ATTD 2021 Invited Speaker Abstracts.

The Official Journal of ATTD Advanced Technologies & Treatments for Diabetes Conference 22‐25 February 2023 I Berlin & Online

Real-World Diabetes Technology: Overcoming Barriers and Disparities.

How can we reach the target of glucose control in type 1 diabetes?

Virtual Clinics for Diabetes Care.

Predictors of use and improvement in glycemic indices after initiating continuous glucose monitoring in real world: Data from Saudi Arabia

COVID-19 Pandemic and Diabetes Care.

Diabetes mellitus, a global health concern, is characterized by complex pathophysiology and presents diverse clinical challenges. Effective management of diabetes hinges on key principles such as glycemic control, lifestyle modifications, and adherence. In non-insulin-requiring Type 2 diabetes (T2D), persistent elevated HbA1c levels remain a challenge. Continuous glucose monitoring (CGM) is pivotal, serving as a cornerstone for optimizing therapy, mitigating hypoglycemia, and reducing the financial burden. Unlike traditional self-monitoring of blood glucose (SMBG), CGM offers continuous, pain-free data, aiding treatment decisions. This review explores CGM’s multifaceted role in non-insulin requiring T2D, scrutinizing HbA1c reduction, glycemic variability, time in range (TIR), exercise, dietary management, early comorbidity detection, and cost-effectiveness. CGM empowers users to monitor and manage their glycemic levels, making it an effective tool for HbA1c reduction. Glycemic variability poses risks, and CGM provides valuable metrics like time below range (TBR), time in range (TIR), and time above range (TAR). CGM effectively minimizes glycemic variability and improves TIR in non-insulin requiring T2D. Additionally, CGM aids in real-time decision-making for physical activity and dietary choices, enhancing the effectiveness of lifestyle modifications. It also assists healthcare providers in identifying early signs of comorbidities, particularly cardiovascular disease, and diabetic retinopathy, through monitoring glycemic variability. While CGM devices may incur costs, studies suggest their cost-effectiveness, considering long-term benefits and complications prevention. This review underscores CGM’s importance in T2D management, even for non-insulin-requiring individuals. Recommendations include CGM use for newly diagnosed people with T2D, those with uncontrolled diabetes, and those adjusting treatments. Personalized glycemic control goals are proposed, aligning CGM’s role in managing hypoglycemia, hyperglycemia, and glycemic variability in T2D. As CGM technology advances and becomes more accessible, it is poised to play an increasingly pivotal role in diabetes management. Crucially, CGM should be employed in consultation with healthcare providers, considering regional disparities in cost-effectiveness and accessibility influenced by insurance coverage and government interventions.

T he past year saw marked advances in research in pediatric diabetes with numerous studies investigating the use of closed-loop systems in the pediatric population. While such technologies are on the horizon for clinical use in pediatrics, other studies in the past year have highlighted the challenges with clinical implementation of insulin pump therapy, a technology that has been available for decades. The hope for an automatedor initially a semiautomated or hybrid closed-loop system requiring the user to give premeal boluses of insulinis well deserved. These systems aim to improve glucose control and lower the burden of care for children with type 1 diabetes (T1D) and their families. However, initial systems will continue to require significant user involvement as well as experienced and informed pediatric diabetes teams for successful adoption of these diabetes technologies. In addition, advances were seen in the use of a novel intranasal formulation of glucagon to treat hypoglycemia that simplifies the current injectable version of this potentially lifesaving medication. A randomized trial on the benefits of metformin in overweight adolescents with T1D found no benefit on HbA1c, but other potential metabolic improvements. Technology was also studied using telehealth to improve diabetes outcomes by delivering care to rural populations and in pediatric patients struggling to achieve treatment goals. Research in diabetes technology in pediatrics has accelerated in the past few years and with the advent of clinical availability of closed-loop technology promises to remain a rich field of investigation for years to come. Pediatric patients and their families should begin to reap the benefits of decades of work on these diabetes technologies to improve glucose control and lower the burden of care for diabetes. We conducted a Medline search for articles on the following topics: diabetes technology, insulin pump therapy (continuous subcutaneous insulin infusion [CSII]), continuous glucose monitoring (CGM), closed-loop systems, and new therapies in T1D relating to the pediatric age group (0-18 years). This article focuses on key articles that were published between July 1, 2015 and June 30, 2016. Use of insulin pump therapy in children and adolescents with type 1 diabetes and its impact on metabolic control: comparison of results from three large, transatlantic paediatric registries

Disclosure: A.Y. Mazori: None. E.S. Markovic: None. C.J. Levy: Advisory Board Member; Self; Dexcom, Eli Lilly & Company. Research Investigator; Self; Abbott Laboratories, Insulet Corporation, Tandem Diabetes Care, Dexcom. Introduction: Glycemic control remains challenging in pregnancies complicated by diabetes mellitus. Strict glycemic targets are required to optimize maternal and neonatal outcomes, but euglycemia is hindered by fluctuating insulin sensitivity and the need for frequent blood-glucose monitoring (BGM). Consensus guidelines recommend therapeutic continuous glucose monitoring (CGM) for pregnant and nonpregnant individuals with type 1 and type 2 diabetes, but current data support therapeutic CGM use in cystic fibrosis (CF)-related diabetes (CFRD) only outside of pregnancy. We report the case of a patient with CFRD who achieved recommended glycemic targets with a therapeutic CGM during a singleton pregnancy. Methods: A case report and literature review are presented. Results: A 32-year-old nulliparous woman with CF became pregnant via frozen-embryo transfer. Prior CF complications included CFRD, pancreatic insufficiency, and recurrent pancreatitis. A therapeutic Dexcom G6 CGM and intermittent BGM were used to monitor glycemic control before and during pregnancy; sensor use exceeded 96%. Pressure-induced sensor attenuations yielded sporadic hypoglycemic values discordant with simultaneous BGM. CGM analysis for the 90 days preceding conception revealed: time in range of 63-140 mg/dL (TIR) was 90.8%, time above range (TAR) 6.3%, and time below range (TBR) 2.9%. Throughout pregnancy, TIR was 92.9%, TAR 3.4%, and TBR 3.6%; no severe hypoglycemia occurred. Daytime (6AM to midnight) and nighttime hypoglycemia were 4.6% and 2.2%, respectively. In the first trimester, TIR was 90.8%, TAR 3.7%, and TBR 5.5%. During the second trimester, the patient achieved TIR 94.2%, TAR 2.6%, and TBR 3.2%. In the third trimester, TIR was 95.7%, TAR 0.9%, and TBR 3.4%. The pregestational CFRD regimen consisted of insulin glargine 12 units and lispro 3-8 units. The basal-insulin dose was 10 units at 13 weeks’ gestation, 9 units at 27 weeks’ gestation, and 8 units at 38 weeks’ gestation. The prandial-insulin doses varied between 1.5-5 units at 13 weeks’ gestation, 0-7 units at 27 weeks’ gestation, and 0-5 units at 38 weeks’ gestation. After an uncomplicated vaginal delivery at 38 weeks and six days’ gestation, maternal fasting hypoglycemia occurred after one dose of glargine 3 units. Euglycemia was obtained without basal, prandial, or correctional insulin. The neonate experienced mild hypoglycemia that resolved with oral glucose gel and feeding. The neonate was neither macrosomic nor large for gestational age (birth weight, 3.54 kg, 71st percentile) and did not require intensive-care unit management. Both the patient and neonate were discharged on postpartum day two. Conclusion: Therapeutic CGM use in a pregnancy complicated by CFRD was effective for maternal and neonatal outcomes. Further study is warranted to examine CGM use and efficacy in this population. Presentation: Saturday, June 17, 2023

BackgroundLifestyle modification is an integral aspect for the management of type 2 diabetes (T2D). However, it is difficult to ensure the accuracy of personalized lifestyle advice. The study aims to analyse the real-world effectiveness of personalized glycemic response based Diabefly-Pro digital therapeutics for better glycemic control.MethodsData from continuous glucose monitoring (CGM) of 64 participants with T2D was analysed. All participants were provided with modified lifestyle plan based on their personalized glycemic response. The CGM data was analysed for a period of 7 days, before and after the introduction of modified lifestyle plan. Primary outcome of the study was change in time in range (TIR). Secondary outcomes of the study were change in mean blood glucose, time above range (TAR), time below range (TBR) and glucose management indicator (GMI).ResultsSignificant improvement in glycemic control was observed after the introduction of personalized lifestyle plan. Median reduction in mean blood glucose was from 139.5 (118.3 to 169.3) mg/dL to 122.0 (101.5 to 148.8) mg/dL (p < 0.0001). TIR and GMI improved from 70.50 (50.75 to 83.50) % to 75.00 (58.25 to 89.00) % (p = 0.0001) and 6.64 (6.13 to 7.35) % to 6.23 (5.74 to 6.86) % (p < 0.0001) respectively. TAR reduced significantly from 17.00 (4.25 to 38.0) % to 6.00 (1.25 to 26.0) % (p < 0.0001). No significant increase in TBR was observed (p = 0.198).ConclusionPersonalized glycemic response-based Diabefly-Pro digital therapeutics program was effective in achieving better glycemic control in people with T2D.

California Children’s Services (CCS) is a supplemental state medical insurance for low income children with chronic medical conditions. Until June 2016, continuous glucose monitors (CGM) were rarely covered by CCS for children with type 1 diabetes (T1D). Current CCS criteria for CGM includes: checking blood sugar 4 times/day and concerns that interfere with T1D management (such as fear of hypoglycemia). Ongoing approval requires CGM use for 5/7 days/week. We evaluated 6 months of CGM use by the first 41 children approved by CCS attending our clinics (age= 11.1 ± 4.7 years [range 3-21 years], T1D duration=4.8 ± 3.7 years, 59% male, 66% on pumps, 63% ethnic minorities and 15% non-English speakers). Most patients used the Dexcom receiver (73%). Thirty-three (81%) remained on CGM for ≥6 months. Of the 8 who stopped, 2 were due to lapses in insurance coverage. The other 6 stopped due to personal preference (5 within 3 months). All who stopped CGM use were English speakers. Among those who continued CGM with complete data (n=29, 71%), the mean percentage time worn at 6 months was 97±8% based on review of the CGM download. HbA1c remained stable over 6 months of CGM use (8.2±1.2%). Blinded CGM use was not available prior to initiation of personal CGM, so we cannot assess if hypoglycemia decreased. However, many of these children with CCS started CGM due to hypoglycemia and/or fear of hypoglycemia. Time in hypoglycemia as low at 6 months (4.3±4.8%). The number of fingersticks remained stable with 6.3/d at initiation and 5.6/d at 6 months. Our clinic data from the first 41 CCS patients approved for CGM demonstrates sustained CGM use for 6 months, even among non-English speakers. In this initial chart review, the incidence of hypoglycemia is low while on CGM. These data on sustained usability of CGM support CCS coverage of CGM. Given FDA approval of CGM use for insulin dosing decisions, expansion of CCS coverage of CGM should be considered to improve bolus adherence. Further studies are needed to promote improved clinical use and outcomes with CGM in this population. Disclosure P. Prahalad: None. B. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company. D. Wilson: Research Support; Self; T1D Exchange, Medtronic MiniMed, Inc., Dexcom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases, Insulet Corporation. Advisory Panel; Self; Tolerion. D.M. Maahs: Advisory Panel; Self; Insulet Corporation. Consultant; Self; Abbott. Research Support; Self; Medtronic, Bigfoot Biomedical, Dexcom, Inc., Insulet Corporation, Roche Diabetes Care Health and Digital Solutions.

Background: We used continuous glucose monitoring (CGM) data to investigate glycemic outcomes in a real-world population with type 1 diabetes (T1D) from South Korea, where the widespread use of CGM and the nationwide education program began almost simultaneously. Methods: Data from Dexcom G6 users with T1D in South Korea were collected between January 2019 and January 2023. Users were included if they provided at least 90 days of glucose data and used CGM at least 70% of the days in the investigational period. The relationship between CGM utilization and glycemic metrics, including the percentage of time in range (TIR), time below range (TBR), and time above range (TAR), was assessed. The study was approved by the Institutional Review Board of Samsung Medical Center (SMC 2023-05-030). Results: A total of 2288 users were included. Mean age was 41.5 years (57% female), with average uploads of 428 days. Mean TIR was 62.4% ± 18.5%, mean TBR <70 mg/dL was 2.6% ± 2.8%, mean TAR >180 mg/dL was 35.0% ± 19.3%, mean glucose was 168.1 ± 35.8 mg/dL, mean glucose management indicator was 7.2% ± 0.9%, and mean coefficient of variation was 36.7% ± 6.0%. Users with higher CGM utilization had higher TIR (67.8% vs. 52.7%), and lower TBR <70 mg/dL (2.3% vs. 4.7%) and TAR >180 mg/dL (30.0% vs. 42.6%) than those with low CGM utilization (P < 0.001 for all). Users whose data were shared with others had higher TIR than those who did not (63.3% vs. 60.8%, P = 0.001). Conclusions: In this South Korean population, higher CGM utilization was associated with a favorably higher mean TIR, which was close to the internationally recommended target. Using its remote data-sharing feature showed beneficial impact on TIR.

Type 2 diabetes (T2D) presents significant challenges for glycemic control, especially among middle-aged adults who face declining insulin sensitivity and multiple comorbidities. Traditional glucose monitoring methods, such as self-monitoring of blood glucose (SMBG) and hemoglobin A1c (HbA1c) measurements, often fail to capture glucose variability and episodes of hypoglycemia or hyperglycemia. Continuous glucose monitoring (CGM) offers a comprehensive alternative, providing real-time data and enabling proactive management of blood sugar levels. This review examined the clinical efficacy of CGM in improving glycemic control for middle-aged adults with T2D. It highlighted CGM’s ability to reduce HbA1c, increase time in range (TIR), and detect nocturnal hypoglycemia, while also discussing its impact on patient behavior, psychological well-being, and adherence to treatment regimens. The methodology for this review involved an in-depth analysis of peer-reviewed studies and clinical trials, focusing on the use of CGM in middle-aged adults with T2D. Barriers to CGM adoption, such as cost and perceived complexity, are also discussed, alongside the potential for future advancements in CGM technology to expand its role in personalized diabetes care. This article underscored the importance of CGM in achieving better long-term glycemic outcomes and improving quality of life for this population. Keywords: Continuous Glucose Monitoring (CGM), Type 2 Diabetes (T2D), Glycemic Control, Time in Range (TIR), Patient Empowerment

Background and Aims: Insulin Degludec (IDeg) , in comparison with Insulin Glargine U100 (IGla) , reduces the risk of hypoglycemic events in people with type 1 diabetes (T1D) . The impact on CGM assessed glycemic metrics: the coefficient of variation (CV) , time in range (TIR) , time below range (TBR) , and time-above range (TAR) is less known. We present CGM results from the HypoDeg trial comparing treatment with IDeg and IGla in people with T1D and recurrent nocturnal severe hypoglycemia. Materials and Methods: This is a pre-defined optional substudy of the HypoDeg trial: a 2-year investigator-initiated, randomized, cross-over trial comparing treatment with IDeg or IGla in 149 participants with T1D and at least one nocturnal severe hypoglycemic event within the last two years. Participants underwent 2 x 6 days of blinded CGM (Medtronic iPro) in each treatment arm after 6 and 12 months of treatment. Seventy-four participants completed at least one CGM period in each treatment arm. The endpoints were CV, TIR (3.9 - 10.0 mmol/L) , TBR at level 2 (&amp;lt; 3.0 mmol/L) and TAR (&amp;gt;10.0mmol/L, &amp;gt;13.9mmol/L) . Time spent in, below, or above range provided as percentage of readings. Results: We collected 261 CGM traces with a mean (SD) observation period of 5.9 (0.7) days. The all-day CV was lower with IDeg than IGla, with a mean (SE) CV of 40.5% (0.9) and 42.5% (0.9) , respectively (p=0.009) . A difference in CV during the night (23:00h to 07:00h) drove this, with a mean CV of 35.7% (1.1) for IDeg versus 39.6% (1.1) for IGla (p=0.001) . The all-day level 2 TBR was lower with IDeg than IGla, with a mean TBR of 1.8% (0.4) and 3.1% (0.4) , respectively (p=0.001) . The percentages of TIR and TAR were not different between treatments. Conclusion: In people with T1D prone to nocturnal severe hypoglycemia, treatment with IDeg results in a lower mean CV, reaching the definition of stable glucose levels during the night and a lower all-day TBR than IGla. Disclosure J.M.Brøsen: None. S.Lerche: None. K.Nørgaard: Advisory Panel; Medtronic, Novo Nordisk A/S, Consultant; Novo Nordisk A/S, Research Support; Dexcom, Inc., Medtronic, Novo Nordisk A/S, Zealand Pharma A/S, Speaker's Bureau; Medtronic, Stock/Shareholder; Novo Nordisk A/S. L.Tarnow: None. B.Thorsteinsson: None. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. R.Agesen: Employee; Novo Nordisk A/S. A.Alibegovic: Employee; Novo Nordisk A/S, Novo Nordisk A/S. H.U.Andersen: Advisory Panel; Abbott Diabetes, Stock/Shareholder; Novo Nordisk A/S. P.Gustenhoff: Advisory Panel; Abbott Diagnostics. T.K.Hansen: None. C.Hedetoft: None. C.R.Stolberg: None. C.B.Juhl: None. Funding Novo Nordisk

Type 1 Diabetes in Children and Adolescents.