Subcutaneous Insulin Infusion Pump Research Articles

Evaluation of the Accuracy of Current Tubeless Pumps for Continuous Subcutaneous Insulin Infusion.

Background: Recently two new tubeless pumps for insulin therapy were introduced. They were tested for accuracy and occlusion detection and compared with the established patch pump Omnipod® (OP).Methods: Using a modified setup for tubeless pumps based on IEC 60601-2-24, the basal rate and bolus delivery of the Accu-Chek® Solo micropump system (ACS) and the A6 TouchCare® System (A6) were measured with a microgravimetric method. Bolus sizes of 0.2, 1, and 10 U, and basal rates of 0.1 and 1 U/h were evaluated in nine repetitions. For each parameter, mean deviation and number of individual boluses or 1-h basal rate windows within ±15% from target were calculated. In addition, occlusion detection time at basal rates of 0.1 and 1 U/h was determined.Results: Mean deviation of boluses of different volumes in the pumps ranged from −3.3% to +4.0% and 40%–100% of individual boluses were within ±15% of the target. During basal rate delivery, 48% to 98% of 1-h windows were within ±15% of the target with a mean deviation between -5.3% and +6.5%. In general, considerable differences between pump models were observed and deviations decreased with increasing doses. In most parameters, ACS was more accurate, and A6 less accurate, than OP. Mean occlusion detection time ranged from ∼3 to 7.5 h at 1 U/h and was >24 h or absent at 0.1 U/h.Conclusions: In this evaluation, significant differences between the tested tubeless pump models were observed that became most evident when regarding delivery errors over short time and small volumes.

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.

Application of Artificial Intelligence Techniques for the Estimation of Basal Insulin in Patients with Type I Diabetes.

Artificial intelligence techniques have been positioned in the resolution of problems in various areas of healthcare. Clinical decision support systems developed from this technology have optimized the healthcare of patients with chronic diseases through mobile applications. In this study, several models based on this methodology have been developed to calculate the basal insulin dose in patients with type I diabetes using subcutaneous insulin infusion pumps. Methods. A pilot experimental study was performed with data from 56 patients with type 1 diabetes who used insulin infusion pumps and underwent continuous glucose monitoring. Several models based on artificial intelligence techniques were developed to analyze glycemic patterns based on continuous glucose monitoring and clinical variables in order to estimate the basal insulin dose. We used neural networks (NNs), Bayesian networks (BNs), support vector machines (SVMs), and random forests (RF). We then evaluated the agreement between predicted and actual values using several statistical error measurements: mean absolute error (MAE), mean square error (MSE), root-mean-square error (RMSE), Pearson's correlation coefficient (R), and determination coefficient (R2). Results. Twenty-four different models were obtained, one for each hour of the day, with each chosen technique. Correlation coefficients obtained with RF, SVMs, NNs, and BNs were 0.9999, 0.9921, 0.0303, and 0.7754, respectively. The error increased between 06:00 and 07:00 and between 13:00 and 17:00. Conclusions. The performance of the RF technique was excellent and got very close to the actual values. Intelligence techniques could be used to predict basal insulin dose. However, it is necessary to explore the validity of the results and select the target population. Models that allow for more accurate levels of prediction should be further explored.

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.

SAT-681 Transient Neonatal Diabetes Mellitus Triggered by EIF2AK3 and PTF1A Mutation

Background: Neonatal diabetes mellitus (NDM) occurs within the first 6 months of life. Advances in molecular genetics have identified various causatives genes. Mutations in EIF2AK3 causes Wolcott-Rallison syndrome characterized by NDM, multiple epiphyseal dysphasia and growth retardation. PTF1A is associated with the development of pancreas and cerebellum. Both EIF2AK3 and PTF1A mutations are causative genes for permanent NDM with spontaneous and autosomal recessive inheritance. We report a neonate with transient NDM with both EIF2AK3 and PTF1A variants confirmed by Sanger sequencing where each parent found to be a heterozygous carrier of each mutation. Case presentation: A two-day old boy was transferred from a local hospital due to hyperglycemia (blood glucose of 385 mg/dL) and glycosuria. Serum c-peptide (0.06 ng/mL) and insulin (0.64 μU/mL) were low. The patient did not present sings of ketoacidosis and was screened negative for pancreatic autoantibodies. The patient did not have any family history of diabetes. Molecular genetic analysis was performed and continuous infusion of intravenous insulin with pre-prandial bolus was started. Oral sulfonylurea therapy was attempted to prevent adverse neurocognitive outcome however, it showed no response and unable to stabilize blood glucose level. Targeted panel sequencing identified two different novel variants: a heterozygous missense mutation (c.3272G>T) in exon 17 of EIF2AK3 gene and heterozygous missense mutation (c.53C > T) in exon 1 of PTF1A gene; both of which have not been previously reported and were no likely pathogenic variants. The patient’s father confirmed to be heterozygous carriers of the EIF2AK3 mutation while mother being heterozygous carriers of the PTF1A mutation. Blood glucose level gradually began to stabilize with insulin therapy, and upon discharge the patient switched to continuous subcutaneous insulin infusion (pump) with continuous glucose monitoring. Conclusions: NDM caused by in combination of EIF2AK3 and PTF1A gene mutation is a rare condition and could resemble the disease progress of transient form of NDM. Although hyperglycemia might not be an issue of lifelong period, early genetic screening and prompt insulin initiation with consistent glucose monitoring are able to prevent further diabetic complications. In addition, the result of genetic testing in our patient raises the possibility of NDM as polygenic form of diabetes.

Abstract #805134: Effect of FIASP on Glycaemic Targets in Type 2 Diabetic Subjects, When Used in the Medtronic Minimed 640G Continuous Subcutaneous Insulin Infusion (CSII) Pump

Abstract #805134: Effect of FIASP on Glycaemic Targets in Type 2 Diabetic Subjects, When Used in the Medtronic Minimed 640G Continuous Subcutaneous Insulin Infusion (CSII) Pump

Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes.

AimsThis real‐world study evaluated the changes in glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics associated with use of the implantable 180‐day Eversense CGM System (Eversense) in patients with type 1 diabetes.Materials and methodsThis was a prospective, multicentre, observational study among adult participants aged ≥18 years with type 1 diabetes across seven diabetes‐care centres in Italy who had Eversense inserted for the first time. HbA1c was measured at baseline and at 180 days. Changes in time in range [TIR (glucose 70–180 mg/dL)], time above range [TAR (glucose >180 mg/dL)], time below range [TBR (glucose <70 mg/dL)] and glycaemic variability were also assessed. Data were also analysed by previous CGM use and by mode of insulin delivery.ResultsOne‐hundred patients were enrolled (mean age 36 ± 12 years, mean baseline HbA1c 7.4 ± 0.92% [57 ± 10 mmol/mol]). Fifty‐six per cent of patients were users of the continuous subcutaneous insulin infusion pump and 45% were previous users of CGM. HbA1c significantly decreased in patients after 180 days of sensor wear (−0.43% ± 0.69%, 5 ± 8 mmol/mol, P < 0.0001). As expected, CGM‐naïve patients achieved the greatest reduction in HbA1c (−0.74% ± 0.48%, 8 ± 5 mmol/mol). TIR significantly increased and TAR and mean daily sensor glucose significantly decreased while TBR did not change after 180 days of sensor wear.ConclusionsReal‐world clinical use of the Eversense CGM System for 180 days was associated with significant improvements in HbA1c and CGM metrics among adults with type 1 diabetes. The study is registered on clinicaltrials.gov (NCT04160156).

High Prevalence of Skin Reactions Among Pediatric Patients with Type 1 Diabetes Using New Technologies: The Alarming Role of Colophonium.

In the past few years, the increasing use of devices for diabetes treatment, such as continuous subcutaneous insulin infusion pumps, flash glucose monitoring, continuous glucose monitoring systems, sensor-augmented pumps, and automated insulin delivery devices, has resulted in important improvements in disease management. Meanwhile, the longer a patient uses a device, the greater the likelihood of developing a skin reaction. Allergic contact dermatitis is the most frequently described skin side effect caused by adhesive tapes contained in the insulin infusion sets or glucose sensor sets and used to connect these devices to the body. We describe 18 patients, followed up at our Pediatric Diabetes Centre, who experienced dermatological complications due to diabetes device use from January 2018 to December 2018. All the patients were patch tested with allergens from a "standard" series and from a "plastics and glues" series. Patch tests resulted positive in 66.7% of patients. Colophonium was the most frequently isolated sensitizing allergen (41.1% of cases). It is a complex mixture of >100 compounds derived from pine trees. Colophonium is commonly used, in both unmodified and modified forms, as a fast-acting adhesive for industrial, medical, or other commercial uses. Its presence in the adhesive of the insulin sets and glucose sensors was confirmed by the manufacturer of some devices brand. On the basis of our results, we stress the importance of contacting manufacturers for product information. We also highlight that there should be stricter legal restrictions to label medical adhesives, even if only small amounts of colophonium are used.

RSSDI consensus recommendations on insulin therapy in the management of diabetes

The Research Society for the Study of Diabetes in India (RSSDI) has regularly updated its Clinical Practice Guidelines on various aspects of diabetes. The pharmacotherapeutic management of diabetes involves a plethora of agents targeting different aetiopathogenic mechanisms administered orally or via injections as well as insulin. While most people with type 1 diabetes need complete insulin replacement therapy with multiple-daily subcutaneous injections of insulin or a continuous subcutaneous insulin infusion pump, patients with type 2 diabetes may also need insulin as and when needed, especially owing to the declining beta cell function due to the progressive nature of their diabetes. To date, various insulin regimens including basal-bolus, split-mixed, premix, and prandial therapy are available which can be individualized based on the patient profile though their prescription is often perceived as complex for management of diabetes, forming a major barrier in the acceptability of insulin. In order to provide physicians with a simple guidance on different aspects of insulin use including choosing the right insulin and regime to match the individual patient, the RSSDI for the first time has formulated this guideline on insulin therapy using simple algorithms for insulin initiation as well as titrations based on a systematic literature search of new clinical evidences on all aspects of insulin use. Insulin therapy is hereby proposed as easy to initiate and maintain, efficacious, and a safer option which when administered appropriately can almost mimic physiological insulin secretion in diabetic patients and help them achieve target glucose control and minimize complications while improving their quality of life.

99 - Glycemic Outcomes in Transition-Age Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion Pumps

Persons with type 1 diabetes (T1D) transitioning from pediatric to adult care are at increased risk for suboptimal glycemic control. Use of continuous subcutaneous insulin infusion (CSII) pumps, which are covered by the [Province] Assisted Devices Program (ADP), may attenuate this risk.

A507 Perioperative Safety and Protocol for Managing Insulin Pump Requiring Patients Undergoing Metabolic and Bariatric Surgery

There is little in the way of data with regard to patients undergoing metabolic and bariatric surgery and the use of continuous subcutaneous insulin infusion (CSII) pumps.

Cost-effectiveness of the use of the continuous subcutaneous insulin infusion pump versus daily multiple injections in type 1 diabetes adult patients at the Mexican Institute of Social Security

BackgroundTo estimate the incremental cost-effectiveness ratio (ICER) of the use of continuous subcutaneous insulin infusion (CSII) therapy versus multiple daily injections (MDI) therapy in adult patients with type 1 diabetes (T1D) at the Mexican Institute of Social Security (IMSS).MethodsAn analysis was developed using the internationally validated Core Diabetes Model (CDM) with which the incidence and progression of acute and chronic complications and the mortality of T1D was simulated throughout life. The baseline characteristics of the simulated cohorts were obtained from Mexican T1D adult patients aged ≥ 18 years that received care at two national IMSS medical centres in 2016. In the base case, the costs of the complications and treatment of the disease with both therapies were estimated in Mexican currency from the perspective of the institution, using Diagnosis Related Groups for outpatient and inpatient care. Utilities were taken from the international bibliography. In a secondary analysis, indirect costs were included using a human capital approach. The model used a lifetime time horizon, and a discount rate of 5% was applied for health outcomes and costs. A one-way sensitivity analysis was conducted on key variables and patient sub-groups; uncertainty was evaluated using a Cost-Effectiveness Acceptability Curve.ResultsThe average age of the cohort was 32 years, with diabetes duration of 19 years, an average HbA1c of 9.2%; 29% were men. A gain of 0.614 Quality Adjusted Life Years (QALYs) was estimated with the use of CSII therapy. The estimated ICER was MXN$478,020 per QALY in the base case, and MXN$369,593 when indirect costs were considered. The sensitivity analysis showed that, in adult patients with HbA1c > 9.0%, the ICER was MXN$262,237.ConclusionsThis is the first economic evaluation study that compares CSII therapy versus MDI therapy for T1D adult patients in Mexico. The insulin pump therapy can be considered cost-effective in the context of the IMSS when considering a threshold of three GDPs per capita with 43.9% probability. Results improve substantially when patients have an HbA1c above 9%.

A Technological Revolution: The Integration of New Treatments to Manage Type 1 Diabetes.

Intensive insulin treatment and frequent self-monitoring of blood glucose (SMBG) have been recognized as pillars of diabetes treatment. Many patients with type 1 diabetes (T1D) struggle to achieve targeted glycemic control. Technology has vastly changed how these tenets to treatment can occur. Continuous subcutaneous insulin infusion (CSII) pumps and continuous glucose monitoring (CGM) can be used in place of their counterparts, multiple daily injections and SMBG. We present a review of CSII, CGM, and of different levels of integration among these two therapies, ranging from low glucose suspension devices to hybrid closed loop insulin delivery. Analysis of the various tools, their effect on glycemic control, and a guide to integrate them into pediatric clinical practice is presented. Although a cure for T1D remains the ultimate goal, technology holds the promise of keeping youth with T1D in targeted control and minimize the burden of this chronic medical condition. [Pediatr Ann. 2019;48(8):e311-e318.].

P298 Impact of continuous subcutaneous insulin infusion (CSII) pump use for Cystic Fibrosis-Related Diabetes (CFRD)

P298 Impact of continuous subcutaneous insulin infusion (CSII) pump use for Cystic Fibrosis-Related Diabetes (CFRD)

Meal Disturbance Effect on Blood Glucose Control for Type 1 Diabetes Using Improved Hovorka Equations

Artificial pancreas (AP) device consists of continuous subcutaneous insulin infusion (CSII)pump, continuous glucose monitoring (CGM) sensor, CGM receiver amd control algorithm which measure and regulate current blood glucose level (BGL) of type 1 diabetes (T1D) patients in automated manner. All components of the AP device are now well-established and readily avaialble in the market; however, its control algorithm is still at infant stage. This sometimes leads to insufficient or excessive amounts of insulin injected into their body causing hyperglycaemia or hypoglycaemia episodes, respectively. Mathematical equations of Hovorka model were widely used in the control algorithm; however, the model had shown somewhat lacking in terms of interaction and interrelation of selected parameters in its glucose-insulin dynamics. An attempt was made by previous workers to modify certain subsytem equations in the Hovorka model involving glucose, plasma insulin and insulin action subsystems by introducing additional parameters which, in turn, resulted in producing so-called improved Hovorka equations. This study aims to develop a computer algorithm in oder to simulate the BGL of T1D patient during their meal intakes using the improved Hovorka equations via MATLAB and model based predictive control (MPC). Resuls showed that different amounts of administered insulin (Ut) namely; 0.0003 U/min and 0.009 U/min were required to maintain the BGL within normal range (4.5 to 6 mmol/L) when the amounts of meals (DG) taken by the patient were at 57g CHO and 86.5g CHO during lunch and dinner times, respectively. However, the BGL was above the normal range, i.e. hyperglycaemia when DG and Ut were at 32g CHO and 0.035 U/min, respectively during breakfast time. In conclusion, this study has proven that the improved Hovorka equations can be used to simulate the meal disturbance effect on BGL for T1D patients.

C-Peptide and Beta-Cell Autoantibody Testing Prior to Initiating Continuous Subcutaneous Insulin Infusion Pump Therapy Did Not Improve Utilization Or Medical Costs Among Older Adults With Diabetes Mellitus

To study the impact of the C-peptide and beta-cell autoantibody testing required by the Center for Medicare and Medicaid Services (CMS) on costs/utilization for patients with diabetes mellitus initiating continuous subcutaneous insulin infusion (CSII) therapy. This retrospective study used propensity score-matched patients. Analysis 1 compared patients 1-year pre- and 2-years post-CSII adoption who met or did not meet CMS criteria. Analysis 2 compared Medicare Advantage patients using CSII or multiple daily injections (MDI) who did not meet CMS criteria for 1-year pre- and 1-year post-CSII adoption. Analysis 3 extended analysis 2 to 2 years postindex and also included a subset of patients ≥55 years old but not yet in Medicare Advantage. Analysis 1 resulted in significantly slower growth in hospital admissions ( P = .0453) in CSII-treated patients who did not meet the criteria. Analyses 2 and 3 showed numerically slower growth in inpatient, outpatient, and emergency department (ED) costs for CSII versus MDI patients (both not meeting criteria). Analysis 3 showed significantly slower growth in ED costs and hospital admissions for CSII versus MDI Medicare Advantage patients before propensity matching (both P<.05). In patients ≥55 years old, ED costs grew more slowly for CSII than MDI therapy ( P = .0678). Numerically slower growth in hospital admissions was seen for pump adopters who did not meet CMS C-peptide criteria, while medical costs growth was similar. For CSII users who did not meet the CMS criteria, numerically slower growth in inpatient, outpatient, ED costs, and hospital admissions occurred versus MDI. CMS = Center for Medicare and Medicaid Services; CSII = continuous subcutaneous insulin infusion; DM = diabetes mellitus; DME = durable medical equipment; ED = emergency department; MDI = multiple daily injections (of insulin).

Preserving Skin Integrity with Chronic Device Use in Diabetes.

Skin integrity and diabetes device placement are ongoing concerns for people with diabetes who utilize continuous glucose monitors (CGMs) and continuous subcutaneous insulin infusion pumps. This is especially significant for individuals with skin sensitivities, pediatric patients, and those who use devices chronically. Dermatological complications are often cited as a barrier to device use and a reason for device discontinuation. Furthermore, it is a frequent topic of discussion in diabetes follow-up visits, although little evidence-based literature exists to guide providers in managing skin integrity issues. The purpose of this article is to review current literature related to the prevalence of dermatological issues with insulin pumps and CGM, discuss published solutions to skin irritation, and to share the consolidated experience of our large academic diabetes clinic to address placement, prophylactic skin care, adhesives, removal, and skin healing with diabetes device use. Recommendations for targeted studies, increased surveillance, and development of new adhesive compounds are suggested to reduce the burden of device wear for management of diabetes.

Type 1 Diabetes in Children and Adolescents.

Type 1 Diabetes in Children and Adolescents.