Patch Pump Research Articles

Addressing the Burden of Multiple Daily Insulin Injections in Type 2 Diabetes with Insulin Pump Technology: A Narrative Review.

The growing prevalence of type 2 diabetes (T2D) remains a leading health concern in the US. Despite new medications and technologies, glycemic control in this population remains suboptimal, which increases the risk of poor outcomes, increased healthcare resource utilization, and associated costs. This article reviews the clinical and economic impacts of suboptimal glycemic control in patients on basal-bolus insulin or multiple daily injections (MDI) and discusses how new technologies, such as tubeless insulin delivery devices, referred to as "patch pumps", have the potential to improve outcomes in patients with T2D.

A Three-Arm Randomized Controlled Study Comparing Patient-Reported Outcomes in People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion or Multiple Daily Injections.

The aim of this study was to compare patient-reported outcomes (PROs) in people with type 1 diabetes using either continuous subcutaneous insulin infusion (CSII) with two different insulin patch pumps or multiple daily injections (MDIs). In this randomized three-arm study, people with type 1 diabetes on MDI therapy were included and used either MDI, the Accu-Chek Solo micropump system (Solo) or Omnipod for 26 weeks. From weeks 26 to 39, all participants used CSII with Solo. Patient-reported outcomes were assessed using the diabetes technology questionnaire (DTQ); in addition, HbA1c values were measured. Overall, 181 participants were randomized (61 MDI arm, 62 Solo arm, 58 Omnipod arm) and 142 completed the study. After 26 weeks in the study, the DTQ "change" score in the Solo group (105.9 [100.6-111.2]; baseline-adjusted mean [95% confidence interval]) was significantly higher than in the MDI group (94.8 [89.6-100.0]) (P = .001). The comparison between the Solo group (105.1 [99.1-111.1]) and the Omnipod group (108.7 [103.1-114.4]) showed no significant differences (P = .382). HbA1c increased by 0.2% ± 0.7% in the MDI group and decreased in both pump groups (Solo group -0.2% ± 0.8% and Omnipod group -0.1% ± 0.8%). Differences in HbA1c between the Solo group and the MDI group were significant (P = .009), but not between the Solo group and the Omnipod group (P = .896). This study showed that switching from MDI to CSII improves both psychosocial well-being and physiological outcomes. Furthermore, there were no substantial differences between the established and the recently released patch pump. Trial registration at www.clinicaltrials.gov is NCT03478969.

Diabetes Technology in People with Type 2 Diabetes: Novel Indications.

Diabetes technology has been continuously evolving. Current versions of continuous glucose monitors (CGM) use minimally invasive designs, monitor glucose values with high accuracy, and can be used to guide insulin dosing. Extensive evidence supports the use of diabetes technology for monitoring and insulin administration in people with type 1 diabetes. However, there is emerging evidence for people with type 2 diabetes. In this review, we present the different technological devices used to monitor glucose and deliver insulin and the evidence supporting their use in people with type 2 diabetes. The use of CGMs in people with type 2 diabetes treated with insulin or non-insulin therapies has been associated with improvements in glycemic control and time spent in hypoglycemia. Smart insulin pens and smart connected devices are options to track compliance and guide insulin delivery in people who do not require insulin pump therapy. Mechanical patch pumps can be used to reduce the burden of multiple daily insulin injections. Automated insulin delivery algorithms improve glycemic control without an increase in hypoglycemia. The use of technology in the management of type 2 diabetes generates glycemic data previously inaccessible, reduces barriers for insulin initiation, improves glycemic control, tracks adherence to therapy, and improves user satisfaction.

A pilot randomised controlled parallel arm trial evaluating treatment satisfaction with the Omnipod DASH® Insulin Management System compared with usual care in adults with type 1 diabetes in Australia: rationale, study design and methodologies

BackgroundInsulin pump therapy (IPT) improves glucose control in people with type 1 diabetes (T1D) compared with multiple daily injections (MDI). However, their size, the tethered insulin infusion set, intrusiveness when operating the device and the need to disconnect during showering limit their acceptance to many who may benefit. The Omnipod DASH® Insulin Management System is a small waterproof tubeless device which is wirelessly controlled by a handheld device which may be an acceptable alternative. However, there are no randomised controlled trials focusing on the impact on user perceptions of tubeless insulin pump therapy. This pilot study aims to assess study feasibility and acceptability of patch pump therapy compared with usual care in adults with T1D in Australia to inform power calculations and progression to a large-scale multi-site randomised controlled study.MethodsA pilot multi-site parallel randomised controlled study will be conducted in sixty-four adults with T1D who are managed on MDI or IPT and self-monitoring with finger-stick blood glucose from four specialist diabetes centres in Victoria, Australia. Following carbohydrate counting education, participants will be randomised to use Omnipod DASH® System (Omnipod group) or continue usual care (usual care group) for 12 weeks, followed by a 12-week extension phase where all participants will use Omnipod DASH® System. The primary outcome measure is feasibility determined by study completion rates with a threshold of 0.80. Acceptability of the intervention (Omnipod DASH® System) will be assessed by the difference in Diabetes Technology Questionnaire ‘current’ (DTQ-current) score at 12 weeks post-randomisation compared to baseline. Secondary outcomes will include other measures of user acceptance, process outcomes, resource outcomes, participant-centred outcomes, healthcare professional perceptions and glycaemic outcomes.DiscussionThis pilot study will provide insights regarding the feasibility of the study design and the first data regarding user acceptance of insulin patch pump technology in Australian T1D adults. We anticipate that this study will provide information informing the design of a larger study evaluating the impact of patch pumps on subjective outcomes that are of significance to the person living with T1D.Trial registrationAustralian New Zealand Clinical Trials Registry (https://anzctr.org.au/) ACTRN12621001195842 (8th September 2021). Please refer to Additional file 1: Appendix 1 for full details.

A novel, small-volume subcutaneous furosemide formulation delivered by an abdominal patch infusor device in patients with heart failure: results of two phase I studies.

Subcutaneous (SC) furosemide has potential advantages over intravenous (IV) furosemide by enabling self-administration or administration by a lay caregiver, such as facilitating early discharge, preventing hospitalizations, and in palliative care. A high-concentration, pH-neutral furosemide formulation has been developed for SC administration via a small patch infusor pump. We aimed to compare the bioavailability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of a new SC furosemide formulation with conventional IV furosemide and describe the first use of a bespoke mini-pump to administer this formulation. A novel pH-neutral formulation of SC furosemide containing 80mg furosemide in ∼2.7mL (infused over 5 h) was investigated. The first study was a PK/PD study of SC furosemide compared with 80mg IV furosemide administered as a bolus in ambulatory patients with heart failure (HF). The primary outcome was absolute bioavailability of SC compared with IV furosemide. The second study investigated the same SC furosemide preparation delivered by a patch infusor in patients hospitalized with HF. Primary outcome measures were treatment-emergent adverse events, infusion site pain, device performance, and PK measurements.The absolute bioavailability of SC furosemide in comparison to IV furosemide was 112%, resulting in equivalent diuresis and natriuresis. When SC furosemide was administered via the patch pump, there were no treatment-emergent adverse events and 95% of participants reported no/minor discomfort at the infusion site. The novel preparation of SC furosemide had similar bioavailability to IV furosemide. Administration via a patch pump was feasible and well tolerated.

Robust alarm design strategy for medical devices: Application to air-in-line detection and occlusion management

Alarm fatigue in the hospital environment is a recurring problem that can be solved through technical, human, or organizational considerations. The use of technical factors to get a robust alarm management system is illustrated here by two case studies related to air-in-line detection in peritoneal dialysis and insulin pump occlusion management. Air-in-line sensors are usually very sensitive to the presence of small bubbles stuck on tubing and may therefore deliver false alarms. To provide a reliable estimate of the cumulated air volume pumped an IR sensor technology that is insensitive to small bubbles was implemented and tested. Another strategy was used to limit false occlusion alarms in an insulin patch pump. The piezoelectric actuator of this micropump was servo-controlled to the pressure sensor signal to allow insulin to flow into the patient despite the presence of a partial occlusion. The false alarm rate is thus reduced by using a self-adaptive occlusion detection threshold that has been evaluated using numerical simulations.

Performance and patients' satisfaction with the A7+TouchCare insulin patch pump system: A randomized controlled non-inferiority study.

We assessed the performance and patient satisfaction of a new insulin patch pump, the A7+TouchCare (Medtrum), compared with the Omnipod system. This multicenter, randomized, open-label, controlled study enrolled 100 adult patients with type 1 or type 2 diabetes mellitus (A1C ≥ 6.5% and ≤ 9.5%, i.e., 48 to 80 mmol/mol) who were assigned with the Omnipod or with the A7+TouchCare pump for 3 months. The primary study outcome was the glucose management indicator (GMI) calculated with continuous glucose monitoring (CGM). Premature withdrawals occurs respectively in 2 and 9 participants in the Omnipod and TouchCare groups. In the Per Protocol analysis, the difference in GMI between groups was 0.002% (95% confidence interval -0.251; 0.255). The non-inferiority was demonstrated since the difference between treatments did not overlap the pre-defined non-inferiority margin (0.4%). There was no significant difference in CGM parameters between groups. On average, patients in both groups were satisfied/very satisfied with the insulin pump system. Patients preferred Omnipod as an insulin management system and especially the patch delivery system but preferred the A7+TouchCare personal diabetes manager to control the system. This study showed that the A7+TouchCare insulin pump was as efficient as the Omnipod pump in terms of performance and satisfaction. The study was registered in the ClinicalTrials.gov protocol register (NCT04223973).

Effect of Sensor-Augmented Patch Pump with Predictive Low-Glucose Suspend Feature Compared to Multiple-Dose Insulin in Patients with Brittle Type 1 Diabetes

Effect of Sensor-Augmented Patch Pump with Predictive Low-Glucose Suspend Feature Compared to Multiple-Dose Insulin in Patients with Brittle Type 1 Diabetes

IDF2022-0959 Sensor Augmented Patch Pump with Predictive Low Glucose Suspend Feature in Elderly Patients with Brittle Diabetes

IDF2022-0959 Sensor Augmented Patch Pump with Predictive Low Glucose Suspend Feature in Elderly Patients with Brittle Diabetes

Future Prospects of Insulin Mutants, Biosimilars, Bioconjugates, and Newer Insulin-Delivery Devices in Diabetes Mellitus

Insulin is the cornerstone of type 1 diabetes therapy and a critical addition for type 2 diabetes control. Despite significant advancements in insulin therapy research, including the creation of innovative insulin formulations and delivery systems, there are still numerous difficulties and unknowns surrounding insulin therapy. The main issues with more recent pharmacological and technological methods are biocompatibility, degradation/clearance of delivery materials, immunogenicity, stability, the precision of dosing, reproducibility of an effect similar to that of endogenous insulin, predictability of performance, and safety over time. In order to achieve a protracted, flatter profile, with fewer instances of hypoglycemia and an improvement in postprandial glucose level, more recent insulin mutants were developed. The "meal" (glucose-responsive) insulins, which are supplied in accordance with an endogenous glucose-sensing feedback mechanism, best represent the future generation of insulin treatment. Insulin delivery methods with novel jet injectors, smart pens, patch pumps, and other needle-free tools for subcutaneous doses are another area of ongoing advancements. Digital health has significantly advanced treatments in recent years. As such, insulin treatments should become more scalable and potentially more cost-effective.

Skin Problems due to Treatment with Diabetes Technology: A Narrative Review

Diabetes devices, such as insulin pumps, glucose sensors, and integrated automated insulin delivery systems, have brought about a transformative impact on the management of diabetes. This impact has been particularly significant for individuals with type 1 diabetes and increasingly for those with type 2 diabetes. These devices are designed for continuous wear, necessitating the consistent use of infusion sets, patch pumps, or glucose sensors that are inserted into the skin. Regrettably, numerous studies have highlighted that skin-related issues stemming from diabetes devices are rather common. These problems encompass various forms of skin injury, allergic and irritative contact dermatitis, itching, wound formation, scarring, and lipodystrophies. The utilization of diabetes devices, both in the present and the foreseeable future, faces significant challenges due to these skin complications, but preventive strategies exist for especially skin injuries including use of a skin care regimen or patches. These challenges culminate not only in the discontinuation of device usage but also in decrease in quality of life and heavier disease burden. This narrative literature review comprehensively synthesizes existing knowledge about skin problems triggered by diabetes devices, encompassing children, adolescents, and adults. The review delves into definitions, underlying causes, prevention strategies, and treatment approaches. Finally, the review provides recommendations for future research directions in skin problems and suggestions for advancement of in the part of diabetes devices in close contact with the skin to reduce device-related skin problems.

The Relationship Between Different Bench Test Methodologies and Accuracy of Insulin Infusion Pumps: A Systematic Literature Review

Diabetes technology has rapidly evolved, and insulin infusion pumps (IIPs) have gained worldwide acceptance in diabetes care. The safety of medical equipment is highly discussed, imposing complex challenges in its use. The accuracy of IIPs can be determined through laboratory tests, generally following the IEC 60601-2-24 protocol. Studies have evaluated the accuracy and precision of IIPs, and there are discrepant results. So, we conducted a Systematic Literature Review to assess the methodologies used to evaluate the accuracy of IIPs, organizing the findings in a compiled perspective. The methodology was based on Kitchenham and Biolchini guidelines, and when possible it was carried out the Bayesian meta-analyses to compare the accuracy of IIPs. Most studies used the microgravimetric technique to evaluate the device accuracy, and some proposed adaptations for the standard protocol. The variation of results was recurrent, and the establishment of a protocol, especially to evaluate patch pumps, is necessary. The present study gives enough data to understand the scenario of the IIPs evaluation, as well as the different protocols that can be explored for its evaluation. This highlights the need for a reliable, practical, and low-cost methodology to assist the evaluation of IIPs.

1495-PUB: Insulin Patch Pumps: Are There Patient-Related Advantages for People with Diabetes?

Objective: Patch pumps, i.e. tubeless insulin pumps, are an attractive alternative to conventional insulin pumps for people with type 1 diabetes and type 2 diabetes on insulin therapy. However, to date, the patient-related benefits of patch pumps are not well understood. Methods: A systematic review was conducted to summarize potential patient-relevant advantages and disadvantages of patch pumps and to assess relevant studies on patient-reported outcomes (PROs) . Relevant studies were identified by a systematic PubMed search. In addition, the reference lists of the respective articles and Google Scholar were checked for further references. English-language articles published before June 30, 2021, were included; no other publication date criteria were specified. Results: A total of 12 studies were included. The results of this analysis demonstrate that patch pumps improve quality of life, reduce diabetes-related symptoms, increase patient satisfaction, and are preferred by patients compared with conventional insulin pumps and daily multiple injection (MDI) therapy. However, several methodological limitations of the identified studies limit the power of this analysis. Conclusions: Despite the limited number of studies evaluating the benefits of patch pumps in relation to PROs, there is increasing evidence that people with diabetes prefer patch pumps compared to MDI and conventional pumps. It is notable that this aspect has been relatively understudied. More systematic studies evaluating the benefit of patch pumps in relation to PROs are needed. Disclosure B.Kulzer: Advisory Panel; Bayer AG, Bayer AG, Becton, Dickinson and Company, Becton, Dickinson and Company, Berlin-Chemie AG, Berlin-Chemie AG, Dexcom, Inc., Dexcom, Inc., Insulet Corporation, Novo Nordisk, Roche Diabetes Care, Sanofi, Sanofi-Aventis Deutschland GmbH, Research Support; Novo Nordisk, Roche Diabetes Care. G.Freckmann: Advisory Panel; Abbott Diabetes, Dexcom, Inc., Lilly, Roche Diabetes Care, Roche Diagnostics, Consultant; Ascensia Diabetes Care, Berlin-Chemie AG, Boydsens, Metronom, mySugr, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Research Support; Dexcom, Inc., Medtronic, Menarini Group, Roche Diabetes Care, Sanofi, Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc., Lilly, Novo Nordisk, Roche Diabetes Care, Terumo Corporation. L.Heinemann: Board Member; Lifecare, Inc., Consultant; Becton, Dickinson and Company, Roche Diabetes Care, Stock/Shareholder; Profil Institut für Stoffwechselforschung GmbH, Science Consulting in Diabetes GmbH. O.Schnell: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly, Roche Diabetes Care. R.Hinzmann: Employee; Roche Diabetes Care. R.Ziegler: Advisory Panel; Eli Lilly and Company, mySugr, Novo Nordisk, Roche Diabetes Care, Speaker's Bureau; A. Menarini Diagnostics, Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Glooko, Inc., Novo Nordisk, Roche Diabetes Care.

791-P: Clinical Data of a New Insulin Micropump System in Children with Type 1 Diabetes Mellitus (T1DM)

Background: To maintain glucose control in T1DM is especially difficult in children that have unpredictable amounts of physical activity and broad eating patterns. Advances in diabetes technology include Continuous Subcutaneous Insulin Infusion (CSII) and patch/tubeless micropumps are newer options available. Patch pumps are free of tubing, small and lightweight. We aimed to report the initial clinical effect of an insulin micropump therapy in a cohort of children with T1DM. Method: We studied pediatric patients (5-years old) , converting from multiple daily injections of insulin (MDI) to Roche Accu-chek Solo tubeless micropump system. Nine children (5 female/4 male) were followed during 1 and 3 months. All patients used Continuous Glucose Monitoring (CGM) and data was collected to learn time spent in hypoglycemia, normoglycemia and hyperglycemia, as well the glucose variability. Results: Data from this small cohort showed that basal insulin infusion rates at baseline and 3 months were similar (7.7U to 7.6U) and insulin bolus requirements reduced from 14.3U to 12.7U, respectively. Based on CGM analysis the table below shows the % of time spent at different glycemia values (mean/SD) , as well its variability. HbA1c was 7.3% at baseline and 7.4% after 3 months, and there were no emergency room admissions due to severe hypoglycemia. Conclusion: The initial results of this new insulin micropump therapy in children showed an improvement on glucose control and variability, without increasing hypoglycemia. Additional studies are necessary to demonstrate the medium and long-term effect of this new device in this population. Disclosure L. Rista: Advisory Panel; Roche Diabetes Care. Speaker's Bureau; AstraZeneca, Novo Nordisk. A. Flores: Speaker's Bureau; Novo Nordisk, Roche Diabetes Care, Sanofi. M. Rivers: Employee; Roche Diabetes Care. C. Vulcano: Employee; Roche Diabetes Care. E. Repetto: Employee; Roche Diabetes Care.

95-LB: Interim Data from a Prospective Study Measuring User Satisfaction and Metabolic Outcome while Using a Novel Modular Patch Pump System

Background and aims: Intensified insulin therapy for type 1 diabetes (T1D) can be administered by multiple daily injection therapy (MDI) or continuous subcutaneous insulin infusion therapy (CSII) . Despite the clinical benefits of CSII, its therapeutic implementation rate remains low. Thus, this study aims to evaluate the change in treatment satisfaction and metabolic changes of people with T1D switching from MDI to CSII therapy using a novel modular patch pump system. Materials and Methods: A total of 50 adults from Argentina with T1D, naïve to CSII, were enrolled in a multi - center, prospective, single - armed study for the Accu-Chek® Solo micropump system (ACS) . Change in diabetes treatment satisfaction after 13 weeks (mean 106, min 83, max 176 days) was assessed by the “Impact and Satisfaction” section of the Diabetes Technology Questionnaire (DTQ) as the primary outcome. In addition, changes in the HbA1c were reported by the investigator as a secondary outcome. Results: The mean DTQ “now” score improved from 92.96 ± 14.98 to 103.15 ± 19.47 (p = 0.0166) and the “change” score, as the primary outcome, was 113.24 ± 17.50 (p < 0.0001) . Based on pre - defined sub - categories, the following mean DTQ scores were measured: 3.83 ± 0.62 for “diabetes distress and burden,” 3.98 ± 0.70 for “hypoglycemia fear, worry and behavior,” 3.59 ± 0.70 for “device acceptance and satisfaction,” 3.92 ± 0.61 for “other.” In addition, the mean HbA1c, as a secondary outcome, decreased from 8.19 % ± 1.36 to 7.83 % ± 1.23 (- 0.37 %pt, p = 0.0148) . Thereby, the HbA1c reduction was not associated with any reported incidents of hypoglycemia. Conclusion: The switch from MDI to the Accu-Chek® Solo micropump system led to a significant improvement of subjects’ treatment satisfaction after 13 weeks, which was linked to a significant reduction of the outcome HbA1c without any reported incidents of hypoglycemia. Disclosure A. Dain: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Diabetes Care, Speaker’s Bureau; Abbott Diabetes, AstraZeneca, Lilly Diabetes, Novo Nordisk. S. Moceri: Employee; Roche Diabetes Care. N. Dagenbach: Employee; Roche Diabetes Care. C. Rees: Employee; Roche Diabetes Care. C. Vulcano: Employee; Roche Diabetes Care. G. Vogt: Employee; Roche Diabetes Care. T. J. Etter: Employee; Roche Diabetes Care. Funding Roche Diabetes Care Gmbh, Mannheim, Germany

Accuracy Evaluation of a Novel Reusable Patch Pump Prototype.

A prototype of an insulin patch pump that operates with a double pump mechanism was tested. Accuracy of bolus delivery of 0.2 U and 1.0 U, and a basal rate of 1.0 U/h were evaluated with a microgravimetric method. In addition, occlusion detection time at basal rates of 0.1 U/h and 1.0 U/h was assessed. Mean deviation from target was lower than 2% for both bolus sizes. Regarding basal rate accuracy, mean deviation over 72 hours was lower than 1%. Occlusion detection occurred in less than 30 minutes with both basal rates. Our study results suggest that the tested pump prototype provides delivery accuracy and occlusion detection that is similar or even better compared to all commercially available pumps tested with a similar experimental approach.

Patch Pumps: Periodic Insulin Delivery Patterns.

Recent in vitro experiments with patch pumps (PP) Omnipod (OP), Omnipod DASH (OP-D), A6 TouchCare (A6), and Accu-Chek Solo (ACS) have observed periodic fluctuations in the delivered amount of insulin during basal rate and consecutive bolus delivery in some PP, calling for a more systematic characterization of these periodic delivery patterns. Here, it was found that during basal rate delivery of 1 U/h, some devices of OP, OP-D, and A6 showed deviations of up to ±30% from target delivery that consistently repeated every 5 hours, whereas ACS showed no clear periodicity with considerably lower deviations. Similar results were found during consecutive bolus delivery of 1 U, where deviations repeated consistently every five boluses in some devices of OP, OP-D, and A6. However, there was a large variability in the periodic delivery patterns between individual devices of the same PP model. Examining their pumping techniques indicated a connection between the insulin delivery mechanism and observed delivery patterns of the PP. However, the clinical impact of such patterns is unclear.

A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus.

This study evaluated the safety and efficacy of tubeless patch pump called EOPatch in patients with well-controlled type 1 diabetes mellitus (T1DM). This 4-week, two-center, open-label, single-arm study enrolled 10 adult patients diagnosed with T1DM with glycosylated hemoglobin less than 7.5%. The co-primary end points were patch pump usage time for one attachment and number of serious adverse events related to the patch pump. The secondary end points were total amount of insulin injected per patch and changes in glycemic parameters including continuous glucose monitoring data compared to those at study entry. The median usage time per patch was 84.00 hours (interquartile range, 64.50 to 92.50). Serious adverse events did not occur during the trial. Four weeks later, time in range 70 to 180 mg/dL was significantly improved (70.71%±17.14 % vs. 82.96%±9.14%, P=0.01). The times spent below range (<54 mg/dL) and above range (>180 mg/dL) also improved (All P<0.05). Four-week treatment with a tubeless patch pump was safe and led to clinical improvement in glycemic control.

Impact of OMNIPOD® on the quality of life of adolescents with type 1 diabetes

IntroductionSeveral pediatric studies have demonstrated that therapy using a conventional insulin pump improves glycemic control and quality of life. At the beginning of this study, a new tubeless insulin pump, Omnipod®, had recently been marketed in France. ObjectivesAnalyze the response of adolescents treated with multiple injections to the proposal to use this new medical device and compare both the quality of life and the glycemic control of adolescents according to their choice. Material and MethodsThis was a prospective, observational study of adolescents aged 10–17 years who had type 1 diabetes for more than 1 year, all treated with multi-injection insulin delivery according to a basal-bolus regimen. They were separated into three groups: group A choosing to use the Omnipod® system, group B taking the time to think before making a decision, and group C choosing to keep their multi-injection therapy. The three groups were compared according to their quality of life with validated tools and glycemic control. ResultsGroups were formed with 30 (25%) patients in group A, 55 patients (45%) in group B, and 36 patients (30%) in group C. As to the WHO Well-Being Index, no significant difference appeared in the study for the patients in the three groups. An increased treatment satisfaction score was found, evolving from 3.79 ± 0.68 to 4.36 ± 0.56, p = 0.002 (group A) and from 3.87 ± 0.7 to 4.16 ± 0.7, p = 0.032 (group B), with no significant change for group C (from 4.39 ± 0.6 to 4.31 ± 0.62, p = 0.582). The wish to change treatment score improved for group A (from 4.14 ± 0.88 to 1.68 ± 0.9; p < 0.001) and group B (from 3.51 ± 1.05 to 1.84 ± 1; p < 0.001), with no significant change for group C (from 1.81 ± 0 0.98 to 1.61 ± 0.8; p = 0.432). There was no significant difference regarding HbA1c rates in the three groups. ConclusionThere was no significant difference in quality-of-life scores between adolescents who chose to switch from multiple injection to the tubeless patch pump and those who retained multi-injection treatment, but increased satisfaction was observed in the former group.

Piezoelectric Silicon Micropump for Drug Delivery Applications

Subcutaneous injection is crucial for the treatment of many diseases. Especially for regular or continuous injections, automated dosing is beneficial. However, existing devices are large, uncomfortable, visible under clothing, or interfere with physical activity. Thus, the development of small, energy efficient and reliable patch pumps or implantable systems is necessary and research on microelectromechanical system (MEMS) based drug delivery devices has gained increasing interest. However, the requirements of medical applications are challenging and especially the dosing precision and reliability of MEMS pumps are not yet sufficiently evaluated. To enable further miniaturization, we propose a precise 5 × 5 mm2 silicon micropump. Detailed experimental evaluation of ten pumps proves a backpressure capability with air of 12.5 ± 0.8 kPa, which indicates the ability to transport bubbles. The maximal water flow rate is 74 ± 6 µL/min and the pumps’ average blocking pressure is 51 kPa. The evaluation of the dosing precision for bolus deliveries with water and insulin shows a high repeatability of dosed package volumes. The pumps show a mean standard deviation of only 0.02 mg for 0.5 mg packages, and therefore, stay below the generally accepted 5% deviation, even for this extremely small amount. The high precision enables the combination with higher concentrated medication and is the foundation for the development of an extremely miniaturized patch pump.