Advanced Diabetes Technologies Research Articles

Advances in diabetes technology to improve the lives of people with cystic fibrosis.

People with cystic fibrosis (CF) are at risk for dysglycaemia caused by progressive beta cell dysfunction and destruction due to pancreatic exocrine disease and fibrosis. CF-related diabetes (CFRD) is a unique form of diabetes that has distinctive features from both type 1 and type 2 diabetes. Recent advances in diabetes technology may be of particular benefit in this population given the complex, multi-system organ involvement and challenging health issues that people with CFRD often face. This review summarises how diabetes technologies, such as continuous glucose monitors (CGMs) and insulin delivery devices: (1) have improved our understanding of CFRD, including how hyperglycaemia affects clinical outcomes in people with CF; (2) may be helpful in the screening and diagnosis of CFRD; and (3) offer promise for improving the management of CFRD and easing the burden that this diagnosis can add to an already medically complicated patient population.

Navigating Advanced Diabetes Technologies in Perioperative Practice: A Survey of Pediatric Anesthesiologists.

Navigating Advanced Diabetes Technologies in Perioperative Practice: A Survey of Pediatric Anesthesiologists.

Technology advances in diabetes pregnancy: right technology, right person, right time.

This review outlines some of the extraordinary recent advances in diabetes technology, which are transforming the management of type 1 diabetes before, during and after pregnancy. It highlights recent improvements associated with use of continuous glucose monitoring (CGM) but acknowledges that neither CGM nor insulin pump therapy are adequate for achieving the pregnancy glucose targets. Furthermore, even hybrid closed-loop (HCL) systems that are clinically effective outside of pregnancy may not confer additional benefits throughout pregnancy. To date, there is only one HCL system, the CamAPS FX, with a strong evidence base for use during pregnancy, suggesting that the pregnancy benefits are HCL system specific. This is in stark contrast to HCL system use outside of pregnancy, where benefits are HCL category specific. The CamAPS FX HCL system has a rapidly adaptive algorithm and lower glucose targets with benefits across all maternal glucose categories, meaning that it is applicable for all women with type 1 diabetes, before and during pregnancy. For women of reproductive years living with type 2 diabetes, the relative merits of using non-insulin pharmacotherapies vs diabetes technology (dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter 2 inhibitors) are unknown. Despite the urgent unmet need and potential benefits, studies of pharmacotherapy and technology use are extremely limited in pregnant women with type 2 diabetes.

Review Article - Diabetes Technology in the Hospital: An Update.

There have been many developments in diabetes technology in recent years, with continuous glucose monitoring (CGM), insulin pump therapy (CSII) and automated insulin delivery (AID) becoming progressively accepted in outpatient diabetes care. However, the use of such advanced diabetes technology in the inpatient setting is still limited for several reasons, including logistical challenges and staff training needs. On the other hand, hospital settings with altered diet and stress-induced hyperglycemia often pose challenges to tight glycemic control using conventional treatment tools. Integrating smarter glucose monitoring and insulin delivery devices into the increasingly technical hospital environment could reduce diabetes-related morbidity and mortality. This narrative review describes the most recent literature on the use of diabetes technology in the hospital and suggests avenues for further research. Advanced diabetes technology has the potential to improve glycemic control in hospitalized people with and without diabetes, and could add particular value in certain conditions, such as nutrition therapy or perioperative management. Taken together, CGM allows for more accurate and patient-friendly follow-up and ad hoc titration of therapy. AID may also provide benefits, including improved glycemic control and reduced nursing workload. Before advanced diabetes technology can be used on a large scale in the hospital, further research is needed on efficacy, accuracy and safety, while implementation factors such as cost and staff training must also be overcome.

Mitigating Severe Hypoglycemia in Users of Advanced Diabetes Technologies: Impaired Awareness of Hypoglycemia and Unhelpful Hypoglycemia Beliefs as Targets for Interventions.

Objective: A subgroup analysis of the Hypoglycemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycemia persisting despite optimized care (HARPdoc) trial was conducted to explore the impact of Blood Glucose Awareness Training (BGAT, a hypoglycemia awareness training program) and the HARPdoc (a psychoeducation addressing unhelpful hypoglycemia beliefs) in reducing severe hypoglycemia (SH) in individuals using advanced diabetes technologies (ADTs). Methods: Data from trial participants who utilized ADTs, including continuous glucose monitors or automated insulin delivery systems, were extracted. Generalized linear mixed-effects models with Poisson distribution or linear mixed-effects models were used to evaluate SH incidence, and Gold questionnaire, Attitudes to Awareness of Hypoglycemia (A2A), Problem Areas in Diabetes (PAID), Hospital Anxiety and Depress Scale (HADS)-anxiety, and HADS-depression scores as measures of hypoglycemia awareness, unhelpful hypoglycemia beliefs, diabetes distress, and anxiety and depression symptoms, respectively. Results: In the 45 participants using ADTs, the BGAT and HARPdoc interventions both reduced SH incidence by more than 50% (P < 0.0001) and yielded improvements in hypoglycemia awareness (P < 0.05). HARPdoc outperformed BGAT in reducing SH at month 24 (P = 0.01). HARPdoc also mitigated unhelpful hypoglycemia beliefs (P < 0.0001), diabetes distress (P < 0.05), and anxiety symptoms (P < 0.05); BGAT demonstrated no significant impacts in these respects. Neither HARPdoc nor BGAT had significant effects on depression symptoms. Conclusion: Psychoeducation (BGAT and HARPdoc) was effective in reducing SH in people using ADTs. HARPdoc may also provide greater long-term SH reduction and improves psychological well-being in this patient group.

Technology for the Management of Type 1 Diabetes Mellitus in Saudi Arabia and MENA Region: A Systematic Review.

Diabetes technology in the form of digital health or medical devices holds a promise for improving the quality of life and glycemic outcomes. A comprehensive insight into diabetes technology and its impact in Saudi Arabia and the MENA region may improve type 1 diabetes mellitus (T1DM) management. This study aimed to assess the impact of different DM-specific technologies: insulin pump therapy, continuous glucose monitoring (CGM), and automated insulin delivery system in terms of glycemic control and QoL among T1DM patients in Saudi Arabia and the MENA region. A systematic literature search was performed in PubMed and Scopus from 2005 until August 2023. The search was based on the PICO strategy, focusing on T1DM patients, diabetes technology, and QoL. The inclusion criteria were studies illustrating the effect of diabetes technologies on glycemic control or quality of life or both among T1DM patients. Systematic reviews, books, letters, or studies, including type 2 diabetes mellitus, were excluded. From 101 articles, eighteen studies were duplicated, and thirty-three studies were excluded after reading the title and abstract. Of the 50 articles analyzed, twenty-five articles did not meet the inclusion criteria. Therefore, 25 articles involving a total of 3088 participants were enrolled in the study. It was shown that a continuous glucose monitoring system and continuous subcutaneous insulin infusion improved the glycemic control and the QoL of T1DM patients. There was a positive impact of insulin pumps, continuous glucose monitoring (CGM) systems, and telemedicine in achieving optimal glucose control and better QoL. Further studies are recommended to clarify the significant role of advanced diabetes technologies.

A Diabetes Pregnancy Technology Roadmap: The 2023 Norbert Freinkel Award Lecture.

Norbert Freinkel emphasized the need for "more aggressive therapy with exogenous insulin" during type 1 diabetes (T1D) pregnancy. Recent advances in diabetes technology, continuous glucose monitoring (CGM), and hybrid closed-loop (HCL) insulin delivery systems allow us to revisit Freinkel's observations from a contemporary perspective. The Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) led to international recommendations that CGM be offered to all pregnant women with T1D to help them meet their pregnancy glucose targets and improve neonatal outcomes. However, despite CGM use, only 35% of trial participants reached the pregnancy glucose targets by 35 weeks' gestation, which is too late for optimal obstetric and neonatal outcomes. The constant vigilance to CGM data and insulin dose adjustment, with perpetual worry about the impact of hyperglycemia on the developing fetal structures, leave many pregnant women feeling overwhelmed. HCL systems that can adapt to marked gestational changes in insulin sensitivity and pharmacokinetics may help to bridge the gap between the nonpregnant time in range glycemic targets (70-180 mg/dL) and the substantially more stringent pregnancy-specific targets (TIRp) (63-140 mg/dL) required for optimal obstetric and neonatal outcomes. Use of HCL (CamAPS FX system) was associated with a 10.5% higher TIRp, 10.2% less hyperglycemia, and 12.3% higher overnight TIRp. Clinical benefits were accompanied by 3.7 kg (8 lb) less gestational weight gain and consistently achieved across a representative patient population of insulin pump or injection users, across trial sites, and across maternal HbA1c categories. Working collaboratively, women, HCL technology, and health care teams achieved improved glycemia with less worry, less work, and more positive pregnancy experiences.

Severe Hypoglycemia and Impaired Awareness of Hypoglycemia Persist in People With Type 1 Diabetes Despite Use of Diabetes Technology: Results From a Cross-sectional Survey.

To determine how diabetes technologies, including continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems, impact glycemic metrics, prevalence of severe hypoglycemic events (SHEs), and impaired awareness of hypoglycemia (IAH) in people with type 1 diabetes in a real-world setting within the U.S. In this retrospective, observational study with cross-sectional elements, participants aged ≥18 years were enrolled from the T1D Exchange Registry/online community. Participants completed a one-time online survey describing glycemic metrics, SHEs, and IAH. The primary objective was to determine the proportions of participants who reported achieving glycemic targets (assessed according to self-reported hemoglobin A1c) and had SHEs and/or IAH. We performed additional subgroup analyses focusing on the impact of CGM and insulin delivery modality. A total of 2,074 individuals with type 1 diabetes were enrolled (mean ± SD age 43.0 ± 15.6 years and duration of type 1 diabetes 26.3 ± 15.3 years). The majority of participants (91.7%) were using CGM, with one-half (50.8%) incorporating AID. Despite high use of diabetes technologies, only 57.7% reported achieving glycemic targets (hemoglobin A1c <7%). SHEs and IAH still occurred, with ∼20% of respondents experiencing at least one SHE within the prior 12 months and 30.7% (95% CI 28.7, 32.7) reporting IAH, regardless of CGM or AID use. Despite use of advanced diabetes technologies, a high proportion of people with type 1 diabetes do not achieve glycemic targets and continue to experience SHEs and IAH, suggesting an ongoing need for improved treatment strategies.

Outpatient screening for anxiety and depression symptoms in adolescents with type 1 diabetes - a cross-sectional survey

BackgroundThe daily demands of type 1 diabetes management may jeopardize adolescents’ mental health. We aimed to assess anxiety and depression symptoms by broad-scale, tablet-based outpatient screening in adolescents with type 1 diabetes in Germany.MethodsAdolescent patients with type 1 diabetes mellitus (n = 2,394; mean age 15.4 y [SD 2.0]; 50.7% male) were screened for anxiety (GAD-7) and depression symptoms (PHQ-9) by self-report questionnaires and linked to clinical data from the DPV patient registry. Logistic regression was used to estimate the contribution of clinical parameters to positive screening results.ResultsAltogether, 30.2% showed a positive screening (score ≥ 7 in either test), and 11.3% reported suicidal ideations or self-harm. Patients with anxiety and depression symptoms were older (15.7 y [CI 15.5–15.8] vs. 15.3 y [CI 15.2–15.4]; p < 0.0001), had higher HbA1c levels (7.9% [CI 7.8-8.0] (63 mmol/mol) vs. 7.5% [CI 7.4–7.5] (58 mmol/mol); p < 0.0001), and had higher hospitalization rates. Females (adjusted odds ratio (aOR) 2.66 [CI 2.21–3.19]; p < 0.0001), patients > 15 years (aOR 1.40 [1.16–1.68]; p < 0.001), who were overweight (aOR 1.40 [CI 1.14–1.71]; p = 0.001), with HbA1c > 9% (> 75 mmol/mol; aOR 2.58 [1.83–3.64]; each p < 0.0001), with a migration background (aOR 1.46 [CI 1.17–1.81]; p < 0.001), or smoking (aOR 2.72 [CI 1.41–5.23]; p = 0.003) had a higher risk. Regular exercise was a significant protective factor (aOR 0.65 [CI 0.51–0.82]; p < 0.001). Advanced diabetes technologies did not influence screening outcomes.ConclusionsElectronic mental health screening was implemented in 42 centers in parallel, and outcomes showed an association with clinical parameters from sociodemographic, lifestyle, and diabetes-related data. It should be integrated into holistic patient counseling, enabling early recognition of mild mental health symptoms for preventive measures. Females were disproportionally adversely affected. The use of advanced diabetes technologies did not yet reduce the odds of anxiety and depression symptoms in this cross-sectional assessment.

WITHDRAWN: Associations Between Hypoglycemia Awareness, Hypoglycemia Beliefs, and Continuous Glucose Monitoring Glycemic Profiles and Anxiety and Depression Symptoms in Adults with Type 1 Diabetes Using Advanced Diabetes Technologies

WITHDRAWN: Associations Between Hypoglycemia Awareness, Hypoglycemia Beliefs, and Continuous Glucose Monitoring Glycemic Profiles and Anxiety and Depression Symptoms in Adults with Type 1 Diabetes Using Advanced Diabetes Technologies

What do young people with type 1 diabetes really think about the new advances in diabetes technology?

What do young people with type 1 diabetes really think about the new advances in diabetes technology?

An mHealth Text Messaging Program Providing Symptom Detection Training and Psychoeducation to Improve Hypoglycemia Self-Management: Intervention Development Study.

Hypoglycemia remains a challenge for roughly 25% of people with type 1 diabetes (T1D) despite using advanced technologies such as continuous glucose monitors (CGMs) or automated insulin delivery systems. Factors impacting hypoglycemia self-management behaviors (including reduced ability to detect hypoglycemia symptoms and unhelpful hypoglycemia beliefs) can lead to hypoglycemia development in people with T1D who use advanced diabetes technology. This study aims to develop a scalable, personalized mobile health (mHealth) behavioral intervention program to improve hypoglycemia self-management and ultimately reduce hypoglycemia in people with T1D who use advanced diabetes technology. We (a multidisciplinary team, including clinical and health psychologists, diabetes care and education specialists, endocrinologists, mHealth interventionists and computer engineers, qualitative researchers, and patient partners) jointly developed an mHealth text messaging hypoglycemia behavioral intervention program based on user-centered design principles. The following five iterative steps were taken: (1) conceptualization of hypoglycemia self-management processes and relevant interventions; (2) identification of text message themes and message content development; (3) message revision; (4) patient partner assessments for message readability, language acceptability, and trustworthiness; and (5) message finalization and integration with a CGM data-connected mHealth SMS text message delivery platform. An mHealth web-based SMS text message delivery platform that communicates with a CGM glucose information-sharing platform was also developed. The mHealth SMS text messaging hypoglycemia behavioral intervention program HypoPals, directed by patients' own CGM data, delivers personalized intervention messages to (1) improve hypoglycemia symptom detection and (2) elicit self-reflection, provide fact-based education, and suggest practical health behaviors to address unhelpful hypoglycemia beliefs and promote hypoglycemia self-management. The program is designed to message patients up to 4 times per day over a 10-week period. A rigorous conceptual framework, a multidisciplinary team (including patient partners), and behavior change techniques were incorporated to create a scalable, personalized mHealth SMS text messaging behavioral intervention. This program was systematically developed to improve hypoglycemia self-management in advanced diabetes technology users with T1D. A clinical trial is needed to evaluate the program's efficacy for future clinical implementation.

Management of Glucose-Lowering Therapy in Older Adults with Type 2 Diabetes: Challenges and Opportunities.

The population of older adults (≥65 years) with type 2 diabetes mellitus (T2DM) is diverse, encompassing individuals with varying functional capabilities, living arrangements, concomitant medical conditions, and life expectancies. Hence, their categorization into different patient profiles (ie, good health, intermediate health, poor health) may aid in clinical decision-making when establishing glycemic goals and pharmacological treatment strategies. Further granularity in assessing each patient profile through interdisciplinary collaboration may also add precision to therapeutic and monitoring decisions. In this review, we discuss with a multidisciplinary approach how to deliver the best benefit from advanced diabetes therapies and technologies to older adults with T2DM according to each patient profile. There remain however several areas that deserve further research in older adults with T2DM, including the efficacy and safety of continuous glucose monitoring and automated insulin delivery systems, the switch to once-weekly insulin, the effectiveness of multidisciplinary care models, and the use of supported telemedicine and remote blood glucose monitoring in the oldest-old (≥85 years) who particularly require the assistance of others.

DiaTrend: A dataset from advanced diabetes technology to enable development of novel analytic solutions

Objective digital data is scarce yet needed in many domains to enable research that can transform the standard of healthcare. While data from consumer-grade wearables and smartphones is more accessible, there is critical need for similar data from clinical-grade devices used by patients with a diagnosed condition. The prevalence of wearable medical devices in the diabetes domain sets the stage for unique research and development within this field and beyond. However, the scarcity of open-source datasets presents a major barrier to progress. To facilitate broader research on diabetes-relevant problems and accelerate development of robust computational solutions, we provide the DiaTrend dataset. The DiaTrend dataset is composed of intensive longitudinal data from wearable medical devices, including a total of 27,561 days of continuous glucose monitor data and 8,220 days of insulin pump data from 54 patients with diabetes. This dataset is useful for developing novel analytic solutions that can reduce the disease burden for people living with diabetes and increase knowledge on chronic condition management in outpatient settings.

Quality of life in the course of a one-year use of an advanced hybrid closed-loop system in adults with type 1 diabetes previously naïve to advanced diabetes technology.

To evaluate the effect of a one-year use of an advanced hybrid closed-loop (AHCL) system on the quality of life, level of anxiety, and level of self-efficacy in adults with type 1 diabetes (T1D) previously treated with multiple daily injections (MDI) and naïve to advanced diabetes technology. A total of 18 participants of a previously published 3-month randomized trial (10 men, 8 women; age 40.9 ± 7.6 years) who were switched directly from MDI/BMG to AHCL completed 12 months of MiniMed 780G™system use (a 3-month randomized trial followed by a 9-month follow-up phase). At month 6 of the study, patients were switched from the sensor GS3 (Continuous Glucose Monitoring) system, powered by Guardian™ Sensor 3) to GS4. Quality of life was assessed using the Polish validated version of the 'QoL-Q Diabetes' questionnaire. The level of anxiety was evaluated with the use of the State-Trait Anxiety Inventory (STAI). Self-efficacy was assessed with the General Self-Efficacy Scale (GSES). Results were obtained at baseline and at the end of the study. Significant increase in QoL was reported in the global score (p=0.02, Cohen d=0.61) and in as many as 11 out of 23 analyzed areas of life: being physically active (p=0.02, Cohen d = 0.71); feeling well (p<.01, Cohen d = 0.73); feeling in control of my body (p<.01, Cohen d = 0.72); looking good (p<.01, Cohen d = 1.07); working (p<.01, Cohen d = 1.12); sleeping (p=0.01, Cohen d = 0.66); eating as I would like (p<.01, Cohen d = 0.79); looking after or being useful to others (p= 0.02, Cohen d = 0.65); being active with pets/animals (p<.01, Cohen d = 0.95); being spontaneous (p=0.02, Cohen d = 0.67); and doing "normal" things (p=0.02, Cohen d = 0.67). Both state (p=0.04, Cohen d = 0.56) and trait (p=0.02, Cohen d = 0.60) anxiety decreased while the general self-efficacy increased (p=0.03, Cohen d = 0.76). No participant stopped the use of the pump. Adult patients with T1D previously treated with MDI and naïve to modern technologies experienced significant improvement in their psychological well-being after transitioning to the AHCL system after 12 months of treatment.

653-P: Associations between Anxiety and Depression Levels and Hypoglycemia Awareness and Beliefs in Long-Term Advanced Diabetes Technology Users with Type 1 Diabetes (T1D)

The information characterizing anxiety and depression levels and associated factors in long-term T1D advanced diabetes technology users is sparse. A cross-sectional observational study in T1D adults using continuous glucose monitors (CGMs) ≥1 year was conducted in a tertiary academic medical center. The Hospital Anxiety and Depression Scale was used to evaluate anxiety levels (HADS-A) and depression levels (HADS-D). CGM % of time with glucose &amp;lt;70 mg/dL, hypoglycemia awareness (measured with Gold questionnaire), hypoglycemia beliefs (with Attitude to Awareness of Hypoglycemia questionnaire) and demographic information were collected. Multivariable linear regression was used to identify factors associated with higher HADS-A and HADS-D. Among 196 participants (63% female; mean±SD age 47±16; 91% non-Hispanic Caucasian; 80% using insulin pumps with 55% closed-loop pump users), mean±SD HADS-A was 6.5±4.0 (40% scores≥8), HADS-D was 4.1±3.1 (15% score≥8), and % of CGM time &amp;lt;70 mg/dL was 2.0±3.0%; 34% had impaired hypoglycemia awareness. Higher HADS-A was independently associated with less time with glucose &amp;lt;70 mg/dL, female sex, younger age, lower hypoglycemia awareness, weaker hypoglycemia concern minimization, and stronger hyperglycemia avoidance prioritization (P&amp;lt;0.05). Higher HADS-D was independently associated with less time with glucose &amp;lt;70 mg/dL, lower hypoglycemia awareness, and stronger hyperglycemia avoidance prioritization (P&amp;lt;0.05). In summary, clinically significant anxiety and depression presented in 40% and 15% of T1D patients using advanced diabetes technologies, respectively. Hypoglycemia awareness and hypoglycemia beliefs, rather than time spent in hypoglycemia, were associated with greater anxiety and depression levels. Attention to hypoglycemia awareness, hypoglycemia beliefs and mental health are needed to improve overall outcomes in T1D advanced technology users. Disclosure Y. Lin: None. J.E. Aikens: None. W. Ye: None. G. Piatt: None. S. Fisher: None. R. Busui: Board Member; American Diabetes Association. Consultant; Averitas Pharma, Inc., Lexicon Pharmaceuticals, Inc., Nevro Corp. Research Support; Novo Nordisk. Consultant; Novo Nordisk, Roche Diagnostics. Research Support; Medtronic, National Institutes of Health. Consultant; Procter &amp; Gamble. Funding National Institute of Diabetes and Digestive and Kidney Diseases (K23DK129724); Michigan Center for Clinical and Translational Research (P30DK092926)

900-P: Patient-Reported Outcomes of Adults with Type 1 Diabetes Using Do-It-Yourself Compared with Commercial Automated Insulin Delivery Systems

Introduction: We aim to assess the difference between open-source do-it-yourself (DIY) and commercial automated insulin delivery (AID) systems in patient-reported outcomes (PRO) of adults with type 1 diabetes (T1D). Methods: Analysis from a prospective, non-inferiority, non-randomized, parallel-cohort study involving 78 non-pregnant adults with T1D, AID users ≥3 months and living in Canada. Participants (25 DIYAID and 53 commercial AID users, 60.3% females, mean age 41.2±14.6 years, mean T1D duration 27.0±14.7 years, median [Q1, Q3] duration of AID use 15.6 [7.8, 27, 4] months, mean HbA1c 6.7±0.7%, median time in range [TIR 70-180 mg/dl] 74.3% [66.8, 81.0]) completed the following validated PRO questionnaires: Diabetes Distress Scale (DDS, high distress level defined as &amp;gt;2.0), Diabetes Treatment Satisfaction Questionnaire (DTS-Q), An Audit of Diabetes-Dependent Quality of Life (ADD-QoL), Hypoglycemia Fear Score II (HFS-II, fear of hypoglycemia defined as scoring ≥3 in any worry subscale item), Pittsburgh Sleep Quality Index (PSQI, poor sleep defined as &amp;gt;5), Clarke and Gold score (hypoglycemia unawareness defined as either score ≥4). Results: DIYAID users reported better sleep quality (66.7% vs 33.3%, p=0.02) and lower HFS-II worry subscale score (28.2 vs 33.2, p=0.03) than commercial AID users, but results did not remain significant after adjusting for sex, age, level of education, T1D and AID use duration, HbA1c, and TIR. The two groups were otherwise comparable in other PROs. Overall, one third of participants reported diabetes distress, 88.3% reported poor sleep, 20.8% reported impaired hypoglycemia awareness and 80.5% reported fear of hypoglycemia. Conclusion: Similar broad QoL and other PROs were observed between DIYAID and commercial AID users, with a persistent and significant diabetes burden for all, despite advanced diabetes technology use and optimal glycemic management. Disclosure M.Lebbar: None. Z.Wu: Other Relationship; Eli Lilly and Company. A.C.Bonhoure: Consultant; Dexcom, Inc. V.Messier: None. A.Brazeau: Other Relationship; Dexcom, Inc., Diabète québec, Ordre des diététistes nutritionnistes du Québec, Research Support; Canadian Institutes of Health Research, Fonds de recherche du Québec en Santé. R.Rabasa-lhoret: Consultant; Dexcom, Inc., Abbott, Janssen Pharmaceuticals, Inc., Novo Nordisk Canada Inc., Sanofi, Lilly, Tandem Diabetes Care, Inc., Insulet Corporation. Funding Canadian Institutes of Health Research (148464)

396-P: The Humanistic Burden of Type 1 Diabetes in U.S. Adults With or Without Recurrent Severe Hypoglycemic Events—A Qualitative Interview Study

Introduction: Despite advances in technology, many people with type 1 diabetes (T1D) still experience severe hypoglycemic events (SHEs). This study explored the perceived humanistic burden of T1D in adults using continuous glucose monitor (CGM) in the US with or without recurrent SHEs. Methods: In 60-minute semi-structured interviews, adult CGM users with self-reported T1D diagnosis (≥5 yrs.) described the burden of TID on quality of life (QoL). Participants ranked the ‘top 3’ negative impacts of T1D on QoL. Subgroup analyses were conducted in participants with recurrent SHE (rSHE; ≥2 SHEs last yr.) and without recurrent SHE (nSHE; ≤1 SHEs last yr.). Results: Participants (N=31; 42% rSHEs, 58% nSHEs) were 74% female and 81% were married. Mean age of T1D diagnosis was 28 yrs. Median SHEs in the past year in the rSHE group were 3 and in the nSHE group were 0. Both groups had mean HbA1c of 7.1%. rSHE and nSHE participants used hybrid closed loop systems (hCLS) (53.8% vs. 44.4%), multiple daily injections (23.1% vs. 33.3%) and continuous subcutaneous insulin infusion pump without hCLS (23.1% vs. 22.2%), respectively. All participants reported negative impacts on physical health, mental health, sleep, relationships, leisure activities, work/studies, and sex life. The ‘top 3’ ranked impacts for the rSHE cohort were physical health and sleep (tied at first) followed by leisure activities. Impacts to physical health, mental health, and relationships were ‘top 3’ for the nSHE cohort. Conclusions: Recurrent severe hypoglycemia is observed to persist despite use of advanced diabetes technology. Negative impacts on physical health ranked as the primary concern in both rSHE and nSHE cohorts. However, moderate variability in ranked negative impact order was observed between the cohorts. Disclosure A.Boateng-kuffour: None. P.Callahan: Consultant; Rhythm Pharmaceuticals, Inc., Abbott Diabetes, HealthCore Inc., BMS, Employee; Vertex Pharmaceuticals Incorporated, Genesis Research. K.Chandarana: Employee; Vertex Pharmaceuticals Incorporated, Stock/Shareholder; Vertex Pharmaceuticals Incorporated. J.L.Gaglia: Advisory Panel; Dompé, Consultant; Vertex Pharmaceuticals Incorporated, Abata Therapeutics, Avotres Inc., Current Health, Research Support; Avotres Inc., Dompé, Imcyse, Stock/Shareholder; Vertex Pharmaceuticals Incorporated. M.Phinney: None. E.Guzman ortega: Research Support; Vertex Pharmaceuticals Incorporated. R.N.Krupnick: Consultant; Vertex Pharmaceuticals Incorporated. M.Reaney: None. W.H.Polonsky: Consultant; Abbott Diabetes, Boehringer Ingelheim and Eli Lilly Alliance, Eli Lilly and Company, Insulet Corporation, Intuity Medical, Inc., MannKind Corporation, Provention Bio, Inc., Sanofi-Aventis U.S., Vertex Pharmaceuticals Incorporated.

1086-P: Humanistic Burden of Type 1 Diabetes in U.S. Adults across Different Age Cohorts—A Qualitative Interview Study

Introduction: This study explores the perceived humanistic burden of type 1 diabetes (T1D) across different age cohorts of adults (18-35 yrs., 36-64 yrs., and 65+ yrs.) in the US who are using continuous glucose monitors (CGM). Methods: Adult CGM users (≥18 years of age) with self-reported T1D diagnosis (≥ 5 yrs.) were interviewed to evaluate the impact of T1D on quality of life (QoL). Participants ranked the ‘top 3’ negative impacts of T1D on QoL using a “Wheel of Life” visual framework, which helped participants identify and describe the multi-faceted impacts of T1D on QoL. Interview transcripts were thematically analyzed. Subgroup analyses were conducted by age cohort. Results: Overall, 31 participants (18-35 yrs., n=10; 36-64 yrs., n=12; 65+ yrs., n=9) took part in the study. Participants were mostly female (74%) and married (81%), with a mean age at diagnosis of 28 yrs. and a reported mean HbA1c level of 7.1% (range: 5.0% - 9.9%); 42% reported having ≥ 2 severe hypoglycemic events (SHEs) in the past year. Impacts on physical health, mental health, sleep, relationships, leisure activities, work/studies, and sex life were reported by participants as affecting their daily lives. Physical health impacts were most frequently ranked in “top 3” negative impacts across age cohorts. Negative impacts on physical health, mental health and sleep were ranked as “top 3” for both the 18-35 yrs. and the 36-64 yrs. age cohorts, while negative impacts on physical health, leisure activities, and relationships were top ranked by the 65+ yrs. cohort. Conclusions: Despite use of advanced diabetes technologies, the humanistic burden of T1D persists across adults of different age cohorts. Participants in all age cohorts reported physical health as the leading negative impact to QoL, while other perceived negative impacts varied in rank order across age cohorts. Disclosure P. Callahan: Employee; Vertex Pharmaceuticals Incorporated, Genesis Research. Consultant; Rhythm Pharmaceuticals, Inc., Abbott Diabetes, HealthCore Inc., BMS. A. Boateng-Kuffour: None. K. Chandarana: Employee; Vertex Pharmaceuticals Incorporated. Stock/Shareholder; Vertex Pharmaceuticals Incorporated. J.L. Gaglia: Consultant; Vertex Pharmaceuticals Incorporated. Stock/Shareholder; Vertex Pharmaceuticals Incorporated. Consultant; Abata Therapeutics, Avotres Inc. Research Support; Avotres Inc. Advisory Panel; Dompé. Research Support; Dompé, Imcyse. Consultant; Current Health. M. Phinney: None. E. Guzman Ortega: Research Support; Vertex Pharmaceuticals Incorporated. R.N. Krupnick: Consultant; Vertex Pharmaceuticals Incorporated. M. Reaney: None. W.H. Polonsky: Consultant; Abbott Diabetes, Boehringer Ingelheim and Eli Lilly Alliance, Eli Lilly and Company, Insulet Corporation, Intuity Medical, Inc., MannKind Corporation, Provention Bio, Inc., Sanofi-Aventis U.S., Vertex Pharmaceuticals Incorporated.

Beyond A1C: exploring continuous glucose monitoring metrics in managing diabetes.

Hemoglobin A1c (HbA1c) has long been considered a cornerstone of diabetes mellitus (DM) management, as both an indicator of average glycemia and a predictor of long-term complications among people with DM. However, HbA1c is subject to non-glycemic influences which confound interpretation and as a measure of average glycemia does not provide information regarding glucose trends or about the occurrence of hypoglycemia and/or hyperglycemia episodes. As such, solitary use of HbA1c, without accompanying glucose data, does not confer actionable information that can be harnessed to guide targeted therapy in many patients with DM. While conventional capillary blood glucose monitoring (BGM) sheds light on momentary glucose levels, in practical use the inherent infrequency of measurement precludes elucidation of glycemic trends or reliable detection of hypoglycemia or hyperglycemia episodes. In contrast, continuous glucose monitoring (CGM) data reveal glucose trends and potentially undetected hypo- and hyperglycemia patterns that can occur between discrete BGM measurements. The use of CGM has grown significantly over the past decades as an ever-expanding body of literature demonstrates a multitude of clinical benefits for people with DM. Continually improving CGM accuracy and ease of use have further fueled the widespread adoption of CGM. Furthermore, percent time in range correlates well with HbA1c, is accepted as a validated indicator of glycemia, and is associated with the risk of several DM complications. We explore the benefits and limitations of CGM use, the use of CGM in clinical practice, and the application of CGM to advanced diabetes technologies.