Insulin Delivery Hardware: Pumps and Pens.

Insulin Delivery Hardware: Pumps and Pens - PMC Skip to main content An official website of the United States government Here's how you know Here's how you know Official websites use .gov A .gov website belongs to an official government organization in the United States. Secure .gov websites use HTTPS A lock ( Lock Locked padlock icon ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites. Search Log in Dashboard Publications Account settings Log out Search… Search NCBI Primary site navigation Search Logged in as: Dashboard Publications Account settings Log in Search PMC Full-Text Archive Search in PMC Journal List User Guide PERMALINK Copy As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. Learn more: PMC Disclaimer | PMC Copyright Notice Diabetes Technol Ther . 2024 Mar 1;26(Suppl 1):S-32–S-44. doi: 10.1089/dia.2024.2503 Search in PMC Search in PubMed View in NLM Catalog Add to search Insulin Delivery Hardware: Pumps and Pens Rayhan Lal Rayhan Lal 1 Division of Endocrinology, Department of Medicine and Department Pediatrics. 2 Stanford Diabetes Research Center, School of Medicine, Stanford University, Stanford, CA, USA. Find articles by Rayhan Lal 1, 2 , Lalantha Leelarathna Lalantha Leelarathna 3 Manchester Diabetes Centre, Manchester University NHS Foundation Trust, Manchester, and Division of Diabetes, Endocrinology and Gastroenterology, University of Manchester, Manchester, United Kingdom. Find articles by Lalantha Leelarathna 3 Author information Article notes Copyright and License information 1 Division of Endocrinology, Department of Medicine and Department Pediatrics. 2 Stanford Diabetes Research Center, School of Medicine, Stanford University, Stanford, CA, USA. 3 Manchester Diabetes Centre, Manchester University NHS Foundation Trust, Manchester, and Division of Diabetes, Endocrinology and Gastroenterology, University of Manchester, Manchester, United Kingdom. Collection date 2024 Mar. Copyright 2024, Mary Ann Liebert, Inc., publishers PMC Copyright notice PMCID: PMC13085264  PMID: 38441453 Introduction W e begin the article with studies assessing the Insulclock connected insulin pen cap. Two studies were conducted in individuals with type 1 and type 2 diabetes (T1D and T2D) not meeting glycemic targets. Both studies demonstrated overall improvements in glycemia. Intriguingly, the technology did seem to increase the number of injections given by the T1D population but not the T2D group. While smart insulin pen caps provide greater technology access for those using pens, equity in access to insulin pumps is covered in two other publications. A retrospective observational study out of London illustrated that among 1631 adults with T1D the most deprived quintile had less diabetes technology and participation in structured education. Despite the United Kingdom's national health-care system, this real-world evidence demonstrates disparities in T1D care, which among diabetes technology was most pronounced with pumps. Payne and colleagues from New Zealand cover the bench-side dosing accuracy of a $100 insulin pump with a Bluetooth-driven stepper motor and three-dimensional (3D) printed parts designed to interface with commercial reservoirs and infusion sets. The application programming interface (API) for a similar pump was published on the open-source software site GitHub in February 2019 ( https://github.com/TheOtherPancreas/TheOtherPancreasAPI ) by the TheOtherPancreas. Despite a cost one to two orders of magnitude less than commercial devices, the system had comparable accuracy to a Medtronic 640G. A cheap, securely commanded pump paired with an open-source automated insulin delivery (AID) algorithm brings global access to AID one step closer, but work remains to deliver continuous glucose monitoring (CGM) worldwide. Once again, the science of insulin infusion sets has been highlighted in this year's publications. Hughes and colleagues examined the lived experience of 707 participants in the T1D Exchange Online Community, with 41% reporting one or more infusion set failures per month. These failures are often heralded by hyperglycemia rather than pump alarms and can lead to consideration of pump discontinuation. The team at the University of Washington report findings of the DERMIS study (Defining, Reviewing, and Monitoring Skin Pathologies in T1D), which used optical coherence tomography and biopsy to assess dermal changes from wearing infusion sets. They noted increased inflammation, vessel density, fibrosis, inflammation, eosinophils, and fat necrosis at infusion sites compared with control sites. These findings help explain the results of another study out of Eli Lilly showing that the pharmacokinetics of insulin are accelerated and the area under the curve (AUC) decreases over 10 days of infusion set wear. It is likely that increased vessel density contributes to the accelerated pharmacokinetics, while inflammation and tissue resistance reduce AUC. Glucose pharmacodynamics from a mixed meal tolerance test demonstrate worse glycemia over prolonged wear of a standard infusion set. Kastner and colleagues published similar findings over 7 days of wear, and we highlight another of their articles challenging prior infusion-set failure criteria. They report that per-protocol analysis of infusion-set failure can often produce significantly different results than the wear times reported by participants. Despite the precedent set by past trials, these findings make us question the way we define infusion-set failure and how we evaluate the wear time of novel infusion sets. In regards to T1D-specific literature, Barlas and colleagues demonstrate that pump therapy is associated with less ultrasound-confirmed lipohypertrophy than multiple daily injections. Rytter conducted a survey of 770 adults with T1D on open-loop insulin pump therapy and found that lower glycated hemoglobin (HbA1c) was associated with timely infusion set changes, few missed boluses, blousing before meals, and participant involvement in setting changes. Chatziravdeli and colleagues performed a systematic review of pump versus multiple daily injections in individuals with T2D. They found that pump therapy was more effective in reducing HbA1c from baseline with a lower total daily insulin dose. Most studies included in their meta-analysis predated the use of modern incretin and sodium-glucose cotransporter 2 (SGLT-2) inhibitor therapy, necessitating well-designed novel investigations. On the issue of safety, Estock and colleagues went to heroic lengths by analyzing 2429 adverse events for pumps from the MAUDE database. It should be noted that this sample represents only 20% of the adverse events filed in the first 6 months of 2020. Worse still, past survey data suggest less than one quarter of adverse device events are reported. The authors report clear themes in the root cause analysis by the pump manufacturer. Quality systems and postmarket surveillance must be built into the manufacturer's processes and regulated with clear timelines for mitigation. Key Articles Reviewed Efficacy of a Connected Insulin Pen Cap in People with Noncontrolled Type 1 Diabetes: A Multicenter Randomized Clinical Trial Gomez-Peralta F, Abreu C, Fernández-Rubio E, Cotovad L, Pujante P, Gaztambide S, Bellido D, Menéndez Torre E, Ruiz-Valdepeñas S, Bello H, Valledor X, Pérez-González J, Ruiz-Valdepeñas L Diabetes Care 2023; 46: 206–208 Efficacy of a Smart Insulin Pen Cap for the Management of Patients with Uncontrolled Type 2 Diabetes: A Randomized Cross-over Trial Galindo RJ, Ramos C, Cardona S, Vellanki P, Davis GM, Oladejo O, Albury B, Dhruv N, Peng L, Umpierrez GE J Diabetes Sci Technol 2023; 17: 201–207 Bench-side Dose Accuracy of an Open-Source Ultra-low-cost Insulin-Pump, with Testing Conducted to IEC 60601-2-24 Payne M, Pooke F, Holder-Pearson L, Chase JG, de Bock M, Campbell J, Knopp J J Diabetes Sci Technol. Published online December 8, 2022. doi: 10.1177/19322968221142316. Evaluation of Insulin Lispro Pharmacokinetics and Pharmacodynamics over 10 Days of Continuous Insulin Infusion in People with Type 1 Diabetes Garhyan P, Pratt E, Klein O, Famulla S, Zijlstra E, Lalonde A, Swinney M, Kazda C, Dassau E J Diabetes Sci Technol 2023; 17: 274–282 Current Insulin Infusion Set Failure Criteria May Be Too Stringent for Real-life Settings and May Skew Infusion Set Failure Outcomes in Extended-wear Infusion Set Studies Kastner JR, Poettler T, Kopanz J, Hochfellner DA, Romey M, Baumann PM, Muchmore D, Strasma PJ, Mader JK Diabetes Obes Metab 2023; 25: 1106–1111 Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community Hughes MS, Douvas JL, Layfield-Bryan M, Blanco LE, Gray JC, Zapotoczny G, Espinoza J, Wilcox JH, Lal RA Diabetes Technol Ther 2023; 25: 426–430 Evaluation of Insulin Pump Infusion Sites in Type 1 Diabetes: The DERMIS Study Kalus A, Shinohara MM, Wang R, Baran JD, Dong X, Khakpour D, Lu J, Hirsch IB Diabetes Care 2023; 46: 1626–1632 Evaluation of Lipohypertrophy in Patients with Type 1 Diabetes Mellitus on Multiple Daily Insulin Injections or Continuous Subcutaneous Insulin Infusion Barlas T, Yalcin MM, Coskun M, Demirel D, Altinova AE, Toruner FB, Karakoc MA, Yetkin I, Akturk M Endocr Pract 2023; 29: 119–126 Associations between Insulin Pump Self-management and HbA1c in Type 1 Diabetes Rytter K, Madsen KP, Andersen HU, Hommel E, Pedersen-Bjergaard U, Schmidt S, Nørgaard K Diabet Med 2023; 40: e15068 A Systematic Review and Meta-analysis of Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injections in Type-2 Diabetes Chatziravdeli V, Lambrou GI, Samartzi A, Kotsalas N, Vlachou E, Komninos J, Tsartsalis AN Medicina (Kaunas) 2023; 59: 141 The Impact of Socio-economic Deprivation on Access to Diabetes Technology in Adults with Type 1 Diabetes Fallon C, Jones E, Oliver N, Reddy M, Avari P Diabet Med 2022; 39: e14906 Insulin Pump-associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes Estock JL, Codario RA, Keddem S, Zupa MF, Rodriguez KL, DiNardo MM Diabetes Technol Ther 2023; 25: 343–355 SMART INSULIN PENS Efficacy of a Connected Insulin Pen Cap in People with Noncontrolled Type 1 Diabetes: A Multicenter Randomized Clinical Trial Gomez-Peralta F 1 , Abreu C 1 , Fernández-Rubio E 2 , Cotovad L 3 , Pujante P 4 , Gaztambide S 3 , Bellido D 3 , Menéndez Torre E 4 , Ruiz-Valdepeñas S 5 , Bello H 5 , Valledor X 5 , Pérez-González J 5 , Ruiz-Valdepeñas L 5 1 Endocrinology and Nutrition Unit, Hospital General de Segovia, Segovia, Spain; 2 Endocrinology and Nutrition Unit, Cruces University Hospital, Bilbao, Spain; 3 Endocrinology and Nutrition Unit, Complejo Hospitalario Universitario de Ferrol (CHUF), A Coruña, Spain; 4 Endocrinology and Nutrition Unit, Hospital Universitario Central de Asturias, and Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain; 5 Research and Development Unit, Insulcloud S.L., Madrid, Spain Diabetes Care 2023; 46: 206–208 Insulclock is a smart insulin pen cap that can be plugged into several brands of insulin pen devices to help track the date, time, and dosage of the last injection, the type of insulin used, and the temperature range ( 1 ). The smart insulin pen cap is connected via Bluetooth to a smartphone, tablet, or personal computer. It has an alarm system with visual and sound alerts designed to prevent insulin omissions and delays in insulin administration. The Insulclock system obtains continuous glucose monitoring (CGM) and glucometer data and integrates this information with insulin injection information in its application (app). This study assessed the efficacy of the insulin pen cap Insulclock on improving glycemic control, treatment adherence, and user satisfaction in people with type 1 diabetes (T1D). Methods In this multicenter, open-label, randomized controlled trial conducted at four Spanish centers, a 4-week run-in phase was followed by a 6-week double-arm phase scheduled over seven visits. In the run-in phase, participants were trained in using the device and app in a masked mode. In the double-arm phase, participants in the active group had access to all the Insulclock system functionalities, such as insulin reminders and CGM, with insulin dose information integrated with the app. All patients were using the FreeStyle Libre 2 CGM as their usual diabetes care and continued using it during the study with all its functionalities, including alarms. The study participants were aged 14–80 years with T1D (hemoglobin A1c [HbA1c] ≥6.5% and/or HbA1c variations ≥1% within the previous 2 years) and regularly attended (≥2 per year) follow-up visits. A glucose rate increase detector algorithm was used to automatically detect meal glucose excursions through the rate of change of glucose from CGM data. An on-time insulin injection was considered when a bolus insulin injection was detected within 45 minutes before the glycemic meal excursion. Meal-time insulin doses not detected by the glucose rate of change methodology were categorized as on time. A bolus was deemed mistimed when the insulin injection occurred within 60 minutes after the meal glycemic excursion start. A bolus was considered missed when the meal excursion was not associated with an insulin injection 45 minutes before to 60 minutes after the CGM rise. The study's primary outcome was the time in range (70–180 mg/dL). Results Seventy-five participants were randomly assigned, and data from 55 participants (73%) were evaluable (active group, n = 26; masked group, n = 29). The increase in time in range was higher in the active versus masked group (5.2% vs −0.8%; P = 0.016). Mean glucose levels decreased in the active group and remained stable in the masked group (−8.7 mg/dL, P = 0.024). Differences between groups in glucose management indicator were significant (−0.31%, P = 0.024). The time above range decreased by 5.5% in the active group and increased by 0.13% in the masked group (−5.6%, P = 0.018). A significantly higher decrease in the high blood glucose index was observed in the active group compared with the masked group (−1.4, P = 0.029). The total number of insulin injections and insulin doses taken on time per month increased in the active group (13.9% and 13.5%, respectively) and decreased in the masked group (−8.3%, P = 0.029, and −10.0%, P = 0.046, respectively). Conclusions Use of the Insulclock system was associated with improved time in range, predominantly due to reduced time above range. The total number of insulin injections and insulin doses taken on time per month increased in the active group. Comments Many people living with T1D are treated with insulin pens. The ability to visualize insulin administration data combined with glucose data allows insulin pen users to understand better insulin's temporal action profile, the importance of preblousing, and the consequences of a delayed or missed meal bolus (similar to insulin pump users). The results of this study show that connected pen cap technology may improve adherence and reduce hyperglycemia. In the current research, a relatively high dropout rate was noted, and ways to improve the usability and utility of smart pens and pen caps technology and further, longer term, and larger studies may be warranted. Even when the cost is not a barrier, we need to find the most suitable or preferred technology for each individual living with T1D, considering individual choices and preferences. Efficacy of a Smart Insulin Pen Cap for the Management of Patients with Uncontrolled Type 2 Diabetes: A Randomized Cross-over Trial Galindo RJ 1 , Ramos C 1 , Cardona S 1 , Vellanki P 1 , Davis GM 1 , Oladejo O 1 , Albury B 1 , Dhruv N 1 , Peng L 2 , Umpierrez GE 1 1 Emory University School of Medicine, Division of Endocrinology and Diabetes, Grady Memorial Hospital, Atlanta, GA; 2 Emory University Rollins School of Public Health, Atlanta, GA J Diabetes Sci Technol 2023; 17: 201–207 Insulclock is a smart insulin pen cap that can be plugged into several brands of insulin pen devices to help track the date, time, and dosage of the last injection, the type of insulin used, and the temperature range ( 1 ). The smart insulin pen cap is connected via Bluetooth to a smartphone, tablet, or personal computer. It has an alarm system with visual and sound alerts designed to prevent insulin omissions and delays in insulin administration. This pilot study assessed the use of the smart insulin pen cap on treatment adherence, glycemic control, and patient satisfaction among insulin-treated patients with poorly controlled type 2 diabetes (T2D). Methods A prospective, randomized (1:1), 26-week, crossover clinical trial in insulin-treated adults (aged 18–80 years) with T2D and hemoglobin A1c (HbA1c) between 7.0% and ≤ 12% ( n = 80), while receiving treatment with basal insulin, including NPH (neutral protamine Hagedorn), glargine, or detemir, at a total daily dose of ≤ 0.5 U/kg/day as monotherapy or in combination with oral antidiabetic agents. Participants were randomized to a 12-week active phase receiving alarms/reminders and a 12-week control/masked phase without feedback. The authors assessed differences between the groups on treatment adherence, insulin omission, mistiming of insulin injections, HbA1c, and treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). For insulin injections recorded as given/administered, the authors defined mistiming if not delivered within 2 hours of the expected daily administration time. Similarly, dose omissions were defined as doses not documented in the diary or not recorded by the device. Cumulative treatment adherence was defined as the proportion of expected injections completed, as captured by the number of weekly basal insulin doses administered and classified as highly adherent (> 85% of completed doses, equivalent to missing one dose per week), moderately adherent (> 60%–85% of completed doses, equivalent to missing 1–3 doses per week), poorly adherent (15%–60% of completed doses, missing 4–5 doses per week), or not adherent (< 15% of completed doses, missing six doses per week). Results Overall, 53% of patients were highly adherent, reporting > 85% of completed doses; 19% were moderately adherent (> 60%–85% of completed doses); 24% were poorly adherent (15%–60% of completed doses); and 3.8% were not adherent (< 15% of completed doses). The participants, on average, missed 23.6% of insulin doses, administered an average of 10.6% of incorrect doses, and administered an average of 7.9% of doses at the incorrect time. Compared with the control/masked phase, the active phase resulted in lower mean daily blood glucose (147.0 ± 34 vs 157.6 ± 42 mg/dL; P < 0.01) and a greater reduction in HbA1c from baseline (−0.98% vs −0.72%; P = 0.006); however, no significant differences in treatment adherence, insulin omission, or insulin mistiming were observed. High patient satisfaction scores were reported in both active and control phases, with a DTSQ change of 15.5 ± 3.7 and 14.9 ± 3.6, respectively. Statistical models showed no residual effect after the crossover between the active and control phases. Conclusions The results of this pilot study indicate that Insulclock, a smart insulin pen cap, may be effective in improving glycemic control with overall good satisfaction in basal insulin-treated patients with T2D. Despite the alarms and reminders from the device, no significant differences in treatment adherence, insulin omission, or insulin mistiming were observed in this relatively short duration (12-week) crossover study. Comments In spite of participating in a clinical trial and providing insulin pens, over 25% of the cohort had poor compliance with insulin therapy. There was a significant improvement in HbA1c in both treatment arms and a greater reduction in HbA1c from baseline (−0.98% vs −0.72%; P = 0.006) with smart insulin pen cap intervention. Despite using a smart pen cap, treatment adherence was not different. What are the possible reasons for this? The study team provided smartphones, insulin, and supplies to all patients at no cost, which may have resulted in higher treatment adherence rates and satisfaction in both groups. Similarly, the frequent phone calls and in-person visits allowed for close supervision and may have influenced the glycemic control and overall high treatment satisfaction in both groups, reducing the between-group difference. Future longer term, real-world studies using the device in a larger number of patients, including those using multiple daily injection therapy, may be helpful. It will also be useful to explore the compliance with other injectable treatments, such as glucagon-like peptide 1 (GLP-1) agonists, using smart pen cap technology in the future. INSULIN INFUSION Bench-side Dose Accuracy of an Open-Source Ultra-low-cost Insulin-Pump, with Testing Conducted to IEC 60601-2-24 Payne M 1 , Pooke F 1 , Holder-Pearson L 1,2 , Chase JG 1 , de Bock M 3 , Campbell J 2 , Knopp J 1 1 Centre for Bio-engineering, Department of Mechanical Engineering, University of Canterbury, Christchurch, New Zealand; 2 Department of Electrical and Computer Engineering, University of Canterbury, Christchurch, New Zealand; 3 Department of Paediatrics, University of Otago, Christchurch, New Zealand J Diabetes Sci Technol. Published online December 8, 2022. doi: 10.1177/19322968221142316. High initial purchase costs (NZ$8800–$10,000) and ongoing expenses associated with pump therapy (NZ$2340) may limit its utilization. Developing an ultra-low-cost-insulin pump could increase affordability, access, and improve care. Accuracy of insulin pumps is judged against the predicate accuracy parameters published in the U.S. Food and Drug Administration (FDA) regulatory documents for the Medtronic 640G. The manufacturer states an accuracy of ± 20% for boluses < 0.1 units and ± 5% for all other boluses and basal rates, and the “Summary of Safety and Effectiveness” datasheet states all hourly intervals should be within ± 5%, with a cumulative error no greater than ± 10%. Methods A Bluetooth-controlled stepper motor capable of interacting with standard commercial reservoirs and infusion sets was built for less than US$100. Such designs were previously described by U.S.-based The Other Pancreas ( 2 ). The pump was tested using methodology given in IEC60601-2-24 (IEC60601-2-24), Sections 50.104 (basal testing), and 50.106 (bolus testing). A microscale (Mettler Toledo XP105) giving 5dp of accuracy was used. The class III water was degassed before use, ensuring consistency between tests. A layer of paraffin oil of < 3 mm thickness was floated on the water to eliminate evaporation. Basal accuracy was evaluated with a “typical rate” of 1 unit/hour. Boluses of 0.025, 1, and 5 units were delivered 25 times. Results The overall basal accuracy of the Medtronic 640G was −0.392% with a maximum variability of 44%, and for the low-cost insulin pump 0.089% with a maximum variability of 24%. For the commercial pump, the deviation of mean delivery volume was −16.00% for 0.025 units, −1.82% for 1 unit, and 1.58% for 5 units. For the low-cost insulin pump, deviation of mean delivery volume was 16.00% for 0.025 units, 1.82% for 1 unit, and 2.4% for 5 units. Conclusions These results show that a low-cost pump can accurately deliver insulin in limited bench testing. The test pump showed less variability than the commercial device and a tendency toward overdelivery of boluses. Of note, the low-cost pump does not include feedback control or safety systems. Testing in other environments and scenarios is required to fully meet IEC60601-2-24 standards. Comments AID is quickly becoming a standard of care for the treatment of T1D ( 3 ). While open-source algorithms (such as APS and Loop) are freely available, low-cost pumps that can be directly controlled by the person with diabetes are unheard of in the United States. Payne and colleagues demonstrated clinically reasonable bench-side accuracy without any significant software feedback control. There will still be costs associated with disposable supplies, but low-cost pumps are essential for delivering AID equitably to the world. Given that this pump was manufactured for one to two orders of magnitude less cost than commercial equivalents, pump manufacturers should be encouraged to pursue price reductions for pump models that are entirely commanded by smartphones. It is also imperative that secure API-level access of insulin delivery be granted to people with diabetes or their caretakers. The more challenging missing element for global access to AID is CGM. Evaluation of Insulin Lispro Pharmacokinetics and Pharmacodynamics over 10 Days of Continuous Insulin Infusion in People with Type 1 Diabetes Garhyan P 1 , Pratt E 2 , Klein O 3 , Famulla S 3 , Zijlstra E 3 , Lalonde A 1 , Swinney M 4 , Kazda C 1 , Dassau E 1,4 1 Eli Lilly and Company, Indianapolis, IN; 2 Lilly Centre for Clinical Pharmacology, Singapore, Singapore; 3 Profil, Neuss, Germany, 4 Eli Lilly and Company, Cambridge, MA J Diabetes Sci Technol 2023; 17: 274–282 Prior studies have examined extended wear of infusion sets in an outpatient setting with continuous glucose monitor (CGM) and insulin pump data. The scientific literature is missing an in-depth evaluation of how insulin pharmacokinetics (PK) and glucose pharmacodynamics (PD) evolve during extended wear. In addition, the authors hypothesized that a nonsteroidal anti-inflammatory drug, meloxicam, added to an insulin formulation could prolong the catheter wear time and maintain the insulin lispro PK and PD properties over time. Methods This was a phase 1, randomized, double-masked, single-center, two-way crossover study conducted at Profil between December 2019 and August 2020 among individuals with type 1 diabetes ≥1 year on stable pump therapy for ≥3 months. The participants randomly received U100 insulin lispro or U100 insulin lispro + 0.25 mg/mL meloxicam through a 6 mm Medtronic Quick-Set. The primary end points were area under the insulin lispro curve from 0 to 5 hours (AUC Ins.0–5h ) after bolus administration before a mixed-meal tolerance test (MMTT) and maximum observed concentration of insulin lispro (C Ins.max ) on days 5, 7, and 10 versus day 3 (baseline). Results Twenty-four participants were screened, 20 were randomized, and 18 completed the study. Insulin PK accelerated from days 1 to 7. The AUC Ins.0–5h was significantly lower on day 10 versus day 3 and did not differ significantly between formulations. The C Ins.max increased on days 5, 7, and 10 versus day 3. The C Ins.max of the lispro and meloxicam was ∼14%–23% lower than insulin lispro alone. Accelerated insulin absorption and a modest loss of total insulin exposure led to a loss of MMTT glycemic control at later time points. Conclusions The PK of insulin changed over catheter wear time even when an anti-inflammatory agent was present. Postprandial glycemic control was adversely affected by the accelerated insulin PK and decreased AUC Ins.0–5h . Comments Both this study and another by Kastner et al. ( 4 ) published in 2023 illustrate more rapid insulin action over days of extended wear but with reduced area under the curve (AUC). Of note, the Kastner study demonstrated a statistically significant reduction in AUC by day 7, whereas the present study showed a more modest effect at day 10. These differences may be attributable to individual differences in subcutaneous tissue resistance that increases over days of wear ( 5 ). All 18 participants completing the trial wore the 6 mm Medtronic Quick-Set for 10 days. The participants were inpatients after day 3, and the authors postulate that the close monitoring may have improved glycemia and reassured the participants about continuing to wear the device though day 10. As in a prior 7-day Quick-Set survival publication ( 6 ), there were several infusion set failures before day 3 and at least 33 unexplained hyperglycemic episodes. These unexplained episodes of hyperglycemia would have met failure conditions in past outpatient studies. As a result, it may be prudent to deliver additional correction doses through extended wear, alter the failure criteria for extended wear infusion set studies, and consider modeling the PK/PD changes in AID systems. Current Insulin Infusion Set Failure Criteria May Be Too Stringent for Real-life Settings and May Skew Infusion Set Failure Outcomes in Extended-wear Infusion Set Studies Kastner JR 1 , Poettler T 2 , Kopanz J 2 , Hochfellner DA 2 , Romey M 1 , Baumann PM 2 , Muchmore D 1 , Strasma PJ 1 , Mader JK 2 1 Capillary Biomedical Inc, Irvine, CA; 2 Medical University of Graz, Division of Endocrinology and Diabetology, Graz, Austria Diabetes Obes Metab 2023; 25: 1106–1111 Infusion set failure criteria were originally described by Patel and colleagues in 2013 for assessing extended wear ( 6 ). These criteria have formed the basis for many subsequent infusion set assessments. Generally, these criteria dictate participant replacement of the infusion set under the following conditions: Unexplained hyperglycemia (> 250 mg/dL), not responsive to pump-delivered correction bolus (50 mg/dL within an hour) Hyperglycemia with ketones Infection Occlusion alarm It may be difficult for participants to follow these criteria. The authors believe a per-protocol analysis will reveal earlier failures than those reported by the participants. Methods Individuals with type 1 diabetes (T1D) were enrolled in a controlled, random-sequence study of three infusion sets (MiniMed Mio, AccuCheck FlexLink, and Capillary Biomedical's investigational angled infusion set) worn for up to 14 days. The primary end point was the duration of infusion set wear until removal due to the prespecified criteria or removal for any other reason (such as accidental removal, pain, or reaching 14 days). In a secondary analysis the data were retrospectively analyzed for per-protocol infusion set failure criteria. Results Among the 13 participants, 6 were female and 7 were male, with a mean age of 36.7 ± 10.5 years. Participants had a body mass index of 24.9 ± 3.3 kg/m 2 , hemoglobin A1c (HbA1c) of 6.9% ± 2.9%, and their diabetes duration was 22.5 ± 7.4 years. Subject-weighted average time until the first failure event was 6.3 ± 4.2 days versus an actual wear time of 9.5 ± 3.8 days ( P < 0.001). Among infusion sets removed where the participants stated the failure criteria had been met, adjudication revealed only 44% (11 of 25) met the protocol definition for failure; 50% were not removed at the time an adjudicated failure occurred, with removal occurring a median of 4.3 days later. Conclusions These data reveal that per-protocol analysis of failure events can produce significantly different results than participant-reported infusion set failures. Participants often wear infusion sets beyond the point of protocol-defined failure, and in some cases the individuals met the criteria five times before removal. The authors recommend modification of the failure criteria to be more representative of the behaviors of those living with T1D. Comments Uniformly evaluating infusion sets over extended wear periods has proven quite challenging. The original Patel criteria ( 6 ) have been modified in subsequent studies ( 7 ). However, it should be noted that some of these studies did perform a per-protocol analysis and adjudication of infusion set failures ( 8 ). The Medtronic Extended Wear Infusion Set has provided a precedent for regulatory clearance of a 7-day infusion set, which is likely to be replicated. However, there remains a fundamental question of what defines infusion set failure. Certainly, a complete occlusion resulting in absolute insulinopenia, hyperglycemia, and ketones would constitute an overt failure. Things become less clear with partial occlusions, leaks, and changes in pharmacokinetics and pharmacodynamics over time, which might be overcome with additional bolusing. One might, for example, consider an accidental pull out as an adhesive failure or infection as a loss of sterility, fundamental to the device, or something to be excluded from analysis. Consensus must be reached on what we consider failure, and this should ideally be evaluated in a systematic and objective manner. Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community Hughes MS 1 , Douvas JL 2 , Layfield-Bryan M 3 , Blanco LE 3 , Gray JC 3 , Zapotoczny G 4 , Espinoza J 4 , Wilcox JH 3 , Lal RA 1,5 1 Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, Stanford University School of Medicine, Stanford, CA; 2 Princeton University, Princeton, NJ; 3 Diatech Diabetes, Inc., Memphis, TN; 4 Department of Pediatrics, Children's Hospital Los Angeles, Los Angeles, CA; 5 Division of Pediatric Endocrinology, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA Diabetes Technol Ther 2023; 25: 426–430 Insulin pump therapy and closed-loop insulin delivery are significant advancements for people with type 1 diabetes (T1D). However, insulin infusion site (IIS) failure is common ( 9 ) and is the weak link in insulin pump therapy/closed-loop systems. Most are approved for only 2- to 3-day use, although an extended wear (up to 7 days) option was recently approved ( 10 ). IIS failure can lead to hyperglycemia, an increased risk for diabetes-related ketoacidosis, and even death. This study explored the real-world experience with IIS failure. Methods A voluntary English-only online survey hosted on SurveyMonkey was available from September 3, 2020, to November 19, 2020. It was distributed through two emails to members of the T1D Exchange Online Community and published on T1D Exchange social media accounts, including Twitter (four posts), Instagram (four posts), Facebook (four posts), and LinkedIn (one post). Eligible respondents were ≥18 years old, resided in the United States, and either had diagnosed type 1 or type 2 diabetes (T1D or T2D) or cared for an individual with T1D or T2D actively using an insulin pump. IIS failures were defined as “when your infusion set/pod does not correctly infuse a bolus or basal rate of insulin from your pump, potentially resulting in hyperglycemia or a loss of blood sugar control. These failures can be caused by numerous issues, including inflammation at the infusion site (and other skin complications), occlusions, leakages, kinking of the cannula, adhesion problems, and dislodgement from the infusion site.” Results The final analysis included 707 responses, comprising 631 adults (89.3%) with diabetes on insulin pumps and 76 caregivers (10.7%). Individuals were also mostly of female gender and White race. The insulin pump brands were Tandem 40.2%, Medtronic 34.9%, and Insulet 24.5%. The mean hemoglobin A1c (HbA1c) was 6.8% ± 1.0%. IIS failures were common: 41.4% participants reported ≥1 per month. Of the participants reporting any history of IIS failure, 56.2%, 25.0%, 9.9%, 5.7%, and 3.2% reported that their most common method of first being alerted to an IIS failure was by experiencing hyperglycemia on glucometer or continuous glucose monitor (CGM), a pump alarm, hyperglycemia symptoms, a site-specific issue (see/smell/feel insulin leak, inflammation, and swelling), or unknown/not alerted, respectively. None of the assessed participant characteristics—including age, household income, HbA1c, insulin total daily dose, duration of insulin pump use, or estimated average IIS wear time > 3 days—was found to have significant odds associated with higher (≥1 per month) or lower (< 1 per month) reported IIS failure frequency. In addition, no individual IIS attributes—including angled, steel, and long cannula types or maximum wear time hard stop of 3 days (i.e., Omnipod)—were predictive of ≥1 IIS failure per month. Feeling burnout was associated with higher odds of IIS failure ≥1 per month (odds ratio [OR], 1.489 [95% CI, 1.024–2.165]), whereas those who reported that they were considering ending pump use had the highest odds of having at least monthly IIS failures (OR, 2.233 [95% CI 1.455–3.427]). Conclusions IIS failure is common and usually detected through the development of hyperglycemia rather than a pump alarm. No assessed demographic factor or IIS characteristic was predictive; however, higher odds of ≥1 failure per month were associated with feelings of burnout (OR, 1.489 [95% CI, 1.024–2.165]) and considering pump discontinuation (OR, 2.233 [95% CI, 1.455–3.427]). Comments The results of this study provide valuable information on the frequency, unpredictability, and burdens of IIS failure, which often go undetected until hyperglycemia develops. This is associated with burnout and discontinuation of pump use. A key strength of this study is the broad definition of IIS, including any incident in which inadequate insulin delivery is recognized. The authors found that a greater burden of reported IIS failure was not predicted by age, household income, HbA1c, insulin total daily dose, duration of pump use, or average IIS wear time. In contrast to findings from this survey, a post hoc analysis by Kanapka et al. ( 11 ) examining 22,741 infusion site wears among 263 participants across two clinical trials found that participants aged < 18 years or with higher baseline HbA1c had greater odds of IIS failure using a definition of prolonged (≥2 hours) hyperglycemia before IIS exchange. The limitations of the current study included sampling bias from a voluntary online English-only survey and the potential for misestimations of event frequencies or glycemic parameters from reliance on self-reported data. The mean HbA1c of the sample was 6.8%, and 92% were White, which may explain the lack of correlation with HbA1c, income, and education. Evaluation of Insulin Pump Infusion Sites in Type 1 Diabetes: The DERMIS Study Kalus A 1 , Shinohara MM 1,2 , Wang R 3 , Baran JD 4 , Dong X 4 , Khakpour D 4 , Lu J 3 , Hirsch IB 4 1 Division of Dermatology, Department of Medicine, School of Medicine, University of Washington, Seattle, WA; 2 Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA; 3 Department of Bioengineering, University of Washington, Seattle, WA; 4 Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, School of Medicine, University of Washington, Seattle, WA Diabetes Care 2023; 46: 1626–1632 Infusion site failures are common and may lead to discontinuation of insulin pump therapy. Defining, Reviewing, and Monitoring Skin Pathology in Type 1 Diabetes Study (DERMIS) was performed to better understand dermal changes associated with chronic subcutaneous insulin infusion. Much of the available data come from animal models. Tissue biopsy and noninvasive imaging with optical coherence tomography (OCT) of infusion sites have never previously been performed in humans. Methods This was a cross-sectional, single-center study, among individuals with type 1 diabetes using vertically inserted cannulas short term (< 10 years) or long term (> 20 years). OCT operating at a 1310 nm central wavelength with a bandwidth of 100 nm was performed immediately before skin punch biopsies were collected at three sites: ( 1 ) the current site; ( 2 ) the recovery site, with the infusion set removed 3 days before biopsy; and ( 3 ) the control site, which was never used for any insulin infusion or injection. Results The analysis enrolled 30 participants. OCT identified characteristics of increased inflammation and vessel density at pump sites compared with control sites. Histologic analysis of the pump sites showed differences in skin architecture, including fibrosis, inflammation (particularly eosinophils at the interface between dermis and fat), and fat necrosis. The eosinophil count was higher in the short-term users but was not associated with insulin type or pump brand. Immunohistochemical staining showed differences in staining for insulin-like growth factor 1 (IGF-I) and transforming growth factor β3 (TGF-β3) between infusion and control sites. Conclusions These findings support allergic sensitization as a potentially common reaction. The leading candidates causing this include insulin preservatives, plastic materials, and adhesive glue used in device manufacturing. The inflammatory response caused by these common allergic responses may result in tissue changes responsible for the infusion site failures seen frequently in clinical practice. Comments Kalus and colleagues present the first human biopsy data from insulin infusion sites. These data are invaluable and necessary to understand infusion set failure. The authors propose that the increased vessel density seen on optical coherence tomography (OCT) angiography is related to injury and repair after catheter insertion. This may also explain the changes in kinetics observed with prolonged infusion set wear. The eosinophil response and inflammation point to a delayed hypersensitivity response, which could be the result of any component of insulin and/or the infusion set itself. Past swine biopsy studies suggested infusion set failure from the insulin protein itself ( 12 ). The authors recommend future studies that include patch testing and industry cooperation to assess the physiology of subcutaneous infusion set failure. INSULIN PUMPS IN TYPE 1 DIABETES Evaluation of Lipohypertrophy in Patients with Type 1 Diabetes Mellitus on Multiple Daily Insulin Injections or Continuous Subcutaneous Insulin Infusion Barlas T, Yalcin MM, Coskun M, Demirel D, Altinova AE, Toruner FB, Karakoc MA, Yetkin I, Akturk M Department of Endocrinology and Metabolism, Faculty of Medicine, Gazi University, Ankara, Turkey Endocr Pract 2023; 29: 119–126 Lipohypertrophy is a common localized complication of insulin administration postulated to occur through activation of insulin growth factors on adipocytes and inflammatory reaction. The reported prevalence of lipohypertrophy among people with type 1 diabetes (T1D) varies widely in the literature from 27.2%–94.9%. The current standard of care for detecting lipohypertrophy is inspection and palpation, which may miss flat lesions. This study identified lipohypertrophy with examination techniques and ultrasound among people with T1D on multiple daily insulin (MDI) injections or pump and revealed the factors associated with the development and severity. Methods This was a single center observational study in adults with T1D. All sites of insulin administration were examined with validated inspection, palpation, and ultrasound techniques. Results The analysis included 66 people with T1D treated with multiple daily injections (MDI, n = 35) or insulin pump ( n = 31) for at least 1 year. The detection rate with ultrasound was significantly higher than by palpation ( P < 0.001). Lipohypertrophy was detected with ultrasound in 30 (85.7%) participants in the MDI group and 22 (71.0%) participants in the pump group. Advanced lipohypertrophy was detected in 13 (37.1%) of the MDI users and in 3 (9.7%) of the pump users. Lipohypertrophy was more severe in the MDI group than in the pump group ( P = 0.013). Lipohypertrophy was associated with diabetes duration, length of infusion set use, body mass index, hypoglycemia, complications, hemoglobin A1c, and insulin dose. In a multiple linear regression analysis injection, incorrect rotation and a history of ketosis were found to be most related to lipohypertrophy severity. Conclusions Ultrasound might be an effective approach for detecting and evaluating the severity of lipohypertrophy. In people with T1D injections may cause more severe lipohypertrophy than pumps. Comments Although validated measures have been described for assessing lipohypertrophy, they have not been used to assess differences related to the modality of insulin administration. The current study demonstrates lipohypertrophy at the higher end of previously reported prevalence figures. Although ultrasound clearly proves a more sensitive detector for lipohypertrophy than inspection and palpation, the clinical significance of disease detected by ultrasound alone is unclear. Regardless, if an individual is experiencing clinically significant lipohypertrophy with injections, pump therapy may offer a potential solution beyond advising more frequent site rotation. Associations between Insulin Pump Self-management and HbA1c in Type 1 Diabetes Rytter K 1,2 , Madsen KP 1,3 , Andersen HU 1 , Hommel E 1 , Pedersen-Bjergaard U 2,4 , Schmidt S 1 , Nørgaard K 1,2 1 Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; 2 Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; 3 Danish Centre for Health Economics, University of Southern Denmark, Odense, Denmark; 4 Department of Endocrinology and Nephrology, Nordsjaellands Hospital, Hillerød, Denmark Diabet Med 2023; 40: e15068 To gain the most benefit from the therapy, insulin pumps require education, training in the technology, and a degree of self-management of the insulin pump. Use of the advanced insulin pump features (temporary basal and dual and/or square wave bolus), the timing of bolus insulin relative to eating, and the intervals of infusion set change are everyday practices that are all considered to impact glucose regulation. This study explored associations between insulin pump self-management and hemoglobin A1c (HbA1c) levels in adult insulin pump users in a large cohort of people with type 1 diabetes (T1D). Methods Adult insulin pump users with T1D ( n = 770, 48% of those invited) completed an online questionnaire. The latest HbA1c levels and demographics were extracted from national registries. Associations between HbA1c and self-management were investigated using backward-selected linear regression models. The authors divided insulin pump self-management factors into more frequent activities (i.e., activities usually performed daily and weekly and less frequent activities). The more frequent activities were infusion set change (0–4 days; 5–10 days), carbohydrate counting (yes; no), bolus behaviors (missing bolus insulin often; once in a while; never or rarely), timing of insulin bolus (during or after; just before; 10–15 minutes before the meal), and use of dual wave, square wave, and temporary basal features (never or rarely; once in a while; often or always). Less frequent activities included insulin pump data upload at home (never or rarely; once a year or less; 2–5 times a year or more), primary responsible person for insulin pump settings adjustment (only the health-care professional [HCP]; mainly HCP; mainly oneself), and which settings (carbohydrate ratio, insulin sensitivity, basal rate, insulin action time, and blood glucose target) one would typically adjust (yes; no). Results Of the 699 responders eligible for the analysis (43% of the invitees), 60% were women; the median age and diabetes duration were 49 and 25 years, respectively. The median duration of insulin pump use was 9 years, and the median HbA1c was 7.3%. In total, 95% reported using carbohydrate counting. Most responders always/often used the bolus guide for food (89%) and correction (88%). Significant associations with HbA1c were found for changing infusion set every 0–4 days relative to 5–10 days (−5 mmol/mol, −0.4%; P = 0.003), and for never/rarely missing a bolus (−6 mmol/mol, −0.5%; P < 0.001) relative to often missing a bolus. Timing insulin 10–15 minutes before meal relative to after meal start was also associated with lower HbA1c (−3 mmol/mol, −0.3%; P = 0.023). Self-adjusting pump settings showed the strongest association with lower HbA1c (−6 mmol/mol, −0.6%; P < 0.001) relative to health-care professionals making all adjustments. Conclusions In this questionnaire-based study of insulin pump users (excluding those on automated insulin delivery devices), timely infusion set change, never or rarely missing a bolus, and insulin timing 10–15 minutes before meals were associated with lower HbA1c. In addition, lower HbA1c levels were found in users who reported being involved in adjusting the pump settings either on their own or in collaboration with their HCP. Comments A limitation of the study is (as in most questionnaire-based research) that the data are self-reported, and those who respond may not necessarily reflect the broader population of interest. It is of note that in the current study the response rate from women and older adults was more than from men and users younger than 25 years. As highlighted by the authors, the study did not analyze insulin pump and CGM upload data. Therefore, we do not have a detailed estimate of the effects on different glycinemic metrics (e.g., time in range and glucose variability) of using advanced features such as temporary basal with exercise and dual wave bolus related to meals. An ideal future study design would combine self-reported self-management and clinical measurements with CGM and insulin pump upload data. Perhaps unsurprisingly, those who self-adjusted their pump settings (likely indicating more motivated individuals?) showed the strongest association with lower HbA1c (−6 mmol/mol, −0.6%; P < 0.001) relative to those who let health-care professionals do all adjustments; this highlights the importance of education and self-empowerment of users in proactively making changes. INSULIN PUMPS IN TYPE 2 DIABETES A Systematic Review and Meta-analysis of Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injections in Type-2 Diabetes Chatziravdeli V 1 , Lambrou GI 2,3 , Samartzi A 4 , Kotsalas N 5 , Vlachou E 6 , Komninos J 4 , Tsartsalis AN 4 1 Department of Orthopedics, General Hospital “Ippokrateion,” Thessaloniki, Greece; 2 Choremeio Research Laboratory, First Department of Pediatrics, National and Kapodistrian University of Athens, Athens, Greece; 3 University Research Institute of Maternal and Child Health & Precision Medicine, National and Kapodistrian University of Athens, Athens, Greece; 4 Department of Endocrinology Diabetes and Metabolism, Naval Hospital of Athens, Athens, Greece; 5 Department of Nephrology, Naval Hospital of Athens, Athens, Greece; 6 Department of Nursing, School of Health Sciences, University of West Attica, Athens, Greece Medicina (Kaunas) 2023; 59: 141 The role of insulin pump therapy in type 1 diabetes is well established ( 13 ), but the place of insulin pump therapy in type 2 diabetes (T2D) has been unclear. The authors performed a meta-analysis to evaluate the use of continuous subcutaneous insulin infusion (CSII) in patients with T2D. Methods A systematic literature search was conducted in NCBI PubMed, Clinicaltrials.gov, and Cochrane Central Register for Controlled Trials databases for relevant studies. The references from relevant reviews on the subject were also screened. The authors used these key terms: type 2 diabetes, continuous insulin infusion, insulin pump, multiple insulin injection, and daily injections. They limited their search criteria to include clinical trials and randomized controlled trials (RCTs) in humans, and only used research published in English. The search was concluded in May 2022. Results The total number of included studies was 13. Ten were RCTs with a parallel study design, and two had a crossover design. CSII was more effective in reducing hemoglobin A1c (HbA1c) from baseline than were multiple daily insulin injections, with a pooled effect of −0.26 ([95% CI, −0.42 to −0.10], P = 0.02). The same impact persisted when RCTs with a parallel design were analyzed separately. No significant difference between fasting plasma glucose and body weight change. The daily insulin dose required to achieve target glucose levels was significantly lower in the intervention group (CSII) than the comparator (pooled standardized mean difference −0.58 [95% CI, −0.76 to −0.40], P < 0.00001). Conclusions Results from this meta-analysis show that insulin pump therapy could be a valuable tool in managing T2D with improved HbA1c achieved with lower insulin use and without weight gain. Comments The treatment of T2D has changed over the years with the introduction of novel GLP-1 and dual agonists and SGLT-2 inhibitors ( 14 , 15 ). Most studies included in the current meta-analysis predated the widespread use of these agents. Given that insulin pump therapy is a more expensive option than most oral agents and injectables, further clinical and cost-effective analyses will be needed to define subgroups of people with T2D who could potentially benefit. For example, in the randomized controlled trial by Reznik et al. ( 16 ) only those with high HbA1c after 2 months of optimization period with multiple daily injection therapy were eligible to be randomized. In this study, the between-group difference in HbA1c was −0.7% (95% CI, −0.9 to −0.4). Recent studies have also explored the benefits of glucose sensors and fully closed-loop insulin delivery in T2D, showing significant benefits of novel diabetes technology in T2D ( 17 , 18 ). TECHNOLOGY SAFETY AND ACCEPTANCE The Impact of Socio-economic Deprivation on Access to Diabetes Technology in Adults with Type 1 Diabetes Fallon C 1 , Jones E 1,2 , Oliver N 1,2 , Reddy M 1,2 , Avari P 1,2 1 Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK; 2 Department of Diabetes and Endocrinology, Imperial College Healthcare NHS Trust, London, UK Diabet Med 2022; 39: e14906 Despite an abundance of data supporting the benefits of technology in type 1 diabetes (T1D) ( 19 ), there are still disparities in terms of access to and use. The National Diabetes Insulin Pump Audit (2019–1920) in England highlighted the lower percentage of those using an insulin pump in the most deprived quintile (15%) compared with the least deprived (23%) ( 20 ). This study assessed the relationship between socioeconomic status and access to diabetes technology and the outcomes in adults with T1D. Methods This is a retrospective observational analysis of all adults with T1D attending three diabetes services in West/Northwest London providing services to a diverse urban population. Adults aged ≥18 years old with a clinical diagnosis of T1D were included in the study. Excluded from data analysis were children, women who were pregnant, or people with a diagnosis of type 2 diabetes or maturity-onset diabetes of the young. Socioeconomic deprivation was assessed by the English Indices of Deprivation 2019 ( 21 ), with deprivation deciles based on the Index of Multiple Deprivation (IMD) 2019. Decile 1 represents the most deprived 10% of neighborhoods in England, while decile 10 represents the least deprived 10%. The data were divided into quintiles using deprivation deciles, as in the English National Diabetes Audits. Results In all, 1631 individuals with T1D were included in this study. The mean ± SD of age was 44 ± 15 years, and 758 participants (47%) were women. The IMD quintiles within White and Black ethnic background groups varied significantly: 62% of the least deprived quintile were of White ethnicity compared with 41% of the most deprived quintile ( P < 0.001), and 15% of the most deprived quintile identified as Black ethnicity compared with 1.1% of the least deprived quintile ( P < 0.001). Overall, 904 people with T1D (55%) attending specialist services were using technology. In all, 391 (24%) used continuous subcutaneous insulin infusion (CSII), 312 (19%) used a real-time continuous glucose monitor (rtCGM), and 558 (34%) used an intermittently scanned CGM (isCGM). There were significantly fewer people using technology in the most deprived quintile compared with the least deprived quintile (45% in the most deprived vs 67% in the least deprived; P < 0.001), with a linear increase in technology use across the quintiles (53% in the second most deprived, 56% in third most deprived, and 62% in second least deprived). The most notable difference was observed with the use of CSII ( P < 0.001) than rtCGM ( P = 0.032) or isCGM ( P = 0.001). As deprivation status increased, adults were less likely to have participated in structured education. Only 23% had completed education in the most deprived quintile compared with 43% in the least deprived areas, showing an almost twofold increase. Data on hemoglobin A1c (HbA1c) were available for 56 adults using CSII alone, 89 adults using rtCGM alone, and 255 adults using isCGM alone. There was no difference in the change in HbA1c from before initiation to 1 year after initiation across the deprivation quintiles for any of the technologies. CSII, rtCGM, and isCGM all showed overall beneficial outcomes, with a mean HbA1c reduction of −7 ± 10 mmol/mol (−2.8 ± 3.1% DCCT), −6.7 ± 11.5 mmol/mol (−2.8 ± 3.2% DCCT), and −6.4 ± 12.8 mmol/mol (−2.7 ± 3.3% DCCT), respectively. Conclusions Adults living in the most deprived quintile had less technology use and less participation in structured education. Irrespective of socioeconomic status or ethnicity, the use of technology improved glycemia in all groups. It is imperative that health disparities are further addressed. Comments U.K. National Health Service provides free health care at the point of delivery, so access to diabetes technology should not be affected by ethnicity, deprivation status, or income. Yet this study shows real-world evidence for differences in the use of diabetes technology across ethnicity and socioeconomic deprivation, with the lowest usage in the most deprived quintile. The largest variation was observed with CSII use. The authors speculated that a key reason may be the variation observed in structured education uptake; the percentage of people completing structured education in the least deprived group was almost double that of the most deprived group. Extracting value from structured education programs like DAFNE (Dose Adjustment for Normal Eating) requires English literacy and numeracy skills. Thus, cultural and language barriers, lower health literacy and confidence, or the inability to take time off work may affect uptake. Equally, potential clinician barriers may exist with assumptions based on which individuals may benefit or be suitable for referral. Importantly for those patients with HbA1c outcomes, there were no overall differences, and glycemia was positively affected in all groups. This suggests that reducing inequalities in technology access may also go some way to address the disparities observed in glycemia. Insulin Pump-associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes Estock JL 1,2 , Codario RA 3,4 , Keddem S 5,6 , Zupa MF 2,4 , Rodriguez KL 2 , DiNardo MM 2 1 Office of Research and Development; Pittsburgh, PA; 2 Center for Health Equity Research and Promotion; Pittsburgh, PA; 3 Department of Endocrinology; VA Pittsburgh Healthcare System, Pittsburgh, PA; 4 Division of Endocrinology & Metabolism, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA; 5 Center for Health Equity Research and Promotion, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA; 6 Department of Family Medicine & Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA Diabetes Technol Ther 2023; 25: 343–355 Insulin pumps account for the second-most medical device injuries reported to the U.S. FDA, with clinical consequences including diabetes-related ketoacidosis, emergency department visits, hospital admissions, and death. The potential causes include physical damage, mechanical failure, software errors, reservoir issues, display problems, battery or power failure, infusion set/site concerns, button or keypad failures, and user error. The authors analyze the FDA's Manufacturer and User Facility Device Experience (MAUDE) database to explore the clinical consequences and potential root causes of insulin pump–associated adverse events. Methods Narrative data from a 20% stratified random sample of reported adverse events that occurred during the first 6 months of 2020 were analyzed. These included five insulin pumps: MiniMed 630G and 670G, Omnipod Eros and DASH, and t:slim X2. Results Of the 2429 adverse events, 92% included a clinical consequence in the narrative description. Among the most common consequences, 47% involved critical hyperglycemia with glucose > 400 mg/dL, and 24% critical hypoglycemia with glucose < 54 mg/dL. Only 50% of the narratives included information to support the identification of a root cause. The most cited root cause in the remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the insulin infusion set or site (8%). Some clinical consequences and root cause remarks were more frequent for specific insulin pump models, but manufacturer reporting may have affected these findings. Conclusions General themes in insulin pump adverse events can be used to raise awareness of potential risks and develop future mitigations. Improvements in adverse event investigation and reporting are necessary. Comments Estock and colleagues went to significant lengths to try to analyze pump-related adverse events in the MAUDE database. Almost every person using diabetes technology will experience some problem, but fewer than a quarter report it to a health-care provider ( 22 ). Device manufacturers and health-care facilities are mandated reporters, but providers, users, and their family members are all voluntary reporters. Health-care provider reporting is relatively rare in the MAUDE database (97% of reports are from device manufacturers), and there is undoubtedly an underestimate of the true adverse event rate. Of note, the MAUDE data analyzed by the authors included AID systems, and it is often unclear how to file adverse events in this context—was it the pump, algorithm, or sensor? There were concerns unique to different manufacturers. For Medtronic, the most cited root cause was the reservoir; for Insulet, it was the pod site; and for Tandem, it was occlusion alarms and programming the pump. This suggests unique opportunities for the pump manufacturers to innovate their respective devices. The authors quite rightly point out that the adverse events observed in their report do not correspond to premarket safety data from pivotal trials. The way we currently conduct these clinical trials does not reveal all safety issues, and it should not be left to academia to conduct these investigations. Quality systems and postmarket surveillance must be built into industry processes and regulated with clear timelines for mitigation. Author Disclosure Statement RL has received consulting fees from Abbott Diabetes Care, Adaptyx Biosciences, Biolinq, Capillary Biomedical, Deep Valley Labs, Gluroo, Physiologic, and Tidepool. He has served on advisory boards for ProventionBio and Lilly. 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