Subcutaneous Insulin Infusion Systems Research Articles

Tecnología aplicada a la diabetes

Diabetes technology refers to devices and applications that people with diabetes use to help manage their disease. There are two main categories: blood glucose monitoring systems (including continuous glucose monitoring (CGM) systems) and insulin delivery devices (including insulin pumps and smart insulin pens). CGM devices measure interstitial blood glucose continuously or intermittently (flash measurements), showing alerts and trends that help predict glucose behavior. The data are represented by the ambulatory glucose profile, which provides measurements and a summary graph to aid in its interpretation. Insulin pumps or continuous subcutaneous insulin infusion systems are devices that infuse rapid-acting insulin continuously with the objective of maintaining glucose levels in range. Among these, hybrid closed loop systems are capable of adjusting insulin infusion according to CGM blood glucose figures. Smart insulin pens are linked to smartphone apps and have features that help patients manage their diabetes (dose reminder, bolus calculator, active insulin monitoring).

Analysis of the use of integrated continuous subcutaneous insulin infusion systems in pregnant women with type 1 diabetes

Analysis of the use of integrated continuous subcutaneous insulin infusion systems in pregnant women with type 1 diabetes

Hemorrhagic Shock Associated with a Subcutaneous Insulin Pump Catheter: First Time Reported Side Effect.

Continuous subcutaneous insulin infusion (CSII) systems, used to treat diabetes for over 40 years may improve glycemic control but also have rare major complications. We report the first hemorrhagic shock on the infusion site of an insulin pump, due to a rectus abdominis hematoma. An eighty-one years old woman with history of cardiovascular events and type 1 diabetes, presented with hemorrhagic shock due to a rectus abdominis hematoma rapidly constituted at the insulin injection site. The situation improved after conservative treatment (blood transfusions, IV fluids, replacement of the CSII with insulin injections). Contributive factors to this complication were overdose of anticoagulant, oversized insulin canula and cough. We recommend increased monitoring of patients using insulin pump with hemorrhagic risk factors. Specific education for the prevention and detection of signs of hemorrhage should lead patients to report this situation promptly, in order to avoid this life-threatening complication.

Monitoring of continuous subcutaneous insulin infusion treatment in Portugal and its implications for diabetes management.

Intensive insulin therapy in the treatment of type 1 diabetes can, in place of multiple daily injections of subcutaneous insulin (MDI), be performed with continuous subcutaneous insulin infusion (CSII) systems. This method allows for better glycemic control and thus reduces the risk of complications of the disease. The aim of this study was to evaluate the results of treatment with CSII in Portugal. A retrospective analysis of the records on the national CSII platform was carried out between January 2010 and August 2021. All the registered patients are followed in certified CSII treatment centers in Portugal. Of the 7135 registered patients, 3807 were excluded due to absence of monitoring data. The reasons for treatment were analyzed and a comparison was made between patients with and without CSII. The statistical significance considered was α < 0.05. A total of 3328 patients were included in the study, 1136 under MDI and 2192 under CSII. The main reasons for CSII use were marked glycemic variability (25%) and HbA1c greater than 7% (23%). Patients under CSII had a lower HbA1c (7.7 ± 1.0% vs. 8.0 ± 1.5%, p < 0.001), as well as a lower frequency of episodes of severe hypoglycemia (1.4 vs. 3.3 per 100 patient-years, p < 0.001), and ketoacidosis (1 vs. 2.4 per 100 patient-years, p < 0.001). The present analysis validates the advantage of using CSII in metabolic control and reduction of acute complications of type 1 diabetes, both severe hypoglycemia and ketoacidosis, in the Portuguese population. CSII therapy is classically associated with an increased risk of ketoacidosis; however, in experienced centers and adequate patient education, the opposite is found.

Efficacy and safety of ultra-rapid insulin analogues in insulin pumps in patients with Type 1 Diabetes Mellitus: A systematic review and meta-analysis

AimsTo assess the efficacy and safety of ultra-rapid insulin analogues used with continuous subcutaneous insulin infusion systems (CSII) in adults with type 1 diabetes (T1DM). MethodsWe searched MEDLINE and Cochrane Library up to May 2022 for randomized controlled trials comparing ultra-rapid with rapid-acting insulin analogues (RAIAs) used with CSII. We performed random effects meta-analyses for % of 24-h time in range of 70–180 mg/dl (TIR), time in hypoglycaemia (<70 mg/dl) and hyperglycaemia (>180 mg/dl), 1- and 2-hour post-prandial glucose [PPG] increment after a meal test, HbA1c and average insulin dose at endpoint, unplanned infusion set changes and severe hypoglycaemia. ResultsNine studies (1,156 participants) were included. Ultra-rapid insulins were superior to RAIAs on TIR (mean difference [MD] 1.1 %, 95 % CI 0.11–2.11), time spent in hypoglycaemia (MD −0.47 %, 95 % CI −0.63 to −30), and 1- and 2-hour PPG (MD −12.20 mg/dl, 95 % CI −19.85 to −4.54 and MD −17.61 mg/dl, 95 % CI −28.55 to −6.66, respectively). Ultra-rapid insulins increased odds of unplanned infusion set changes (odds ratio 1.60, 95 % CI 1.26–2.03). ConclusionUltra-rapid acting insulins provided better PPG control compared to RAIAs but their use might result in more infusion set changes.

Faster Insulin Aspart for Continuous Subcutaneous Insulin Infusion: Is It Worth It?

IntroductionFaster insulin aspart (fASP) is the new formulation of insulin aspart (ASP) with a left-shifted pharmacokinetic profile, allowing better control of early postprandial hyperglycemia and a reduction in the risk of late post-meal hypoglycemia. However, it can be associated with more frequent infusion set changes. The purpose of this study is to evaluate efficacy and safety one, three, and six months after starting fASP in continuous subcutaneous insulin infusion (CSII) systems.MethodsThis is a retrospective study that included adults with type 1 diabetes mellitus, users of CSII ≥3 months, who started fASP. Exclusion criteria included less than one month of follow-up after the intervention, concomitant initiation of pharmacological therapy, pre-conception period, and non-use of continuous glucose monitoring.ResultsA total of 77 individuals were included, of which 52 (67.5%) were female, aged 39.87 ± 13.10 years, with a mean time under CSII of 7.30 ± 3.58 years and a median follow-up time after transition to fASP of six months. There was a trend to a global glycemic control improvement at six months after starting fASP: numeric increase in time in range (56.40 ± 12.62% vs 60.15 ± 13.53%, p=0.148), reduction in time above range (37.76 ± 13.05% vs 34.67 ± 14.94%, p=0.557), time below range (6.00 (5.00)% vs 4.50 (5.25)%, p=0.122), and mean glucose (174.29 ± 25.14 mg/dL vs 167.00 ± 25.30 mg/dL, p=0.207). There was a reduction in body mass index (BMI) at six months after switching to fASP (25.08 (4.59) kg/m2 vs 24.45 (3.05) kg/m2, p=0.010), despite the absence of a significant variation in total daily insulin. Adverse event and discontinuation rates were 7.8% and 6.5%, respectively, with no documented episodes of diabetic ketoacidosis or severe hypoglycemia.ConclusionsfASP proved to be a safe and effective therapeutic option in CSII systems associated with a significant BMI reduction, aspects that might justify its preference.

Can a Mixture of Insulin and a Nonsteroidal Anti-inflammatory Drug Prolong Insulin Pump Catheter Wear Time in Adults With Type 1 Diabetes?

Continuous subcutaneous insulin infusion systems (CSIIs) are commonly used by patients with diabetes. According to manufacturer and health agency recommendations, patients are advised to change their infusion set after 2 to 3 days (1). This rule of thumb is largely based on observational data suggesting that longer wear time is associated with increased catheter malfunctions, adverse events (AEs) at the insertion site and subsequent metabolic complications (2–4). However, in an international survey of 14,015 type 1 or type 2 diabetes CSII users from Europe and North America, over 18% of patients reported wearing their catheters for longer than the recommended time (5).

Self-reported Severe and Nonsevere Hypoglycemia in Type 1 Diabetes: Population Surveillance Through the BETTER Patient Engagement Registry: Development and Baseline Characteristics

ObjectivesThe BETTER (BEhaviors, Therapies, TEchnologies and hypoglycemic Risk in Type 1 diabetes) registry is a type 1 diabetes population surveillance system codeveloped with patient partners to address the burden of hypoglycemia and assess the impact of new therapies and technologies. The aim of this report was to describe the baseline characteristics of the BETTER registry cohort. MethodsA cross-sectional baseline evaluation was performed of a Canadian clinical cohort established after distribution of an online questionnaire. Participants were recruited through clinics, public foundations, advertising and social media. As of February 2021, 1,430 persons ≥14 years of age and living with type 1 diabetes or latent-autoimmune diabetes (LADA) were enrolled. The trial was registered on ClinicalTrials.gov (NCT03720197). ResultsParticipants were (mean ± standard deviation) 41.2±15.7 years old with a diabetes duration of 22.0±14.7 years, 62.0% female, 92.1% Caucasian and 7.8% self-reporting as LADA, with 40.9% using a continuous subcutaneous insulin infusion (CSII) system and 78.0% using a continuous glucose monitoring (CGM) system. The most recent glycated hemoglobin ≤7% was reported by 29.7% of participants. At least 1 episode of hypoglycemia <3.0 mmol/L (level 2-H) in the last month was reported by 78.4% of participants, with a median (interquartile range) of 5 (3, 10) episodes. The occurrence of severe hypoglycemia (level 3-H) in the last 12 months was reported by 13.3% of participants. Among these, the median number of episodes was 2 (1, 3). ConclusionsWe have established the first surveillance registry for people living with type 1 diabetes in Canada relying on patient-reported outcomes and experiences. Hypoglycemia is a highly prevalent burden despite a relatively wide adoption of CSII and CGM use.

Total daily dose of insulin at the beginning of treatment with Continuous Subcutaneous Insulin Infusion system: which is the best formula?

Total daily dose of insulin at the beginning of treatment with Continuous Subcutaneous Insulin Infusion system: which is the best formula?

Enhancing Choices Regarding the Administration of Insulin Among Patients With Diabetes Requiring Insulin Across Countries and Implications for Future Care.

There are a number of ongoing developments to improve the care of patients with diabetes across countries given its growing burden. Recent developments include new oral medicines to reduce cardiovascular events and death. They also include new modes to improve insulin administration to enhance adherence and subsequent patient management thereby reducing hypoglycaemia and improving long-term outcomes. In the case of insulins, this includes long-acting insulin analogues as well as continuous glucose monitoring (CGM) systems and continuous subcutaneous insulin infusion systems, combined with sensor-augmented pump therapy and potentially hybrid closed-loops. The benefits of such systems have been endorsed by endocrine societies and governments in patients with Type 1 diabetes whose HbA1c levels are not currently being optimised. However, there are concerns with the low use of such systems across higher-income countries, exacerbated by their higher costs, despite studies suggesting their cost-effectiveness ratios are within accepted limits. This is inconsistent in higher-income countries when compared with reimbursement and funding decisions for new high-priced medicines for cancer and orphan diseases, with often limited benefits, given the burden of multiple daily insulin injections coupled with the need for constant monitoring. This situation is different among patients and governments in low- and low-middle income countries struggling to fund standard insulins and the routine monitoring of HbA1c levels. The first priority in these countries is to address these priority issues before funding more expensive forms of insulin and associated devices. Greater patient involvement in treatment decisions, transparency in decision making, and evidence-based investment decisions should help to address such concerns in the future.

Continuous glucose monitoring and insulin pump therapy in pregnant women with type 1 diabetes mellitus.

We examined the impact of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring systems (CGM) during pregnancy in women with pre-gestational type 1 diabetes (T1DM) on glycemic control and subsequent adverse outcomes. In this observational, one-center study we analyzed records of consecutive 109 T1DM pregnancies (2016-2017). The final analyzed group consisted of 81 singleton pregnancies who met inclusion and exclusion criteria. We searched for the association between the use of CSII with or without CGM and pregnancy planning with glycated hemoglobin A1c (HbA1c) through pregnancy and after delivery as well as maternal and infant outcomes. Patients using CSII and CGM vs CSII without CGM and MDI (multiple daily injections) users had the lowest HbA1c levels during and after pregnancy (5.3%, 5.3%, 5.2% and 5,5% in the 1st, 2nd, 3rd trimester and postpartum visit, p = 0.003, p = 0.030, p = 0.039 and p = 0.002, respectively). Patients treated with insulin pumps with CGM and additional functions of automatic insulin delivery suspension on low glucose level (SLG) or predictive low glucose suspend (PLGS) during the third trimester and after pregnancy achieved a significantly lower HbA1c than the other CSII patients. We did not find any differences between the study groups in gestational age at delivery, preterm births, birth weight or macrosomia risk. Despite very good glycemic control, the risk of macrosomia remained high (19.7%). The use of pumps equipped with CGM, especially with automatic insulin delivery suspension, may improve glycemic control in pregnant T1DM women. The proportion of macrosomia remained high.

169-LB: Type 1 Diabetes Mellitus and Stiff-Person Syndrome

Introduction: Type 1 diabetes mellitus (T1DM) is often associated with other autoimmune diseases. One of them is Stiff-Person Syndrome (SPS), a rare neurological disorder characterized by muscle spasms and progressive muscle stiffness, which most often affects females. Glutamic acid decarboxylase antibodies (anti-GAD) are associated with the pathogenesis of this disease as well as T1DM. These antibodies cause a deficit in the synthesis of γ-aminobutyric acid (GABA) that is essential both in the function as neurotransmitter and in the secretion of insulin in pancreatic β cells. Clinical case: We present the case of a 32-year-old female patient diagnosed with T1DM at 18 years old. Currently under intensive functional insulin therapy and flash glucose monitoring (FGM). Since 2019 with subcutaneous insulin infusion system. At the age of 26, the patient reports dystonia in the left lower limb with subsequent involvement of the contralateral lower limb, upper limbs, trunk and face. Collaboration was made with the Neurology department. Among the laboratory findings, of note: positive serum anti-GAD65 (5437 U/mL; &amp;lt;1) and positive cerebrospinal fluid anti-GAD65 (126.23 U /mL; &amp;lt;1). The diagnosis of SPS was made. The patient started human immunoglobulin therapy with progressive clinical improvement. Estimated HbA1c from FGM was 6,8 % at February, 2021. Discussion: The association between T1DM and SPS is frequent. In this case, a patient with a known history of T1DM was presented, but cases of diagnosis of T1DM in patients with SPS have also been described. About 43% of patients have T1DM at the time of diagnosis of SPS. Anti-GAD are involved in the pathophysiology of these two diseases and anti-GAD titers are much higher in cases of association with SPS (about 50 to 100 times). In the treatment of patients with T1DM, physicians should be alert to the onset of other autoimmune diseases and active surveillance is essential for early diagnosis. Disclosure C. A. Araújo: None. C. Baptista: None. I. Paiva: None. A. Morgadinho: None.

Development and validation of an instrument (CSII - Brazil) to assess users' conceptual and procedural knowledge of continuous subcutaneous infusion systems.

To develop, adapt and validate an instrument named "CSII - Brazil" to assess users' conceptual and procedural knowledge of continuous subcutaneous insulin infusion systems. Methodological and exploratory study developed in three stages: a) instrument development; b) content validation and cultural adaptation (evaluation by a committee of experts and pre-test with CSII users); c) psychometric validation through instrument application in a sample of 60 patients by means of the web tool e-Surv. Internal consistency and reproducibility analyses were performed within IBM SPSS Statistics 20 programming environment. The 16 multiple-choice question instrument successfully attained a content validity index of 0.97, showing satisfactory internal consistency, with 0.61 Cronbach's alpha [95% CI 0.462-0.746] and an intraclass correlation coefficient of 0.869 [95% CI: 0.789-0.919] between the test and retest scores. The CSII - Brazil instrument is considered adequate and validated to assess continuous subcutaneous infusion system users' conceptual and procedural knowledge.

Insulin pump therapy and continuous glucose monitoring in adults with type 2 diabetes: where are we now?

Technology in diabetes is rapidly evolving, with the aim of helping affected people to safely optimize their blood glucose control. New technologies are now considered as an essential tool for managing glycemia predominantly in people with type 1 diabetes, and clinical trials have demonstrated that in these subjects the use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems are associated with improved glycemic control along with a better quality of life. Literature regarding technologies and type 2 diabetes is relatively lacking, but innovations may have an important role also in the management of these patients. Some studies in adults with type 2 diabetes have shown benefits with the use of CGM in terms of glycemic variability and improved therapeutic adjustments. Clinical trials about CSII and CGM use in type 2 diabetes may have some pitfalls and future studies are needed to assess how these advanced systems could improve clinical outcomes and also ensure cost-effectiveness in this population. In this narrative review, we aim to highlight the most relevant studies on this topic and to focus on the potential role of new technological devices in type 2 diabetes management.

Investigation of factors that cause insulin precipitation and/or amyloid formation in insulin formulations

BackgroundMultiple daily subcutaneous injections (MDSIs) are mainly used for formulating an insulin therapy for diabetic patients; however, they also cause insulin-derived amyloidosis (IDA) and lead to poor glycemic control. In addition, for the continuous subcutaneous insulin infusion system (CSII), precipitation frequently causes catheter occlusion and, if the precipitate in the formulations is amyloid, the injection of the insoluble amyloid into the subcutaneous tissue leads to IDA. The aim of this study was to conduct in vitro experiments and present a situation where insulin formulations cause precipitation and amyloid formation.MethodsHumulin®R and NovoRapid® were used as model formulations for MDSIs and CSII, respectively. The generation of the precipitation was evaluated by measuring turbidity, and amyloid formation was evaluated by using Thioflavin T. Humulin®R was mixed with saline buffer solutions and glucose solutions to evaluate the effect of dilution. In addition, we created an experimental system to consider the effect of the time course of condition changes, and investigated the effects of insulin concentration, m-cresol existence, and pH change on the generation of the precipitate and amyloid in the formulation.ResultsIn both the original and diluted formulations, physical stimulation resulted in the formation of a precipitate, which in most cases was an amyloid. The amyloid was likely to be formed at a near neutral pH. On the contrary, although a precipitate formed when the pH was decreased to near the isoelectric point, this precipitate was not an amyloid. Further decreases in pH resulted in the formation of amyloids, suggesting that both the positive and negative charged states of insulin tended to form amyloids. The formulation additive m-cresol suppressed amyloid formation. When additives were removed from the formulation, the amyloid-containing gel was formed in the field of substance exchange.ConclusionsTo consider changes in conditions that may occur for insulin formulations, the relationship between the formation of precipitates and amyloids was demonstrated in vitro by using insulin formulations. From the in vitro study, m-cresol was shown to have an inhibitory effect on amyloid formation.

Kalman Filter-Based Novel Methodology to Assess Insulin Pump Accuracy.

Background: Insulin pump or continuous subcutaneous insulin infusion (CSII) system is a widely adopted contemporary treatment for type 1 diabetes and is a major component of an artificial pancreas (AP). CSII accuracy is essential for glycemic control and to-date such metric has not been given sufficient study, especially at the range of the lowest basal rate. The gold-standard assessment method IEC (International Electrotechnical Commission) 60601-2-24 has some limitations. Our study presents a new accurate and reactive method for CSII system evaluation based on direct flow measurement. Materials and Methods: A leading-edge assessment method based on a double measurement approach utilizing a direct mass flow meter and a time-stamped microgravimetric bench test was combined with a Bayesian-based mathematical filter (Kalman). The performance of this new method was evaluated while assessing the delivery precision of an off-the-shelf insulin pump at several basal rates. The proposed methodology offers a double reading-volume and flow rate-which provides direct instantaneous flow rate. CSII dose errors were evaluated using mean absolute relative dispersion (MARD) at different time intervals windows over the whole test. Results: The metrological aspect of the measurements and filtering performance were consistent. CSII precision is shown to be different in terms of the flow rate value: MARD15min (2 UI/h) = 12.7%, MARD15min (0.5 UI/h) = 20.4%, and MARD15min (0.1 UI/h) = 65.0%. MARD240min (2 UI/h) = 8.1%, (0.5 UI/h), MARD240min (0.5 UI/h) = 18.8%, and MARD240min (0.1 UI/h) = 18.4%. Instantaneous flow rate results highlight an irregular stroke-based delivery. Conclusion: This new method to assess insulin pump administration has been validated and highlights the current imprecision in insulin delivery, especially for the lowest basal rate, which is mainly used in pediatric cases and AP system delivery. This leading-edge method should be used to precisely compare several CSII performances in those contexts.

Avoiding hypoglycemia: the use of insulin pump combined with continuous glucose monitor in type 1 diabetes crossing a Rocky Gorge.

Continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring systems (CGMS) have been proven very effective in diabetes management. This study evaluated the usefulness of these devices during prolonged, intense physical activity in an uncontrolled natural environment away from the clinical research center. Non-randomized, prospective and observational study. During the summer, 38 participants with type 1 diabetes crossed the Samaria gorge, the second largest gorge in Europe (17 km). Twenty subjects on CSII combined with real-time CGMS and 18 on multiple daily injections (MDI) combined with professional (retrospective) CGMS participated in the program. All participants were unsupervised during the event. All 38 participants managed to reach the destination point safely. There were no episodes of severe hypoglycemia. The duration of the exercise (mean ±SD) was 6.4 ± 1.3 h. The CSII group exhibited significantly lower hypoglycemic episodes during exercise (0.1 ± 0.3 vs. 0.4 ± 0.6; P = 0.047) as well as lower AUC below 70 mg/dl compared with the MDI, during the 24 h (0.61 ± 0.78 vs. 1.84 ± 1.55; P = 0.007). Individuals on CSII were significantly less likely to develop a hypoglycemic episode during exercise (P = 0.038). Exercise induced nocturnal hypoglycemia was not prevented effectively in neither group. CSII combined with CGMS is effective in controlling blood glucose levels in type 1 diabetics who perform prolonged strenuous exercise. The use of insulin pump technology in regions with hot Mediterranean climates is safe and can provide protection against exercise-induced hypoglycemia. Development of precise instructions for T1DM who occasionally get involved in exercise activities, requires further studies.

Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital.

The use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems has gained wide acceptance in diabetes care. These devices have been demonstrated to be clinically valuable, improving glycemic control and reducing risks of hypoglycemia in ambulatory patients with type 1 diabetes and type 2 diabetes. Approximately 30–40% of patients with type 1 diabetes and an increasing number of insulin-requiring patients with type 2 diabetes are using pump and sensor technology. As the popularity of these devices increases, it becomes very likely that hospital health care providers will face the need to manage the inpatient care of patients under insulin pump therapy and CGM. The American Diabetes Association advocates allowing patients who are physically and mentally able to continue to use their pumps when hospitalized. Health care institutions must have clear policies and procedures to allow the patient to continue to receive CSII treatment to maximize safety and to comply with existing regulations related to self-management of medication. Randomized controlled trials are needed to determine whether CSII therapy and CGM systems in the hospital are associated with improved clinical outcomes compared with intermittent monitoring and conventional insulin treatment or with a favorable cost-benefit ratio.

A Retrospective Review of the Clinical Characteristics and Blood Glucose Data from Cellnovo System Users using Data Collected from the Cellnovo Online Platform.

Technological advances have led to innovative insulin delivery systems for patients with type 1 diabetes mellitus. In particular, the combination of miniature engineering and software algorithms contained in continuous subcutaneous insulin infusion (CSII) system pumps provide the user and the healthcare practitioner with an opportunity to review and adjust blood glucose (BG) levels according to system feedback, and to modify or programme their regimen according to their needs. While CSII pumps record a number of data parameters such as BG level, carbohydrate intake, activity and insulin delivered, these data are generally ‘locked in’ and can only be accessed by uploading to a cloud-based system, thus information is not contemporaneous. The Cellnovo Diabetes Management System (Cellnovo, Bridgend, UK) allows data to be transmitted securely and wirelessly in real time to a secure server, which is then retrieved by an online platform, the Cellnovo Online platform, enabling continuous access by the user and by clinicians. In this article, the authors describe a retrospective review of the patient data automatically uploaded to the Cellnovo Online platform. Baseline clinical and demographic characteristics collected at the start of pump therapy are shown for all patients, and BG data from a sub-cohort of patients who have been using the system for at least 6 months and who take and record an average of three BG level tests per day are presented to demonstrate glycaemic data over time.

Impact of the Omnipod® Insulin Management System on Quality of Life: A Survey of Current Users.

Few recent studies have examined the impact of continuous subcutaneous insulin infusion systems on patient-reported quality of life (QOL). We explored QOL changes resulting from treatment with the Omnipod® Insulin Management System (Insulet Corp., Billerica, MA). One thousand two hundred forty-five adults (>18 years) with type 1 diabetes and current Omnipod users completed an online questionnaire examining perceived changes in QOL and glycemic control since Omnipod initiation. The QOL dimensions included overall well-being (World Health Organization-5, modified to examine changes retrospectively), diabetes distress (Type 1 Diabetes Distress Scale, current distress and a modified retrospective version), and psychosocial impact (two subscales from the Diabetes Technology Impact Measure, perceived control over diabetes, and hypoglycemic safety). Regression analyses examined associations between demographics, key psychological factors, and perceived change in glycemic control with the QOL dimensions. Broad QOL and clinical benefits associated with Omnipod use were common. The majority reported positive changes in the following: overall well-being (53.5%), perceived control over diabetes (72.5%), hypoglycemic safety (50.6%), and diabetes distress (69.6%). Worsening in any of these areas was uncommon. In addition, 64.2% of patients reported glycemic improvement post-Omnipod initiation, while 35.2% reported a decrease in severe hypoglycemic episodes. Trust in one's Omnipod, perceived improvement in glycemic control, and reductions in severe hypoglycemia independently predicted benefits in all QOL measures (all P < 0.001). These findings suggest that Omnipod users perceived substantial QOL benefits from the device; benefits are more apparent in those who trust the device and have noted positive changes in glycemic control.