Safety and Feasibility Evaluation of Automated User Profile Settings Initialization and Adaptation With Control-IQ Technology.

BACKGROUND: Optimization of automated insulin delivery (AID) settings is required to achieve desirable glycemic outcomes. We evaluated safety and efficacy of a computerized system to initialize and adjust insulin delivery settings for the t:slim X2 insulin pump with Control-IQ technology in adults with type 1 diabetes (T1D). METHODS: After a 2-week continuous glucose monitoring (CGM) run-in period, adults with T1D using multiple daily injections (MDI) (N = 33, mean age 36.1 years, 57.6% female, diabetes duration 19.7 years) were transitioned to 13 weeks of Control-IQ technology usage. A computerized algorithm generated recommendations for initial pump settings (basal rate, insulin-to-carbohydrate ratio, and correction factor) and weekly follow-up settings to optimize glycemic outcomes. Physicians could override the automated settings changes for safety concerns. RESULTS: Time in range 70 to 180 mg/dL improved from 45.7% during run-in to 69.1% during the last 30 days of Control-IQ use, a median improvement of 18.8% (95% confidence interval [CI]: 13.6-23.9, P < .001). This improvement was evident early in the study and was sustained over 13 weeks. Time <70 mg/dL showed a gradual decreasing trend over time. Percentage of participants achieving HbA1c <7% went from zero at baseline to 55% at study end (P < .001). Only six of the 318 automated settings adaptations (1.9%) were overridden by study investigators. CONCLUSIONS: Computerized initiation and adaptation of Control-IQ technology settings from baseline MDI therapy was safe in adults with T1D. The use of this simplified system for onboarding and optimizing Control-IQ technology may be useful to increase uptake of AID and reduce staff and patient burden in clinical care.

Real-World Use of Control-IQ Technology Is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study.

Objective: Severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) remain significant risks with intensive insulin therapy. While these adverse event (AE) rates are generally very low in advanced hybrid closed-loop (AHCL) clinical studies, prospectively collected real-world AE rates are lacking. Research Design and Methods: The Control-IQ Observational (CLIO) study was a single-arm, prospective, longitudinal, postmarket surveillance study of individuals with type 1 diabetes (T1D) age 6 years and older who began the use of t:slim X2 insulin pump with Control-IQ technology in the real-world outpatient setting. AEs were reported monthly over 12 months and were compared to historical data from the T1D Exchange. Patient-reported outcomes were assessed quarterly. All study visits were virtual. Results: Three thousand one hundred fifty-seven participants enrolled from August 2020 through March 2022. Two thousand nine hundred ninety-eight participants completed through 12 months. SH rates were significantly lower than historic rates for children (9.31 vs. 19.31 events/100 patient years, d = 0.29, P < 0.01) and adults (9.77 vs. 29.49 events/100 patient years, d = 0.53, P < 0.01). DKA rates were also significantly lower in both groups. Lower observed rates of AEs occurred independent of baseline hemoglobin A1c or prior insulin delivery method. Time in range 70-180 mg/dL was 70.1% (61.0-78.8) for adults, 61.2% (52.4-70.5) for age 6-13, 60.9% (50.1-71.8) for age 14-17, and 67.3% (57.4-76.9) overall. Reduction in diabetes burden was consistently reported. Conclusions: SH and DKA rates were lower for users of t:slim X2 with Control-IQ technology compared to historical data for both adults and children. Real-world use of this AHCL system proved safe and effective in this virtual study design. The study was registered at clinicaltrials.gov (NCT04503174).

Smartphone Bolus Feature Increases Number of Insulin Boluses in People With Low Bolus Frequency.

BACKGROUND: The t:connect mobile app from Tandem Diabetes Care recently added a feature to allow t:slim X2 insulin pump users to initiate an insulin bolus from their personal smartphone. User experience and user interface considerations prioritized safety and ease of use, and we examined whether the smartphone bolus feature changed bolus behavior in individuals who bolused less than three times/day. METHODS: We performed a retrospective analysis of t:slim X2 insulin pump users in the United States who had remotely updated their insulin pump software to be compatible with the smartphone bolus version of the app and who gave less than three boluses per day prior to the smartphone bolus update. RESULTS: Of the 4470 early adopters who met these criteria, the median number of boluses was 2.2 per day (prior to smartphone bolus update) versus 2.7 per day (after smartphone bolus update), equating to approximately half a bolus more delivered per day (P < .001). Overall, a median of one bolus per day was administered by smartphone app as opposed to being initiated from the screen on the insulin pump. CONCLUSION: This analysis found a significant increase in bolusing behavior among early adopters of the smartphone bolus feature of the t:connect mobile app.

A Virtual Training Program for the Tandem t:slim X2 Insulin Pump: Implementation and Outcomes.

Insulin pump training has traditionally been performed in-person. The coronavirus disease 2019 (COVID-19) pandemic necessitated vast increases in the number of virtual pump trainings for Tandem t:slim X2 insulin pump starts. A customized structured pump training curriculum specifically tailored to virtual learning was deployed in early 2020, and included (1) preparation for training with use of the t:simulator app, (2) use of the teach-back method during video training, and (3) automating data uploads for follow-up. Retrospective analysis from >23,000 pump training sessions performed from January 1, 2020 to July 28, 2020 showed sensor time-in-range for up to 6 months after training was 72% (60%-81%) for virtual training versus 67% (54%-78%) for in-person training. Higher user satisfaction (4.78 ± 0.52 vs. 4.64 ± 0.68; P < 0.01) and higher user confidence (4.61 ± 0.75 vs. 4.47 ± 0.0.85; P < 0.01) were reported after the virtual sessions. Virtual pump training was well received and proved safe and effective with the new virtual training curriculum.

Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology.

Background: The t:slim X2™ insulin pump with Control-IQ™ technology, an advanced hybrid closed-loop system, became available in the United States in early 2020. Real-world outcomes with use of this system have not yet been comprehensively reported. Methods: Individuals with type 1 diabetes (T1D) (≥14 years of age) who had ≥21 days of pump usage data were invited via email to participate. Participants completed psychosocial questionnaires (Technology Acceptance Scale [TAS], well-being index [WHO-5], and Diabetes Impact and Devices Satisfaction [DIDS] scale) at timepoint 1 (T1) (at least 3 weeks after starting Control-IQ technology) and the DIDS and WHO-5 at timepoint 2 (T2) (4 weeks from T1). Patient-reported outcomes (PROs) and glycemic outcomes were reviewed at each timepoint. Results: Overall, 9,085 potentially eligible individuals received the study invite. Of these, 3,116 consented and subsequently 1,435 participants completed questionnaires at both T1 and T2 and had corresponding glycemic data available on the t:connect® web application. Time in range was 78.2% (70.2%-85.1%) at T1 and 79.2% (70.3%-86.2%) at T2. PROs reflected high device-related satisfaction and reduced diabetes impact at T2. Factors contributing to high trust in the system included sensor accuracy, improved diabetes control, reduction in extreme blood glucose levels, and improved sleep quality. In addition, participants reported improved quality of life, ease of use, and efficient connectivity to the continuous glucose monitoring system as being valuable features of the system. Conclusions: Continued real-world use of the t:slim X2 pump with Control-IQ technology showed improvements in psychosocial outcomes and persistent achievement of recommended TIR glycemic outcomes in people with T1D.

The Development and Psychometric Validation of the Diabetes Impact and Device Satisfaction Scale for Individuals with Type 1 Diabetes.

BACKGROUND: With the rapid development of new insulin delivery technology, measuring patient experience has become especially pertinent. The current study reports on item development, psychometric validation, and intended use of the newly developed Diabetes Impact and Device Satisfaction (DIDS) Scale. METHOD: The DIDS Scale was informed by a comprehensive literature review, and field tested as part of two focus groups. The finalized measure was used at baseline and 6 months post-assessment with a large US cohort. Exploratory factor analyses (EFAs) were conducted to determine and confirm factor structure and item selection. Internal reliability, test-retest reliability, and convergent/divergent validity of the emerged factors were tested with demographics, diabetes-specific information, and diabetes behavioral and satisfaction measures. RESULTS: In all, 778 participants with type 1 diabetes (66% female, mean age 47.13 ± 17.76 years, 74% insulin pump users) completed surveys at both baseline and post-assessment. EFA highlighted two factors-Device Satisfaction (seven items, Cronbach's α = 0.85-0.90) and Diabetes Impact (four items, Cronbach's α = 0.71-0.75). DIDS Scale demonstrated good concurrent validity and test-retest reliability. CONCLUSION: The DIDS Scale is a novel and a brief assessment tool with robust psychometric properties. It is recommended for use across all insulin delivery devices and is considered appropriate for use in longitudinal studies. Future studies are recommended to evaluate the performance of DIDS Scale in diverse populations with diabetes.

Real-World Improvements in Hypoglycemia in an Insulin-Dependent Cohort With Diabetes Mellitus Pre/Post Tandem Basal-Iq Technology Remote Software Update.

OBJECTIVE: Software updatable insulin pumps, such as the t:slim X2 pump from Tandem Diabetes Care, enable access to new technology as soon as it is commercialized. The remote software update process allows for minimal interruption in therapy compared to purchasing a new pump; however, little quantitative data exist on the software update process or on pre/post therapeutic outcomes. We examined real-world usage and impact of a remote software updatable predictive low-glucose suspend (PLGS) technology designed to reduce hypoglycemic events in people with insulin-dependent diabetes. METHODS: Approximately 15,000 U.S. Tandem pump users remotely updated their t:slim X2 software to Basal-IQ PLGS technology since its commercial release. We performed a retrospective analysis of users who uploaded at least 21 days of pre/post PLGS update usage data to the Tandem t:connect web application between August 28, 2018, and October 21, 2019 (N = 6,170). Insulin delivery and sensor-glucose values were analyzed per recent international consensus and American Diabetes Association guidelines. Software update performance was also assessed. RESULTS: Median software update time was 5.36 minutes. Overall glycemic outcomes for pre and post software update showed a decrease in sensor time <70 mg/dL from 2.14 to 1.18% (-1.01; 95% confidence interval [CI], -0.97, -1.05; P<.001), with overall sensor time 70 to 180 mg/dL increasing from 57.8 to 58.5% (0.64; 95% CI, 0.04, 1.24; P<.001). These improvements were sustained at 3, 6, and 9 months after the update. CONCLUSION: Introduction of a software updatable PLGS algorithm for the Tandem t:slim X2 insulin pump resulted in sustained reductions of hypoglycemia. ABBREVIATIONS: ADA = American Diabetes Association; CGM = continuous glucose monitoring; CI = confidence interval; PLGS = predictive low-glucose suspend; SG = sensor glucose; T1D = type 1 diabetes; T2D = type 2 diabetes; TIR = time-in-range.

Reducing Hypoglycemia in the Real World: A Retrospective Analysis of Predictive Low-Glucose Suspend Technology in an Ambulatory Insulin-Dependent Cohort.

Objective: Analyze real-world usage and impact of a predictive low-glucose suspend (PLGS) insulin delivery system for maintenance of euglycemia and prevention of hypoglycemic events in people with insulin-dependent diabetes. Methods: Retrospective analysis of Tandem Basal-IQ users who uploaded at least 21 days of PLGS usage data between August 31, 2018, and March 14, 2019 (N = 8132). Insulin delivery and sensor-glucose concentrations were analyzed. The times spent below 70 mg/dL, between 70 and 180 mg/dL, and above 180 mg/dL were assessed. Subgroup analyses were conducted to examine matched pre-/postoutcomes with experienced users (n = 1371) and performance over time for a mixed subgroup with >9 weeks of data (n = 3563). Results: The mean age of patients was 32.4 years, 52% were female, 96% had type 1 diabetes, and 4% had type 2 diabetes. Mean duration on PLGS was 65 days. Algorithm introduction led to a 45% median relative risk reduction in sensor time <70 mg/dL, pre/post (% <70:2.0, 1.1), while the mean glucose remained stable (168 and 168 mg/dL). Mean frequency of hypoglycemic events decreased from one every 9 days to one every 30 days. Total daily insulin dose decreased from 43.4 to 42.3 U in the pre/post subgroup. Manual override of the system was low (4.5%). The number of daily suspensions remained stable (4.9). Conclusions: Introduction of PLGS resulted in effective and sustained prevention of hypoglycemia without a significant increase in mean blood glucose and may be considered for people with type 1 diabetes at risk for hypoglycemia.