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Background: Most adolescents with type 1 diabetes (T1D) do not achieve a glycated hemoglobin (HbA1c) <7.0%, which is the current clinical target. mHealth can offer a scalable and age-appropriate delivery method for behavioral interventions to lower adolescents' HbA1c levels, while applying established behavior change and behavioral economics theories can enhance scientific rigor., Methods: We aim to conduct a pilot randomized clinical trial of a novel mHealth intervention called Coin2Dose (Cash-Only INcentives To promote insulin DOSE engagement), in a sample of youth with T1D: 1) to obtain measures of feasibility and acceptability and 2) to examine preliminary efficacy versus a standard care control group based on differences in youth's daily BOLUS scores, HbA1c levels, and Time in Range (TIR) at post-intervention and 3-month post-intervention follow-up. This pilot RCT is already registered in http://ClinicalTrials.gov (NCT#05280184)., Results: Our pilot will recruit youth with T1D 11-17 years-old who use an insulin pump or Bluetooth connected insulin pen and have an average daily BOLUS score ≤2.5. Youth randomized to Coin2Dose will receive the intervention for 12 weeks followed by a 12-week maintenance period. The pilot is scheduled to start July 2022 and to conclude in 2025., Discussion: At the conclusion of the pilot, we will have information about the feasibility and acceptability of two different behavioral economic incentive structures for improving BOLUS scores. The work is anticipated to progress to final efficacy trial. We will disseminate study results through presentations at local, national, and international conferences and through peer-reviewed diabetes and psychology journals., Competing Interests: Declaration of Competing Interest Dr. Mark Clements is the Chief Medical Officer for Glooko and receives material research support from Abbott Diabetes Care and Dexcom; these are not related to this protocol. Dr. Larry Fox also receives material research support from Dexcom which is not related to this protocol. The remaining authors report no conflicts of interest., (Copyright © 2022. Published by Elsevier Inc.)

Background: Paper-based and computer-based insulin infusion algorithms facilitate appropriate glycemic therapy. The data comparing these algorithms in the management of diabetic ketoacidosis in the intensive care unit (ICU) setting are limited. We aimed to determine the differences in time to diabetic ketoacidosis resolution and incidence of hypoglycemia between computer and paper-based insulin infusion., Methods: Single-institution retrospective review of patients admitted to the ICU with diabetic ketoacidosis between 4/1/2015 and 7/20/2018. Our institution introduced computer-based insulin infusion (Glucommander) to the intensive care unit on 3/28/2016. Patients were grouped into either paper-based group (preintervention) or a computer-based group (postintervention). Summary and univariate analyses were performed., Results: A total of 620 patients (paper-based=247; computer-based=373) with a median (IQR) age of 40 (26-56) years were included; 46% were male. Patients in the computer-based group were significantly older (p=0.003); otherwise, there were no significant differences in gender, race, body mass index and HbA1c. The mean (±SD) time to diabetic ketoacidosis resolution in the computer-based group was significantly lower than the paper-based group (p=0.02). The number of patients in the paper-based group who developed severe hypoglycemia (<50 mg/dl) was significantly higher {8% vs 1%; p<0.0001}., Conclusion: Our analyses demonstrate statistically significant decreases in time to DKA resolution and hypoglycemic events in DKA patients who were managed using a computer-based insulin infusion algorithm providing a more effective and safer option when compared to paper-based insulin infusion., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Background: Insulin infusions are commonly utilized to control hyperglycemia in critically ill patients and decrease hyperglycemia associated complications. Safety concerns have been raised in trials evaluating methods of glycemic control regarding the incidence of hypoglycemia and its relationship to increased mortality. Electronic glycemic management systems (eGMS) may result in less variable blood glucose (BG) control and less hypoglycemia. This study aimed to compare BG control, time in target BG range, and the rate of hypoglycemia when critically ill patients were managed with an insulin infusion guided by paper-based protocol (PBP) versus eGMS., Methods: This retrospective review compared critically ill patients ≥ 18 years old that received insulin infusion from March to May 2015 (PBP group) and October to January 2017 (eGMS group). The primary outcome was the incidence of hypoglycemia. Secondary outcomes included frequency and severity of hypoglycemia, duration in glycemic target, length of insulin therapy, as well as ICU and hospital length of stay., Results: Fifty-four patients were evaluated, 27 in each group. Percentage of days with BG <70 mg/dL was significantly reduced after eGMS implementation (21.5% v 1.3%, P < .0001) including the frequency of severe hypoglycemia (BG < 40 mg/dL) (5.4% v 0.01%, P < .0001). Patients in the eGMS group spent a greater amount of time in target BG range (31.5% v 63.7%, P < .0001)., Conclusions: An eGMS has the potential to address many of the unmet needs of an optimal glycemic control strategy, minimizing hypoglycemia, and glycemic variability in a heterogeneous critically ill population.

Background: Stress-induced hyperglycemia is a common feature of intensive care unit (ICU) patients. Besides mean blood glucose (BG) level, glucose variability and hypoglycemia have been highlighted as independent predictors of ICU and hospital mortality. Recent ICU recommendations suggest using insulin infusion protocols that can minimize glucose variability and hypoglycemic risk. Our aim was to assess the efficacy, safety, and acceptance by nurses of a paper-based simple dynamic insulin protocol compared with those by nurses of a paper-based static protocol., Methods: This is a 1 year stepped-wedge study that compared a static sliding scale protocol (SP - static protocol) with a validated dynamic paper-based intravenous insulin infusion protocol (DP - dynamic protocol) in medical ICU patients of a single university hospital. Patients with stress-induced hyperglycemia >9.9 mmol/L and ≥48 h intravenous insulin infusion were included in this trial., Results: One hundred thirty-one patients were included and received continuous intravenous insulin infusion managed with SP (n = 65) or DP (n = 66). Glucose variability was significantly higher in the SP group than in the DP group (mean average glucose excursion index: 0.90 [0.00-1.91] mmol/L vs. 0.00 [0.00-0.90] mmol/L, respectively; P = 0.001). The percentage of time spent in the target range (7.7-9.9 mmol/L) was lower in the SP group than in the DP group (42.5% [28.8%-54.2%] vs. 47.5% [36.6%-57.1%]; P = 0.037). Low BG (<4.4 mmol/L) and hypoglycemia (<3.3 mmol/L) were more frequent in the SP group than in the DP group. According to a satisfaction survey, this protocol was well accepted by nurses., Conclusions: Our simple and feasible paper-based, dynamic insulin infusion protocol reduced glycemic variability and hypoglycemic risk in a medical ICU.

Objective: The use of continuous intravenous regular human insulin (RHI) infusion is often necessary to achieve glycemic control in critically ill patients. Because insulin is a high-risk medication owing to the potential for severe hypoglycemia, it is imperative that insulin infusion algorithms are designed to be safe, effective, and instructionally clear. The safety and efficacy of our intravenous RHI infusion algorithm protocol has been previously established (Nutrition 2008;24:536-45); however, the protocol violations by nursing personnel were not examined. The objective of this study was to assess nursing adherence to our RHI infusion algorithm., Methods: Continuous RHI infusion algorithm violations were retrospectively evaluated in adult patients admitted to a trauma intensive care unit who received concurrent continuous enteral and/or parenteral nutrition therapy and our algorithm for at least 3 d. Blood glucose (BG) monitoring was done every 1 to 2 h with the target BG at 70 to 149 mg/dL (3.9 to 8.3 mmol/L). Nursing adherence to the RHI infusion protocol was evaluated for each patient by comparing the adjustments in insulin infusion rates documented by the nursing personnel with the prescribed adjustments per our graduated continuous intravenous RHI infusion algorithm., Results: A total of 4150 BG measurements necessitating the determination of the appropriate RHI dosage rate by nursing personnel in 40 patients occurred during the observational period. The target BG was achieved for a mean of 20 h/d and none of the patients had an episode of severe hypoglycemia (BG <40 mg/dL or 2.2 mmol/L). The overall rate of algorithm violations was 12.1%. The algorithm violations accounted for a single episode of mild to moderate hypoglycemia (BG 40 to 60 mg/dL or 2.2 to 3.3 mmol/L) in 4 patients and 65 total episodes of hyperglycemia (BG ≥150 mg/dL or 8.3 mmol/L) in 18 patients., Conclusion: An adherence rate of nearly 90% is indicative of excellent nursing adherence compared with other published paper-based algorithms that examined protocol adherence. These data, combined with our previously published glycemic control data, indicate that this RHI infusion algorithm is an effective one for hyperglycemic trauma patients receiving continuous enteral and/or parenteral nutritional therapy., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: To evaluate the safety and efficacy of replacing a paper-based protocol with a computer-guided glucose management system (CGMS) for the treatment of postoperative hyperglycemia in the cardiovascular intensive care unit (CVICU)., Methods: With use of a before-and-after analysis, adult patients (≥18 years) discharged from the CVICU and treated with the paper protocol were compared with patients discharged from the CVICU and treated with the CGMS. Of the 1,648 patients analyzed, 991 were in the CGMS group. Clinical end points were evaluated by using the Wilcoxon test. Unadjusted and adjusted hazard ratios (HRs) for each hypoglycemic end point were calculated from Cox models with use of the proportional hazards regression procedure, and clinical end points were adjusted for potential confounders., Results: Patients treated with the paper protocol were 6 times as likely to experience clinical hypoglycemia (blood glucose ≤70 mg/dL) as patients treated with the CGMS (adjusted HR = 6.06; P<.0001) and more than 7 times as likely to experience severe hypoglycemia (blood glucose ≤40 mg/dL) (adjusted HR = 7.59; P=.01). Despite the increased risk of hypoglycemia, no significant difference in length of stay or mortality was observed between the groups., Conclusion: CGMS treatment of postoperative hyperglycemia in CVICU patients can successfully attain goal glucose levels with a significant reduction in hypoglycemia in comparison with a paper protocol. This association persists after controlling for covariates.

Background: There is variability in the extent of outcome achievement between computerized insulin infusion programs (CIIPs) and paper-based protocols (PBPs). This reported variability may be improved by intensive CIIP training prior to implementation. The objective was to evaluate the impact of a CIIP following intensive nurse training versus a PBP in a critical care setting., Methods: A retrospective cohort study was performed on patients admitted to a mixed intensive care unit comparing glucose control between the CIIP following intensive training and a PBP. Consecutive patients on each protocol were assessed to obtain glucose concentrations and outcomes. The primary measure was the percentage of blood glucose values within target range (90-130 mg/dL). Patient glucose values were pooled and assessed using the χ(2) test for independence., Results: In total, 61 patients with 5,495 glucose tests were included in the PBP group, and 51 patients with 5,645 glucose tests in the CIIP group. A greater percentage of glucose tests was within target range in the CIIP group (68.4% vs. 36.5%, P<0.001). In the CIIP group, time-to-target (median [interquartile range] 5 [3-8] h vs. 7 [4-20] h, P=0.02) and severe hypoglycemic events were reduced (26 vs. 6, P<0.0001)., Conclusions: The nurse-driven CIIP led to a higher percentage of glucose values within target range, faster achievement of target glucose values, and a reduction in the number of severe hypoglycemic events. This improved outcome achievement compared with previous reports may be associated with intensive user training.

Background: In large-scale epidemiology, bloodspot sampling by fingerstick onto filter paper has many advantages, including ease and low costs of collection, processing and transport. We describe the development of an enzyme-linked immunoassay (ELISA) for quantifying insulin from dried blood spots and demonstrate its application in a large trial., Methods: We adapted an existing commercial kit (Mercodia Human Insulin ELISA, 10-1113-01) to quantify insulin from two 3-mm diameter discs (≈6 µL of blood) punched from whole blood standards and from trial samples. Paediatricians collected dried blood spots in a follow-up of 13,879 fasted children aged 11.5 years (interquartile range 11.3-11.8 years) from 31 trial sites across Belarus. We quantified bloodspot insulin levels and examined their distribution by demography and anthropometry., Results: Mean intra-assay (n = 157) coefficients of variation were 15% and 6% for 'low' (6.7 mU/L) and 'high' (23.1 mU/L) values, respectively; the respective inter-assay values (n = 33) were 23% and 11%. The intraclass correlation coefficient between 50 paired whole bloodspot versus serum samples, collected simultaneously, was 0.90 (95% confidence interval 0.85 to 0.95). Bloodspot insulin was stable for at least 31 months at -80°C, for one week at +30°C and following four freeze-thaw cycles. Paediatricians collected a median of 8 blood spots from 13,487 (97%) children. The geometric mean insulin (log standard deviation) concentrations amongst 12,812 children were 3.0 mU/L (1.1) in boys and 4.0 mU/L (1.0) in girls and were positively associated with pubertal stage, measures of central and peripheral adiposity, height and fasting glucose., Conclusions: Our simple and convenient bloodspot assay is suitable for the measurement of insulin in very small volumes of blood collected on filter paper cards and can be applied to large-scale epidemiology studies of the early-life determinants of circulating insulin.

Objective: To validate use of chip-based immunoaffinity capillary electrophoresis on dried blood spot samples (DBSS) to measure obesity-related hormones., Methods: Chip-based immunoaffinity capillary electrophoresis was used to measure adiponectin, leptin and insulin in capillary serum and DBSS in pregnant women and infant heelstick at birth and six weeks. Concordance of measurements was determined with Pearson's correlation and Bland-Altman plots., Results: We report high concordance between results obtained from serum and DBSS., Conclusions: Ease of sample collection and storage makes DBSS an optimal method for use in studies involving neonates and young children, as well as studies conducted in areas where freezer storage is not available., (Copyright © 2011 Wiley-Liss, Inc.)

Background: Paper-based continuous intravenous insulin protocols for tight glycaemic control (TGC) are typically complex, error-prone, time-consuming and burdensome. Little is known about the errors that occur as a result of misinterpretation and whether computerised protocols reduce errors., Objective: To compare the errors resulting from protocol misinterpretation, time required to manage insulin infusions and nursing satisfaction between a computerised insulin protocol and a paper-based protocol., Methods: In a crossover study, 62 ICU nurses completed 10 TGC simulated scenarios for the computerised and paper protocols. Scenarios evaluated three phases of insulin management: initiation, titration and transition. Scenarios response errors, time to completion and user satisfaction were examined., Results: A total of 620 responses were recorded using both protocols. The computerised protocols were associated with higher user satisfaction, as well as: fewer errors in the titration (13 vs. 113 errors, p=.0001) and transition phases (9 vs. 23 errors, p=.001), fewer dosing errors, although not statistically significant (p=.096), in the initiation phase, and less time to complete in the titration phase (6 vs. 9.5 min, p=.0001)., Conclusions: In a simulated environment, a computerised protocol for TGC resulted in significant insulin dosing error reduction, saved time and improved nurse satisfaction., (Copyright 2010 Elsevier Ltd. All rights reserved.)

Background: Hyperglycemia is common in critically ill patients and is an independent risk factor for in-hospital morbidity and mortality., Objective: To assess compliance with a paper-based, multiplication-factor, intravenous insulin protocol., Methods: A retrospective chart review was conducted in a 720-bed urban, academic medical center in Boston, Massachusetts. During a 1-month period, compliance with and the consequent safety and efficacy of the Brigham and Women's Hospital paper-based, multiplication-factor, intravenous insulin protocol was evaluated., Results: The primary endpoint of protocol compliance, defined as correct adjustment to insulin infusion rate and correct timing of bedside blood glucose concentration (BBGC) checks +/-10 minutes of prespecified BBGC check according to the Brigham and Women's Hospital Intravenous Insulin Protocol (BHIP), was 47.2%. Seventy-two patients met inclusion criteria. Appropriate adjustment of infusion rates occurred 68.2% (1206/1768) of the time. Compliance with the timing of BBGC checks was found to be the majority of protocol violations. BBGCs were monitored +/-5 minutes of indicated time per the protocol 26.2% (463/1768) of the time. Blood glucose concentration checks within extended timing of +/-10 minutes of indicated time per the protocol occurred 793 (44.8%) times. Blood glucose concentration monitoring took place greater than 20 minutes past indicated time 450 (25.5%) times. In 1768 measurements, blood glucose concentrations between 40 and 60 mg/dL occurred 23 (1.3%) times in 12 (16.7%) patients. Blood glucose concentrations 40 mg/dL or less were detected 3 (0.17%) times in 2 (2.7%) patients. None of these hypoglycemic events led to documented complications., Conclusions: Overall, a rather low level of compliance with a paper-based, multiplication-factor, intravenous insulin protocol was observed, which warrants further investigation. Compliance rates in this evaluation were found to be similar to the rates observed in previously evaluated fixed-dose intravenous insulin protocols. Protocol noncompliance may be associated with hypo- and hyperglycemia.

The incorporation of electronic medical records into busy physician clinics has been a major development in the healthcare industry over the past decade. Documentation of key nursing activities, especially when interacting with patients who have chronic diseases, is often lacking or missing from the paper medical record. A case study of a patient with diabetes mellitus was created. Well established methods for the assessment of usability in the areas of human-computer interaction and computer supported cooperative work were employed to compare the nursing documentation of two tasks in a commercially available electronic medical record (eRecord) and in a paper medical record. Overall, the eRecord was found to improve the timeliness and quality of nursing documentation. With certain tasks, the number of steps to accomplish the same task was higher, which may result in the perception by the end user that the tool is more complex and therefore difficult to use. Recommendations for the eRecord were made to expand the documentation of patient teaching and adherence assessment and to incorporate web technology for patient access to medical records and healthcare information.

Insulin is preferred as the first-line agent for glucose management of gestational diabetes mellitus and type 2 diabetes in pregnancy when nutritional and lifestyle modifications are unable to achieve pregnancy-specific glucose targets. Individual heterogeneity in defects of insulin secretion or sensitivity in liver and muscle, unique genetic influences on pregnancy glycemic regulation, and variable cultural and lifestyle behaviors that affect meal, activity, sleep, and occupational schedules necessitate a personalized approach to insulin regimens. Newer insulin preparations have been developed to mimic the physiologic release of endogenous insulin, maintaining appropriate basal levels to cover hepatic gluconeogenesis and simulate the rapid, meal-related, bolus rise of insulin. Such physiologic basal-bolus dosing of insulin can be administered safely, achieving tighter glycemic control while reducing episodes of hypoglycemia. Insulin initiation and titration require understanding the pharmacodynamics of different insulin preparations in addition to a patient's glycemic profiles, effect of variable nutritional intake and mealtimes, physical activity, stress, timing of sleep cycles, and cultural habits. Educating and empowering patients to learn how their glucose responds to insulin, portion and content of meals, and physical activity can increase personal engagement in therapy, flexibility in eating patterns, and improved glycemic control. This Clinical Expert Series article is focused on optimizing insulin management (initiation, dosing, and titration) of gestational and type 2 diabetes in pregnancy., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

This work provides a synthesis of the perceptions of people with type 1 diabetes mellitus (T1DM) and healthcare professionals about the acceptability, implementation, and equity of continuous subcutaneous insulin infusion (CSII). A qualitative evidence synthesis was carried out. Three online databases (Medline, Embase, and Web of Science) were searched. Qualitative articles which were available in Spanish or English were included. A descriptive thematic synthesis was conducted according to PRISMA and ENTREQ guidelines. Thirty-two references met the inclusion criteria of the study and were included out of an initial 345 identified references. Seven main themes were identified: (a) acceptability, (b) adaptation to the insulin pump, (c) facilitators for the adequate use of insulin pump, (d) variability of acceptability, (e) barriers for the use of insulin pump, (f) feasibility and implementation considerations, and (g) equity. CSII is well accepted by most people with T1DM, with some exceptions. CSII can relieve management burden, increase autonomy and flexibility and improve family relationships. There were multiple perceived barriers to its continued use. Future studies should continue to analyze inequalities in access and use of the CSII., (© 2024 The Author(s). Nursing & Health Sciences published by John Wiley & Sons Australia, Ltd.)

Measuring energy balance and energy metabolism can provide crucial information for understanding the ecological and behavioral drivers of an animal's energetic and physiological condition. Both urinary C‐peptide (uCP) of insulin and urinary total triiodothyronine (uTT3) have been validated as noninvasive biomarkers of energy balance and metabolic activity in haplorrhine primates. This study attempts to validate uCP and uTT3 measures in strepsirrhines, a phylogenetically distinct primate clade, using the ruffed lemur (genus Varecia) as a model. We experimentally manipulated the diet of captive black‐and‐white (Varecia variegata) and red (Varecia rubra) ruffed lemurs at Duke Lemur Center across a 4‐week period. We collected urine samples from subjects (n = 5) each day during 1 week of control diet, 2 weeks of calorie‐restricted diet and 1 week of refeeding, designed to temporarily reduce energy balance and metabolism. We also tested the outcome of filter paper as a storage method by comparing to controls (frozen at −20°C) to assess its suitability for studies of wild populations. We successfully measured uCP and uTT3 levels in frozen urine samples using commercial enzyme immunoassay kits and found that both biomarkers were excreted at lower concentrations (C‐peptide: 1.35 ng/mL, 54% reduction; TT3: 1.5 ng/mL, 37.5% reduction) during calorie‐restricted periods compared to normal diet periods. Filter paper recovery for uCP was 19%, though values were significantly positively correlated with frozen control samples. uTT3 could not be recovered at measurable concentrations using filter paper. These methods enable noninvasive measurement of energetic conditions in wild strepsirrhines and subsequent assessment of relationships between energy balance and numerous socioecological drivers in primate populations. HIGHLIGHTS: Both C‐peptide (CP) and total triiodothyronine (TT3) are measurable in lemur urine using commercial enzyme immunoassays.Concentrations of both metabolites decrease when animals are subjected to caloric restriction.Both metabolites can be measured when stored at −20°C, whereas filter paper is a viable storage option only for CP and not triiodothyronine. [ABSTRACT FROM AUTHOR]

An isotope dilution mass spectrometry (IDMS) method that involves peptide-based protein analysis was developed to accurately quantify insulin. In this study, a signature peptide (GFFYTPK) obtained from tryptic digestion of insulin was selected as a surrogate for insulin. Then, the optimal conditions for signature peptide analysis through mass spectrometry detection and enzymatic digestion were determined. The analytical performance of this method was assessed and validated using porcine insulin-certified reference material. The linear range of the insulin calibration curve ranged from 0.05 ~ 2 mass ratios, with recoveries ranging from 96.15 to approximately 101.15%. The limit of detection was 0.19 ng/mL, and the limit of quantification was 0.63 ng/mL. The quantitative results corresponded well with a certified value that was obtained from measuring a porcine insulin reference material with amino acid-based IDMS. In addition, the target peptide GFFYTPK can be found in other species of insulin. This method was also applied for the quantification of human insulin-certified reference material. Finally, we applied the method to quantify the concentrations of simulated serum insulin. These findings suggested that this signature peptide-based IDMS approach can accurately quantify insulin levels, can assign a certified value to insulin reference materials, and has the potential to quantify serum insulin with traceable measurements., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

The recent clearance by the United States Food and Drug Administration of Tidepool Loop sets an important precedent within the medical device landscape. For the first time, an automated insulin delivery mobile application-based on an algorithm initially designed and developed by users -has been recognised as safe and effective by a regulatory body. The aim of this paper is twofold: firstly, we map out the regulatory pathways and processes that were navigated by Tidepool, the non-profit behind Tidepool Loop, in order to make this landmark moment possible. Secondly, we set out potential approvals processes in the European Union and United Kingdom with a view to examining the challenges to obtaining regulatory clearance for Tidepool Loop in these jurisdictions. In so doing, we highlight the significant differences, not only between the United States and European systems but also between the European Union and Great Britain systems. We conclude by arguing that the complexity encountered when seeking to introduce an innovative solution in different regulatory systems has the potential to act as a disincentive to open source developers from seeking regulatory approvals for such technologies in the future., (© 2023 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)