bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Karlsburg Diabetes Management System: Translation from Research to eHealth Application
Authors: Salzsieder Eckhard , Augstein Petra 
Published: January 2014

Background: Several telemedicine-based eHealth programs exist, but patient-focused personalized decision support (PDS) is usually lacking. We evaluated the acceptance, efficiency, and cost-effectiveness of telemedicine-assisted PDS in routine outpatient diabetes care. Methods: Data are derived from the Diabetiva® program of the German health insurance company BKK TAUNUS. Diabetiva offers telemedicine-based outpatient health care in combination with PDS generated by the Karlsburg Diabetes Management System, KADIS®. This retrospective analysis is based on data from the first year of running KADIS-based PDS in routine diabetes care. Participants were insured persons diagnosed with diabetes and cardiovascular diseases. For final analysis, patients were grouped retrospectively as users or nonusers according to physician acceptance or not (based on questionnaires) of the KADIS-based PDS. Results: A total of 538 patients participated for more than one year in the Diabetiva program. Of these patients, 289 had complete data sets (two continuous glucose monitoring measurements, two or more hemoglobin A1c (HbA1c) values, and a signed questionnaire) and were included in the final data analysis. Of the physicians, 74% accepted KADIS-based PDS, a rate that was clearly related to HbA1c at the beginning of the observation. If KADIS-based PDS was accepted, HbA1c decreased by 0.4% (7.1% to 6.7%). In contrast, rejection of KADIS-based PDS resulted in an HbA1c increase of 0.5% (6.8% to 7.3%). The insurance company revealed an annual cost reduction of about 900 € per participant in the Diabetiva program. Conclusions: KADIS-based PDS in combination with telemedicine has high potential to improve the outcome of routine outpatient diabetes care.
Creating a Place for Caregivers in Personal Health: The iHealthSpace Copilot Program and Diabetes Care
Authors: Chung Jeanhee , Berkowicz David A. , Ho Benjamin , Jernigan Michael , Chueh Henry 
Published: January 2014

Background: As America's baby boom generation reaches retirement, the number of elders, and, in turn, the number of lay individuals who support them, will continue to increase. With the important services caregivers provide, it is critical that we recognize and provide assistance to the informal caregivers who play this important role in our society. The network of support provisioned by relatives, partners, friends, and neighbors suggests that the dyadic, unidirectional caregiver-care recipient relationship assumed by caregiver research so far and by resources deployed to assist caregivers may be insufficient to ascertain and meet the needs of the care community. Methods: In this article, we describe the extension of a Web-based personal health record system, iHealthSpace, for explicitly and openly incorporating caregivers into the care community. Results: Using this portal, a set of business rules was implemented to support the creation of custodial accounts. These business rules will be used to create modules that support diabetes care in an adult population. Conclusions: We successfully extended an existing patient portal to accommodate the creation of custodial accounts. We will use this portal to assess the impact of custodial access in the care of older patients with diabetes.
“Smart Tattoo” Glucose Biosensors and Effect of Coencapsulated Anti-Inflammatory Agents
Authors: Srivastava Rohit , Jayant Rahul Dev , Chaudhary Ayesha , McShane Michael J. 
Published: January 2014

Background: Minimally invasive glucose biosensors with increased functional longevity form one of the most promising techniques for continuous glucose monitoring. In the present study, we developed a novel nanoengineered microsphere formulation comprising alginate microsphere glucose sensors and anti-inflammatory-drug-loaded alginate microspheres. Methods: The formulation was prepared and characterized for size, shape, in vitro drug release, biocompatibility, and in vivo acceptability. Glucose oxidase (GOx)- and Apo-GOx-based glucose sensors were prepared and characterized. Sensing was performed both in distilled water and simulated interstitial body fluid. Layer-by-layer self-assembly techniques were used for preventing drug and sensing chemistry release. Finally, in vivo studies, involving histopathologic examination of subcutaneous tissue surrounding the implanted sensors using Sprague-Dawley rats, were performed to test the suppression of inflammation and fibrosis associated with glucose sensor implantation. Results: The drug formulation showed 100% drug release with in 30 days with zero-order release kinetics. The GOx-based sensors showed good enzyme retention and enzyme activity over a period of 1 month. Apo-GOx-based visible and near-infrared sensors showed good sensitivity and analytical response range of 0–50 mM glucose, with linear range up to 12 mM glucose concentration. In vitro cell line studies proved biocompatibility of the material used. Finally, both anti-inflammatory drugs were successful in controlling the implant-tissue interface by suppressing inflammation at the implant site. Conclusion: The incorporation of anti-inflammatory drug with glucose biosensors shows promise in improving sensor biocompatibility, thereby suggesting potential application of alginate microspheres as “smart tattoo” glucose sensors with increased functional longevity.
Enhanced Absorption of Nasulin™, an Ultrarapid-Acting Intranasal Insulin Formulation, Using Single Nostril Administration in Normal Subjects
Authors: Stote Robert , Miller Michael , Marbury Thomas , Shi Leon , Strange Poul 
Published: January 2014

Background: This pharmacokinetic (PK) study was designed to investigate the maximum intranasal insulin dose that could be achieved by repeated doses in a single nostril of a nasal spray of recombinant regular human insulin 1% in combination with cyclopentadecalactone (CPE-215) 2%, a compound that enhances absorption of molecules across mucous membranes (Nasulin™, CPEX Pharmaceuticals, Inc.). Method: A nine-period crossover study of 8 healthy, nonsmoking subjects (ages 18–50, body mass index <33 kg/m2, weight >70 kg) were studied. In a fasted state, subjects were randomly given 25, 50, and 75 U in a single nostril on the first day and randomly given 50, 75, and 100 U doses utilizing both nostrils on two subsequent days. After a 45-minute PK assessment, subjects were given a meal. To determine the mechanism of enhanced absorption in a single nostril, a second study utilizing 24 subjects under similar conditions received 25 U, placebo (P) that included CPE-215 plus 25 U, and 50 U in a single nostril. Results: Single nostril administration revealed enhanced absorption with maximum concentrations (Cmax) of 13, 65, and 96 μU/ml for the 25, 50, and 75 U doses, respectively. Dual nostril administration in two cohorts resulted in Cmax of 31/42, 65/52, and 88/79 μU/ml for the 50, 75, and 100 U, respectively. In the second cohort, Cmax was 23, 19, 56 μU/ml for the 25, P + 25, and 50 U doses, respectively. Conclusions: Repeated dosing in a single nostril resulted in enhanced absorption; this was not due to the increased CPE-215 but to the increased insulin administered.
Injection Force of SoloSTAR® Compared with other Disposable Insulin Pen Devices at Constant Volume Flow Rates
Authors: van der Burg Thomas 
Published: January 2014

Background: Injection force is a particularly important practical aspect of therapy for patients with diabetes, especially those who have dexterity problems. This laboratory-based study compared the injection force of the SoloSTAR® insulin pen (SoloSTAR; sanofi-aventis) versus other available disposable pens at injection speeds based on the delivered volume of insulin released at the needle. Method: Four different prefilled disposable pens were tested: SoloSTAR containing insulin glargine; FlexPen® and the Next Generation FlexPen® (NGFP) (Novo Nordisk), both containing insulin detemir; and KwikPen® containing insulin lispro (Eli Lilly). All pens were investigated using the maximum dispense volume for each pen type [80 units (U) for SoloSTAR; 60 U for the other pens], from the free needle tip dispensing into a beaker. Twenty pens of each type were fitted with the recommended needles and tested at two dose speeds (6 and 10 U/s); each pen was tested twice. Results: Mean plateau injection force and maximum injection force were consistently lower with SoloSTAR compared with FlexPen, NGFP, and KwikPen at both injection speeds tested. An injection speed of 10 U/s was associated with higher injection force compared with 6 U/s for all the pens tested ( p < .001). Conclusions: SoloSTAR stands out because of its low injection force, even when compared with newer insulin pen devices such as the KwikPen and NGFP. This may enable patients, especially those with dexterity problems, to administer insulin more easily and improve management of their diabetes.
Analysis of the Injection Force of Solostar® Compared with other Disposable Insulin Pen Devices at Constant Volume Flow Rates
Authors: Carter Alan W. 
Published: January 2014

Insulin pen devices have greatly enhanced the portability and accessibility to insulin therapy for millions of people with diabetes. Comparison research data should be reviewed thoroughly. In this issue of Journal of Diabetes Science and Technology, the study presented by Thomas van der Burg is balanced in number of samples tested, same tensile meter, and identical units per second delivery rate into an open beaker. Mean plateau force of SoloSTAR® and KwikPen® were Significantly lower. KwikPen and SoloSTAR utilized 5-mm length 31-gauge (G) needles vs 6-mm 31G needles for FlexPen® and Next Generation FlexPen®, perhaps skewing results in favor of shorter needles instead of device design. Individual understanding of correct insulin use, appropriate self-monitoring of blood glucose, vision and dexterity capability, and affordability of therapy must be considered first. SoloSTAR holds one unique market advantage, delivery of up to 80 units of insulin per injection.
Evaluation of Dexterity in Insulin-Treated Patients with Type 1 and Type 2 Diabetes Mellitus
Authors: Pfützner Julia , Hellhammer Juliane , Musholt Petra , Pfützner Anke H. , Böhnke Jan , Hero Torsten , Amann-Zalan Ildiko , Ganz Manfred , Forst Thomas , Pfützner Andreas 
Published: January 2014

Background: Daily routine for insulin-treated patients with diabetes mellitus requires correct performance of self-monitoring of blood glucose and insulin injections several times a day. Dexterity skills may play an important role in the performance efficacy of these procedures. Methods: We collected data of insulin-treated (>10 years) patients with different age ranges [healthy controls, 14 female/11 male, age (mean ± standard deviation) 55 ± 7 years; type 1 diabetes mellitus (T1DM) patients, 12/13, 45 ± 9 years, disease duration 23.9 ± 6.5 years; T2DM patients, 8/17, 64 ± 6 years, 16.2 ± 6.9 years; T2DM patients (>70 years of age), 9/16, 75 ± 4 years, 19.7 ± 7.0 years]. After assessment of neuropathy (temperature, pain, and vibration perception), the patients participated in two dexterity test batteries [Jebsen-Taylor hand-function test (JHFT) and motoric performance series (MPS)]. Results: Patients with type 2 diabetes showed disturbed vibration perception as compared to the other groups. The dexterity results were influenced by age to a large extent. Older T2DM patients performed worst in the majority of the subtests (e.g., JHFT, writing nondominant hand: Control, 40.8 ± 11.7 s; T1DM, 46.3 ± 50.9 s, not significant versus control; old T2DM, 68.1 ± 29.5 s, p < .05; young T2DM, 52.5 ± 26.2 s, p < .05). Patients with type 1 diabetes showed similar JHFT and MPS results than the 10-year-older control subjects and performed outside of the age-dependent normal reference range. Conclusions: Manual skills and dexterity differed between the groups, and age-corrected reduced skills were common in both T1DM and T2DM patients in this study. Our findings underline the importance of considering dexterity and manual skills when designing medical devices for patients with diabetes mellitus.
Integration of Remote Blood Glucose Meter Upload Technology into a Clinical Pharmacist Medication Therapy Management Service
Authors: Schenk Robert J. , Schenk Jenna 
Published: January 2014

A pharmacist-delivered, outpatient-focused medication therapy management (MTM) program is using a remote blood glucose (BG) meter upload device to provide better care and to improve outcomes for its patients with diabetes. Sharing uploaded BG meter data, presented in easily comprehensible graphs and charts, enables patients, caregivers, and the medical team to better understand how the patients' diabetes care is progressing. Pharmacists are becoming increasingly more active in helping to manage patients' complex medication regimens in an effort to help detect and avoid medication-related problems. Working together with patients and their physicians as part of an interdisciplinary health care team, pharmacists are helping to improve medication outcomes. This article focuses on two case studies highlighting the Diabetes Monitoring Program, one component of the Meridian Pharmacology Institute MTM service, and discusses the clinical application of a unique BG meter upload device.
Design of a Decision Support System to Help Clinicians Manage Glycemia in Patients with Type 2 Diabetes Mellitus
Authors: Rodbard David , Vigersky Robert A. 
Published: January 2014

Objective: We sought to develop a computerized clinical decision support for clinicians treating patients with type 2 diabetes mellitus (T2DM). Methods: We designed, developed, and tested a computer-assisted decision support (CADS) system using statistical analyses of self-monitoring of blood glucose data, laboratory data, medical and medication history, and individualized hemoglobin A1c goals. A rule-based expert system generated recommendations for changes in therapy and accompanying explanations. Results: A clinical decision support system (CADS) was developed that considers 9 classes of medications and 69 regimens with combinations of up to 4 therapeutic agents. The preferred sequences of regimens can be customized. The program is integrated with a “comprehensive diabetes management system,” electronic medical record systems, and a method for uploading data from memory glucose meters via telephone without use of a computer or the Internet. The software provides a report to the clinician regarding the overall quality of glycemic control and identifies problems, e.g., hypoglycemia, hyperglycemia, glycemic variability, and insufficient data. The program can recommend continuation of current therapy, adjustment of dosages of current medications, or change of regimen and can provide explanations for its recommendations. If the user rejects the recommendations, the program will recommend alternative approaches. The CADS also provides access to Food and Drug Administration-approved prescribing information, guidelines from professional organizations, and selections from the general medical literature. The system has been extensively tested with real and synthetic data and is ready for evaluation in multicenter clinical trials. Conclusion: A clinical decision support system to assist with the management of patients with T2DM was designed, developed, tested, and found to perform well.
Perioperative Hyperglycemia and Postoperative Infection after Lower Limb Arthroplasty
Authors: Mraovic Boris , Suh Donghun , Jacovides Christina , Parvizi Javad 
Published: January 2014

Background: One of the most serious complications after major orthopedic surgery is deep wound or periprosthetic joint infection. Various risk factors for infection after hip and knee replacement surgery have been reported, including patients' comorbidities and surgical technique factors. We investigated whether hyperglycemia and diabetes mellitus (DM) are associated with infection that requires surgical intervention after total hip and knee arthroplasty. Methods: We reviewed our computerized database for elective primary total hip and knee arthroplasty from 2000 to 2008. Demographic information, past medical history of patients, perioperative biochemistry, and postoperative complications were reviewed. Patients were divided into two groups: Infected group (101 patients who had surgical intervention for infection at our institution within 2 years after primary surgery) and noninfected group (1847 patients with no intervention with a minimum of one year follow-up. The data were analyzed using t, chi-squared, and Fisher's exact tests. Results: There were significantly more diabetes patients in the infected group compared with the noninfected group (22% versus 9%, p < .001). Infected patients had significantly higher perioperative blood glucose (BG) values: Preoperative BG (112 ± 36 versus 105 ± 31 mg/dl, p = .043) and postoperative day (POD) 1 BG (154 ± 37 versus 138 ± 31 mg/dl, p < .001). Postoperative morning hyperglycemia (BG >200 mg/dl) increased the risk for the infection more than two-fold. Non-DM patients were three times more likely to develop the infection if their morning BG was >140 mg/dl on POD 1, p = .001. Male gender, higher body mass index, knee arthroplasty, longer operative time and hospital stay, higher comorbidity index, history of myocardial infarction, congestive heart failure, and renal insufficiency were also associated with the infection. Conclusions: Diabetes mellitus and morning postoperative hyperglycemia were predictors for postoperative infection following total joint arthroplasty. Even patients without a diagnosis of DM who developed postoperative hyperglycemia had a significantly increased risk for the infection.
The Association between Driving Distance and Glycemic Control in Rural Areas
Authors: Zgibor Janice C. , Gieraltowski Laura B. , Talbott Evelyn O. , Fabio Anthony , Sharma Ravi K. , Karimi Hassan 
Published: January 2014

Background: In order to optimize care and improve outcomes in people with diabetes, adequate access to health care facilities and resources for self-management is required. Methods: Data on 3369 individuals with type 2 diabetes who received education at 7 diabetes centers were collected prospectively between June 2005 and January 2007. The driving distances of subjects who were in good control [hemoglobin A1c (A1C) >7.0%] were compared with the driving distances of those who were not (A1C >7.0%). The association between A1C and improvement in A1C with travel burden was tested. Results: The mean distance subjects traveled to visit their center was 13.3 miles. The results indicated that residing more than 10 miles from the diabetes management center [odds ratio (OR) = 1.91, p < .0001], being younger (OR = 0.99, p = .00015), and having a longer duration of diabetes (OR = 1.03, p = .0007) were significant contributors to a A1C >7% adjusted for individual- and community-level factors. In addition, those who lived within 10 miles of their center were 2.5 times more likely to have improved their A1C values between their first and last Office visits. Conclusion: Health care providers should be aware of travel burden as a potential barrier to glycemic control. In the future, it may be useful to minimize driving distance for individuals with diabetes, perhaps by improved public transportation, more diabetes center locations in rural areas, telemedicine, or home visits.
Disease Registries on the Nationwide Health Information Network
Authors: Russler Daniel 
Published: January 2014

Background: Donation by individuals of their protected health information (PHI) for evidence-based research potentially benefits all individuals with disease through improved understandings of disease patterns. In the future, a better understanding of how disease features combine into unique patterns of disease will generate new disease classifications, supporting greater specificity in health management techniques. However, without large numbers of people who donate their PHI to disease registries designed for research, it is difficult for researchers to discover the existence of complex patterns or to create more specific evidence-based management techniques. In order to identify new opportunities in disease registry design, an analysis of the current stage of maturity of the newly created U.S. Nationwide Health Information Network (NwHIN) related to large-scale consumer donation of PHI is presented. Methods: Utilizing a use-case analysis methodology, the consumer-centric designs of the policies and technologies created for the NwHIN were examined for the potential to support consumer donations of PHI to research. Results: The NwHIN design has placed the enforcement point for the policy-based release of PHI over the Internet into a specialized gateway accessible to consumer authorization. However, current NwHIN policies leave the final decision regarding release of PHI for research to the health care providers rather than to the consumers themselves. Conclusions: Should disease registries designed for research be established on the NwHIN, consumers might then directly authorize the donation of their PHI to these disease registries. However, under current NwHIN policies, consumer authorization does not guarantee release of PHI by health providers.
Use of a Large Diabetes Electronic Medical Record System in India: Clinical and Research Applications
Authors: Pradeepa Rajendra , Prabu Anbalagan Viknesh , Jebarani Saravanan , Subhashini Sivasankaran , Mohan Viswanathan 
Published: January 2014

Background: The diabetes electronic medical record (DEMR) has emerged as an effective information management tool with the potential to improve diabetes care and research. This study reports on the usefulness of the DEMR system at Dr. Mohan's Diabetes Specialities Centre (DMDSC), Chennai, India, for clinical and research purposes. Methods: The DEMR, set up in 1996 at DMDSC, connects data of nine centers/clinics in different geographical areas in Southern India. The present data analysis is based on a total of 226,228 patients registered in the DEMR system at DMDSC between the years 1991 and 2010. Results: The DEMR included data of 139,906 male and 86,322 female patients, of whom 92.6% had type 2 diabetes mellitus (T2DM), 1.4% had type 1 diabetes mellitus (T1DM), and the rest had other types. Patients with T2DM had higher prevalence rates of neuropathy (33.1% vs 13.0%, p < .001), microalbuminuria (25.5% vs 20.0%, p < .001), coronary artery disease (17.5% vs 9.2%, p < .001) and peripheral vascular disease (3.9% vs 2.8%, p = .017) compared with T1DM patients, while prevalence of diabetic retinopathy was similar (37.9% vs 35.7%, p = .06). Prevalence of microvascular and macrovascular complications of diabetes increased with increasing glycated hemoglobin levels ( p for trend < .001) and increasing diabetes duration ( p for trend < .001). Conclusions: The DEMR helps track diabetes care and is a valuable tool for research.