Continuous Subcutaneous Insulin Infusion Pump Research Articles

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.

Development of a Real-time Force-based Algorithm for Infusion Failure Detection.

Continuous subcutaneous insulin infusion (CSII) is a common treatment option for people with diabetes (PWD), but insulin infusion failures pose a significant challenge, leading to hyperglycemia, diabetes burnout, and increased hospitalizations. Current CSII pumps' occlusion alarm systems are limited in detecting infusion failures; therefore, a more effective detection method is needed. We conducted five preclinical animal studies to collect data on infusion failures, utilizing both insulin and non-insulin boluses. Data were captured using in-line pressure and flow rate sensors, with additional force data from CSII pumps' onboard sensors in one study. A novel classifier model was developed using this dataset, aimed at detecting different types of infusion failures through direct utilization of force sensor data. Performance was compared against various occlusion alarm thresholds from commercially available CSII pumps. The testing dataset included 251 boluses. The Bagging classifier model showed the highest performance metrics among the models tested, exhibiting high accuracy (96%), sensitivity (94%), and specificity (98%), with lower false-positive and false-negative rate compared with traditional occlusion alarm pressure thresholds. Our study developed a novel non-threshold classifier that outperforms current occlusion alarm systems in CSII pumps in detecting infusion failures. This advancement has the potential to reduce the risk of hyperglycemia and hospitalizations due to undetected infusion failures, offering a more reliable and effective CSII therapy for PWD. Further studies involving human participants are recommended to validate these findings and assess the classifier's performance in a real-world setting.

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.

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.

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.

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.

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.

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.

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.

Glycemic variability leads to higher levels of auto-oxidized oxysterol species in patients with type 1 diabetes mellitus.

Hyperglycemia and glycemic variability (GV) are associated with oxidative stress in patients with diabetes mellitus (DM). Oxysterol species, produced by the non-enzymatic oxidation of cholesterol, are potential biomarkers of oxidative stress. This study examined the relationship between auto-oxidizedoxysterols and GV in patients with type 1 DM. Thirty patients with type 1 DM using a continuous subcutaneous insulin infusion pump therapy and a healthy control group (n = 30) were included in this prospective study. A Continuous Glucose Monitoring System device was applied for 72h. Blood samples were taken for oxysterols produced by non-enzymatic oxidation [7-ketocholesterol (7-KC) and cholestane-3β, 5α, 6β-triol (Chol-Triol)] levels at 72h. Short-term glycemic variability parameters, mean amplitude of glycemic excursions (MAGE), the standard deviation of glucose measurements (Glucose-SD), and mean of daily differences (MODD) were calculated with continuous glucose monitoring data. HbA1c was used to evaluate glycemic control and HbA1c-SD (the SD of HbA1c over the past year) for long-term glycemic variability. 7-KC and Chol-triol levels were significantly higher in the study group than in the control group. Strong positive correlations were found between 7-KC with MAGE(24-48h) and Glucose-SD(24-48h). 7-KC was positively correlated with MAGE(0-72h) and Glucose-SD(0-72h). No significant correlation was found between HbA1c and HbA1c -SD with oxysterol levels. The regression models showed that SD(24-48h) and MAGE(24-48h) predicted 7-KC levels while HbA1c did not. Glycemic variability leads to higher levels of auto-oxidized oxysterol species in patients with type 1 DM independent of long-term glycemic control.

Effectiveness of continuous subcutaneous insulin infusion versus multiple daily injections on glycaemic control among older adults with type 2 diabetes: protocol for systematic review and meta-analysis

IntroductionInsulin therapy plays an irreplaceable role in glycaemic control among older adults with type 2 diabetes mellitus (T2DM) and can be administered by either multiple daily injections (MDI) of insulin...

Insulin pump complications among children with diabetes

Several children with diabetes in our clinic use continuous subcutaneous insulin infusion therapy. Recently a 5-year-old presented with a dysfunctional pump, and it took 2 days to identify the problem and resolve it. What are the potential pitfalls of insulin pumps in children and how can these be prevented? The use of continuous subcutaneous insulin infusion pumps has increased considerably during the past decade. Adverse events can range from mild events that can be resolved by troubleshooting at home, to severe incidents that necessitate admission to the hospital. Adverse events include technical issues, skin complications that can lead to infection, and metabolic imbalances that can lead to hospitalization. Long-term monitoring and targeted education are needed for children and their families to ensure early identification of problems with the pump and to avoid diabetic ketoacidosis or hypoglycemia.

Dual‐hormone artificial pancreas for glucose control in type 1 diabetes: A meta‐analysis

AimTo evaluate the efficacy and safety of a dual‐hormone artificial pancreas (DH) in type 1 diabetes.Material and MethodsPubMed, Embase, the Cochrane Library and ClinicalTrials.gov were searched for studies published up to February 16, 2022. We included randomized controlled trials that compared DH with single­hormone artificial pancreas (SH), continuous subcutaneous insulin infusion (CSII) or sensor‐augmented pumps (SAP), and predictive low glucose suspend systems (PLGS) in type 1 diabetes. The primary outcome was percent time in target (3.9‐10 mmol/L [70‐180 mg/dL]). Data were summarized as mean differences (MDs) or risk differences (RDs).ResultsA total of 17 randomized crossover trials (438 participants) were included. There were nine trials of DH versus SH, 13 trials of DH versus SAP/CSII, and two trials of DH versus PLGS. For time in target, DH showed no significant difference in time in target compared with SH (MD 2.69%, 95% confidence interval [CI] −0.38 to 5.76) but resulted in 16.05% (95% CI 12.06 to 20.05) and 6.89% (95% CI 2.63 to 11.14) more time in target range compared with SAP/CSII and PLGS, respectively. DH slightly reduced time in hypoglycaemia (MD −1.20%, 95% CI −1.85 to −0.56) but increased the risk of gastrointestinal symptoms (RD 0.18, 95% CI 0.08 to 0.27) compared with SH.ConclusionsThe results of this study suggest that DH has a comparable effect on time in target compared with SH, but is associated with a longer time in target range compared with SAP/CSII and PLGS. The DH slightly reduced time in hypoglycaemia but may increase the risk of gastrointestinal symptoms compared with the SH. PROSPERO registration number: CRD42022314015.

Trajectory and predictors of HbA1c in children and adolescents with type 1 diabetes-A Danish nationwide cohort study.

Poor glycemic control in type 1 diabetes increases the risk of chronic complications and it is essential to identify life periods and predictors associated with deteriorating HbA1c . The aim was to describe specific HbA1c trajectories in Danish children and adolescents with type 1 diabetes and study associations with clinical and sociodemographic factors. 5889 children with type 1 diabetes were included from the nationwide Danish Registry of Childhood and Adolescent Diabetes with annual visits during 1996-2019. Trajectories of HbA1c were modeled with linear mixed-effects models (using age as time scale, included as cubic spline) and with an individual-specific random intercept and slope. The following cofactors were included stepwise into the model: sex, age at diagnosis, calendar year, parental education, immigrant status, health care region, blood glucose monitoring (BGM) frequency, treatment modalities: continuous subcutaneous insulin infusion (pump) versus multiple daily insulin injection therapy (pen) and continuous glucose monitoring. HbA1c overall increased during age while there was a significant decreasing secular trend. Older age at diagnosis was associated with a steeper trajectory, and non-Danish origin and shorter parental education were each associated with higher levels of HbA1c across age. A lower BGM frequency was associated with a markedly poorer HbA1c trajectory, while no significant differences were shown for different treatment modalities. Glycemic outcome worsened with age during childhood and adolescence, which is of clinical concern. Important predictors for a poorer glycemic trajectory were later age at diabetes diagnosis, shorter parental education, non-Danish origin and, in particular low BGM frequency.

Effectiveness, safety, and parental satisfaction of insulin pump therapy versus multiple-dose injection therapy in preschool children with type 1 diabetes: A systematic review and meta-analysis

Background: Despite the increasing demand for continuous subcutaneous insulin infusion (CSII) or insulin pump therapy in preschool children with Type 1 diabetes (T1D), reports on its advantages over conventional methods, particularly multiple dose injection (MDI) therapy, are scant. Objectives: We aimed to investigate the effectiveness, safety, and parental satisfaction of using CSII compared to MDI in preschool children with T1D. This study also seeks to establish criteria to help clinicians choose patients most suitable for CSII. Methods: Relevant terms based on the study outcomes were used to search electronic databases and manual search for the literature. Selected articles were then thoroughly reviewed and evaluated. Results: The effect in the meta-analysis showed a small, nonsignificant positive effect on HbA1c of the CSII compared to the MDI insulin intervention method (mean Cohen's d effect size = 0.25, Standard Error = 0.18, P = 0.16 (n = 127)) and a small, nonsignificant negative effect on safety of the CSII compared to the MDI insulin intervention method (mean Cohen's d effect size = −0.26, SE = 0.36, P = 0.47 [n = 70]). For parental satisfaction, data were small and therefore inappropriate for meta-analysis. Conclusion: For preschool children, the effectiveness and safety of insulin pump therapy compared with MDI therapy was considered statistically nonsignificant. All preschool children with T1D can be considered potentially eligible candidates for insulin pump therapy. Suggested selection criteria to apply when considering preschool children for insulin pump therapy were presented.

Rapid resolution of life-threatening hyperkalaemia in diabetic ketoacidosis with intensive insulin therapy.

A 28-year-old man with a history of type 1 diabetes mellitus on a continuous subcutaneous insulin infusion pump presented to the emergency department with generalised malaise and elevated blood sugar. His insulin pump was found to be turned off, which the patient was not aware of. The initial

Accuracy of a Low-Cost Continuous Subcutaneous Insulin Infusion Pump Prototype: In Vitro Study Using Combined Methodologies.

Considering that infusion devices are safety-critical systems, the main goal of this paper is to evaluate the infusion accuracy and precision of a low-cost insulin infusion pump prototype, using two different methodologies. The first one used a microgravimetric method adapted from IEC60601-2-24, and the second estimated the displacement of the syringe plunger in response to programmed infusions. The low-cost prototype resulted in a compact and functional device with good accuracy. The prototype infused the programmed fluid doses with an average error of 2.2%. The percentage of infusions within ± 5% accuracy was 42.50 and of 84.17% for the ± 15% limit. The developed miniaturized mechanical system presented functionality, precision, and accuracy when coupled to the electronic system, responded well to repeatability tests. Additionally, the results from in vitro tests demonstrated that the performance of the device is satisfactory and comparable to commercial continuous insulin infusion pumps. This study presents a low-cost prototype as a candidate to be used by type 1 diabetic patients in Brazil and developing countries, especially in the context of public health.

(Keynote) Continuous Glucose Monitoring Systems - Current Status and Future Perspectives of the Flagship Technologies in Biosensor Research -

The history of the development of glucose sensors is synonym of the history of biosensor research. Glucose sensors created the past and current largest market in the industrialized biosensors. The most of the commercially available glucose sensors have been dedicated to the disposable sensor strips for self-monitoring of blood glucose (SMBG), thereby diabetic patients know which treatments and amounts of treatments to self-administer and to learn how activities affect their blood glucose levels. Currently, continuous glucose monitoring (CGM) systems have been recognized as the ideal monitoring systems for glycemic control of diabetic patients, expecting the replacement of SMBG sensors. Glucose monitoring using SMBG sensors requires taking tiny blood sample using a “lancet” to prick your finger or some other alternate sites for testing, whereas CGM systems monitor glucose level at interstitial fluid (ISF) where CGM sensor is inserted. At present, the glucose concentration in blood and ISF samples are recognized as the clinically relevant values. In 2018, the U.S. Food and Drug Administration (FDA) approved a medical device comprising CGM system, a continuous subcutaneous insulin infusion pump and a control algorithm that can supply an appropriate amount of basal insulin based on the CGM results as an artificial pancreas. Consequently, it became possible to automatically and continuously control the blood glucose level. In 2019, synthetic receptor employing long-term implantable CGM system, was approved as the prescription device, which realized up to 90 days (180 days in Europe) operation. These technological achievements boosted up CGM systems and sensors as the flagship technologies in the biosensor research.In this presentation, I will overview the current status and future perspectives of sensors for CGM systems.

Estrategia terapéutica en el paciente diabético (III). Insulinoterapia

Insulin is the main treatment in type 1 diabetes mellitus and a therapeutic option in type 2 diabetic patient. In gestational diabetes, and other special conditions (for example, diabetes following pancreatectomy), insulin is the treatment of choice, too. In order to make the patient euglycemic the most of the time, we have basal and prandial insulins, as well as prefixed mixtures, which control both fasting blood glucose and postprandial blood glucose. Continuous subcutaneous insulin-infusion pumps, is other therapeutic option for type 1 diabetic patient, whose advantages in selected and trained patients, are metabolic control and to lower the risk of hypoglycemia. Insulin allergy is the only absolute contraindication for this treatment; synthetic insulin is reducing this disorder. Taking into account insulin is metabolized and excreted by liver and kidney, respectively, kidney and liver failure have to be taken into account in insulin dose adjustment. Hypoglycemia is the main adverse effect. Nowadays, local adverse effects caused by subcutaneous administration are less frequent. In diabetic patient, health training is key, mainly in those where insulin is being used.

1011-P: Effect of Fluctuating Temperature on Pump Delivery

Background: Accuracy of continuous subcutaneous insulin infusion (CSII) is essential for glycaemic control. Our study presents results of accuracy assessment of three off-the-shelves CSII under fluctuating temperature at 0,5UI/h. Methods: CSII systems accuracy was assessed by a double measurement approach utilizing a direct mass flow meter and a time-stamped micro-gravimetric test bench combined with a Kalman mathematical filter. CSII was placed inside a chamber of fluctuating temperature: 8h-tests were composed of successions of 1h at 32°C, 1h at 5°C, and compared to 8-hour tests at a 22°C fixed temperature. Accuracy was evaluated using mean of dose error. Mean absolute relative dispersion (MARD) of error was also computed for 15min time-windows. Stroke regularity was assessed in terms of frequency and volume. Tests were conducted both with insulin and medical water. Results: Delivery errors follow temperature profile. MARD of error is significantly higher with fluctuating temperature (85.2%, 44.4%, 20.4% according to each of the 3 CSII pump models) vs. fixed temperature (13.3%, 9.5%, 12.7%). No difference was observed between insulin and medical water. Stroke volume is affected by temperature changes rather than stroke frequency. Conclusion: Temperature and its fluctuations may affect the accuracy and amounts of insulin delivered by CSII. The clinical impact of the difference in insulin intake requires clinical investigations. Disclosure S. Girardot: Employee; Self; Air Liquide. Employee; Spouse/Partner; Air Liquide. P. Jacquemier: Employee; Self; Air Liquide. F. Mousin: Employee; Self; Air Liquide. C. Rendekeu: Employee; Self; Air Liquide. S. Hardy: None. J. Riveline: None.