Tert-butylhydroquinone and tert-butylcatechol positivity as warning lights of skin sensitization to tert-butylphenol derivatives in adhesives and diabetes devices.

INTRODUCTION: Tert-butylphenol (TBP) derivatives, antioxidants in adhesives and diabetes devices, may provoke allergic contact dermatitis (ACD). OBJECTIVES: The objective of this study is to report sensitization to TBP derivatives in medical devices and to highlight that tert-butylhydroquinone (BHQ) and tert-butylcatechol (TBC) are potential screeners in this regard. METHODS: Fifteen patients with ACD from adhesives and diabetes devices were patch tested to different TBPs: BHQ 1% pet., TBC 0.25% pet., BHA 2% pet., BHT 2% pet., 4-tert-butylphenol (TBP) 1% pet. and 2,4-di-tert-butylphenol (di TBP) 1% pet. The culprit devices (medical adhesives, sanitary pads, diabetes devices) and TBP patch preparations were analysed using gas chromatography-mass spectrometry (GC-MS). RESULTS: BHQ (9/13), TBC (7/13), and to a lesser extent BHT (3/15), BHA (2/15) and TBP (2/13) gave positive reactions. Seven patients had developed ACD from adhesives and diabetes devices, respectively, and one patient from sanitary pads. GC-MS analyses of the medical devices and patch test materials confirmed the presence of the patch-test positive TBPs, or chemically related derivatives, or, interestingly, tert-butylbenzoquinones (BBQ) were found, that is, spontaneously formed, highly reactive TBP metabolites, likely (pseudo-) cross reacting with the patch tested TBPs. CONCLUSION: TBPs might be overlooked sensitizers in medical devices, and BHQ and TBC are potential screeners in this regard.

Development and psychometric analysis of the Diabetes Device Confidence Scale for school nurses.

BACKGROUND: School nurses need to be equipped to help students with diabetes devices. No existing tools assess school nurse self-efficacy in using devices. OBJECTIVE: To develop and evaluate the psychometric properties of a novel scale to measure school nurse confidence with diabetes devices. RESEARCH DESIGN AND METHODS: We generated a list of items with community partners and examined logical validity. We then revised and distributed the item set to school nurses in Pennsylvania to examine aspects of structural validity, convergent validity, and internal consistency reliability. We used item response theory to refine the scale. RESULTS: Facilitated discussion with collaborators generated an initial list of 50 potential items. Based upon the item-content validity index, we revised/eliminated 13 items. School nurses (n = 310) in Pennsylvania completed an updated 38-item scale; the majority had experience with insulin pumps or continuous glucose monitors. Exploratory factor analysis identified a one-factor solution, suggesting a unidimensional scale. We eliminated 13 additional items based upon significant inter-item correlation or skewed response patterns. Item response theory did not identify additional candidate items for removal. Despite a high degree of redundancy (Cronbach's alpha > 0.90), we retained all remaining items to maximize the future utility of the scale. CONCLUSION: The 25-item, unidimensional Diabetes Device Confidence Scale is a new tool to measure school nurse confidence with diabetes devices. This scale has future clinical, programmatic, and research applications. Combined with knowledge assessments, this scale can serve to evaluate school nurse device use readiness, assess training gaps, and tailor interventions.

Isocyanates may contribute to allergic contact dermatitis from diabetes devices and wound dressings.

BACKGROUND: Isocyanates are well-known occupational allergens, but can also be present in medical devices. OBJECTIVES: To highlight that contact sensitization to isocyanates might contribute to allergic contact dermatitis (ACD) from polyurethane (PU)-containing diabetes devices and wound dressings. PATIENTS AND METHODS: Nineteen patients with suspected ACD from diabetes devices and/or wound dressings were patch tested to an isocyanate series. Four wound dressings, six diabetes devices and four monomeric isocyanate patch test preparations were analysed with gas chromatography - mass spectrometry. RESULTS: Eight patients reacted to isocyanates and corresponding amines: 3 to isophorone diisocyanate (IPDI), 4 to 4,4'-diaminodiphenylmethane (MDA), 4 to 2,4-toluene diisocyanate (TDI) and 1 to polymeric methylene diphenyl diisocyanate (PMDI). Three of four wound dressings contained isocyanates (methylene diphenyl diisocyanate [MDI], TDI and/or IPDI), whereas five of six diabetes devices contained 4,4'-MDI, and one of them also IPDI. None of the medical devices contained 1,6-hexamethylene diisocyanate. Contrary to IPDI, and especially MDI, only the concentration of the TDI patch test preparation corresponded approximately (80%) to its label. CONCLUSION: Patch tests with isocyanates may be worth-while in patients with suspected ACD from PU-containing medical devices. Besides MDA, and PMDI, also TDI might potentially be a marker for MDI-sensitization.

Greek School Nurses' Confidence With Diabetes Devices.

Aim School nurses often use diabetes mellitus devices as part of the care provided to students with Type 1 Diabetes Mellitus. The aim of this study was to explore the psychometric properties of the Greek version of the Diabetes Devices Confidence Scale (DDCS). Methods In this cross-sectional, descriptive study, 143 school nurses completed the DDCS. This is a self-administered questionnaire exploring the nurses' confidence in the use of diabetes devices. The scale was translated and culturally adapted according to the WHO guidelines. The Intraclass Correlation Coefficient and Cronbach's Alpha Index were used to explore the reliability and internal consistency, respectively. The construct validity was tested via exploratory and confirmatory factor analysis (EFA, CFA). Data were analyzed via Statistical Package for the Social Sciences (SPSS), version 22.0 (IBM Corp., Armonk, NY, USA). Results Significant correlations were observed between the two administrations (p<0.001) indicating the good reliability of the scale (ICC = 0525, p<0.001) while Cronbach's Alpha was 0.966 suggesting excellent internal consistency. The EFA resulted in a unidimensional solution explaining 53.7% of the total variance. The CFA showed that the model presents good fit to the data. Conclusions The DDCS is a reliable and valid tool to test the nurses' confidence in diabetes devices.

An Occlusive Hydrocolloid-Based Patch Is Effective, Feasible, and Safe As a Treatment of Irritant Contact Dermatitis Due to Diabetes Devices in Children and Adolescents with Type 1 Diabetes.

Irritant contact dermatitis (ICD) occurs frequently with the use of diabetes devices, but no guidelines for treatment exist. Since subsequent devices need intact skin for intended use, quick healing is crucial. Normal wound healing is expected to be 7-10 days. This was a single-center cross-over study that investigated the effectiveness of an occlusive hydrocolloid-based patch versus nonocclusive treatment of ICD. Participants were aged 6-20 years with active ICD caused by using diabetes device. First study period was patch treatment for 3 days. A control arm was initiated if a new ICD occurred within 30 days. ICD healed completely in 21% of the patch group but none in the controls. Itching was reported as an adverse event (AE) in both arms, but only one additional AE was noted in the patch arm: an infection at a different site from investigated. The hydrocolloid-based patch showed signs of faster healing of ICD with no additional AEs, but larger studies are needed.

Observed Characteristics Associated with Diabetes Device Use Among Teens with Type 1 Diabetes.

BACKGROUND: Despite advancements in diabetes technologies, disparities remain with respect to diabetes device use in youth with type 1 diabetes (T1D). We compared sociodemographic, diabetes, and psychosocial characteristics associated with device (pump and continuous glucose monitor [CGM]) use in 13- to 17-year-old teens with T1D. MATERIALS/METHODS: Data were derived from a multicenter clinical trial to optimize self-care and glycemic control in teens with T1D. We categorized teens as pump users versus non-users and CGM users versus non-users based on their diabetes device usage. Chi-square and t-tests compared characteristics according to device use. RESULTS: The sample comprised 301 teens (50% female) with baseline mean ± SD age 15.0 ± 1.3 years, T1D duration 6.5 ± 3.7 years, and HbA1c 8.5 ± 1.1% (69 ± 12 mmol/mol). Two-thirds (65%) were pump users, and 27% were CGM users. Pump users and CGM users (vs. non-users) were more likely to have a family annual household income ≥$150,000, private health insurance, and a parent with a college education (all P < .001). Pump users and CGM users (vs. non-users) also performed more frequent daily blood glucose (BG) checks (both P < .001) and reported more diabetes self-care behaviors (both P < .05). Pump users were less likely to have baseline HbA1c ≥9% (75 mmol/mol) (P = .005) and to report fewer depressive symptoms (P = .02) than pump non-users. Parents of both CGM and pump users reported a higher quality of life in their youth (P < .05). CONCLUSION: There were many sociodemographic, diabetes-specific, and psychosocial factors associated with device use. Modifiable factors can serve as the target for clinical interventions; youth with non-modifiable factors can receive extra support to overcome potential barriers to device use.

The Need for Data Standards and Implementation Policies to Integrate Insulin Delivery Data Into the Electronic Health Record.

Integration of insulin dosing data into the electronic health record (EHR), combined with other patient-generated health care data, would facilitate the use of wirelessly connected insulin delivery systems, including smart insulin pens, insulin pumps, and advanced hybrid closed-loop systems. In 2022, Diabetes Technology Society developed the Integration of Continuous Glucose Monitoring Data into the EHR (iCoDE) Project, which is the first consensus standard for integrating data from a wearable device into the EHR. The iCoDE Standard is a comprehensive guide for any health care delivery organization or hospital for automatically integrating continuous glucose monitoring data into the EHR. Diabetes Technology Society is following iCoDE with the Integration of Connected Diabetes Device Data into the EHR (iCoDE-2) Project, to similarly provide guidance for integrating insulin delivery data into the EHR alongside continuous glucose monitoring data.

A Cross-Sectional Pilot Survey of Rural Clinic Attitudes and Proficiency with Insulin Pumps and Continuous Glucose Monitoring Devices.

Purpose: To examine the perceptions, proficiencies, and barriers of diabetes device use among rural clinic providers. Methods: A total of 210 surveys were sent through e-mail and/or U.S. Postal Service to rural clinics throughout Alaska, Idaho, Montana, Oregon, Washington, and Utah based on discussions with rural clinic network leadership in the states. Responses were included if the participant was 18 years of age and older, and worked at a rural clinic as a physician, physician assistant, nurse, nurse practitioner, allied health worker, or clinic manager. Results: Respondents included clinic management (13%), midlevel providers (physician assistants and nurse practitioners) and allied health workers (pharmacists, dietitians, and social workers, 30.8%), nurses (30.8%), and physicians (23.1%). We had a low response rate (20%; n = 41), but of those who said they work with patients who have diabetes, only 47.4% indicated that they use diabetes devices as part of their patients' treatment. The most common barrier reported among respondents suggested that additional medical team expertise is needed in their community or clinic to adopt insulin pumps and/or continuous glucose monitoring for qualified patients (75.9% and 80.8%, respectively). Conclusion: Lack of provider experience and having patients managed by out-of-area experts were the biggest reasons for providers not seeing or managing patients using these devices. Lack of provider access, patient satisfaction with current diabetes regimens, unsupportive health care team, patient literacy, and patient fear showed limited to negligible endorsements from survey respondents. A variety of potential solutions to this problem of limited provider experience and training are also offered.

Advances in Glucose Monitoring and Automated Insulin Delivery: Supplement to Endocrine Society Clinical Practice Guidelines.

Endocrine Society guideline recommendations on diabetes technology in adults originate from the 2016 guideline titled "Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline." Society recommendations on diabetes technology in children are contained in the 2011 guideline titled "Continuous Glucose Monitoring: An Endocrine Society Clinical Practice Guideline." The field of diabetes technology is a rapidly advancing one, with new devices released annually and data from clinical trials published frequently. This report describes the most recent findings since the 2011 and 2016 guidelines were written, combining summaries of new literature with the authors' clinical experience of new devices. Although we describe what we believe to be important scientific and technological updates since these guidelines were published, we are not advancing formal additions or amendments to previously offered recommendations.