Randomized trial of technology-assisted self-monitoring of blood glucose by low-income seniors: improved glycemic control in type 2 diabetes mellitus.

Self-monitoring of blood glucose (SMBG) has been recommended for people with type 2 diabetes mellitus. This trial tested an automated self-management monitor (ASMM) that reminds patients to perform SMBG, provides feedback on results of SMBG, and action tips for improved self-management. This delayed-start trial randomized participants to using the ASMM immediately (IG), or following a delay of 6 months (DG). Glycated hemoglobin (HgbA1c) level and survey data was collected at home visits every 3 months. 44 diabetic men and women, mean age 70, completed the 12-month trial. Baseline HgbA1c was 8.1 % ± 1.0, dropping to 7.3 ± 1.0 by 9 months, with a 3-month lag in the DG (F = 3.56, p = 0.004). Decrease in HgbA1c was significantly correlated to increased frequency of SMBG, R = 0.588, p < 0.01. Providing older diabetics with objective immediate contingent feedback resulted in more frequent SMBG that correlated with better glycemic control. This type of technology may provide real-time feedback not only to patient users, but to the health care system, allowing better integration of provider recommendations with patient-centered action.

Cultural and Social Challenges of Diabetes Self-Management Education Through Physicians' Voices.

OBJECTIVE: The aim of this study is to understand how the physician-patient relationship is related to referral practices for diabetes self-management education and physicians' perceptions of culturally competent health care delivery at a large health system affiliated with an academic medical center in a Midwestern city. METHODS: Sixteen physicians (6 family medicine, 6 internal medicine, 4 endocrinology) participated in semistructured interviews. Interviews were audio-recorded, transcribed, and coded. Data were thematically analyzed using MAXQDA software. RESULTS: All physicians considered diabetes self-management education a very important part of diabetes treatment, but physician referral patterns to diabetes education varied. Study findings indicated that both high and low referring physicians reported providing care that was responsive to personalized patient needs, including cultural beliefs, attitudes, and behaviors that affect health/health care. Building relationships and rapport with patients led to discussions of understanding barriers to diabetes management. CONCLUSION: This study highlights physicians' perceptions of and concerns about referrals to diabetes self-management education and the treatment of type 2 diabetes. Physicians understood the personal, environmental, and health care factors that limit the number of racial/ethnic minorities from participating. PRACTICAL IMPLICATIONS: In addition to diabetes education, physicians suggested that additional resources or programs will help them address socioeconomic factors beyond their control and to understand cultural preferences.

Immune Checkpoint Inhibitor-Associated Type 1 Diabetes Mellitus: Case Series, Review of the Literature, and Optimal Management.

With the introduction of immune checkpoint inhibitors into clinical practice, various autoimmune toxicities have been described. Antibodies targeting the receptor:ligand pairing of programmed death receptor-1 (PD-1) and its cognate ligand programmed death-ligand 1 (PD-L1) in rare reports have been associated with autoimmune diabetes mellitus. We report 2 cases of rapid-onset, insulin-dependent, type 1 diabetes mellitus in the setting of administration of nivolumab, a fully human monoclonal antibody to PD-1, and atezolizumab, a humanized monoclonal antibody to PD-L1. This appears to be the first report of autoimmune diabetes mellitus associated with atezolizumab. In addition, we provide a brief review of similar cases reported in the literature and a discussion of potential mechanisms for this phenomenon and propose a diagnostic and treatment algorithm.

Use of secondary clinical data for research related to diabetes self-management education.

BACKGROUND: Diabetes self-management education (DSME) is a key component of ensuring optimal diabetes outcomes. Electronic medical record (EMR) systems have transformed diabetes management by providing organized and useful data. However, important gaps remain in the process of how practice settings track referrals and attendance to DSME. PURPOSE: The purpose of this study was to use EMR data to examine patients' demographic, behavioral, and diabetes risk factors by referral pattern to a DSME program in a large midwestern Academic Medical Center. METHODS: A retrospective cross-sectional design using 2006-2013 EMR data from a Clinical Research Data Warehouse (CRDW). Data on 10,000 patients with type 2 diabetes mellitus (T2DM) were randomly extracted from the CRDW for analysis. Multiple logistic regression analysis was employed to explore adjusted associations with referral to DSME. RESULTS: Seven hundred forty patients with T2DM were referred to DSME. Results show that age at diagnosis, insurance status, race/ethnicity, language, alcohol use, use of insulin, HbA1c, LDL, systolic blood pressure, ophthalmology appointment, coronary artery disease, neuropathy, diabetic-retinopathy, and nephropathy were found to be factors significantly associated with a referral to DSME. Language emerged as a significant result; non-English speakers were more likely to receive a referral to DSME. CONCLUSIONS: Patients referred for DSME had appropriate medical complications or social needs that would benefit from intensive education; however, there remains a considerable opportunity for improving the DSME referral process. Aspects of the physician decision-making process to refer or not refer patients to DSME warrant further investigation.

Tumoral calcinosis presenting with eyelid calcifications due to novel missense mutations in the glycosyl transferase domain of the GALNT3 gene.

CONTEXT: Familial tumoral calcinosis (TC) is a rare autosomal recessive disorder characterized by metastatic calcifications, often periarticular. Biochemical findings include hyperphosphatemia, high 1,25-dihydroxyvitamin D levels, and elevated tubular maximum for phosphate reabsorption per deciliter of glomerular filtrate (TmP/GFR). TC is caused by biallelic mutations of the genes encoding either fibroblast growth factor 23 (FGF23) or uridine diphosphate-N-acetyl-alpha-D-galactosamine:polypeptide N-acetylgalactosaminyltransferase 3 (GalNAc transferase 3 or GALNT3). OBJECTIVE: The objective was to identify mutations in FGF23 or GALNT3 responsible for a mild TC phenotype by DNA sequencing and to determine serum FGF23 levels by ELISA. PATIENTS OR OTHER PARTICIPANTS: The subject was a 25-yr-old Caucasian woman with eyelid calcifications and biochemical features of TC. RESULTS: Eyelid biopsy revealed superficial dermis calcifications. There was no history of metastatic calcifications, mineral homeostasis abnormalities, or renal dysfunction. Biochemistry revealed normal levels of calcium, creatinine, PTH, and 25-hydroxyvitamin D, with elevated phosphorous, TmP/GFR, and high normal 1,25-dihydroxyvitamin D levels. Intact FGF23 was undetectable (< 3 pg/ml), whereas C-terminal FGF23 was elevated (698.2 RU/ml). Mutation detection revealed compound heterozygosity for two novel mutations in the glycosyl transferase domain of the GALNT3 gene. CONCLUSION: Previously reported GALNT3 mutations in TC have been null mutations. This study shows that missense mutations affecting the glycosyl transferase domain of GalNAc transferase 3 also cause TC. Elevated C-terminal FGF23 fragments with undetectable intact FGF23 suggest that the mutant enzyme lacks the ability to glycosylate FGF23 and that glycosylation by GalNAc transferase 3 is necessary for secretion of functional full-length FGF23.

Effect of hemoglobin concentration variation on the accuracy and precision of glucose analysis using tissue modulated, noninvasive, in vivo Raman spectroscopy of human blood: a small clinical study.

Tissue modulated Raman spectroscopy was used noninvasively to measure blood glucose concentration in people with type I and type II diabetes with HemoCue fingerstick measurements being used as reference. Including all of the 49 measurements, a Clarke error grid analysis of the noninvasive measurements showed that 72% were A range, i.e., clinically accurate, 20% were B range, i.e., clinically benign, with the remaining 8% of measurements being essentially erroneous, i.e., C, D, or E range. Rejection of 11 outliers gave a correlation coefficient of 0.80, a standard deviation of 22 mg/dL with p<0.0001 for N=38 and places all but one of the measurements in the A and B ranges. The distribution of deviations of the noninvasive glucose measurements from the fingerstick glucose measurements is consistent with the suggestion that there are at least two systematic components in addition to the random noise associated with shot noise, charge coupled device spiking, and human factors. One component is consistent with the known variation of fingerstick glucose concentration measurements from laboratory reference measurements made using plasma or whole blood. A weak but significant correlation between the deviations of noninvasive measurements from fingerstick glucose measurements and the test subject's hemoglobin concentration was also observed.

A comparison of diabetes education administered through telemedicine versus in person.

OBJECTIVE: To determine whether diabetes education can be provided as effectively through telemedicine technology as through in-person encounters with diabetes nurse and nutrition educators. RESEARCH DESIGN AND METHODS: A total of 56 adults with diabetes were randomized to receive diabetes education in person (control group) or via telemedicine (telemedicine group) and were followed prospectively. The education consisted of three consultative visits with diabetes nurse and nutrition educators. The in-person and telemedicine groups were compared using measures of glycemic control (HbA(1c)) and questionnaires to assess patient satisfaction and psychosocial functioning as related to diabetes. Outcome measures were obtained at baseline, immediately after the completion of diabetes education, and 3 months after the third educational visit. RESULTS: Patient satisfaction was high in the telemedicine group. Problem Areas in Diabetes scale scores improved significantly with diabetes education (adjusted P < 0.05, before vs. immediately after education and 3 months after education), and the attainment of behavior-change goals did not differ between groups. With diabetes education, HbA(1c) improved from 8.6 +/- 1.8% at baseline to 7.8 +/- 1.5% immediately after education and 7.8 +/- 1.8% 3 months after the third educational visit (unadjusted P < 0.001, P = 0.089 adjusted for BMI and age), with similar changes observed in the telemedicine and in-person groups. CONCLUSIONS: Diabetes education via telemedicine and in person was equally effective in improving glycemic control, and both methods were well accepted by patients. Reduced diabetes-related stress was observed in both groups. These data suggest that telemedicine can be successfully used to provide diabetes education to patients.

Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) project: technical implementation.

The Columbia University Informatics for Diabetes Education and Telemedicine IDEATel) project is a four-year demonstration project funded by the Centers for Medicare and Medicaid Services with the overall goal of evaluating the feasibility, acceptability, effectiveness, and cost-effectiveness of telemedicine. The focal point of the intervention is the home telemedicine unit (HTU), which provides four functions: synchronous videoconferencing over standard telephone lines, electronic transmission for fingerstick glucose and blood pressure readings, secure Web-based messaging and clinical data review, and access to Web-based educational materials. The HTU must be usable by elderly patients with no prior computer experience. Providing these functions through the HTU requires tight integration of six components: the HTU itself, case management software, a clinical information system, Web-based educational material, data security, and networking and telecommunications. These six components were integrated through a variety of interfaces, providing a system that works well for patients and providers. With more than 400 HTUs installed, IDEATel has demonstrated the feasibility of large-scale home telemedicine.

Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: rationale and design.

The Columbia University Informatics for Diabetes Education and Telemedicine (IDEATel) Project is a four-year demonstration project funded by the Centers for Medicare and Medicaid Services with the overall goals of evaluating the feasibility, acceptability, effectiveness, and cost-effectiveness of telemedicine in the management of older patients with diabetes. The study is designed as a randomized controlled trial and is being conducted by a state-wide consortium in New York. Eligibility requires that participants have diabetes, are Medicare beneficiaries, and reside in federally designated medically underserved areas. A total of 1,500 participants will be randomized, half in New York City and half in other areas of the state. Intervention participants receive a home telemedicine unit that provides synchronous videoconferencing with a project-based nurse, electronic transmission of home fingerstick glucose and blood pressure data, and Web access to a project Web site. End points include glycosylated hemoglobin, blood pressure, and lipid levels; patient satisfaction; health care service utilization; and costs. The project is intended to provide data to help inform regulatory and reimbursement policies for electronically delivered health care services.

A device for noninvasive assessment of vascular impairment risk in the lower extremity.

The repeatability and resolution of the clinical gold standard of vascular assessment, the ankle-brachial index (ABI), was compared to that of a new device that dynamically assesses tissue perfusion during external loading utilizing laser Doppler flowmetry. Eight subjects of varying levels of vascular impairment were tested in successive weeks using two different sites on the subject's posterior calf. These new measures included the perfusion decrease as well as the unloading delay during cyclic loading. Some new dynamic tissue perfusion measures demonstrated comparable levels of reproducibility with the ABI (e.g., 10%-20%). Only the unloading delay showed potentially enhanced resolution over ABI measures. The perfusion decrease showed little resolution, and the remaining parameters exhibited too great variability (25%-90%). The unloading delay associated with the reperfusion response during cyclic loading displayed the greatest combination of reproducibility and differentiation between subject groups of varying levels of vascular impairment. The preliminary results of this pilot study were also used to estimate sample sizes necessary to detect possible significant (P<0.05) differences between subject groups for all measured perfusion parameters. From these calculations, at least 30 subjects are needed for future study in each of the five subject groups.

Comparison of palpation-guided versus ultrasound-guided fine-needle aspiration biopsies of thyroid nodules in an outpatient endocrinology practice.

OBJECTIVE: To investigate the role of thyroid ultrasonography in our outpatient endocrine practice. METHODS: We compared the efficacy of ultrasound-guided fine-needle aspiration biopsy (US-FNAB) of thyroid nodules with that of palpation-guided aspiration (P-FNAB) and determined the malignancy rates of palpable and nonpalpable nodules. All patients referred for assessment of thyroid nodular disease from October 1997 through August 2001 were included in the study. Fine-needle aspirations were performed by palpation guidance until October 1999, after which US-FNAB was exclusively performed. All thyroid examinations, ultrasound imaging, and aspiration biopsies were performed by the same endocrinologist in an office-based setting. Histopathologic and cytologic diagnoses were compared for patients who underwent thyroidectomy. RESULTS: A total of 376 nodules in 276 patients were aspirated during a 47-month period. P-FNAB was used on 157 nodules, and US-FNAB was performed on 219 nodules (both procedures were done on 21 nodules). For palpable thyroid nodules that were resected, the cytologic diagnostic accuracy rate was 60.9% and 80% for P-FNAB and US-FNAB, respectively. With use of ultrasound guidance, the sensitivity, positive predictive value, and negative predictive value increased significantly. In addition, the inadequate specimen rate decreased from 11.2% in the P-FNAB group to 7.1% in the US-FNAB group. Among the nodules that were not palpable, the malignancy rate was similar to that for the palpable thyroid nodules (5.1% versus 6.8%). CONCLUSION: US-FNAB improved the cytologic diagnostic accuracy, sensitivity, and positive predictive value and reduced the false-negative rate in comparison with P-FNAB. The malignancy rate for nonpalpable thyroid nodules was similar to that for palpable nodules.