bluuebunny/crossref_metadata_2025_split huggingface dataset:
Self-Monitoring of Blood Glucose in Type 1 Diabetes Patients with Insufficient Metabolic Control: Focused Self-Monitoring of Blood Glucose Intervention Can Lower Glycated Hemoglobin A1C
Authors: Skeie Svein , Kristensen Gunn B. B. , Carlsen Siri , Sandberg Sverre 
Published: January 2014

Objective: Little attention has been given and few studies have been published focusing on how to optimize self-monitoring of blood glucose (SMBG) use to monitor daily therapy for persons with type 1 diabetes mellitus. This study was designed to evaluate the effect on glycated hemoglobin (A1C) of a structured intervention focused on SMBG in type 1 diabetes patients with insufficient metabolic control (A1C ≥ 8%) using a randomized clinical trial design. Method: One hundred fifty-nine outpatients with type 1 diabetes on multiple injection therapy with insulin and A1C ≥8% were recruited and randomized to one group receiving a focused, structured 9-month SMBG intervention ( n = 59) and another group receiving regular care based on guidelines ( n = 64). Results: Glycated hemoglobin values (mean % ± standard deviation) at study start was similar: 8.65 ± 0.10 in the intervention group and 8.61 ± 0.09 in the control group. The two groups were comparable (age, gender, body mass index, complication rate, and treatment modality) at study start and had mean diabetes duration and SMBG experience of 19 and 20 years, respectively. At study end, there was decrease in A1C in the intervention group ( p < .05), and the A1C was 0.6% lower compared with the control group (p < .05). No increase in the number of minor or major hypoglycemia episodes was observed in the intervention group during the study period. Conclusions: A simple, structured, focused SMBG intervention improved metabolic control in patients with longstanding diabetes type 1 and A1C ≥ 8%. The intervention was based on general recommendations, realistic in format, and can be applied in a regular outpatient setting.
Changes in Diabetes Distress Related to Participation in an Internet-Based Diabetes Care Management Program and Glycemic Control
Authors: Fonda Stephanie J. , McMahon Graham T. , Gomes Helen E. , Hickson Sara , Conlin Paul R. 
Published: January 2014

Background: This article investigated how changes in diabetes distress relate to receiving care management through an Internet-based care management (IBCM) program for diabetes and level of participation in this program. Further, it examined the relationship between diabetes distress and changes in glycemic control. Methods: We enrolled patients of the Veterans Affairs Boston Healthcare System with diabetes who had hemoglobin A1c (HbA1c) levels of ≥9.0%. Subjects were randomized to usual care ( n = 52) or IBCM ( n = 52) for 1 year. We measured diabetes distress at baseline and quarterly thereafter using the Problem Areas in Diabetes (PAID) questionnaire. Glycemic control was determined by baseline and quarterly HbA1c. For subjects randomized to IBCM, we measured participation by observing frequency and consistency of their usage of the IBCM patient portal over 12 months. Linear mixed models were used to analyze THE data. Results: PAID scores declined over time for both treatment groups. Among subjects randomized to IBCM, the decline in PAID scores over time was significant for sustained users of the IBCM patient portal but not for nonusers. Moreover, subjects whose usage of the patient portal was sustained throughout the study had lower PAID scores at baseline. With respect to changes in glycemic control, HbA1c reduced individual differences in PAID scores by 44%; a lower baseline HbA1c was associated with lower baseline PAID scores, and over time, the decrease in HbA1c was associated with further decreases in the PAID score. Conclusions: Participation in IBCM varies by initial diabetes distress, with people with less distress participating more. For people who participate, IBCM further mitigates diabetes distress. There is also a relationship between achievements in glycemic control and subsequent lowering of diabetes distress. Future research should identify how to maximize fit between patient needs and the provisions of IBCM, with the aim of increasing patient engagement in the active management of their health using this care modality. A key to maximizing fit might be first addressing metabolic control aggressively and then using IBCM for sustainment of health.
Comparison of the Dose Accuracy of Prefilled Insulin Pens
Authors: Weise Alexander , Pfützner Johannes W. , Borig Julia , Pfützner Anna M. , Safinowski Michael , Hänel Heike , Musholt Petra B. , Pfützner Andreas 
Published: January 2014

Background: Prefilled insulin pens have become a convenient and accurate way for diabetes patients to inject insulin. Their ease of use has helped to reduce the resistance of patients with type 1 diabetes and type 2 diabetes in the United States and Europe toward initiation of insulin therapy. This study compared the dosing accuracy of two prefilled insulin pens (the SoloStar® from Sanofi Aventis, Berlin, Germany, and the Next Generation [NG] FlexPen® from Novo Nordisk, Mainz, Germany). Methods: The dosing accuracy was tested for both pens with 24 × 10 international units of insulin (IU) and 9 × 30 IU injection volumes to investigate whether the pens comply within the acceptable International Organization for Standardization (ISO) limits of 10% (±1 IU) for 10 IU and 5% (±1.5 IU) for 30 IU. The doses were applied each with a new needle strictly according to the instructions for use of the pen manufacturers. A sensitive pharmaceutical balance was used for the assessment of the applied volumes, and the results were corrected for the specific density of the insulin formulations. We used 18 insulin pens (from two different production lots each) for the two volumes, respectively, resulting in a total of 432 doses per pen with 10 IU and 162 doses per pen with 30 IU. Results: Both pens showed a very good performance, which was better for the 10 IU dose than in comparative previous studies. The NG FlexPen (mean absolute percent deviation 10 IU/30 IU: 1.63 ± 0.84%/1.23 ± 0.76%) was even more accurate than the SoloStar (2.11 ± 0.92%/1.54 ± 0.84%, p > .001/ p > .05 versus the NG FlexPen). Only 0.2% of the doses were outside the ISO limit at 10 IU, with the NG FlexPen (0.6% at 30 IU). The corresponding figures for the SoloStar were 0.4% and 1.8%, respectively. Conclusions: A direct head-to-head comparison of the two prefilled insulin pens with a standardized protocol resulted in a more stable dosing accuracy of both pens as compared to previous investigations. In this investigation, the NG FlexPen was more accurate than the SoloStar at both tested doses.
A Review of Health Literacy and Diabetes: Opportunities for Technology
Authors: Boren Suzanne Austin 
Published: January 2014

Background: The objective of this study was to assess the published literature on health literacy and diabetes, as well as identify opportunities for technology to strengthen information skills and modify behavior to improve diabetes health outcomes. Methods: Medline (1990–2008), the Cumulative Index to Nursing and Allied Health Literature (1990–2008), and the Education Resources Information Center (1990–2008) were searched, and reference lists from included articles were reviewed to identify additional studies. Articles were included that presented measures of literacy or numeracy specific to diabetes, examined associations between health literacy and diabetes outcomes, or tested a health literacy intervention among persons with diabetes. Results: Twenty-four articles were included in this review. Five articles reported on measures of literacy or numeracy specific to diabetes. Thirteen of the fifteen cross-sectional studies (87%) associated limited health literacy with poorer diabetes outcomes. Two of the four (50%) health literacy intervention studies lead to improved health outcomes. Conclusions: The cross-sectional studies provide evidence of an association between health literacy and diabetes outcomes; however, there is a need to design and test strategies to improve diabetes health outcomes that consider health literacy. Information and communication technology opportunities could help to mediate the effect that limited health literacy has on diabetes-related health outcomes.
Requirements for Calibration in Noninvasive Glucose Monitoring by Raman Spectroscopy
Authors: Lipson Jan , Bernhardt Jeff , Block Ueyn , Freeman William R. , Hofmeister Rudy , Hristakeva Maya , Lenosky Thomas , McNamara Robert , Petrasek Danny , Veltkamp David , Waydo Stephen 
Published: January 2014

Background: In the development of noninvasive glucose monitoring technology, it is highly desirable to derive a calibration that relies on neither person-dependent calibration information nor supplementary calibration points furnished by an existing invasive measurement technique (universal calibration). Method: By appropriate experimental design and associated analytical methods, we establish the sufficiency of multiple factors required to permit such a calibration. Factors considered are the discrimination of the measurement technique, stabilization of the experimental apparatus, physics-physiology-based measurement techniques for normalization, the sufficiency of the size of the data set, and appropriate exit criteria to establish the predictive value of the algorithm. Results: For noninvasive glucose measurements, using Raman spectroscopy, the sufficiency of the scale of data was demonstrated by adding new data into an existing calibration algorithm and requiring that (a) the prediction error should be preserved or improved without significant re-optimization, (b) the complexity of the model for optimum estimation not rise with the addition of subjects, and (c) the estimation for persons whose data were removed entirely from the training set should be no worse than the estimates on the remainder of the population. Using these criteria, we established guidelines empirically for the number of subjects (30) and skin sites (387) for a preliminary universal calibration. We obtained a median absolute relative difference for our entire data set of 30 mg/dl, with 92% of the data in the Clarke A and B ranges. Conclusions: Because Raman spectroscopy has high discrimination for glucose, a data set of practical dimensions appears to be sufficient for universal calibration. Improvements based on reducing the variance of blood perfusion are expected to reduce the prediction errors substantially, and the inclusion of supplementary calibration points for the wearable device under development will be permissible and beneficial.
Eliminating the Blood: Ongoing Outbreaks of Hepatitis B Virus Infection and the Need for Innovative Glucose Monitoring Technologies
Authors: Thompson Nicola D. , Perz Joseph F. 
Published: January 2014

Background: As part of routine diabetes care, capillary blood is typically sampled using a finger-stick device and then tested using a handheld blood glucose meter. In settings where multiple persons require assistance with blood glucose monitoring, opportunities for bloodborne pathogen transmission may exist. Methods: Reports of hepatitis B virus (HBV) infection outbreaks in the United States that have been attributed to blood glucose monitoring practices were reviewed and summarized. Results: Since 1990, state and local health departments investigated 18 HBV infection outbreaks, 15 (83%) in the past 10 years, that were associated with the improper use of blood glucose monitoring equipment. At least 147 persons acquired HBV infection during these outbreaks, 6 (4.1%) of whom died from complications of acute HBV infection. Outbreaks appear to have become more frequent in the past decade, primarily affecting long-term care residents with diabetes. Each outbreak was attributed to glucose monitoring practices that exposed HBV-susceptible persons to blood-contaminated equipment that was previously used on HBV-infected persons. The predominant unsafe practices were the use of spring-loaded finger-stick devices on multiple persons and the sharing of blood glucose testing meters without cleaning and disinfection between uses. Conclusion: Hepatitis B virus infection outbreaks associated with blood glucose monitoring have occurred with increasing regularity in the Unites States and may represent a growing but under-recognized problem. Advances in technology, such as the development of blood glucose testing meters that can withstand frequent disinfection and noninvasive glucose monitoring methods, will likely prove useful in improving patient safety.
Toward an Agent-Based Patient—Physician Model for the Adoption of Continuous Glucose Monitoring Technology
Authors: Verella J. Tipan , Patek Stephen D. 
Published: January 2014

Health care is a major component of the U.S. economy, and tremendous research and development efforts are directed toward new technologies in this arena. Unfortunately few tools exist for predicting outcomes associated with new medical products, including whether new technologies will find widespread use within the target population. Questions of technology adoption are rife within the diabetes technology community, and we particularly consider the long-term prognosis for continuous glucose monitoring (CGM) technology. We present an approach to the design and analysis of an agent model that describes the process of CGM adoption among patients with type 1 diabetes mellitus (T1DM), their physicians, and related stakeholders. We particularly focus on patient—physician interactions, with patients discovering CGM technology through word-of-mouth communication and through advertising, applying pressure to their physicians in the context of CGM device adoption, and physicians, concerned about liability, looking to peers for a general level of acceptance of the technology before recommending CGM to their patients. Repeated simulation trials of the agent-based model show that the adoption process reflects the heterogeneity of the adopting community. We also find that the effect of the interaction between patients and physicians is colored by the nature of the environment as defined by the model parameters. We find that, by being able to represent the diverse perspectives of different types of stakeholders, agent-based models can offer useful insights into the adoption process. Models of this sort may eventually prove to be useful in helping physicians, other health care providers, patient advocacy groups, third party payers, and device manufacturers understand the impact of their decisions about new technologies.
Hemoglobin A1c Point-of-Care Assays; A New World with a Lot of Consequences!
Authors: Lenters-Westra Erna , Slingerland Robbert J. 
Published: January 2014

Background: Point-of-care instruments for the measurement of hemoglobin A1c (HbA1c) may improve the glycemic control of people with diabetes by providing a rapid result if the performance of the instruments used is acceptable. A 0.5% HbA1c difference between successive results is considered a clinically relevant change. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols. Methods: The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center. Results: At HbA1c levels of 5.1 and 11.2%, total coefficients of variation (CV) for the In2it were 4.9 and 3.3%, respectively, and for the DCA Vantage were 1.7 to 1.8% and 3.7 to 5.5% depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods. Conclusion: Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5% for HbA1c, the Clinical Laboratory Improvement Amendments rules for waived point-of-care instruments should be revised. An obligation for participating in external quality schemes and taking adequate action should be considered for POC instruments that perform poorly.
Communication Plays a Critical Role in Web-Based Monitoring
Authors: Levine Betty A. , Turner Jeanine Warisse , Robinson James D. , Angelus Pamela , Hu Tang Ming-Jye 
Published: January 2014

Background: Patient-health care practitioner (HCP) interaction via a Web-based diabetes management system may increase patient monitoring of their blood glucose (BG) levels. Methods: A three-center, nonrandomized, prospective feasibility study of 109 Native Americans with poorly controlled type 1 diabetes mellitus and type 2 diabetes mellitus were recruited from Alabama, Idaho, and Arizona. The study intervention included the use of a Web-based diabetes management application (MyCareTeam®) that allowed timely interaction between patients and HCPs. Information about diabetes, nutrition, and exercise was also available. Finally, patients were able to provide BG readings to their HCP via the MyCareTeam system. Results: As a result, 59.6% of the patients sent one or more messages to their HCP, 92.67% received one or more messages from their HCP, and 78.89% received one or more person-centered messages from their HCP. Additionally, the number of times a patient logged into the system and the frequency with which they tested their blood sugar were correlated with (a) the number of messages sent to their HCP, (b) the total number of messages received from their HCP, and (c) the number of person-centered messages received from their HCP. Thus patients who sent more messages also tested their BG more frequently, as measured by the number of BG readings uploaded from their meter to the MyCareTeam database. Person-centered messages seem to be particularly important to motivating the patient to monitor their BG levels and use the Web-based system. Conclusions: These results suggest that patient—HCP interaction and, in particular, more personalized interactions increases patient frequency of BG monitoring.
Cleveland Clinic Cardiovascular Intensive Care Unit Insulin Conversion Protocol
Authors: Olansky Leann , Sam Sharon , Lober Cheryl , Yared Jean-Pierre , Hoogwerf Byron 
Published: January 2014

Background: The importance of near-normal blood glucose in the immediate postoperative period is generally accepted and is best achieved in the perioperative period with a constant intravenous (IV) infusion of insulin. This requires intensive nursing only achievable in an intensive care unit (ICU) setting. Glucose management after transfer to a regular nursing floor (RNF) has not been studied systematically. In August 2006, the Cleveland Clinic began using long-acting insulin glargine as the insulin infusion was terminated in the ICU. Methods: This prospective analysis examined all patients receiving IV insulin infusion after cardiothoracic surgery in a 1 month period. The analyses evaluated the safety and efficacy of a protocol using a transition to subcutaneous insulin glargine of 50% of the calculated 24 h requirement at the end of the ICU insulin infusion protocol in preparation for transfer to the RNF. Results: Only 1 patient in 99 developed hypoglycemia, and no patient suffered severe hypoglycemia (glucose < 40 mg/dl), while the majority (70%) had euglycemia (glucose between 70 and 150 mg/dl). Conclusions: This approach was both safe—as there was very little hypoglycemia (1 patient in 99)—and effective, as blood sugar was well controlled in most subjects. Efficacy for achieving euglycemia was 70%. Efficacy was likely reduced because of the upper limit of insulin glargine dosage imposed by some providers as a safety consideration. Although there was a physician option to override, the maximum protocol dose of 30 U was rarely exceeded, leading to inadequate dosing in some subjects who required high insulin infusion rates in the ICU.
Clinical Update on Optimal Prandial Insulin Dosing Using a Refined Run-to-Run Control Algorithm
Authors: Zisser Howard , Palerm Cesar C. , Bevier Wendy C. , Doyle Francis J. , Jovanovic Lois 
Published: January 2014

Background: This article provides a clinical update using a novel run-to-run algorithm to optimize prandial insulin dosing based on sparse glucose measurements from the previous day's meals. The objective was to use a refined run-to-run algorithm to calculate prandial insulin-to-carbohydrate ratios (I:CHO) for meals of variable carbohydrate content in subjects with type 1 diabetes (T1DM). Method: The open-labeled, nonrandomized study took place over a 6-week period in a nonprofit research center. Nine subjects with T1DM using continuous subcutaneous insulin infusion participated. Basal insulin rates were optimized using continuous glucose monitoring, with a target fasting blood glucose of 90 mg/dl. Subjects monitored blood glucose concentration at the beginning of the meal and at 60 and 120 minutes after the start of the meal. They were instructed to start meals with blood glucose levels between 70 and 130 mg/dl. Subjects were contacted daily to collect data for the previous 24-hour period and to give them the physician-approved, algorithm-derived I:CHO ratios for the next 24 hours. Subjects calculated the amount of the insulin bolus for each meal based on the corresponding I:CHO and their estimate of the meal's carbohydrate content. One- and 2-hour postprandial glucose concentrations served as the main outcome measures. Results: The mean 1-hour postprandial blood glucose level was 104 ± 19 mg/dl. The 2-hour postprandial levels (96.5 ± 18 mg/dl) approached the preprandial levels (90.1 ± 13 mg/dl). Conclusions: Run-to-run algorithms are able to improve postprandial blood glucose levels in subjects with T1DM.
Can Technology Improve Adherence to Long-Term Therapies?
Authors: Reach Gérard 
Published: January 2014

Background: Therapeutic nonadherence is defined as the lack of equivalence between the behavior of the patients and their prescribed medical treatment. Consequences of nonadherence include not only health outcomes, but also cost saving. Thus, this issue gets paramount importance in contemporary medicine. Method: The aim of this article is to discuss the relationships between technology and adherence by asking the following three questions. (1) How can technology be used to monitor patient adherence? (2) Considering the mechanisms of nonadherence in chronic diseases, is there room for technology in interventions aimed to improve patient adherence? (3) What about adherence to technology in diabetes care? Results and Conclusion: Technology may help improve adherence to long-term therapies by (1) giving a concrete representation of adherence rewards, (2) overcoming immediate obstacles to adherence, such as the fear of hypoglycemia, and (3) providing an opportunity for patient-doctor conversations. This assumes, however, that both the patient and the doctor are convinced that technologies are useful.