Severe Hypoglycemic Episodes Research Articles

Incidence and Costs of Hypoglycemia among Type II Diabetes Mellitus Patients in Turkey

We aimed to determine the lifetime and one-year incidence of hypoglycemia in adults who had been treated following a diagnosis of Type II Diabetes Mellitus (T2DM), the factors that affected this incidence, and its effect on the use of health care resources. The descriptive cross-sectional cost study included adult T2DM patients who had an outpatient examination. Using a face-to-face interview method, patients were required to complete a questionnaire containing questions about sociodemographic characteristics, T2DM diagnosis and treatment features, and hypoglycemia events. Episode treatment costs of the patients in whom hypoglycemia was observed were calculated as direct cost per episode from the payer perspective. The mean age of the patients (n = 220) was 48.1 ± 11.8 (range 26-79) years, and the mean duration of disease was 4.5 ± 3.0 (range 1-16) years. According to treatment modalities, the frequency of hypoglycemia in the last year was 4.7% in the patients receiving oral antidiabetic drugs and 32.7% in the patients using insulin. In addition, 61.9% of the patients who had a hypoglycemic event in the last year presented to hospital, and 57.7% of these patients were hospitalized because of the hypoglycemic event. The incidence of hypoglycemia was 18 episodes of hypoglycemia per 100 patient years for T2DM patients and 25 severe hypoglycemia episodes per 100 patient years for patients using insulin. Significant predictors of hypoglycemia included insulin therapy (p = 0.000), regular use of medications (p = 0.013), hospitalization in the last year (p = 0.008), and exercise (p = 0.042). The average cost of a hypoglycemic event was calculated as Purchasing Power Parity İn Dollars ($PPP) 1.370.2 ± 1.407.0 (149.8-5,048.8). T2DM complications are the cause of a high economic burden. Hypoglycemia, which is one of these complications, is observed more frequently in patients who receive insulin therapy, who use regular medication, who do not exercise regularly, and who have been hospitalized in the last year.

Effect of Digital-Tool-Supported Basal Insulin Titration Algorithm in Reaching Glycemic Control in Patients with Type 2 Diabetes in Mexico.

My Dose Coach (MDC) is a mobile application combined with a web portal that can suggest optimized basal insulin (BI) injection doses using Self-Measured Plasma Glucose (SMPG) and hypoglycemia data. This study aimed to evaluate its efficacy on patients reaching SMPG and Fasting blood glucose (FBG) target range 90-130 mg/dl (5-7.2 mmol/L) goals without severe hypoglycemic episodes. We also addressed the mean reduction in glycated hemoglobin (A1C), FBG, and SMPG and the improvement in the WHO's Five Well Being Index (WBI). This prospective pilot study involved the use of MDC in outpatients with type 2 diabetes (T2DM) from a Hospital in Northern Mexico. Patients on treatment with any BI were included in the study. The follow-up was of 16 weeks. Student t-tests or McNemar test were used for effect comparisons. We included 158 patients (46.8% women), mean (SD) age 51 (10.3) years. We achieved SMPG target range in 58.9% [mean (95CI) reduction of 30.9 mg/dl (22.5-37.7; P < .001)] of the patients [66(28) days], with no severe hypoglycemia events. FBG goal was reached in 55.7% [mean (95CI) reduction of 63.4 mg/dl (49.6-77.2; P < .001)]. The mean (95CI) reduction of A1C was 1.78% (1.47-2, P < .01) with the last observation carried forward. There was a mean (95CI) increase of 2.23 (-3, -1.4, P < .01) points in WBI scale. MDC successfully helped to achieve FBG and SMPG goals, reduced A1C, and increased WBI with no severe hypoglycemia events.

Clinically Serious Hypoglycemia Is Rare and Not Associated With Time-in-range in Youth With New-onset Type 1 Diabetes.

Early initiation of continuous glucose monitoring (CGM) is advocated for youth with type 1 diabetes (T1D). Data to guide CGM use on time-in-range (TIR), hypoglycemia, and the role of partial clinical remission (PCR) are limited. Our aims were to assess whether 1) an association between increased TIR and hypoglycemia exists, and 2) how time in hypoglycemia varies by PCR status. We analyzed 80 youth who were started on CGM shortly after T1D diagnosis and were followed for up to 1-year post diagnosis. TIR and hypoglycemia rates were determined by CGM data and retrospectively analyzed. PCR was defined as (visit glycated hemoglobin A1c) + (4*units/kg/day) less than 9. Youth were started on CGM 8.0 (interquartile range, 6.0-13.0) days post diagnosis. Time spent at less than 70 mg/dL remained low despite changes in TIR (highest TIR 74.6 ± 16.7%, 2.4 ± 2.4% hypoglycemia at 1 month post diagnosis; lowest TIR 61.3 ± 20.3%, 2.1 ± 2.7% hypoglycemia at 12 months post diagnosis). No events of severe hypoglycemia occurred. Hypoglycemia was rare and there was minimal difference for PCR vs non-PCR youth (54-70 mg/dL: 1.8% vs 1.2%, P = .04; < 54mg/dL: 0.3% vs 0.3%, P = .55). Approximately 50% of the time spent in hypoglycemia was in the 65 to 70 mg/dL range. As TIR gradually decreased over 12 months post diagnosis, hypoglycemia was limited with no episodes of severe hypoglycemia. Hypoglycemia rates did not vary in a clinically meaningful manner by PCR status. With CGM being started earlier, consideration needs to be given to modifying CGM hypoglycemia education, including alarm settings. These data support a trial in the year post diagnosis to determine alarm thresholds for youth who wear CGM.

Длительный гликемический контроль и факторы, ассоциированные с ответом на помповую инсулинотерапию у детей

Background : In recent years, pump-based insulin therapy, also known as continuous subcutaneous insulin infusion (CSII), has become a common treatment for children with type 1 diabetes mellitus (T1DM). Despite the fact that, in general, children with type 1 diabetes achieve the best glycemic control indices during pump therapy, while there is a significant heterogeneity of metabolic outcomes among individual patients, many children with CSII do not reach the target level of HbA1c. Objective: To assess the level of glycemic control and factors associated by withdrawal of use, the response to treatment with prolonged use of CSII in children with type 1 diabetes. Materials and methods : The study included 458 children aged 1 to 18 years, treated to pump therapy at least 3 years before the study, the presence of the analyzed data in the register. Results: The level of HbA 1c decreased by -0.7% compared with the primary endpoint, which was accompanied by an increase in the number of patients who reached the target level of HbA 1c (<7.5%) from 17% to 36%. The best response was observed for patients under 6 years of age with HbA 1c over 9% for pump insulin therapy, as well as in patients who regularly use additional bolus and basal functions and CGM. The main reason for stopping the use of the insulin pump is the inconvenience of using and wearing — 47.7%. Risk factors for pump abandonment: later age of start treatment on CSII and frequent episodes of severe hypoglycemia. Conclusion: According to the results of the study, it was shown that pump therapy is an effective method of insulin therapy, which allows to achieve a lower level of HbA 1c compared to the initial values.

Management of type 1 diabetes mellitus during the COVID-19 pandemic

BackgroundPatients with type 1 diabetes mellitus (DM) require intensive monitoring, which was adversely affected during coronavirus disease 2019 (COVID-19) restrictions. MethodsWe evaluated the management of type 1 DM and the role of telephonic consultation and follow-up in 46 patients (10 on insulin pump) with type 1 DM at our centre from 1 February 2020 to 31 January 2021. Patients were telephonically counselled fortnightly. Web-based diabetes education sessions for the patients and parents were conducted. Finally, change in HbA1c during the period of the study, frequency of severe hypoglycaemia, hospital admissions for hyperglycaemic emergencies and degree of satisfaction with care rendered by the treating team were assessed by ratings scored by the patients. ResultsFive episodes of severe hypoglycaemia were noted in three patients. Two patients had diabetic ketoacidosis. Patients on insulin pump showed a mean baseline HbA1c of 7.8%. Nine of these patients (90%) showed an improvement in Hba1c during the study period compared to 64.3% of patients on conventional regimen. There were no episodes of severe hypoglycaemia or hospitalization with DKA noted in these patients. Only two patients had COVID-19 disease with mild manifestations. Overall satisfaction levels with therapy were high. ConclusionThis study illustrates the role played by teleconsultation and video conferencing during the period of the COVID-19 pandemic in ensuring optimal healthcare delivery to patients with type 1 DM. Some of these methods can be used even after the pandemic to improve patient convenience and reduce the out-patient burden on the hospitals.

Improvements in Glycemic Control Achieved by Altering the tmax Setting in the iLet® Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial.

IntroductionWe investigated the safety of, and glucose control by, the insulin-only configuration of the iLet® bionic pancreas delivering fast-acting insulin aspart (faster aspart), using the same insulin-dosing algorithm but different time to maximal serum drug concentration (tmax) settings, in adults with type 1 diabetes.MethodsWe performed a single-center, single-blinded, crossover (two 7-day treatment periods) escalation trial over three sequential cohorts. Participants from each cohort were randomized to a default tmax setting (t65 [tmax = 65 min]) followed by a non-default tmax setting (t50 [tmax = 50 min; cohort 1], t40 [tmax = 40 min; cohort 2], t30 [tmax = 30 min; cohort 3]), or vice versa, all with faster aspart. Each cohort randomized eight new participants if escalation-stopping criteria were not met in the previous cohort.ResultsOverall, 24 participants were randomized into three cohorts. Two participants discontinued treatment, one due to reported ‘low blood glucose’ during the first treatment period of cohort 3 (t30). Mean time in low sensor glucose (< 54 mg/dl, primary endpoint) was < 1.0% for all tmax settings. Mean sensor glucose in cohorts 1 and 2 was significantly lower at non-default versus default tmax settings, with comparable insulin dosing. The mean time sensor glucose was in range (70–180 mg/dl) was > 70% for all cohorts, except the default tmax setting in cohort 1. No severe hypoglycemic episodes were reported. Furthermore, there were no clinically significant differences in adverse events between the groups.ConclusionThere were no safety concerns with faster aspart in the iLet at non-default tmax settings. Improvements were observed in mean sensor glucose without increases in low sensor glucose at non-default tmax settings.Trial RegistrationClinicalTrials.gov, NCT03816761.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01087-x.

Update on islet cell transplantation.

Chronic diabetes-related complications continue to exert a rapidly growing and unsustainable pressure on healthcare systems worldwide. In type 1 diabetes, glycemic control is particularly challenging, as intensive management substantially increase the risk of severe hypoglycemic episodes. Alternative approaches to address this issue are required. Islet cell transplantation offers the best approach to reduce hypoglycemic risks and glycemic lability, while providing optimal glycemic control. Although ongoing efforts have improved clinical outcomes, the constraints in tissue sources and the need for chronic immunosuppression limit the application of islet cell transplantation as a curative therapy for diabetes. This review provides an update on islet cell transplantation, focusing on recent clinical experience, ongoing research, and future challenges. Current evidence demonstrates advances in terms of long-term glycemic control, improved insulin independence rates, and novel approaches to eliminate chronic immunosuppression requirements after islet cell transplantation. Advances in stem cell-based therapies provide a promising path towards truly personalized regenerative therapies, solving both tissue supply shortage and the need for lifelong immunosuppression, enabling widespread use of this potentially curative treatment. However, as these therapies enter the clinical realm, regional access variability and ethical questions regarding commercialization are becoming increasingly important and require a collaborative solution. In this state-of-the-art review, we discuss current clinical evidence and discuss key aspects on the present and future of islet cell transplantation.

Real-time continuous glucose monitoring in preterm infants (react): An International, open-label, randomised, controlled trial.

Continuous interstitial glucose monitoring (CGM) is used to assess glycaemic status in some adults and older children with diabetes.1, 2 Additionally, CGM has been used in term, preterm and low birthweight newborns to evaluate glucose concentrations during the first days of life,3 to evaluate efficacy of dextrose gel in preventing hypoglycaemia,4 or to detect episodes of low glucose, which would go unrecognised with standard, intermittent blood sampling.3, 4 CGM could potentially decrease the number of invasive capillary samplings.5 In the current study, the efficacy of CGM in maintaining glucose within a specified range was investigated. Overall, the intervention arm spent more time within the target range (94%) compared to the standard group (84%) or a total of 13 more hours. Although not statistically significant, more infants in the intervention group (15% vs. 12%) experienced at least one episode of hypoglycaemia (glucose = 2.2–2.6 mmol/L) with 13% in the intervention group versus 7% in the standard group having at least one episode of severe hypoglycaemia (glucose <2.2 mmol/L), consistent with previous studies showing that hypoglycaemic episodes might go unnoticed if relying solely on intermittent sampling. Alternatively, the different incidence of hypoglycaemia could be explained by higher rate of insulin use in the intervention arm (61%) compared to the standard group (37%) and a post hoc analysis of infants receiving insulin might have clarified this possibility. The intervention group had less continuous episodes longer than one hour with sensor glucose <2.6 mmol/L and less time in the hyperglycaemic range. The use of CGM was safe regarding episodes of infection or discomfort. The protocol's6 recommendation to start or increase the insulin dose when glucose levels reach 8 mmol/L might explain why more infants in the intervention arm received insulin in the first week of life compared with the standard group. The total dose of insulin was similar between groups, raising the possibility that infants in the intervention arm might have received insulin for transient elevated glucose levels. Different glucose thresholds and different durations of elevated levels before starting insulin might change the impact of CGM on insulin exposure. One interesting exploratory finding was a higher incidence of NEC in the standard group, possibly due to more time spent in the hyperglycaemic range. This deserves further investigation. The authors did not mention the proportion of growth restricted (IUGR) or small for gestational age infants. It is worth considering whether IUGR or other subgroups of infants with increased glycaemic variability in the first week of life (infants of diabetic mothers, congenital infections and HIE) would have demonstrated a different efficacy of CGM. This study adds to the mounting evidence that CGM in preterms used to achieve glycaemic control is safe and efficacious. It extends the results from previous smaller studies to a larger, multicentre one. The optimal glucose concentration target range for preterms was not addressed. However, the results show that CGM can be used to improve future studies investigating different target glucose ranges in relationship to short- and long-term outcomes. Dr. Rozance has received a StatStrip Glucose Meter from Nova Biomedical for use in his research laboratory. https://ebneo.org/preterm-continuous-glucose-monitoring

Successful Transitioning Children and Adolescents with Type 1 Diabetes from Multiple Daily Injections to Advanced Hybrid Closed Loop System in 10 Days: A Prospective Intervention Study on MiniMed 780G System

Background: Advanced Hybrid Closed Loop (AHCL) systems provide superior glycemic control in children and adolescents with Type 1 Diabetes (T1D). Current studies included participants with previous pump and Continuous Glucose Monitoring (CGM) experience. We aimed to study transitioning these patients on Multiple Daily Injections (MDI) without prior pump experience to AHCL systems within a short period, utilizing a structured initiation protocol and the glycemic control they achieved with the MiniMed 780G system. Methods: In this prospective open label single-arm, single-center, clinical investigation, we recruited children and adolescents (aged 7-17 years) with T1D on MDI therapy and HbA1c below 12.5% from Sidra Medicine (Doha, Qatar). All participants followed a structured initiation protocol including 4 steps: step 1: AHCL system assessment (1 hour discussion with educator); step 2: AHCL system training (2-hours sessions in 4 consecutive days with groups of 2 to 3 participants and caregivers); step 3: SAP use for 3 days; step 4: AHCL system use for 12 weeks, cumulating in 10 days from MDI to AHCL initiation. The primary outcome of the study was the change in the time spent in the target in range (TIR) of 70-180 mg/dl and HbA1c from baseline (MDI + CGM, 1 week) to study phase (AHCL, 12 weeks). This study is registered with ClinicalTrials.gov, number NCT04308291, and is completed. Findings: Between October 25, 2020, and February 5, 2021, 34 participants were recruited and all of them completed the 12 weeks study. TIR increased from 42.1±18.7% at baseline to 78.8±6.1% in the study phase ( p <0.001). HbA1c decreased from 8.6±1.7% (70±18.6 mmol/mol) at baseline, to 6.5±0.7% (48±7.7 mmol/mol) at the end of the study ( p =0.001). The participants used the sensor for a median of 96% of the time and spent a median of 90% in AHCL during the 12 weeks. No episodes of severe hypoglycemia or DKA were reported. Interpretation: Children and adolescents with T1D on MDI therapy who initiated the AHCL system following a 10-days structured protocol achieved the internationally recommended goals of glycemic control with TIR >70% and a HbA1c of <7%. Clinical Trial Registration: This study is registered with ClinicalTrials.gov, number NCT04308291, and is completed. Funding: This study was funded by Sidra Medicine in Doha, Qatar. Declaration of Interest: Authors declare no competing interests. Ethical Approval: The study was approved by the local and National Ethics Committee in Qatar and all participants, and their guardians signed a written informed assent/consent before the start of study-related procedures.

Financial Calendar

Patients with type 1 diabetes mellitus (DM) require intensive monitoring, which was adversely affected during coronavirus disease 2019 (COVID-19) restrictions.We evaluated the management of type 1 DM and the role of telephonic consultation and follow-up in 46 patients (10 on insulin pump) with type 1 DM at our centre from 1 February 2020 to 31 January 2021. Patients were telephonically counselled fortnightly. Web-based diabetes education sessions for the patients and parents were conducted. Finally, change in HbA1c during the period of the study, frequency of severe hypoglycaemia, hospital admissions for hyperglycaemic emergencies and degree of satisfaction with care rendered by the treating team were assessed by ratings scored by the patients.Five episodes of severe hypoglycaemia were noted in three patients. Two patients had diabetic ketoacidosis. Patients on insulin pump showed a mean baseline HbA1c of 7.8%. Nine of these patients (90%) showed an improvement in Hba1c during the study period compared to 64.3% of patients on conventional regimen. There were no episodes of severe hypoglycaemia or hospitalization with DKA noted in these patients. Only two patients had COVID-19 disease with mild manifestations. Overall satisfaction levels with therapy were high.This study illustrates the role played by teleconsultation and video conferencing during the period of the COVID-19 pandemic in ensuring optimal healthcare delivery to patients with type 1 DM. Some of these methods can be used even after the pandemic to improve patient convenience and reduce the out-patient burden on the hospitals.

168-OR: Five-Year Follow-up after Islet Transplantation in Nonuremic Patients with Type 1 Diabetes Mellitus and Hypoglycemia Unawareness: Favorable Long-Term Outcomes of Multicenter Trial at University of Chicago

Introduction: Prospective randomized multicenter trial did not find advantage of CXCR1/2 blocker (Reparixin) over placebo in islet transplantation in patients with type 1 diabetes mellitus and problematic hypoglycemia at 1 year follow-up. We note favorable metabolic outcomes at 5-year follow-up in trial cohort from our center. Material and Methods: 12 patients with type 1 diabetes and problematic hypoglycemia received a total 19 islet transplants (max 2 per patient) within one year. Eight patients were randomly assigned and received Reparixin and 4 received placebo within first week after each transplant in addition to standard immunosuppression (anti-thymocyte globulin, tacrolimus, and mycophenolate). Results: 11/12 patients achieved insulin independence during the study period. At 5-year follow-up 4/8 (50%) remained insulin free with HbA1c &amp;lt;6.0 % in Reparixin group vs. 1/4 (25%) in placebo group. One patient had partial islet function without severe hypoglycemic episodes (SHE). Diabetic neuropathy and renal function remained unchanged while retinopathy improved in 3/6 (50%) patients. 6/12 (50%) patients left the study: 3/6 proceeded with pancreas transplant and remain off insulin, the remaining 3/6 stopped immunosuppression with decline of islet graft function, deterioration of glucose control (HbA1c &amp;gt; 7.0 %), and recurrence of SHE. No patients experienced any cardiovascular events nor became persistently sensitized (current PRA 0%). Conclusions: Repeat islet transplantation led to insulin independence in 91% of patients; 50% of patients in Reparixin group and 25% in placebo. Secondary diabetic complications did not progress. No patients became persistently sensitized. Subsequent pancreas transplantation was feasible and effective in patients with decline of islet graft function. Disclosure P. J. Bachul: None. A. Perez-gutierrez: None. A. C. Lucander: None. J. Fung: None. P. Witkowski: None. G. S. Generette: None. P. Borek: None. J. S. Pyda: None. R. Anteby: None. L. Basto: None. L. Perea: None. K. Golab: None. M. Tibudan: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (P30DK02059); Kovler Family Fund; Dompé farmaceutici S.p.A.

674-P: Efficacy and Safety of Cotadutide, a Dual GLP-1 and Glucagon Receptor Agonist in Patients with T2DM and DKD

Background: Cotadutide, a dual glucagon-like peptide (GLP-1) and glucagon receptor agonist, is in development for NASH and T2DM with DKD. GLP-1 receptor agonists have been shown to delay the onset of macroalbuminuria in DKD. The glycemic and renal effects of cotadutide were assessed in a phase 2a, randomized, controlled trial (NCT03550378). Methods: The trial enrolled 41 patients with T2DM (HbA1c 6.5-10.5%) and CKD stage 3 (eGFR 30-59 mL/min/1.73 m2), on insulin and/or oral glucose-lowering therapy and BMI 25-45 kg/m2. Patients were randomized to once-daily subcutaneous cotadutide (n = 21) titrated up to 300 µg or placebo (PBO; n = 20) for 32 days. Endpoints included glucose response during a mixed meal tolerance test (MMTT), time spent within a target glucose range over a 7-day period on continuous glucose monitoring (CGM) and body weight. Exploratory measures included eGFR, UACR, C-peptide and NT-proBNP. Results: After 32 days, cotadutide compared with PBO reduced MMTT glucose AUC (-26.7%; 90% CI -34.6% to -18.8%; 7-day mean glucose -47.9 mg/dL vs. PBO) and increased CGM time spent in target range over 32 days by 36.0% vs. PBO to 78.7% (both p ≤ 0.003). Cotadutide was associated with 35.2% reduction in insulin dose, 0.88 µg/L increase in C-peptide and 3.7% reduction in body weight (all p ≤ 0.012). There was no change in eGFR. In patients with baseline micro- or macroalbuminuria (n = 18), UACR was reduced by 50.6% (p = 0.0504 vs. PBO). In addition, NT-proBNP level was reduced with cotadutide vs. PBO (-79.7 ng/L vs. -9.42 ng/L, p = 0.040). Safety and tolerability findings were consistent with the known mechanism of action of GLP-1 receptor agonists. There were no episodes of severe hypoglycemia, and CGM time &amp;lt; 54 mg/dL was 1.65% with cotadutide vs. 0.82% with PBO. Conclusion: In patients with T2DM and DKD, short term treatment with cotadutide had robust effects on glucose lowering. The reduction in albuminuria suggests that cotadutide has renoprotective potential in DKD, but further evaluation is warranted. Disclosure V. E. Parker: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. P. Ambery: Employee; Self; AstraZeneca. H. L. Heerspink: Consultant; Self; AbbVie Inc., Astellas Pharma Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Chinook, CSL Behring, Fresenius Medical Care, Gilead Sciences, Inc., Janssen Research &amp; Development, LLC, Merck &amp; Co., Inc., Mitsubishi Corporation Life Sciences Limited, Mundipharma International, Novo Nordisk, Retrophin, Inc., Research Support; Self; AbbVie Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Janssen Research &amp; Development, LLC. R. J. Mccrimmon: Advisory Panel; Self; Novo Nordisk Inc., Sanofi-Aventis, Board Member; Self; Novo Nordisk Foundation, Research Support; Self; AstraZeneca. L. Jermutus: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. T. Hoang: None. H. Schlichthaar: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk. F. W. Gibb: Speaker’s Bureau; Self; Abbott Diabetes. B. Wenzel: None. M. G. Posch: None. Y. Chang: None. M. Petrone: None. L. Hansen: Employee; Self; AstraZeneca.

First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes.

Background: The objective of this study was to assess the safety and effectiveness of the first commercial configuration of a tubeless automated insulin delivery system, Omnipod® 5, in children (6–13.9 years) and adults (14–70 years) with type 1 diabetes (T1D) in an outpatient setting.Materials and Methods: This was a single-arm, multicenter, prospective clinical study. Data were collected over a 14-day standard therapy (ST) phase followed by a 14-day hybrid closed-loop (HCL) phase, where participants (n = 36) spent 72 h at each of three prespecified glucose targets (130, 140, and 150 mg/dL, 9 days total) then 5 days with free choice of glucose targets (110–150 mg/dL) using the Omnipod 5. Remote safety monitoring alerts were enabled during the HCL phase. Primary endpoints were difference in time in range (TIR) (70–180 mg/dL) between ST and HCL phases and proportion of participants reporting serious device-related adverse events.Results: Mean TIR was significantly higher among children in the free-choice period overall (64.9% ± 12.2%, P < 0.01) and when using a 110 mg/dL target (71.2% ± 10.2%, P < 0.01), a 130 mg/dL target (61.5% ± 7.7%, P < 0.01), and a 140 mg/dL target (64.8% ± 11.6%, P < 0.01), and among adults using a 130 mg/dL target (75.1% ± 11.6%, P < 0.05), compared to the ST phase (children: 51.0% ± 13.3% and adults: 65.6% ± 15.7%). There were no serious device-related adverse events reported during the HCL phase, nor were there episodes of severe hypoglycemia or diabetic ketoacidosis.Conclusion: The Omnipod 5 System was safe and effective when used at glucose targets from 110 to 150 mg/dL for 14 days at home in children and adults with T1D.

716-P: Transition from Multiple Daily Injections (MDI) to Omnipod 5 Automated Insulin Delivery System Improves A1C in Type 1 Diabetes (T1D)

Many of those with T1D in the US use MDI as their insulin delivery method. Hybrid closed-loop (HCL) systems such as the Omnipod 5 System may improve glycemic outcomes and reduce treatment burden, however, these systems must be accessible to current MDI users. We performed a subgroup analysis of participants transitioning directly from MDI in the pivotal study of the Omnipod 5 System. Children (6-13.9 y) and adults (14-70 y) with T1D≥6 months and A1C<10% used the HCL system for 3 months at home, after a 14-d run-in phase of MDI as their standard therapy (ST). Primary efficacy endpoints were change in A1C and percent time with sensor glucose in target range (TIR, 70-180 mg/dL) during HCL compared with MDI. Thirteen children (mean±SD, age 11±2 y, T1D duration 4±2 y, A1C 7.7±1.0%, 77% CGM users) and 23 adults (age 38±13 y, T1D duration 16±12 y, A1C 7.4±0.9%, 91% CGM users) used MDI as ST. HCL use among children and adults improved TIR by 16.7±14.0% and 12.7±12.5%, and reduced A1C by 1.0±0.8% and 0.5±0.7%, respectively, compared with MDI (all p<0.05, Table). There were no episodes of severe hypoglycemia or diabetic ketoacidosis in this subgroup. Direct transition from MDI to the Omnipod 5 System is feasible and effective in reducing A1C and improving TIR in T1D. Most participants (97%) chose to continue HCL use during an extension phase, suggesting high acceptability of the system among MDI users.View largeDownload slideView largeDownload slide DisclosureV. Shah: Advisory Panel; Self; Medscape, Sanofi, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, vTv Therapeutics. L. M. Laffel: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Dompe, Insulogic LLC, Janssen Pharmaceuticals, Inc., Laxmi Therapeutic Devices, LifeScan, Lilly Diabetes, Medtronic, Provention Bio, Inc. G. Aleppo: Consultant; Self; Dexcom, Inc., Insulet Corporation, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. I. B. Hirsch: Consultant; Self; Abbott Diabetes, Bigfoot Biomedical, Inc., Research Support; Self; Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Medtronic. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. J. E. Pinsker: Advisory Panel; Self; Medtronic, Consultant; Self; Eli Lilly and Company, Tandem Diabetes Care, Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. T. T. Ly: Employee; Self; Insulet Corporation. A. B. Criego: Consultant; Self; Bigfoot Biomedical, Inc., Other Relationship; Self; Sanofi, Research Support; Self; Abbott Diabetes, Eli Lilly and Company, Insulet Corporation, Medtronic. A. L. Carlson: Board Member; Self; JDRF, Other Relationship; Self; Medtronic, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Omnipod, Sanofi, UnitedHealth Group. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Quintiles, Sanofi, Senseonics, Senseonics, Tolerion, Inc., viking. B. W. Bode: Advisory Panel; Self; Eli Lilly and Company, Consultant; Self; Bigfoot Biomedical, Inc., Companion Medical, Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Abvance Therapeutics, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Dompe, Eli Lilly and Company, Eyenuk, Inc., Insulet Corporation, Jaeb Center for Health Research, Medtronic, Nova Biomedical, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanofi, Senseonics, Viacyte, Inc., vTv Therapeutics, Xeris Pharmaceuticals, Inc., Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk, Sanofi, Stock/Shareholder; Self; AgaMatrix, Aseko, Inc., Glytec, LLC. S. A. Brown: Research Support; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Tolerion, Inc.FundingInsulet Corporation

96-LB: Glycemic Management over 6 Months with the Omnipod 5 Automated Insulin Delivery System

Safe and effective use of the Omnipod 5 System was demonstrated in adults and children with type 1 diabetes (T1D) during a 3-month pivotal study. Longer studies are needed to evaluate durability of glycemic benefit. Those completing the pivotal study were invited to continue system use for an additional 12 months, with 95% enrolling in the extension. We present results from the first 3-month follow-up. Participants aged 6-70y with T1D≥6 months and A1C<10% used the system in Automated Mode at home. Following the pivotal study, A1C was measured again after 3 months (6 months of total use). Safety and efficacy endpoints were occurrence of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) and change in A1C, respectively. Participants (n=217) were aged (mean±SD) 24±17y with T1D duration 11±11y. A1C was lower after 6 months of system use than at baseline for children and adults (p<0.001, Table). For children, A1C was not significantly different between end of pivotal and the 3-month extension, while adults had an additional -0.1% decrease (p<0.01). There was 1 episode of DKA and no episodes of SH during the 3-month extension phase. The safety and improved glycemic outcomes from the pivotal study persisted for an additional 3 months of system use in this large cohort of participants, with 99% continuing into the next extension phase. Sustained reduction of A1C indicates the potential long-term benefit of the Omnipod 5 System.View largeDownload slideView largeDownload slide DisclosureA. L. Carlson: Board Member; Self; JDRF, Other Relationship; Self; Medtronic, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Omnipod, Sanofi, UnitedHealth Group. J. Sherr: Advisory Panel; Self; Cecelia Health, Insulet Corporation, Medtronic, Consultant; Self; Insulet Corporation, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic, Speaker’s Bureau; Self; Lilly Diabetes. S. N. Mehta: None. L. M. Laffel: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Dompe, Insulogic LLC, Janssen Pharmaceuticals, Inc., Laxmi Therapeutic Devices, LifeScan, Lilly Diabetes, Medtronic, Provention Bio, Inc. V. Shah: Advisory Panel; Self; Medscape, Sanofi, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, vTv Therapeutics. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Boston Therapeutics, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Kowa Pharmaceuticals America, Inc., Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Poxel SA, Quintiles, Sanofi, Senseonics, Tolerion, Inc., Viking Therapeutics. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. T. C. Jones: None. G. Aleppo: Consultant; Self; Dexcom, Inc., Insulet Corporation, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. A. B. Criego: Consultant; Self; Bigfoot Biomedical, Inc., Other Relationship; Self; Sanofi, Research Support; Self; Abbott Diabetes, Eli Lilly and Company, Insulet Corporation, Medtronic. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. T. T. Ly: Employee; Self; Insulet Corporation. Omnipod 5 research group: n/a. G. P. Forlenza: Advisory Panel; Self; Medtronic, Consultant; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. B. W. Bode: Advisory Panel; Self; Eli Lilly and Company, Consultant; Self; Bigfoot Biomedical, Inc., Companion Medical, Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Abvance Therapeutics, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Dompe, Eli Lilly and Company, Eyenuk, Inc., Insulet Corporation, Jaeb Center for Health Research, MedtroFundingInsulet Corporation

109-LB: Comparative Effectiveness of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (iDeg-100) in Insulin-Naïve Type 2 Diabetes Adults: RESTORE-2 Real-World Study

Second generation basal insulin (2BI) provide similar/improved efficacy with better safety compared to first generation BI. Real-world data on 2BI in patients with type 2 diabetes (T2D) are still limited. The study aimed at comparing effectiveness of 2BI (Gla-300 vs. iDeg-100) in insulin-naïve T2D. This was a retrospective, non-inferiority, multicenter study, from electronic medical records. All patients initiating Gla-300 or iDeg-100 in January 2017-2020 were 1:1 propensity score matched. Linear mixed models for repeated measures were applied to assess changes during 6 months in HbA1c, fasting blood glucose (FBG), body weight, and insulin doses. Incidence rates (IR) of hypoglycemic events were compared using Poisson regression models. Overall, 19 centers provided data on 357 patients in each PSM cohort. Estimated mean baseline levels of HbA1c were 9.2%. Marked reductions in HbA1c after 6 months were documented: -1.70%; (95%CI -1.90; -1.50) in Gla-300 group and -1.69%; (95%CI -1.89; -1.49) in IDeg-100 group (between group mean difference: 0.01; 95%CI -0.29; 0.27), confirming non-inferiority of Gla-300 vs. IDeg-100. FBG was reduced by about 60 mg/dl in both groups; minor changes in body weight were documented. In both groups, the mean prescribed dose was about 12 U (0.15 U/Kg) and was slightly titrated during 6 months up to +4U (0.20 U/Kg). IR (episodes per patient-months) of BG≤70 mg/dl was 0.13 (95%CI 0.07;0.26) in Gla-300 group and 0.14 (95%CI 0.07;0.27) in IDeg-100 group (p=0.87). IR of BG&amp;lt;54 mg/dL was 0.02 (95%CI 0.01;0.05) in Gla-300 group and 0.02 (95%CI 0.01;0.04) in IDeg-100 group (p=0.49). No severe hypoglycemic episodes were reported. In T2DM adults, initiation of Gla-300 or IDeg-100 was associated with similar improvements in glycemic control, no weight gain, low hypoglycemia rates, with no severe episodes. These data can contribute in overcoming clinical inertia in BI initiation and dose titration. Disclosure G. Fadini: Board Member; Self; Novo Nordisk, Sanofi, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk, Sanofi. R. Buzzetti: None. A. Nicolucci: Advisory Panel; Self; AstraZeneca, Research Support; Self; Novo Nordisk, Pikdare, Sanofi, Shionogi &amp; Co., Ltd., SOBI. M. Rossi: Research Support; Self; Novo Nordisk, Sanofi, Shionogi &amp; Co., Ltd., Swedish Orphan Biovitrum AB. M. Larosa: Employee; Self; Sanofi. D. Cucinotta: None. On behalf of restore-2 study group: n/a. Funding Sanofi

637-P: Effectiveness of Fixed Ratio Combination of IGlarLixi in People with Type 2 Diabetes Mellitus: Experience from Routine Clinical Practice

Background: Currently no data are available on the real-world effectiveness of the fixed ratio combination of insulin glargine 100 U/ml and lixisenatide (iGlarLixi). This non-interventional study (it was conducted in Hungary) aimed to evaluate its effects on glycaemic control and hypoglycaemia in real-world practice. Methods: The single-arm, 6-month (with follow-up visits at 3 and 6 months) study included uncontrolled adults with type 2 diabetes (HbA1c&amp;gt;7,5%) treated by oral antidiabetics (OAD) +/- basal insulin. iGlarLixi treatment was started at the time of inclusion. Results: Of the included 442 participants, 353 were involved in the efficacy analyses. 282 (79.9%) subjects were treated with OADs, while the remaining 71 (20.1%) with basal insulin and OAD(s) before inclusion. The proportion of participants achieving at least 1.0% HbA1c reduction during the observation period was 60.9% (primary endpoint). All glycaemic variables (mean±SD) improved significantly (p&amp;lt;0,001) during follow-up (HbA1c from 8.9±1.3% to 7.4 ±1.0%, fasting blood glucose from 9.0±2.2 mmol/L to 6.9±1.2 mmol/L, and postprandial blood glucose from 11.3±2.3 mmol/L to 8.5±1.5 mmol/L). All changes were clinically and statistically significant. Body weight was also decreased from 90.5±18.0 kg to 88.2±17.8 kg. Only 37 subjects (10.5%) self-reported at least one symptomatic hypoglycaemic episode during the study. There was no severe hypoglycaemic episode being reported. Frequency of gastrointestinal adverse events was low (5 patients, 1.4%). Conclusion: The first prospective, non-interventional study confirmed several results from the LIXILAN programme in a real-life setting. iGlarLixi significantly improved glycaemic control with low frequency of hypoglycaemia and gastrointestinal adverse events in a heterogenous population of people with type 2 diabetes. Results confirm similar efficacy and safety in routine clinical care than in randomized controlled trials. Disclosure J. T. Kis: None. G. Nagy: Employee; Self; Sanofi-Aventis. P. Stella: Employee; Self; Sanofi-Aventis. Funding Sanofi

100-LB: Infusion Set Survival and Performance during the Medtronic Extended-Wear Infusion Set (EWIS) Pivotal Trial

Objective: Most insulin infusion sets (ISs) are labeled for 2- or 3-days use. The Medtronic EWIS is designed to increase wear time up to 7 days. This study reports on EWIS survival and performance during the pivotal trial (ClinicalTrials.gov: NCT04113694).Method: This multi-center (15), single-arm, non-randomized, non-inferiority trial in 259 participants (18-80yrs) with T1D using the MiniMed™ 670G system (with Humalog™ or Novolog™ insulin) involved wearing a 2- or 3-day IS for 2 weeks (run-in) followed by 12 consecutive EWIS wears (study phase). The latter was worn for ≥174 hours or until set failure. Safety and performance (i.e., a priori target of <16% failure rate due to unexplained hyperglycemia) were evaluated. Exploratory analysis of glycemic control (e.g., A1C, sensor glucose and time spent at glucose ranges) and insulin use during 3-day IS and EWIS wear were also evaluated.Result: The EWIS survival rate was 74.8% versus the 67.7% rate of 2- or 3-day ISs (p<0.05). The EWIS rate was 77.8% when excluding inadvertent early removals. Glycemic control outcomes were improved during EWIS use (Table) and there were no episodes of EWIS-related severe hypoglycemia or DKA.Conclusion: The 7-day EWIS was safe and its performance was superior at ≥174 hours compared to the performance observed for 2- or 3-day infusion sets.View largeDownload slideView largeDownload slide DisclosureB. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. B. Horowitz: Research Support; Self; Abbott Laboratories, BD, Celgene, Crinetics Pharmaceuticals, Gan & Lee Pharmaceuticals, Medtronic, Speaker’s Bureau; Self; AstraZeneca, Lilly Diabetes, Merck & Co., Inc., Novo Nordisk Inc. K. B. Kaiserman: Advisory Panel; Self; Medtronic, Consultant; Self; Medtronic, Employee; Self; MannKind Corporation, Research Support; Self; Medtronic, Speaker’s Bureau; Self; Medtronic, Stock/Shareholder; Self; MannKind Corporation. S. Huang: None. V. Chen: Employee; Self; Medtronic. G. Zhang: Employee; Self; Medtronic. S. Chattaraj: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic. R. L. Brazg: Research Support; Self; Abbott Diabetes, Ascensia Diabetes Care, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Pfizer Inc., Roche Diagnostic USA, Senseonics. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. Y. C. Kudva: Research Support; Self; Dexcom, Inc. S. K. Garg: Advisory Panel; Self; Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. G. Grunberger: Research Support; Self; Medtronic, Speaker’s Bureau; Self; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk. J. Thrasher: Advisory Panel; Self; Medtronic, Board Member; Self; Medtronic, Consultant; Self; Medtronic, Research Support; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Mylan N. V., Novo Nordisk, Sanofi, Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Medtronic, Sanofi. A. Cavale: Research Support; Self; Eli Lilly and Company, Medtronic. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Boston Therapeutics, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Kowa Pharmaceuticals America, Inc., Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Poxel SA, Quintiles, Sanofi, Senseonics, Tolerion, Inc., Viking Therapeutics.

106-LB: Real-Life Efficacy and Safety of IDegLira in Type 2 Diabetic Patients during COVID-19: A 6-Month Follow-Up by Teleconsultation in Bucaramanga, Colombia

Objective: Determine impact of degludec / liraglutide (ideglira) on HBA1c, fasting glucose, total daily insulin dose (TDID), hypoglycemia in adults with type II Diabetes Mellitus (T2DM), during covid-19 and follow-up by teleconsultation Methods: Secondary analysis of an anonymized database of sixty one patients with T2DM, evaluated hba1c, fasting glucose, TDID, and hypoglycemic episodes, Before, 3 and 6 months after IDEGLIRA. Weight could not me measured due to teleconsultation limitation. Performed univariated analysis of cuantitative viariables, bivariated analysis of clinical variables pre and post ideglira treatment. patients received tele-education by a diabetes educator for insulin titration Results: 59% women, previos IDEGLIRA: 45.9% used 1 oral antidiabetic 29.5% used 2 and 55.7% used oral antidiabetics plus insulin. 54.1% used basal insulin regimen, the mean TDID was 38 units previous ideglira use, and 26 U after use (p= 0.0001). The mean for HBA1c levels was 8.44% (SD:1.4) prior to the use of ideglira, 7.78% (SD: 0.9) at 3rd month and 7.4% (SD:0.91) at 6th month. Significant differences were found when comparing zero months to three months (p= 0.01), and zero to six months (p= 0.0001), and comparing 3 and 6 months (p=0.003). Goal of hba1c &amp;lt;7% was 10% before ideglira, 19% at 3rd month and 43% at 6th month, There was statistical diference between 0 to 3 and 0 to 6th month (p= 0.01). Mean fasting glucose level was 149.1 mg/dL, 125.4 mg/dL and 108.9 mg/dL for 0, 3 and 6 months respectively. Differences were found between 0 and 3 months (p=0,04), and 0 and 6 months (p= 0.01). None of these patients presented any episode of severe hypoglycemia during follow up. Conclusion: in this real life COVID-19 teleconsultation follow up for 3 and 6 months, The use of ideglira showed statistically significant changes on HBA1c, fasting glucose levels and TDID without causing severe hypoglycemia. Disclosure G. A. Parra serrano: None. M. Torreslanghammer: None. S. Serranogomez: None. A. J. Pintoarias: None.

137-OR: Dasiglucagon Ready-to-Use Autoinjector Is More Reliably and Quickly Administered than Glucagon Emergency Kit (GEK)

Dasiglucagon is a novel glucagon analog, stable in aqueous solution and suitable for delivery in a ready-to-use autoinjector (HypoPal®) for the treatment of severe hypoglycemia. This study was performed to assess HypoPal device handling vs. GEK during simulated episodes of severe hypoglycemia. Participants included persons with diabetes (PWD) and their caregivers and untrained bystanders (UB) with no experience with diabetes. Participants had no experience with either device. PWD were trained by staff and subsequently trained caregivers (TC) on the use of devices; UB received no instruction on use prior to simulations. Primary outcome was success of TC to correctly use HypoPal vs. GEK. Secondary outcomes included success of UB, time to successful administration, and assessment of confidence in, ease of use of and preference for each device. The success rate was significantly greater for HypoPal vs. GEK in TC (p These data support that dasiglucagon HypoPal use is easier, more reliable, and faster than the use of GEK and offers the potential to improve the time to recovery from a severe hypoglycemic event. Disclosure N. Bailey: Research Support; Spouse/Partner; Zealand Pharma A/S. J. Dimsits: Employee; Self; Zealand Pharma A/S. R. Tehranchi: Employee; Self; Zealand Pharma A/S. D. M. Kendall: Employee; Self; Zealand Pharma A/S, Employee; Spouse/Partner; Amgen Inc., Stock/Shareholder; Self; Eli Lilly and Company, MannKind Corporation. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. Funding Zealand Pharma A/S