Control-IQ Technology Use in Individuals With High Insulin Requirements: Results From the Multicenter Higher-IQ Trial.

BACKGROUND: Control-IQ technology version 1.5 allows for a wider range of weight and total daily insulin (TDI) entry, in addition to other changes to enhance performance for users with high basal rates. This study evaluated the safety and performance of the updated Control-IQ system for users with basal rates >3 units/h and high TDI in a multicenter, single arm, prospective study. METHODS: Adults with type 1 diabetes (T1D) using continuous subcutaneous insulin infusion (CSII) and at least one basal rate over 3 units/h (N = 34, mean age = 39.9 years, 41.2% female, diabetes duration = 21.8 years) used the t:slim X2 insulin pump with Control-IQ technology version 1.5 for 13 weeks. Primary outcome was safety events (severe hypoglycemia and diabetic ketoacidosis (DKA)). Central laboratory hemoglobin A1c (HbA1c) was measured at system initiation and 13 weeks. Participants continued using glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose transport protein 2 (SGLT-2) inhibitors, or other medications for glycemic control and/or weight loss if on a stable dose. RESULTS: All 34 participants completed the study. Fifteen participants used a basal rate >3 units/h for all 24 hours of the day. Nine participants used >300 units TDI on at least one day during the study. There were no severe hypoglycemia or DKA events. Time in range 70-180 mg/dL was 64.8% over the 13 weeks, with 1.0% time <70 mg/dL. Hemoglobin A1c decreased from 7.69% at baseline to 6.87% at 13 weeks (-0.82%, P < .001). CONCLUSIONS: Control-IQ technology version 1.5, with wider range of weight and TDI input and enhancements for users with high insulin requirements, was safe in individuals with T1D in this study.

Usability and training differences between two personal insulin pumps.

The purpose of this study was to determine if there were usability and training differences between the Medtronic MiniMed Paradigm Revel Insulin Pump and the Tandem Diabetes Care t:slim Insulin Pump during use by representative users, performing representative tasks, in a simulated use environment. This study utilized a between-subjects experimental design with a total of 72 participants from 5 sites across the United States. Study participants were randomized to either the Revel pump group or the t:slim Pump group. Participants were 18 years of age or older and managed their diabetes using multiple daily insulin injections. Dependent variables included training time, training satisfaction, time on task, task failures, System Usability Scale (SUS) ratings, perceived task difficulty, and a pump survey that measured different aspects of the pumps and training sessions. There was a statistically significant difference in training times and error rates between the t:slim and Revel groups. The training time difference represented a 27% reduction in time to train on the t:slim versus the Revel pump. There was a 65% reduction in participants' use error rates between the t:slim and the Revel group. The t:slim Pump had statistically significant training and usability advantages over the Revel pump. The reduction in training time may have been a result of an optimized information architecture, an intuitive navigational layout, and an easy-to-read screen. The reduction in use errors with the t:slim may have been a result of dynamic error handling and active confirmation screens, which may have prevented programming errors.

Crossing the technology divide: practical strategies for transitioning patients from multiple daily insulin injections to sensor-augmented pump therapy.

PURPOSE: To describe the benefits of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) systems compared with self-monitoring of blood glucose (SMBG) and multiple daily injection (MDI) therapy; to assess the benefits of sensor-augmented pump therapy (SAPT) in patients with type 1 diabetes; and to present an evidence-based practical protocol for introducing SAPT in patients with no prior pump or CGM experience. CONCLUSION: Continuous glucose monitoring and CSII have advantages over SMBG and MDI, respectively, in terms of A1C and hypoglycemia reduction. The Sensor-Augmented Pump Therapy for A1C Reduction (STAR) 3 trial demonstrated that initiating both CGM and CSII in selected adult and pediatric patients with type 1 diabetes unable to meet glycemic goals with intensive insulin injection therapy significantly improved glucose control. In all subjects using SAPT, A1C levels fell rapidly from baseline to 3 months and remained significantly lower than among subjects in the SMBG+MDI group for 1 year. A distinguishing feature of the STAR 3 study was its stepwise protocol for systematizing education and self-management support using Web-based training modules and therapy management software. The demonstrated strengths of this education protocol recommend it as a model for implementing SAPT in the broader population of patients with type 1 diabetes who have not achieved their glycemic goals with optimized MDI therapy.