OBJECTIVETo identify and define clinically meaningful type 1 diabetes outcomes beyond hemoglobin A1c (HbA1c) based upon a review of the evidence, consensus from clinical experts, and input from researchers, people with type 1 diabetes, and industry. Priority outcomes include hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis (DKA), and patient-reported outcomes (PROs). While priority outcomes for type 1 and type 2 diabetes may overlap, type 1 diabetes was the focus of this work.RESEARCH AND METHODSA Steering Committee—comprising representatives from the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange—was the decision-making body for the Type 1 Diabetes Outcomes Program. Their work was informed by input from researchers, industry, and people with diabetes through Advisory Committees representing each stakeholder group. Stakeholder surveys were used to identify priority outcomes. The outcomes prioritized in the surveys were hypoglycemia, hyperglycemia, time in range, DKA, and PROs. To develop consensus on the definitions of these outcomes, the Steering Committee relied on published evidence, their clinical expertise, and feedback from the Advisory Committees.RESULTSThe Steering Committee developed definitions for hypoglycemia, hyperglycemia, time in range, and DKA in type 1 diabetes. The definitions reflect their assessment of the outcome’s short- and long-term clinical impact on people with type 1 diabetes. Knowledge gaps to be addressed by future research were identified. The Steering Committee discussed PROs and concluded that further type 1 diabetes–specific development is needed.CONCLUSIONSThe Steering Committee recommends use of the defined clinically meaningful outcomes beyond HbA1c in the research, development, and evaluation of type 1 diabetes therapies.

A one-time algorithmic adjustment of open-loop settings did not alter glucose control in a relatively short duration outpatient closed-loop study. The CLC system proved very robust and adaptable, with minimal (<2%) time spent in the hypoglycemic range in either arm.

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Women with T1D have glycemic variability changes that are specific to the individual and are linked to phase of cycle. An increased risk of hyperglycemia was observed during periovulation and early luteal phases compared to the early follicular phase; these changes appear to be associated with decreased insulin sensitivity during the luteal phase.

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Previous research has demonstrated significantly improved glycemic outcomes in people with type 1 diabetes (PWT1D) and type 2 diabetes (PWT2D) who initiated use of Control-IQ technology by updating their existing pump software. This study examined glycemic outcomes by prior therapy (excluding software updaters) for PWT1D and PWT2D after they onboarded to Control-IQ technology. We performed retrospective analyses involving PWT1D and PWT2D from the US who purchased a new Tandem pump with Control-IQ technology and uploaded their pump data to t:connect® web application from Tandem Diabetes Care as of December 7, 2020. In all, 29,732 participants (94% T1D, 6% T2D) were included in the analysis. Median age of the sample was 40 years and majority had been using an insulin pump as prior therapy (66%) while 34% were transitioning from MDIs. After receiving their Tandem pump, prior pump users started using Control-IQ technology earlier (median days: T1D=16, T2D=16) than prior MDI users (T1D=21 days, T2D=23 days), mainly reflecting additional training provided to prior MDIs to onboard successfully to the new system. After 180 days of starting Control-IQ technology, for prior pump users with T1D, TIR was 74% (median, IQR 65-81%) and time below &lt;70mg/dl (TBR) was 1.2% (IQR 0.6-2.1%). For prior pump users with T2D, TIR was 76% (IQR 69-82%) and TBR was 0.5% (IQR 0.2-1.0%). For participants transitioning from MDI, Control-IQ technology resulted in TIR of 74% (IQR 64-83%) and 0.9% TBR (IQR 0.4-1.7%) for PWT1D and 74% TIR (IQR 63-84%) and 0.3% TBR (IQR 0.1-0.6%) for PWT2D. Irrespective of prior therapy, PWT1D changed their pump settings (e.g., basal rates, carbohydrate ratio) more frequently (median: 3) vs. PWT2D (median: 2). Using Control-IQ technology, both PWT1D and PWT2D (irrespective of prior therapy) achieved very similar TIR outcomes. However, T2D users showed lower rates of hypoglycemia (TBR) vs. their T1D counterparts. Disclosure J. W. Morberg: Employee; Self; Tandem Diabetes Care. H. Singh: Employee; Self; Tandem Diabetes Care. M. Mcelwee-malloy: Employee; Self; Tandem Diabetes Care. S. Habif: Employee; Self; Tandem Diabetes Care. A. Constantin: Employee; Self; Tandem Diabetes Care.

The Tandem Diabetes Care® t:slim X2TM insulin pump with Control-IQTM technology is an advanced hybrid closed-loop system, cleared by the FDA in December 2019. To date various studies have demonstrated glycemic and patient-reported improvements using this system. However, there are no published qualitative studies evaluating real-world experiences of using Control-IQ technology. As part of a larger, real-world study involving people with type 1 diabetes (T1D) using Control-IQ technology, we randomly selected and invited participants (Ps) to phone interviews to discuss their experiences using this system. Semi-structured, in-depth interviews were conducted in May-June 2020. They were audio-recorded and transcribed verbatim. Interviews were conducted by two experienced health professionals and lasted an average of 23 minutes (range 9-50 minutes). Interview transcripts were imported into NVivo V.12 for data coding and analysis. Interviews were analyzed using inductive thematic analysis. In all, 27 T1D adults (14 women, 13 men) were interviewed. Four major themes (T) emerged: the initiation phase (T1), successes (T2), and challenges (T3) with Control-IQ technology, and its impact on quality of life (QoL) (T4). Ps reported taking some time to trust the new automated system and “feeling comfortable in letting it do its thing” (T1). Improved sleep quality, glycemic control (HbA1c), and sensor time in range were commonly reported by Ps (T2) along with reduced burden of diabetes management (T2). A few Ps discussed their need for the system to be more aggressive while managing hyperglycemia (T3). Overall, Ps described valuable improvements in their QoL, including reduced stress and decision-making around diabetes management, and increased freedom and spontaneity in daily life (T4). These qualitative findings highlight the significant impact of Control-IQ technology on Ps glycemic control, psychological health, and their ability to engage in daily life activities. Disclosure H. Singh: Employee; Self; Tandem Diabetes Care. M. Mcelwee-malloy: Employee; Self; Tandem Diabetes Care. H. Sanchez: Employee; Self; Tandem Diabetes Care. S. Habif: Employee; Self; Tandem Diabetes Care.

Background: Understanding qualities that make up trust in AID systems is imperative for successful development of systems built for long-term use. Previous research has demonstrated that trust is associated with: (a) better glycemic outcomes, (b) decreased self-management burdens, and (c) continued use of therapy. Method: In December 2018, 5,037 individuals with diabetes responded to an online survey administered by dQ&A. We analyzed a subgroup of 386 survey participants who reported on their use of an AID system (The t:slim X2™ insulin pump with Basal-IQ® technology from Tandem Diabetes Care® = 116 ; The MiniMed 670G insulin pump system from Medtronic = 270). Results: Hierarchical multiple regression analysis was used to ascertain the significance of ease of use (device level) and psychosocial (individual level) predictors of trust in AID systems. There were no issues with multicollinearity (all VIFs &lt; 3). In Model 1, ease of use accounted for 45% of variance in trust, F (3,382) = 106.74, p &lt; .001. After psychosocial predictors were added in Model 2, variance accounted for was 64%, explaining an additional 19% of unique variance in trust, F (3,379) = 65.46, p &lt; .001. Conclusion: These findings suggest that both ease of use and psychosocial outcomes are distinctly informative and instrumental in the development of trust in AID systems. Disclosure M.L. Manning: Employee; Self; Tandem Diabetes Care. M. McElwee-Malloy: Employee; Self; Tandem Diabetes Care. K.C. Stoner: Other Relationship; Self; Multiple companies and organizations in the diabetes field (greater than 10). S. Habif: Employee; Self; Tandem Diabetes Care.