healthy diet and activity patterns. Access will be an important challenge for those with T2D because AID is costly, and coverage has thus far been limited to patients with type 1 diabetes.