Insulin Infusion Pump Research Articles

Diabetes Control and Clinical Outcomes among Children Attending a Regional Paediatric Diabetes Service in Australia

Australian children with diabetes commonly struggle to achieve optimal glycaemic control, with minimal improvement observed over the past decade. The scarcity of research in the rural and regional Australian context is concerning, given high incidence rates and prominent barriers to healthcare access in these areas. We conducted a retrospective audit of 60 children attending a regional Australian paediatric diabetes service between January 2020 and December 2023. The majority of patients had type 1 diabetes (n = 57, 95.0%); approximately equal numbers were managed with continuous subcutaneous insulin infusion (CSII) pumps vs. multiple daily injections (MDIs), whilst 88.3% (n = 53) also utilised continuous glucose monitoring (CGM). The mean age at last visit was 14.0 years (SD, 3.4), mean diabetes duration 5.8 years (SD, 4.6), and mean HbA1c level 8.1% (65.3 mmol/mol); only 36.8% achieved the national target of 7.5% (58 mmol/mol). Mean BMI-SDS was 0.8 (SD, 1.0); almost half (n = 27, 45.0%) were overweight or obese. Many patients had mental health conditions (31.7%), which were associated with higher hospitalisation rates (p = 0.007). The attendance rate was 83.2%, with a mean of 3.3 clinic visits per year (SD, 0.7); higher attendance rates were associated with increased CGM sensor usage (r = 0.395, p = 0.007 Overall, the diabetes service performed similarly to other clinics with regards to glycaemic control. Whilst achieving treatment targets and addressing comorbidities remains a challenge, the decent attendance and the high uptake of healthcare technologies is commendable. Further efforts are needed to improve diabetes management for this regional community.

The Effect of COVID-19 Pandemic on Quality of Life in Children with Type 1 Diabetes Mellitus and Their Families Using Insulin Infusion Pumps

Objective: This study aimed to assess the impact of the coronavirus disease (COVID-19) pandemic on the quality of life (QOL) of children with type 1 Diabetes Mellitus (T1DM) and their families, specifically focusing on the effects of insulin infusion pumps. We also aimed to identify changes in both children's and parents' QOL during the pandemic period. Methods: This study utilized the KINDL (KINDer Lebensqualitätsfragebogen: Children’s QOL) questionnaire for the children, and the World Health Organization Quality of Life (WHOQOL)-BREF Turkish Version (TR) (WHO-QOL-BREF-TR) scale for their parents. Data were collected using Google Forms, with assessments performed before and during the pandemic. Results: The study included 61 participants, 38 of whom were female (62.3%), with a mean age of 12.7±2.9 years and a mean diabetes duration of 6.4±2.5 years. Pre-pandemic KINDL scores for "emotional health" and "school" were significantly higher than those during the pandemic (p=0.022 and p=0.002, respectively). Surprisingly, HbA1c levels improved during the pandemic compared to the pre-pandemic values (p

Interesting Life Journey of a Type 1 Diabetes Individual from the Era of Injectable Insulins to the Hybrid Closed-Loop Insulin Pump

Abstract Continuous subcutaneous insulin infusion (CSII) pump has shown good outcomes in individuals with diabetes. An individual with type 1 diabetes (T1D) was diagnosed in 1996 at the age of 14 years with GAD-positive and absent C Peptide reserves confirming the diagnosis. Initially, the individual was started with the conventional treatment for T1D consisting of multiple insulin injections per day, however, with this treatment, there was a wide fluctuation in the blood sugar levels with frequent hyperglycemic and hypoglycemic episodes, and could not achieve strict HbA1c control. In 2019, the treatment was switched to a 620G CSII pump, the fluctuations in blood sugar levels were reduced, but still, there were occasional hyperglycemic and hypoglycemic episodes failing to achieve the target HbA1c control. In 2022, again the treatment was changed to the latest 780G CSII pump termed the artificial pancreas which helped the person with T1D to achieve strict blood sugar level control and excellent ‘Time in Range’ with no hyperglycemic and hypoglycemic episodes and a better quality of life.

Clinical efficacy of endovascular revascularization combined with vacuum-assisted closure for the treatment of diabetic foot.

The diabetic foot is a common cause of disability and death, and comorbid foot infections usually lead to prolonged hospitalization, high healthcare costs, and a significant increase in amputation rates. And most diabetic foot trauma is complicated by lower extremity arteriopathy, which becomes an independent risk factor for major amputation in diabetic foot patients. To establish the efficacy and safety of endovascular revascularization (ER) combined with vacuum-assisted closure (VAC) for the treatment of diabetic foot. Clinical data were collected from 40 patients with diabetic foot admitted to the Second Affiliated Hospital of Soochow University from April 2018 to April 2022. Diabetic foot lesions were graded according to Wagner's classification, and blood flow to the lower extremity was evaluated using the ankle-brachial index test and computerized tomography angiography of the lower extremity arteries. Continuous subcutaneous insulin infusion pumps were used to achieve glycemic control. Lower limb revascularization was facilitated by percutaneous tran-sluminal balloon angioplasty (BA) or stenting. Wounds were cleaned by nibbling debridement. Wound granulation tissue growth was induced by VAC, and wound repair was performed by skin grafting or skin flap transplantation. Of the 35 cases treated with lower limb revascularization, 34 were successful with a revascularization success rate of 97%. Of these, 6 cases underwent stenting after BA of the superficial femoral artery, and 1 received popliteal artery stent implantation. In the 25 cases treated with infrapopliteal artery revascularization, 39 arteries were reconstructed, 7 of which were treated by drug-coated BA and the remaining 32 with plain old BA. VAC was performed in 32 wounds. Twenty-four cases of skin grafting and 2 cases of skin flap transplantation were performed. Two patients underwent major amputations, whereas 17 had minor amputations, accounting for a success limb salvage rate of 95%. ER in combination with VAC is a safe and effective treatment for diabetic foot that can significantly improve limb salvage rates. The use of VAC after ER simplifies and facilitates wound repair.

Efficacy and Safety of Insulin Pump Therapy in Children and Adolescents with Type 1 Diabetes Mellitus

Continuous subcutaneous insulin infusion (CSII) pump represents a treatment option that can aid in achieving an important goal to reduce the most frequent complications associated with treatment; hypoglycemic and hyperglycemic episodes, which have also a great impact on life quality of patients. This study was conducted to report the effect and safety of insulin pump therapy on glycemic control, hypoglycemia and diabetic ketosis (DKA) rates in Libyan type 1 diabetic (T1D) patients. A descriptive and retrospective study which included patients treated and followed up at Tripoli University Hospital. Fifty-seven T1D patients used CSII pump enrolled in this study. Assessment of hypoglycemia, DKA, measuring the glycosylated hemoglobin (HbAlc) values at time of diagnosis (prior to CSII) and at time of study conduction. Mean age was 12.72 year ± 3.8 SD. Mean duration of diabetes was 7.28 years ± 3.9 SD. The baseline mean HbA1c was 8.58 ± 1.73% during Multiple Daily Injections (MDI) at pre-pump and 7.76 ± 1.33% post initiation of CSII (p = 0.001), with higher proportion of patient’s post-pump treated had good metabolic control with HbA1c compared to pre-pump infusion 23, 40.4% and 16, 28.1%, respectively. Both the incidence of ketoacidosis and severe hypoglycemic episodes was improved compared with MDI pre-pump significantly during CSII (P<0.001). This study supports that CSII is an effective alternative in managing T1DM. In addition, therapy with insulin pump in children with diabetes is very efficient and safe with obvious reduction of HbA1c and significantly diminished rates of DKA and hypoglycemia.

Continuous glucose monitoring metrics in pregnancy with type 1 diabetes mellitus.

Managing diabetes during pregnancy is challenging, given the significant risk it poses for both maternal and foetal health outcomes. While traditional methods involve capillary self-monitoring of blood glucose level monitoring and periodic HbA1c tests, the advent of continuous glucose monitoring (CGM) systems has revolutionized the approach. These devices offer a safe and reliable means of tracking glucose levels in real-time, benefiting both women with diabetes during pregnancy and the healthcare providers. Moreover, CGM systems have shown a low rate of side effects and high feasibility when used in pregnancies complicated by diabetes, especially when paired with continuous subcutaneous insulin infusion pump as hybrid closed loop device. Such a combined approach has been demonstrated to improve overall blood sugar control, lessen the occurrence of preeclampsia and neonatal hypoglycaemia, and minimize the duration of neonatal intensive care unit stays. This paper aims to offer a comprehensive evaluation of CGM metrics specifically tailored for pregnancies impacted by type 1 diabetes mellitus.

Control of Fractional Order Bergman’s Glucose-Insulin Minimal Model

Type 1 diabetes (TID) is a chronic disease which occurs by the destruction of beta cell, insulin producing hormone, in pancreas. Exogenous infusion of insulin, subcutaneously or via insulin infusion pump, is required for the regulation of blood glucose concentration in diabetic patients. In the paper is presented a comparisons among, proportional integral (PI), fractional-order proportional integral (FO-PI), sliding mode control (SMC) and fractional-order sliding mode control (FO-SMC) controllers, for the regulation of the blood glucose level utilizing the fractional-order Bergman’s minimal model. Genetic algorithms are applied to optimized the listed controllers. In analyzing the performances of the proposed controllers, meal effect is considered as an external disturbance.

Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump With Acoustic Volume and Flow Sensing in Simulated High-Consequence Situations.

Goal: An insulin pump's failure to deliver insulin in the right amount at the right time is a preventable cause of hospitalization. We evaluated key performance metrics of a novel insulin pump that prevents "silent insulin non-delivery" caused by blockage, delivery of air and site leakage. This is accomplished via an acoustic sensor that measures the volume of insulin delivered with each pulse in real-time. Methods: We tested long and short-term flow accuracy, occlusion-detection time and pressure, and air management of the new device (ND) versus 3 U.S. commercial insulin pumps (CIPs) using standardized methods. Results: The ND outperformed CIPs on long-term basal flow rate error. Occlusion detection was 5 to 22.5 times faster depending on the basal rate and resulted in significantly lower (2 to 5x) pressures at time of occlusion. With air included in the drug reservoir, the tested CIPs can infuse air without detection, while the ND prevented air delivery without interruption. Conclusions: Bench tests of the ND versus 3 commercially available pumps showed improved occlusion detection and air management without flow performance tradeoffs. Additionally, the lower delivery pressure measured at time of occlusion suggests a substantially lower potential for site leakage at both basal and bolus rates. These enhancements combine to decrease the likelihood of silent insulin non-delivery.

Judicious use of modern technology with antihyperglycemic agents: The changing landscape of type 2 diabetes management

Abstract Background: Continuous subcutaneous insulin infusion (CSII) pump has shown good outcomes in patients with both type 1 and type 2 diabetes mellitus. Here, we present an individual with type 2 diabetes and obesity who was on a high dosage of insulin and oral hypoglycemic agents (OHA) were able to get diabetes under good control with weight reduction after using a hybrid artificial closed-loop insulin pump system along with glucagon-like peptide 1 receptor agonist (GLP-1RA) and sodium-glucose co-transporter-2 (SGLT-2) inhibitor. Case Presentation: A 60-year-old lady with type 2 diabetes presented with uncontrolled blood sugars despite high doses of insulin and a combination of OHAs. She was also depressed and frustrated due to uncontrolled blood sugars despite repeated changes made in her treatment plan using an insulin pump along with GLP-1RA (dulaglutide) and SGLT-2 inhibitor (empagliflozin). Results: After changing the treatment plan, her HbA1c levels decreased from 10.1% to 7.3% after 3 months. The microalbuminuria reverted to normoalbuminuria (59.9–12.2 µg/mg of creatinine). Improvement has been observed in the fasting C-peptide levels from 0.50 to 0.86 pmol/L and stimulated C–C-peptide levels from 1.2 to 2.05 pmol/L. As she lost nearly 7 kg of weight, she felt satisfied with a better quality of life. Even her depression settled down. Conclusion: Use of CSII pump along with dulaglutide and empagliflozin helped in controlling blood sugars, bringing down weight with an overall improvement in mental health and renal function; in this, difficult to treat the patient.

Pediatric Type 1 Diabetes: Is Age at Onset a Determining Factor in Advanced Hybrid Closed-Loop Insulin Therapy?

The integration of continuous glucose monitoring systems with insulin infusion pumps has shown improved glycemic control, with improvements in hyperglycemia, hypoglycemia, Hb1Ac, and greater autonomy in daily life. These have been most studied in adults and there are currently not many articles published in the pediatric population that establish their correlation with age of debut. Prospective, single-study. A total of 28 patients (mean age 12 ± 2.43 years, 57% male, duration of diabetes 7.84 ± 2.46 years) were included and divided into two groups according to age at T1D onset (≤4 years and >4 years). Follow-up for 3 months, with glucometric variables extracted at different cut-off points after the start of the closed-loop (baseline, 1 month, 3 months). Significant improvement was evidenced at 1 month and 3 months after closed-loop system implantation, with better glycemic control in the older age group at baseline at TIR (74.06% ± 6.37% vs. 80.33% ± 7.49% at 1 month, p < 0.003; 71.87% ± 6.58% vs. 78.75% ± 5.94% at 3 months, p < 0.009), TAR1 (18.25% ± 4.54% vs. 14.33% ± 5.74% at 1 month, p < 0.006; 19.87% ± 5.15% vs. 14.67% ± 4. 36% at 3 months, p < 0.009) and TAR2 (4.75% ± 2.67% vs. 2.75% ± 1.96% at 1 month, p = 0.0307; 5.40% ± 2.85% vs. 3% ± 2.45% at 3 months, p < 0.027). the use of automated systems such as the MiniMedTM780G system brings glucometric results closer to those recommended by consensus, especially in age at T1D onset >4 years. However, the management in pediatrics continues to be a challenge even after the implementation of these systems, especially in terms of hyperglycemia and glycemic variability.

Combining Glucose Monitoring and Insulin Infusion in an Integrated Device: A Narrative Review of Challenges and Proposed Solutions.

The introduction of automated insulin delivery (AID) systems has enabled increasing numbers of individuals with type 1 diabetes (T1D) to improve their glycemic control largely. However, use of AID systems is limited due to their complexity and costs associated. The user must wear both a continuously monitoring glucose system and an insulin infusion pump. The glucose sensor and the insulin catheter must be inserted at two different body sites using different insertion devices. In addition, the user must pair and manage the different systems. These communicate with the AID software implemented on the pump or on a third device such as a dedicated display device or smart phone application. These components might be developed and commercialized by different manufacturers, which in turn can cause difficulties for patients seeking technical support. A possible solution to these challenges would be to integrate the glucose sensor and insulin catheter into a single device. This would allow the glucose sensor and insulin catheter to be inserted simultaneously, eliminating the need for pairing, and simplifying system management. In recent years, different technologies have been developed and evaluated in clinical investigations that combine the glucose sensor and the insulin catheter in one platform. The consistent finding of all these studies is that integration has no adverse effect on insulin infusion and glucose measurements provided that certain conditions are met. In this review, we discuss the perceived challenges of such an approach and discuss possible solutions that have been proposed.

Monitoring Statistical Properties of Kalman Filter Residuals in an Artificial Pancreas to Detect Overnight Pump Malfunctions Causing Insulin Suspension

Continuous Subcutaneous Insulin Infusion (CSII) pumps are essential components in a closed-loop insulin delivery system (the so-called artificial pancreas), a recent therapeutic option for type 1 diabetes management. The efficacy of glucose regulation obtained by such a system might be severely compromised if the pump fails, possibly putting the patient’s safety at risk. Therefore, reliable and timely detection of these malfunctions is of critical practical importance. For this reason, in this study we present a novel algorithm specifically designed to detect overnight pump malfunctions resulting in insulin suspension. This algorithm adopts a real-time model-based approach and builds upon our team’s previous work, which relied solely on the magnitude of prediction residuals. In contrast, our current contribution extends the fault detection strategy by incorporating a comprehensive analysis of various statistical properties associated with the residuals. These properties encompass not only the magnitude but also the sample mean, median, variance, power, and other statistics related to the whiteness of the residuals. The considered linear black-box patients’ models have been individualized by estimating the model parameters on seven days of each patient’s data. Subsequently, the model is used in a Kalman filter to generate the predicted glucose levels with their confidence intervals. The effectiveness of the new strategy is compared to the previously proposed approach on an in-silico dataset generated by the UVa/Padova Type 1 Diabetes simulator, which has been accepted by the US Food and Drug Administration as a substitute for animal testing prior to human clinical trials with an artificial pancreas. The best performing detection strategy is based on the sign-sum test and achieves a recall of 91.3%, while generating less than 1 false alarm every 10 days. This improves the performance of our previous contribution that exhibits a comparable number of false alarms, but an overall lower recall metric, equal to 82.7%. The proposed algorithm is designed to complement other dedicated modules within the system, aiming to detect malfunctions related to glucose sensors (such as missed samples and pressure-induced sensitivity losses) as well as human errors (including missed meal announcements). A robustness analysis has been conducted to examine the performance of the algorithm in the presence of these additional anomalies. The results of these analyses demonstrated that the proposed algorithm maintains its sensitivity to pump malfunctions while exhibiting only a marginal increase in false alarms.

Mast Cell Deficiency in Mice Attenuates Insulin Phenolic Preservative-Induced Inflammation.

One major obstacle that limits the lifespan of insulin infusion pumps is surmounting the tissue site reaction at the device implantation site. All commercial insulin formulations contain insulin phenolic preservatives (IPPs) designed to ensure insulin protein stability and prolong shelf-life. However, our laboratory demonstrated that these preservatives are cytotoxic and induce inflammation. Mature mast cells (MCs) reside in cutaneous tissue and are one of the first responders to an epidermal breach. Upon activation, MCs release proinflammatory and immunomodulatory prepacked mediators that exacerbate these inflammatory reactions. Thus, we hypothesized that once the epidermis is breached, cutaneous MCs are triggered inciting the inflammatory response to IPP-induced inflammation. This hypothesis was pursued utilizing our modified in vivo mouse air pouch model, including a c-kit dependent (C57BL/6J-kitW-sh/W-sh) and a c-kit independent (Cpa3-Cre; Mcl-1fl/fl) MC-deficient mouse model. Leukocytes were quantified in the mouse air pouch lavage fluid following flow cytometry analysis for IPP infusion under three different states, insulin-containing phenolic preservatives (Humalog®), insulin preservatives alone, and normal saline as a control. The air pouch wall was assessed using histopathological evaluations. Flow cytometry analysis demonstrated a statistically significant difference in inflammatory cell recruitment for both MC-deficient mouse models when compared to the control strain including infused control saline. Significantly less inflammation was observed at the site of infusion for the MC-deficient strains compared to the control strain. Overall, concordant results were obtained in both mouse types, C57Bl6-kitW-sh/W-sh and Cpa3-Cre; Mcl-1fl/fl. These findings in multiple model systems support the conclusion that MCs have important or possible unique roles in IPP-induced inflammation.

InsNET: Accurate Basal and Bolus Insulin Dose Prediction for Closed Loop Diabetes Management.

It has been demonstrated that closed-loop diabetes management results in better glycemic control and greater compliance than open-loop diabetes management. Deep learning models have been used to implement different components of artifical pancreas. In this work, a novel deep learning model InsNET has been proposed to estimate the basal and bolus insulin level and insulin bolus in patients with type I diabetes utilizing subcutaneous insulin infusion pumps for closed loop diabetes management system. The proposed InsNET is formed with a Wide-Deep combination of LSTM and GRU layers. Additionally, physical activity level has been included as an input in comparison to previous models where only past glucose levels (CGM), meal intake (CHO) and past insulin dosage were used as inputs. The proposed model was tested on In-silico data, and it achieved a Mean Absolute Error (MAE) of 0.002 and Root Mean Squared Error (RMSE) of 0.007 for UVA/Padova Dataset and MAE of 0.001 and RMSE OF 0.003 for mGIPsim Dataset.Clinical relevance- Insulin dose determination is an important as aspect of artificial pancreas. This work describes a deep learning model to determine accurate basal and bolus insulin dosage.

Maternal and fetal outcomes in a retrospective cohort of obstetrical patients that used an insulin pump paired with a continuous glucose monitor

Objective To assess maternal and neonatal outcomes in pregnant pregestational diabetic patients using a continuous subcutaneous insulin infusion (CSII) pump paired with a continuous glucose monitor (CGM). Methods This retrospective cohort study included 55 patients who delivered within one healthcare system from October 2019 to October 2022 with pregestational diabetes managed using CSII pumps paired with CGM. Maternal blood glucose (BG) data were analyzed for the two-week period preceding delivery. The percentage of time spent at a BG level of less than 140 mg/dL was recorded and compared between patients with and without obstetric and neonatal morbidities. Results Patients who delivered with severe preeclampsia (S. PreE) had a significantly lower mean percentage of time spent at BG < 140 mg/dL than those who did not (S. PreE 15/55, 63.1% ± 19.0 vs. 40/55, 73.6% ± 13.8; p = 0.03). Mothers who had a preterm birth (PTB) had a significantly lower mean percentage of time spent at BG < 140 mg/dL than those who delivered at term (PTB 35/55, 66.4% ± 16.4 vs 20/55, 78.3% ± 11.9; p = 0.006). The mean percentage of time spent at a BG < 140 mg/dL among mothers of neonates with respiratory distress syndrome (RDS) was significantly lower than those without RDS (RDS present 13/55, 59.7% ± 20.4 vs 42/55, 74.1% ± 12.7; p = 0.003). There was a significant correlation between a greater neonatal birth weight percentile and worse time spent at BG < 140 mg/dL (r = − 0.31; p = 0.02). No other significant differences were observed between the groups. Conclusion Improved blood glucose levels in pregestational diabetic patients using a CSII pump and CGM is associated with reduced maternal and neonatal morbidity as well as lower birth weight percentile neonates. Future studies are needed to clarify how much time each day a patient needs to spend below a given blood sugar, how long this blood glucose should be maintained, and what specific blood glucose target should be selected.

Clinical and molecular description of two cases of neonatal diabetes secondary to mutations in PDX1.

Pancreatic dysgenesis (PD) is a rare congenital disease, with less than 100 cases reported in the literature. In most cases, patients are asymptomatic and the diagnosis is made incidentally. In this report, we present the case of two brothers with a history of intrauterine growth retardation, low birth weight, hyperglycemia, and poor weight gain. The diagnosis of PD and neonatal diabetes mellitus was made by an interdisciplinary team composed of an endocrinologist, a gastroenterologist, and a geneticist. Once the diagnosis was made, treatment with an insulin pump, pancreatic enzyme replacement therapy, and supplementation with fat-soluble vitamins was decided. The use of the insulin infusion pump facilitated the outpatient treatment of both patients. Pancreatic dysgenesis is a relatively rare congenital anomaly; most of the time, patients are asymptomatic and are diagnosed incidentally. The diagnosis of pancreatic dysgenesis and neonatal diabetes mellitus should be made with an interdisciplinary team. Due to its flexibility, the use of an insulin infusion pump facilitated the management of these two patients.

1156-P: Diabetes Technology in the Pediatric Inpatient Setting

Introduction: Continuous subcutaneous insulin infusion (CSII) pumps and continuous glucose monitors (CGMs) improve glycemic control and quality of life for children with diabetes. This study assessed the existence and content of pediatric inpatient diabetes technology policies in U.S. hospitals. Methods: A cross-sectional survey was distributed to the Pediatric Pharmacy Association listserv. The survey had multiple-choice and open-ended items related to hospital practices on insulin pump and CGM use in the pediatric inpatient setting. Results: Only 17 of the 31 responding hospitals (54.8%) allowed CGM use in the pediatric inpatient setting with 13 (76.5%) of those having written CGM policies. Primary barriers to allowing CGM use were lack of policy (n=11, 78.6%), limited policy knowledge (n=9, 64.3%), and lack of EMR integration (n=6, 42.9%). Most hospitals reported not utilizing CGM high and low blood sugar alarms (n=10, 58.8%). Hospitals typically used finger stick blood glucose testing while patients used a CGM (n=13, 76.5%). More hospitals (n=29, 93.5%) reported an option for insulin pump use in the pediatric inpatient setting with 96.6% (n=28) having a written policy. Overall, hospitals’ reported policies did not differ for pump use in children admitted for diabetes complications versus nondiabetes diagnoses (n=24, 85.7%). Less than half had specific policies for suspected pump site failure (n=13, 46.4%). Verification of pump doses varied greatly with hospitals reporting nursing verification (n=17, 58.6%), patient report (n=10, 34.5%) and no verification policy (n=2, 6.9%). Conclusion: Most hospital respondents had policies for inpatient insulin pump use while fewer had policies allowing CGM use. Best practice standards support having written guidelines to ensure patient safety and to guide the pediatric care team. Policy repositories may be a helpful resource for hospitals that lack written guidelines. Disclosure N. Rajagopal: None. A. Bailey: None. C. Ngo: None. A.D. Hendrix-Dicken: Stock/Shareholder; Catalyst Pharmaceuticals, Johnson &amp; Johnson, AstraZeneca. S. Mercer: None. M. Condren: Consultant; Wolters Kluwer Health.

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.

Impact on glucometric variables and quality of life of the advanced hybrid closed-loop system in pediatric and adolescent type 1 diabetes.

In recent years, technological advances in the field of diabetes have revolutionized the management, prognosis, and quality of life of diabetes patients and their environment. The aim of our study was to evaluate the impact of implementing the MiniMed 780G closed-loop system in a pediatric and adolescent population previously treated with a continuous subcutaneous insulin infusion pump and intermittent glucose monitoring. Data were collected from 28 patients with type 1 diabetes aged 6 to 17 years, with a follow-up of 6 months. We included both glucometric and quality of life variables, as well as quality of life in primary caregivers. Metabolic control variables were assessed at baseline (before system change) and at different cutoff points after initiation of the closed-loop system (48 hours, 7 days, 14 days, 21 days, 1 month, 3 months, 6 months). Time in range 70-180 mg/dL increased from 59.44% at baseline to 74.29% in the first 48 hours after automation of the new system, and this improvement was maintained at the other cutoff points, as was time in hyperglycemia 180-250 mg/dL (24.44% at baseline to 18.96% at 48 hours) and >250 mg/dL (11.71% at baseline to 3.82% at 48 hours). Our study showed an improvement in time in range and in all time spent in hyperglycemia from the first 48 hours after the automation of the system, which was maintained at 6 months.

Process-Aware Attacks on Medication Control of Type-I Diabetics Using Infusion Pumps

As medical infusion pumps are known to be vulnerable to cybersecurity threats, industrial reports, guidelines, and state-of-the art research have focused on securing such devices. This includes hardening a pump's network communications, wireless interfaces, and patching software flaws that can allow adversaries to compromise the device's usability and potentially lead to adverse effects on patients. Still, a very small percentage of this work has focused on securing devices against <italic xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">process-aware attacks</i> that target the business logic behind medical treatment processes, even though it is widely known that deviations or disruptions in continuous medication administration may be harmful, even lethal. In this work, we first develop a threat model on an insulin infusion pump used for blood glucose regulation in Type-I diabetics. We then set up a generalized Simulink model of common insulin pumps used for Type-I diabetic treatment and perform a volume control assessment to investigate the probability of process-aware cyber-attacks to cause patient harm through microalterations on continuous medical administration that stay within operational limits but manage to impact a patient's health. We achieve this by manipulating the business process logic behind semiautomatic drug administration on the insulin pump model that uses continuous glucose monitoring systems. We validate attack models capable of causing adverse impact on patients through performance degradation of the drug administration processes.