Insulin Delivery Devices Research Articles

Evaluation of Clinical Outcomes With the V-Go Wearable Insulin Delivery Device in Patients With Type 2 Diabetes.

Uncontrolled type 2 diabetes can lead to a multitude of health complications. Insulin therapy is recommended when patients are unable to reach their A1C goal with oral or noninsulin injectable diabetes medications. This study evaluated the clinical benefits of switching from multiple daily insulin injections to a wearable insulin delivery device (V-Go). A retrospective chart review was conducted on 44 patients who received prescriptions for the V-Go at two family medicine offices. Investigators found a significant reduction in A1C and daily insulin requirements with no impact on weight or BMI.

Transforming type 1 diabetes: the next wave of innovation.

The discovery of insulin in 1921 enabled pharmaceutical production of animal insulins for the treatment of people with type 1 diabetes by 1922. The last several decades have witnessed enormous scientific progress in the therapy of type 1 diabetes, yet some developments have been incremental, and insulin is not a cure. Herein, I highlight key scientific advances potentially poised to improve the quality of life and treatment outcomes in type 1 diabetes. These innovations range from newer insulin analogues to the development of smart insulins, oral and weekly insulins, glucose sensors and closed-loop insulin-delivery devices, as well as strategies for durable human beta cell replacement coupled with selective immune manipulation to preserve beta cell function. Finally, progress in the prediction and prevention of type 1 diabetes highlights the ongoing challenges and potential for altering the natural history of the disease or eliminating type 1 diabetes altogether.

Smart Insulin Pens: Advancing Digital Transformation and a Connected Diabetes Care Ecosystem.

With the first commercially available smart insulin pens, the predominant insulin delivery device for millions of people living with diabetes is now coming into the digital age. Smart insulin pens (SIPs) have the potential to reshape a connected diabetes care ecosystem for patients, providers, and health systems. Existing SIPs are enhanced with real-time wireless connectivity, digital dose capture, and integration with personalized dosing decision support. Automatic dose capture can promote effective retrospective review of insulin dose data, particularly when paired with glucose data. Patients, providers, and diabetes care teams will be able to make increasingly data-driven decisions and recommendations, in real time, during scheduled visits, and in a more continuous, asynchronous care model. As SIPs continue to progress along the path of digital transformation, we can expect additional benefits: iteratively improving software, machine learning, and advanced decision support. Both these technological advances, and future care delivery models with asynchronous interactions, will depend on easy, open, and continuous data exchange between the growing number of diabetes devices. SIPs have a key role in modernizing diabetes care for a large population of people living with diabetes.

Clinical Evaluation of Basal-Bolus Therapy Delivered by the V-Go® Wearable Insulin Delivery Device in Patients with Type 2 Diabetes: A Retrospective Analysis.

Insulin therapy is frequently required to achieve glycemic targets (A1c) in type 2 diabetes (T2D); however, clinicians and patients face barriers with the complexities of multiple daily injection regimens. Patch-like wearable insulin devices, such as V-Go, may simplify and optimize this complexity. This study evaluated the change in A1C and insulin total daily dose (TDD) in a suboptimally-controlled (not achieving A1C targets) T2D population after switching to V-Go. A retrospective chart analysis at a diabetes clinic was performed to evaluate change in A1c measurements from baseline (V-Go initiation) to end of study observation. Of the 139 patients enrolled, A1C significantly decreased from baseline (−1.5 ± 1.79%; p < 0.001). Patients prescribed insulin at baseline (n = 122) used significantly less insulin TDD (−8 u/day; p = 0.006). The percentage of patients meeting the target of A1C < 8% increased from 14% at baseline to 48% at study completion (p = 0.008). Patients prescribed a basal-bolus regimen prior to V-Go achieved an A1C reduction of 1.5 ± 2.0% (p < 0.0001) and experienced the greatest reduction in TDD (−24 u/day; p < 0.0001). Thus, patients switching to V-Go from a variety of therapies at baseline experienced reductions in A1C while using less insulin, with a reduction in clinically relevant hypoglycemia, indicating the potential benefit of V-Go in optimizing and simplifying T2D care.

Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes

IntroductionWe compared the efficacy and safety of human regular insulin (HRI) versus rapid-acting insulin (RAI) in a type 2 diabetes population already using the V-Go insulin delivery device.Research design and...

Stimuli-Responsive Insulin Delivery Devices.

The development of new diabetes treatment strategies has garnered much interest given that conventional management therapies for type 1 diabetes fail to provide optimal glycemic control while creating a high burden of self-care to patients. Stimuli-responsive, "closed-loop" systems are particularly attractive due to their ability to mimic dynamic ß cell function by releasing insulin in response to fluctuating glucose levels in real-time and with minimal patient discomfort. In this short review, we focus on stimuli-responsive, reservoir-based insulin delivery devices. We explore and evaluate systems that are either physiologically or externally triggered. While obstacles remain before such technologies can be translated to clinical settings, further optimization of delivery systems forebodes that these technologies will have a tremendous impact on type 1 diabetes treatment.

Consensus on Choice of Insulin Pen Devices in Routine Clinical Practice in India.

Although insulin delivery devices are widely used by the patients, there is a paucity of published guidelines to help professionals manage their patients in insulin therapies. To provide simple and easily implementable guidelines to health care physicians on the choice of insulin delivery devices in routine clinical practice, experts in diabetes gathered together and discussed the recommendations at the National insulin Summit 2018. An ideal insulin delivery device should accurately deliver the prescribed dose of insulin and be easy to use. Recommendations are: (1) insulin should be initiated by using an insulin device if the patient seems to discontinue insulin therapy. (2) Pen devices offer accurate dosing than a syringe and vial and are associated with cost savings in the long term. (3) Switching over from syringes and vial to disposable pen devices improves adherence. (4) FlexPen® offers better accuracy, and it requires lower dose force and injection force than SoloStar® and KwikPen® (5). Durable delivery pens such as NovoPen® 4 maintain accuracy and low dose force compared with vials and syringes. (6) One pen should be used by only one patient. (7) Regular counseling on the proper use of the pen device is required regularly. This consensus-based recommendation is a useful reference tool for health care practitioners to initiate insulin therapy in patients with diabetes by using the appropriate insulin pen device.

Multicenter Real-World Assessment of the Effectiveness of V-Go Wearable Insulin Delivery Device in Adult Patients with Type 2 Diabetes (ENABLE Study): A Retrospective Analysis.

PurposePatch-like wearable insulin delivery devices are gaining acceptance as a treatment modality for insulin delivery in patients with diabetes. These devices aim to simplify and optimize insulin delivery while reducing barriers associated with a basal-bolus insulin regimen. As clinicians aim to learn more about this method of insulin delivery, real-world evidence can provide insight for patient identification and treatment guidance. This study was performed to evaluate the change in glycemic control (A1C) and insulin total daily dose (TDD) after switching to V-Go wearable insulin delivery device in a type 2 diabetes population with suboptimal control using conventional insulin delivery regimens.Patients and MethodsElectronic health records were queried to identify patients meeting inclusion criteria. Study objectives evaluated change in A1C and insulin TDD compared to baseline. A total of 283 patients were enrolled across 9 diabetes specialty sites.ResultsA1C significantly decreased from baseline at 3 months (−1.01% ± 0.09; P=0.0001) and 7 months (−1.04% ± 0.10; P<0.0001) after switching to V-Go. TDD of insulin significantly decreased at 3 months (−17 ± 3 U/day; P<0.0001) and 7 months (−14 ± 3 U/day; P<0.0001). Stratifying by prescribed baseline insulin regimen (basal-bolus, basal only or premix) or diabetes duration (<5 years to >20 years) demonstrated significant glycemic improvements from baseline with V-Go regardless of baseline regimen or duration of diabetes. After 7 months of V-Go use, the percent of patients considered high risk (A1C >9.0%) was reduced by nearly half (46% to 24%), and 52% of patients overall achieved an A1C <8%.ConclusionThis study represents the largest real-world study of the effectiveness of V-Go in patients with type 2 diabetes. Significant improvements in glycemic control with a reduction in insulin utilization were achieved across varying baseline insulin regimens and regardless of diabetes duration supporting the clinical benefits of this patch-like wearable insulin delivery device.

Access to insulin delivery devices and glycated haemoglobin in lower-income countries.

BACKGROUNDYoung people with type 1 diabetes in low-and-middle income countries face many challenges in accessing care, with various essential supplies needed for survival and long-term health.AIMTo study insulin delivery devices and glycated haemoglobin (HbA1c) testing.METHODSA survey was conducted in 2019 of leading diabetes centres in 41 countries supported by the Life for a Child Program. The survey covered numerous aspects concerning availability and costs at all levels of the health system, local usage patterns and attitudes, obstacles, and other aspects.RESULTSThirty-seven countries returned the survey (90.2% response rate). Key findings included: Syringe use was most common (83.1%), followed by insulin pens (16.7%) and pumps (0.2%). 48.6% of public health systems did not provide syringes, even with a co-payment. Use of suboptimal syringe/needle combinations was common. Needles were generally reused in almost all countries (94.3%, n = 35). Aside from donated supplies, there was variable access to HbA1c testing within public health facilities, and, when available, patients often had to cover the cost. Provision was further compromised by numerous problems including stock-outs, and challenges with understanding the test, equipment maintenance, and refrigeration.CONCLUSIONLarge gaps exist for adequate access to appropriate insulin delivery devices and HbA1c testing. Public health systems in low-and-middle income countries should increase affordable provision. There are also needs for specific health professional training and diabetes education; elimination of customs duties and taxes; development of inexpensive, robust HbA1c testing methods that do not require refrigeration of testing supplies; differential pricing schemes; and other solutions.

The Reference Guide to Integrate Smart Insulin Pens Into Data-Driven Diabetes Care and Education Services.

More than 7 million Americans who have diabetes use insulin therapy. The majority continue to use syringes and vials or traditional insulin pens to deliver their insulin doses. Using these tools to deliver insulin presents numerous challenges for both the person with diabetes and their clinicians. This article provides an in-depth introduction to a new category of insulin delivery devices and integrated management systems, referred to as smart insulin pens. The article includes information about how these integrated insulin delivery systems can reduce many of the challenges of rapid-acting insulin dosing via injection by enabling easier and more accurate dose recording, dose calculations, and sharing of diabetes management data with clinicians. This article also discusses new roles for diabetes care and education specialists in diabetes data-driven care and practice and addresses how smart insulin pens represent one of many newer digital diabetes management tools that can assist people with diabetes and their clinicians to optimally achieve and deliver quality, data-driven diabetes care. Newer and simplified insulin delivery devices with their integrated management systems, such as smart insulin pens, have the potential to minimize the challenges and complexities associated with insulin injection therapy while also providing people with diabetes and their clinicians more complete and integrated data in easily transmitted reports that support more efficient data analysis.

1033-P: Trends in U.S. Insulin Use for People with Diabetes: 2009-2017

Objective: Examine trends of insulin regimens, delivery devices and glucose monitoring among people with type 1 diabetes (T1D) or type 2 diabetes (T2D) in the U.S. from 2009-2017. Methods: The IBM® MarketScan® Commercial and Medicare databases were used to identify trends for insulin use over 9 years among people with T1D or T2D who filled a prescription for insulin in a calendar year. Total annual sample size ranged from 373,975 to 660,512. The analyses examined insulin regimen, method of delivery, and use of glucose monitoring systems separately for people with T1D or T2D. Generalized estimating equations were used to test whether trends were statistically significant. Results: For people with either T1D or T2D, use of short/rapid insulin only and use of analog insulins increased while premix insulin use decreased (all P&amp;lt;0.0001) from 2009 to 2017. Basal insulin only use increased for people with T2D over the study period (P&amp;lt;0.0001). Among people with T1D, vial with pump use increased significantly; the use of disposable pens increased in both cohorts (all P&amp;lt;0.0001). The observed use of continuous glucose monitoring (CGM) was numerically higher for patients with T1D compared to patients with T2D, although use significantly increased (both P&amp;lt;0.0001) over the study period for both cohorts. Conclusion: Results suggest that insulin prescribing continues to change with advances in insulin delivery technology and glucose monitoring systems. Disclosure M. Perez-Nieves: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. R. Juneja: Employee; Self; Eli Lilly and Company. L. Fan: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. E. Meadows: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. M.J. Lage: Consultant; Self; Eli Lilly and Company. Consultant; Spouse/Partner; Eli Lilly and Company. E.L. Eby: Employee; Self; Eli Lilly and Company.

Distanční léčba diabetu: Co mohou pacient, lékař a sestra zvládnout na dálku?

Due to the spread of new coronavirus disease, COVID-19, social interactions between people have been significantly reduced. In healthcare, outpatient care is a high-risk frontline of infection transmission in both patients and healthcare professionals. The presence of routine digital communication, remote data management and the availability of glucose monitoring and insulin delivery devices have given diabetology a certain advantage in this situation. However, the potential of these modalities has not been fully utilized so far. We provide an overview of practical methods of distance patient management, which can be used in most diabetes outpatient clinics without any difficult adjustments or additional investments. This approach can be used in different patients according to their treatment strategies and individual abilities.

Evolution of Insulin Delivery Devices: From Syringes, Pens, and Pumps to DIY Artificial Pancreas.

The year 2021 will mark 100 years since the discovery of insulin. Insulin, the first medication to be discovered for diabetes, is still the safest and most potent glucose-lowering therapy. The major challenge of insulin despite its efficacy has been the occurrence of hypoglycemia, which has resulted in sub-optimal dosages being prescribed in the vast majority of patients. Popular devices used for insulin administration are syringes, pens, and pumps. An artificial pancreas (AP) with a closed-loop delivery system with > 95% time in range is believed to soon become a reality. The development of closed-loop delivery systems has gained momentum with recent advances in continuous glucose monitoring (CGM) and computer algorithms. This review discusses the evolution of syringes, disposable, durable pens and connected pens, needles, tethered and patch insulin pumps, bionic pancreas, alternate controller-enabled infusion (ACE) pumps, and do-it-yourself artificial pancreas systems (DIY-APS).

SAT-LB113 Psychosocial Benefits of Using Basal-IQ® Predictive Low Glucose Suspend Technology in a Real-World Setting: Results From Pediatric Patients With Type 1 Diabetes

Recent literature has highlighted remarkable clinical benefits of the Basal-IQ PredictiveLow Glucose Suspend (PLGS) technology for both pediatric and adult patients with type 1diabetes (PwT1D). Although less frequently acknowledged in the literature, psychosocial benefits and other patient-reported outcomes (PROs) related to this technology, are critical to its sustained and satisfactory use. For purposes of this study, we analyzed pediatric PwT1Ds (n=123) who had recently started using the t:slim X2 insulin pump with Basal-IQ technology (Tandem Diabetes Care). These pediatric users were part of a larger recruited sample that also included adults with T1D (not described here). Amongst other clinical and demographic measures, pediatric PwT1Ds completed the Diabetes Impact and Device Satisfaction (DIDS) scale at baseline and then again at 6 months post-assessment(PA). The DIDS is a brief, reliable, and validated measure to ascertain device-specific satisfaction as well as impact of diabetes management in PwT1D. Pre-Post differences on DIDS were analyzed using repeated measures analysis of variance. Mean age of the pediatric sample was 12.25 years, female=45%, mean HbA1c=7.62%. At baseline, 91%used CGM, 27% used multiple daily injections, and 73% used insulin pumps as their therapy method. Parents/caregivers completed the DIDS on behalf of their child in most cases (92%). At PA, pediatric PwT1Ds, demonstrated significant changes on both subscales of the DIDS. Significant improvements were observed for device-related satisfaction (DS) (p<.001) whereas significant reduction was noted for diabetes-related impact (DI) (p<.01) indicating reduced burden of diabetes on daily life. These findings were noted regardless of patients’ baseline insulin delivery methods (MDI or insulin pump). For DS, at PA, patients reported the most improvement on items relating to“satisfaction with insulin delivery device” (29% increase, p<.001) and “hassle to use” (58%decrease, p<.001). For DI, items indicating the most reduction of diabetes impact were“worry about going low” (36% decrease, p<.001) and “wake up at night to treat low BG”(27% decrease, p<.001). These findings highlighted robust real-world evidence for psychosocial benefits of Basal-IQ technology for pediatric patients and their parents/caregivers. Using psychosocial PROs while evaluating medical devices and technologies is critical as they improve our understanding of patients’ experiences with these systems and their impact on quality of life. These aspects may not always be reflected in patients’ clinical outcomes but are essential for determining long term use and acceptance of new treatments and management regimens.

OR30-02 Efficacy and Safety Comparison Between U100 Regular Human Insulin and U100 Rapid Acting Insulin When Delivered by a 24 Hour Wearable Insulin Delivery Device in Type 2 Diabetes

Introduction: Increasing insulin prices have led to a renewed debate to determine if Rapid Acting Insulin (RAI) analogs offer an advantage over less expensive Regular Human Insulins (RHI). The steep increase in the cost of RAI has led to rationing of insulin or the total discontinuance of therapy by many patients due to cost. For many, RHI provides a more affordable option for insulin therapy when compared to RAI, especially if the limitations of the insulin profile can be overcome by delivering RHI through continuous subcutaneous insulin infusion (CSII) using a wearable insulin delivery device. To our knowledge, no data exists in a type 2 diabetes (T2D) population comparing RAI to RHI when delivered via CSII. Methods: This 14 week multi-center prospective, randomized parallel, non-inferiority study in a T2D population compared the efficacy and safety of RAI versus RHI when delivered by V-Go®, a 24-hr wearable patch-like insulin delivery device that provides a preset continuous basal rate of insulin and on-demand bolus dosing. This study was conducted in a real-world practice setting under usual standard of care. Glucose lowering agents were to remain stable unless removal warranted due to documented clinically significant hypoglycemia and the only specific guidance for insulin titration was to down-titrate if blood glucose levels were consistently lower than target range. Patients administering RAI with V-Go were randomized 1:1 to continue RAI or to switch to RHI. Primary endpoint assessed non-inferiority for the between group net difference in HbA1c derived from a mixed model analysis. Between group differences from baseline for insulin total daily dose (TDD) and hypoglycemia (based on 7 point glucose profiles) were evaluated as secondary endpoints. Results: One hundred thirteen patients (59 RHI and 54 RAI) were evaluated. Baseline characteristics were similar between cohorts. The mean change in HbA1c with RHI was -0.60% from a baseline of 8.41% vs -0.38% from a baseline of 8.33% with RAI (estimated treatment difference [ETD]: -0.22%; 95% confidence interval [CI] -0.67% to 0.22%; non-inferiority margin<0.4% and p=0.007). The mean change in TDD with RHI was 0.8 U/day from a baseline of 61.0 U/day vs 1.8 U/day from a baseline of 61.3 U/day with RAI (ETD: -1.04 U/day; 95% CI: -3.18 U/day to 1.11 U/day; p=0.92). The absolute change in percent of patients reporting hypoglycemia (≤ 70 mg/dL) from pre-randomization to post-randomization was +5.08% with RHI vs + 5.56% with RAI (ETD: -0.48%; 95% CI: -10.6% to 9.1%; p=0.91). Severe hypoglycemia was not reported in either cohort. Conclusion: Patients with T2D administering RAI with V-Go can safely switch to RHI maintaining similar glycemic control.

Abstract #863213: Patient Perspectives on Satisfaction and Trust Related to Insulin Delivery Devices - What Matters Most?

Abstract #863213: Patient Perspectives on Satisfaction and Trust Related to Insulin Delivery Devices - What Matters Most?

Safety and Effectiveness of an Investigational Insulin Delivery Device Providing Basal/Bolus Therapy with Rapid-Acting or Regular Human Insulin in Adults with Type 2 Diabetes.

Background: This study undertook to assess usability, 24-h glycemic profiles, and safety of an investigational basal/bolus insulin delivery device (IDD) providing rapid-acting or regular human insulin (RHI) for people with type 2 diabetes (T2D) transitioning from multiple daily insulin injections (MDIs).Methods: This prospective, single-center, open-label two-period study enrolled adults with T2D and glycated hemoglobin (HbA1c) 7%–11% (53–97 mmol/M). Participants continued the usual MDI therapy during a 2- to 3-day in-clinic MDI period and then within 7 days were switched to the IDD, using current insulin dose, for a 6-day in-clinic IDD period, with blinded continuous glucose monitoring throughout the in-clinic periods.Results: We enrolled 21 participants (mean ± standard deviation age 57 ± 8 years; HbA1c 8.2% ± 0.9% [66 ± 9.8 mmol/M]) using U-100 insulin lispro (n = 11) or who switched to U-100 RHI (n = 10). Glycemic measures improved from the MDI to IDD period, including fasting blood glucose (BG), 141.2 ± 38.3 mg/dL (7.8 ± 2.1 mmol/L) versus 121.2 ± 35.0 mg/dL (6.7 ± 1.9 mmol/L; P = 0.002), respectively; 24-h mean BG, 137.0 ± 20.5 mg/dL (7.6 ± 1.1 mmol/L) versus 125.0 ± 16.5 mg/dL (6.9 ± 0.9 mmol/L; P = 0.004); and time in range (at 70–180 mg/dL; 3.9–10 mmol/L), 81.0% ± 14.4% versus 87.5% ± 10.6% (P = 0.008). No significant differences between MDIs and IDD use were recorded for time <70 mg/dL (1.6% ± 2.7% vs. 3.1% ± 2.7%, P = 0.08), CV%, or mean of daily differences. Mean amplitude of glycemic excursions was significantly lower with the IDD (P = 0.011). There were no significant differences between insulin lispro and RHI for any glycemic measure. No serious adverse events were recorded.Conclusions: In the context of this exploratory study, the IDD was safe and effective to administer insulin lispro and RHI for adults with T2D.

Precision Dosing of Rapid-Acting Insulin Matters.

Despite several molecular and technological advances in insulin therapy and insulin delivery, global evidence highlights inadequate glycemic control in populations with type 1 diabetes (T1D) and type 2 diabetes (T2D). In this review, we discuss the importance of more precise dosing of insulin as one of the approaches to improve glycemic control while reducing hypoglycemic events. This report is based on the expert opinion of authors and literature search of articles relevant to the past and present insulin delivery devices in diabetes management, especially half-unit insulin pens. We describe the various factors that facilitate better glycemic control, focusing on the impact of appropriate insulin delivery device selection on diabetes management. Precision dosing of insulin is a lesser-studied factor that contributes toward better glycemic control. Insulin pens have consistently outperformed syringes as delivery devices due to their greater accuracy and precision of dosing, ease-of-use, and patient preference. These advantages make them better suited to administer insulin in hypoglycemia-prone insulin-sensitive people with T1D, particularly younger children and geriatric patients. Half-unit insulin pens further extend this benefit by delivering half-unit doses of insulin accurately. They may contribute to better management of diabetes by allowing flexible dosing for mealtimes and physical activities even in erratic diet situations or illnesses by offering corrective doses in small increments. They are ideal delivery devices for insulin-sensitive people with T1D who require greater accuracy and precision in insulin delivery to achieve more stringent glycemic control.

The Development and Psychometric Validation of the Diabetes Impact and Device Satisfaction Scale for Individuals with Type 1 Diabetes.

With the rapid development of new insulin delivery technology, measuring patient experience has become especially pertinent. The current study reports on item development, psychometric validation, and intended use of the newly developed Diabetes Impact and Device Satisfaction (DIDS) Scale. The DIDS Scale was informed by a comprehensive literature review, and field tested as part of two focus groups. The finalized measure was used at baseline and 6 months post-assessment with a large US cohort. Exploratory factor analyses (EFAs) were conducted to determine and confirm factor structure and item selection. Internal reliability, test-retest reliability, and convergent/divergent validity of the emerged factors were tested with demographics, diabetes-specific information, and diabetes behavioral and satisfaction measures. In all, 778 participants with type 1 diabetes (66% female, mean age 47.13 ± 17.76 years, 74% insulin pump users) completed surveys at both baseline and post-assessment. EFA highlighted two factors-Device Satisfaction (seven items, Cronbach's α = 0.85-0.90) and Diabetes Impact (four items, Cronbach's α = 0.71-0.75). DIDS Scale demonstrated good concurrent validity and test-retest reliability. The DIDS Scale is a novel and a brief assessment tool with robust psychometric properties. It is recommended for use across all insulin delivery devices and is considered appropriate for use in longitudinal studies. Future studies are recommended to evaluate the performance of DIDS Scale in diverse populations with diabetes.

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.