Tenofovir-Diphosphate and Emtricitabine-Triphosphate Adherence Benchmarks in Dried Blood Spots for Persons with HIV Receiving Tenofovir Alafenamide and Emtricitabine-based Antiretroviral Therapy (QUANTI-TAF).

BACKGROUND: QUANTI-TAF aimed to establish tenofovir-diphosphate/emtricitabine-triphosphate (TFV-DP/FTC-TP) adherence benchmarks in dried blood spots (DBS) for persons with HIV (PWH) receiving tenofovir alafenamide/emtricitabine (TAF/FTC)-based antiretroviral therapy (ART). METHODS: During a 16-week pharmacokinetic study, PWH received TAF/FTC-based ART co-encapsulated with an ingestible sensor to directly measure cumulative (enrollment to final visit) and 10-day adherence. At monthly visits, intraerythrocytic concentrations of TAF/FTC anabolites (TFV-DP/FTC-TP) in DBS were quantified by LC-MS/MS and summarized at steady-state (week 12 or 16) as median (IQR). Linear mixed-effects models evaluated factors associated with TFV-DP/FTC-TP. RESULTS: 84 participants (86% male, 11% female, and 4% transgender), predominantly receiving bictegravir/TAF/FTC (73%) enrolled. 92% completed week 12 or 16 (94% receiving unboosted ART). TFV-DP for <85% (7/72), ≥85%-<95% (9/72), and ≥95% (56/72) cumulative adherence was 2696 (2039-4108), 3117 (2332-3339), and 3344 (2605-4293) fmol/punches. All participants with ≥85% cumulative adherence had TFV-DP ≥1800 fmol/punches. Adjusting for cumulative adherence, TFV-DP was higher with boosted ART, lower BMI, and in non-Blacks. FTC-TP for <85% (14/77), ≥85%-<95% (6/77), and ≥95% (57/77) 10-day adherence was 3.52 (2.64-4.48), 4.58 (4.39-5.06), and 4.96 (4.21-6.26) pmol/punches. All participants with ≥85% 10-day adherence had FTC-TP ≥2.5 pmol/punches. Low-level viremia (HIV-1 RNA ≥20-<200 copies/mL) occurred at 60/335 (18%) visits in 33/84 (39%) participants (range: 20-149 copies/mL), with similar TFV-DP (3177 [2494-4149] fmol/punches) compared with HIV-1 RNA <20 copies/mL visits (3279 [2580-4407] fmol/punches). CONCLUSIONS: We propose PK-based TFV-DP (≥1800 fmol/punches)/FTC-TP (≥2.5 pmol/punches) benchmarks in DBS for PWH receiving unboosted TAF/FTC-based ART with ≥85% adherence. In the setting of high adherence, low-level viremia was common.

Role of bicarbonate supplementation on urine uric acid crystals and diabetic tubulopathy in adults with type 1 diabetes.

Uricosuria and crystallization are increasingly recognized risk factors for diabetic tubulopathy. This pilot clinical trial aimed to determine the acute effect of urinary alkalinization using oral sodium bicarbonate (NaHCO3 ) on UA crystals in adults with type 1 diabetes (T1D). Adults with T1D, ages 18 to 65 years (n = 45, 60% female, HbA1c, 7.5 ± 1.2%, 20.2 ± 9.3 years duration) without chronic kidney disease (eGFR ≥60 mL/min/1.73 m2 and albumin-to-creatinine ratio < 30 mg/g) received 2 doses of 1950 mg oral NaHCO3 over 24 hours. Fasting urine and serum were collected pre- and post-intervention. UA crystals were identified under polarized microscopy. Urine measurements included: osmolality, pH, UA, creatinine and kidney injury molecule-1 (KIM-1). NaHCO3 therapy increased mean ± SD urine pH from 6.1 ± 0.7 to 6.5 ± 0.7 (P < .0001). Prior to therapy, 31.0% of participants had UA crystals vs 6.7% post therapy (P = .005). Change in urine pH inversely correlated with change in urine KIM-1 (r:-0.51, P = .0003). In addition, change in urine UA over 24 hours correlated with change in urine KIM-1 (r:0.37, P = .01). In conclusion, oral NaHCO3 normalized urine pH and decreased UA crystals, and may hold promise as an inexpensive and safe tubulo-protective intervention in individuals with T1D.

Technosphere insulin (Afrezza): a new, inhaled prandial insulin.

OBJECTIVE: To review the pharmacology, pharmacokinetics, safety, and efficacy of Technosphere insulin (TI), a new inhaled insulin product. DATA SOURCES: Searches were conducted in PubMed/MEDLINE, Scientific Citation Index, and abstracts from both the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) meetings from 2005 to August 2014, utilizing the search terms Afrezza, Technosphere, Afresa, and inhaled insulin. References were reviewed to identify additional sources. STUDY SELECTION AND DATA EXTRACTION: Studies with adequate sample sizes, evaluating clinically relevant end points were included. DATA SYNTHESIS: TI is approved by the Food and Drug Administration as a bolus insulin to treat patients with type 1 and type 2 diabetes. Its glucose-lowering properties are less than that of rapid-acting insulins, but it does demonstrate less hypoglycemia. TI's kinetics make it the fastest absorbed of any insulin available, although its overall onset of action appears similar to insulin lispro. It represents an alternative to bolus injections but would likely be used concomitantly with injected basal insulin. Major adverse effects are respiratory in nature, with cough being the most prominent. There is a small decrease in the forced expiratory volume in 1 s (FEV1) with TI; this appears to be consistent, nonprogressive, and reversible. Patients using TI must receive pulmonary function tests periodically throughout therapy. TI is contraindicated in patients with chronic lung disease and should be used with caution in patients who smoke. CONCLUSION: TI is a novel inhaled insulin that provides prandial coverage to patients with diabetes, representing an alternative to bolus insulin injections.

Frequency of Continuous Glucose Monitoring Use and Change in Hemoglobin A1C for Adults with Type 1 Diabetes in a Clinical Practice Setting.

OBJECTIVE: To estimate the frequency of continuous glucose monitoring (CGM) use and change in hemoglobin A1c (HbA1c) compared to self-monitoring of blood glucose (SMBG) alone in adults with type 1 diabetes in a clinical practice setting. METHODS: We retrospectively identified 66 adult type 1 diabetes patients at the Barbara Davis Center for Diabetes (BDC) who first initiated CGM between 2006 and 2011 and 67 controls using SMBG. The frequency of CGM use was estimated from survey recall and defined as the mean number of days/month of CGM use during a maximum follow-up of 10 months. Change in HbA1c was calculated as the difference between the baseline value and the lowest follow-up value. RESULTS: The mean change in HbA1c for CGM users was -0.48% (95% confidence interval [CI]: -0.67, -0.28) and for SMBG users was -0.37% (95% CI: -0.56, -0.18). The between-group mean difference in change in HbA1c, adjusted for patient characteristics, was -0.11% (95% CI: -0.38, 0.16), whereas the subgroup with a baseline HbA1c ≥7.0% and users of CGM ≥21 days/month was -0.36% (95% CI: -0.78, 0.05). Nearly half (n = 32, 48%) used CGM <21 days/month. The reasons for low frequency of CGM use or discontinuation included sensor costs, frequency of alarms, inaccuracy, and discomfort. CONCLUSIONS: These CGM data from clinical practice suggest a trend toward decreasing HbA1c for adults with type 1 diabetes, especially in patients with higher baseline HbA1c and higher frequency of CGM use. Future studies are needed to assess the use of CGM in larger populations of clinical practice adult type 1 diabetes patients.

Association between continuous glucose monitoring metrics and clinical outcomes in adults with type 1 diabetes in a real-world setting.

AIMS: Continuous glucose monitoring (CGM) metrics can assist diabetes management. Consensus statements recommend > 70 % time in range (TIR) and ≤ 36 % glucose coefficient of variation (CV). However, how these targets perform in clinical practice is unknown. This retrospective, longitudinal cohort study analyzed relationships between TIR, CV, glycated hemoglobin (HbA1c), and hypoglycemia in a real-world setting. METHODS: Data of 542 adults with type 1 diabetes who used CGM (January 2014-July 2020) were analyzed. Associations between TIR and HbA1c at the same and subsequent visits, incidence rate ratios (IRRs) for hypoglycemia at different CVs, and number of hypoglycemic events at cross-sections of HbA1c and CV were estimated by regression. RESULTS: TIR was inversely related to HbA1c; for every 10 % increase in TIR, HbA1c was significantly reduced by 0.34 % (4 mmol/mol) and 0.20 % (2 mmol/mol) at the same and subsequent visits, respectively. Level 2 hypoglycemia was significantly reduced at CV < 30 %, 30-33 %, 33.1-36 %, and 36.1-40 %: adjusted IRRs vs CV ≥ 40.1 % of 0.14, 0.28, 0.32, and 0.50, respectively. Hypoglycemic events were reduced at lower CV across HbA1c levels and at higher HbA1c across CV levels. CONCLUSION: This study quantifies HbA1c improvements with increased TIR and hypoglycemia reductions with improved CV in clinical practice.

Cost-effectiveness of continuous glucose monitoring and intensive insulin therapy for type 1 diabetes.

BACKGROUND: Our objective was to determine the cost-effectiveness of Continuous Glucose Monitoring (CGM) technology with intensive insulin therapy compared to self-monitoring of blood glucose (SMBG) in adults with type 1 diabetes in the United States. METHODS: A Markov cohort analysis was used to model the long-term disease progression of 12 different diabetes disease states, using a cycle length of 1 year with a 33-year time horizon. The analysis uses a societal perspective to model a population with a 20-year history of diabetes with mean age of 40. Costs are expressed in $US 2007, effectiveness in quality-adjusted life years (QALYs). Parameter estimates and their ranges were derived from the literature. Utility estimates were drawn from the EQ-5D catalogue. Probabilities were derived from the Diabetes Control and Complications Trial (DCCT), the United Kingdom Prospective Diabetes Study (UKPDS), and the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Costs and QALYs were discounted at 3% per year. Univariate and Multivariate probabilistic sensitivity analyses were conducted using 10,000 Monte Carlo simulations. RESULTS: Compared to SMBG, use of CGM with intensive insulin treatment resulted in an expected improvement in effectiveness of 0.52 QALYs, and an expected increase in cost of $23,552, resulting in an ICER of approximately $45,033/QALY. For a willingness-to-pay (WTP) of $100,000/QALY, CGM with intensive insulin therapy was cost-effective in 70% of the Monte Carlo simulations. CONCLUSIONS: CGM with intensive insulin therapy appears to be cost-effective relative to SMBG and other societal health interventions.

Comparative effectiveness research in DARTNet primary care practices: point of care data collection on hypoglycemia and over-the-counter and herbal use among patients diagnosed with diabetes.

BACKGROUND: The Distributed Ambulatory Research in Therapeutics Network (DARTNet) is a federated network of electronic health record (EHR) data, designed as a platform for next-generation comparative effectiveness research in real-world settings. DARTNet links information from nonintegrated primary care clinics that use EHRs to deliver ambulatory care to overcome limitations with traditional observational research. OBJECTIVE: Test the ability to conduct a remote, electronic point of care study in DARTNet practices by prompting clinic staff to obtain specific information during a patient encounter. RESEARCH DESIGN: Prospective survey of patients identified through queries of clinical data repositories in federated network organizations. On patient visit, survey is triggered and data are relinked to the EHR, de-identified, and copied for evaluation. SUBJECTS: Adult patients diagnosed with diabetes mellitus that scheduled a clinic visit for any reason in a 2-week period in DARTNet primary care practices. MEASURES: Survey on hypoglycemic events (past month) and over-the-counter and herbal supplement use. RESULTS: DARTNet facilitated point of care data collection triggered by an electronic prompt for additional information at a patient visit. More than one-third of respondents (33% response rate) reported either mild (45%) or severe hypoglycemic events (5%) in the month before the survey; only 3 of those were also coded using the ICD-9 (a significant difference in detection rates 37% vs. 1%). Nearly one-quarter of patients reported taking an OTC/herbal, 4% specifically for the treatment of symptoms of diabetes. CONCLUSIONS: Prospective data collection is feasible in DARTNet and can enable comparative effectiveness and safety research.

Improved glycemic control in intensively treated adult subjects with type 1 diabetes using insulin guidance software.

BACKGROUND: Management of type 1 diabetes could be significantly improved with the availability of computerized insulin algorithms for home use. METHODS: This was a 1-year open label randomized control trial involving 123 adult subjects with type 1 diabetes (hemoglobin A1c values 7.5-11%) assigned to either the insulin guidance software (ACCU-CHEK) [Roche, Indianapolis, IN] Advisor) for personal data assistant (experimental group) or the control group. The primary aim of the study was to see if subjects using insulin dosing advisor software will improve glucose control over 1 year. The principal end point was an improvement in A1c at 6 and 12 months by >or=0.4%. RESULTS: Baseline demographics were similar in the two groups. Mean A1c was 8.54+/-0.11% in the control group and 8.42+/-0.11% (P=0.4265) in the experimental group. The mean A1c was significantly lower from 3 to 12 months in the experimental group (P<0.02). A1c reduction of >or=0.6% was maintained at 12 months in the experimental group. Also, a significantly higher number of subjects achieved A1c <7.5% in the experimental group from 3 to 9 months. Within target range glycemia (70-150 mg/dL) was higher in the experimental group at 3-9 months without any change in insulin dose or weight. Above target range glycemia was lower in the experimental group throughout the study. Frequency of testing per day was higher in the experimental group. Nocturnal hypoglycemia was not different between groups; however, the experimental group experienced more severe hypoglycemic events. CONCLUSIONS: This is the first report that shows improved glycemic control can be maintained over 12 months in patients with type 1 diabetes by using Advisor with no change in insulin dose and weight.

Review of phase 2 studies utilizing the AIR particle technology in the delivery of human insulin inhalation powder versus subcutaneous regular or lispro insulin in subjects with type 1 or type 2 diabetes.

Insulin therapy is underutilized in the treatment of diabetes mellitus for many reasons, including both patient and provider resistance. Targeting postprandial blood glucose control in patients with either type 1 or type 2 diabetes has been demonstrated to improve overall glycemic control, but the reluctance to use injectable insulin demonstrates the need for the development of alternative routes for insulin delivery. The development of inhaled insulin systems was designed to improve the ease of insulin use for patients and help alleviate fears they may have with injectable insulin. Human insulin inhalation powder (HIIP) (Eli Lilly, Indianapolis, IN/Alkermes, Cambridge, MA) has been demonstrated in Phase 2 studies to have similar effects on glycemic profiles compared to both insulin lispro and regular insulin. Hypoglycemia during HIIP was similar to that of regular insulin but was associated with greater hypoglycemic risk compared to insulin lispro. In addition, the AIR Inhaled Insulin system (Lilly/Alkermes), which delivers HIIP, has been demonstrated to be easy to use and requires minimal patient education, which may improve overall medication compliance. Phase 3 studies are ongoing to further evaluate safety and efficacy of HIIP.

Educational practices regarding anticoagulation and dental procedures in U.S. dental schools.

Evidence suggests that stopping oral anticoagulation with warfarin is not necessary in patients requiring low-risk dental procedures and may actually increase thrombosis risk. However, widespread belief remains among dentists that stopping oral anticoagulation for dental procedures is necessary. The purpose of this study was to investigate the teaching practice of U.S. dental faculty responsible for providing education to dental students about anticoagulation. Surveys were mailed in 2003 and 2004 to fifty-five U.S. dental faculties to assess their teaching practice regarding anticoagulation and dental procedures. Twenty-eight (50.9 percent) of the schools returned surveys. Contrary to evidence indicating anticoagulation does not need to be altered, many dental faculty responded that they teach dental students to discuss with medical providers/patients about altering warfarin therapy for several routine procedures: 21.4 percent (cleaning), 14.3 percent (restorative treatment), 46.4 percent (single simple extraction), 64.3 percent (multiple simple extractions), and 17.9 percent (root canal). However, 67.9 percent stated an International Normalized Ratio (INR) of 2.0-3.0 would be acceptable prior to dental procedures. A discrepancy was also found between the number of faculty recommending altering warfarin in intermediate- to high-risk individuals compared to those recommending heparin bridging for the same patients. Overall, this study identified inconsistencies between teaching practices in U.S. dental schools and medical evidence. Dental faculty should consider comparing their teaching material with evidence regarding anticoagulation and dental procedures. Continuing education may be necessary for practicing dentists regarding this topic.

Prevalence of multiple cardiac risk factors in US adults with diabetes.

PURPOSE: The National Cholesterol Education Program, Adult Treatment Panel III (NCEP ATP III) included diabetes mellitus (DM) as a risk factor for major coronary events equivalent to existing coronary heart disease (CHD). This study estimates the national prevalence of additional CHD risk factors for US adults with and without DM and heart disease using Medical Expenditure Panel Survey (MEPS) data. METHODS: In this retrospective study using nationally representative 2000 and 2002 MEPS survey data, DM and CHD for adult respondents (n = 44 481) were identified by ICD-9 codes or self-reported DM, coronary heart disease, angina, heart attack or stroke, or other heart disease. Six additional risk factors assessed were hypertension, hypercholesterolemia, smoking, age (> or = 45 years [men], > or = 55 years [women]), obesity, and physical inactivity. The national prevalence of cardiac risk factors was assessed in four subgroups: CHD-/DM-; CHD-/DM+; CHD+/DM-, CHD+/DM+. RESULTS: The CHD-/DM+ group had significantly higher mean risk factor counts than did the CHD-/DM- group and the CHD+/DM- group (2.6 versus 1.4 and 2.4, respectively; both p < 0.01). The CHD+/DM+ group had the highest mean risk factor count at 3.4. Proportions of US adults in each subgroup with two or more risk factors were CHD-/DM-: 39.5%; CHD-/DM+: 81.9%; CHD+/DM-: 74.9%; CHD+/DM+: 95.1%. Limitations of this study include the use of self-reported data and the lack of data regarding family history of CHD, both of which are likely to result in conservative prevalence estimates. CONCLUSION: Results presented here indicate that diabetes, with or without co-morbid heart disease, is associated with a high prevalence of cardiac risk factors in US adults. The prevalence estimates reported here demonstrate the extensiveness of this public health issue. It is essential that medical providers treat modifiable risk factors in patients with diabetes aggressively with lifestyle modifications and pharmacotherapy consistent with NCEP ATP III recommendations.

The cost effectiveness of anticoagulation management services for patients with atrial fibrillation and at high risk of stroke in the US.

BACKGROUND: Anticoagulation therapy with warfarin is widely considered the standard of care for stoke prophylaxis in patients with atrial fibrillation who are at high risk of stroke. Community-based studies in the US have reported that the effectiveness of anticoagulation varies by management approach and that patients receiving warfarin have international normalised ratio (INR) values within the target therapeutic range less than half the time. OBJECTIVE: To estimate the lifetime societal costs and health benefits of warfarin therapy to prevent strokes, specifically in elderly patients (mean age 70 years) with atrial fibrillation who are at high risk of stroke, when anticoagulation is managed through usual care versus anticoagulation management services, where dedicated anticoagulation professionals (e.g. physician or pharmacist) monitor and oversee patients. METHODS: Semi-Markov decision model with a 30-day cycle length and 10-year time horizon (to reflect the mean life expectancy of the study population). Univariate sensitivity analyses and Bayesian second-order multivariate probabilistic sensitivity analysis using Monte Carlo simulation were performed. Outcomes measures were costs and QALYs. Most of the probability and outcome estimates included were derived from the recent SPORTIF (Stroke Prevention using ORal Thrombin Inhibitor in atrial Fibrillation) V trial. Utility values were derived from a large, nationally representative sample of individuals in the Medical Expenditure Panel Survey and were adjusted for age, sex, race, ethnicity, income, education and co-morbidity. Resource utilisation was based on experience at the University Medicine Group Practice Anticoagulation Clinic (University of Colorado, Denver, CO, USA) and costs ($US; 2004 values) included were for warfarin and aspirin (acetylsalicylic acid) use and those associated with major bleeding, treatment of primary events, routine INR and biochemistry monitoring, ECGs, and clinic visits. Costs and outcomes were discounted by 3% per annum. RESULTS: The anticoagulation management service improved effectiveness by 0.057 (95% credible interval 0, 0.36) QALYs and reduced costs by $US2100 (95% credible interval -$US19,800, $US300) [2004 values] compared with usual care. Results were sensitive to the extent of the increase in risk of primary events (all strokes and systemic embolic events attributable to usual care, but were robust to variation in other input variables). The anticoagulation management service was the dominant strategy in 91% of Monte Carlo simulations. CONCLUSION: The anticoagulation management service appears to cost less and provide greater effectiveness than usual care. To enhance stroke prophylaxis among high-risk patients with atrial fibrillation, physicians and Medicare plans may wish to consider augmenting 'usual care' by the addition of patient-monitoring technology strategies such as formally organised anticoagulation monitoring programmes.

Cardiovascular Outcomes of New Medications for Type 2 Diabetes.

Cardiovascular (CV) disease remains the leading cause of death in people with diabetes, highlighting the importance of using treatment options that do not increase CV risk or possibly decrease CV outcomes. Since 2008, the Food and Drug Administration has required demonstration of CV safety for all new medications developed for the glycemic management of diabetes. Seven trials have been published that have established CV safety for three DPP-4 inhibitors (alogliptin, saxagliptin, and sitagliptin), three GLP-1 receptor agonists (liraglutide, lixisenatide, and semaglutide), and one sodium-glucose cotransporter-2 inhibitor (empagliflozin). Three of those studies also established superiority with liraglutide, empagliflozin, and semaglutide at reducing the composite primary endpoint of major CV events (CV death, nonfatal myocardial infarction, and nonfatal stroke). In addition, one trial found an increase in heart failure hospitalizations with saxagliptin. The findings of these trials must be compared and contrasted cautiously given the differences in patient populations and trial designs, but together they provide important information that can be used to shape our treatment guideline recommendations and patient-specific treatment decisions.

Obesity, insulin resistance, and type 1 diabetes mellitus.

PURPOSE OF REVIEW: To summarize recent studies about obesity, insulin resistance, and type 1 diabetes mellitus (T1DM). RECENT FINDINGS: Overweight and obesity continue to be prevalent among individuals with T1DM. Obesity rates appear to have reached a plateau among children with T1DM in some parts of the world. The risk for development of T1DM is increased by obesity and may occur at an earlier age among obese individuals with a predisposition. Obesity increases the risk for comorbidities among individuals with T1DM, especially metabolic syndrome, and microvascular and macrovascular diseases. Metformin, glucagon-like peptide-1 agonist therapy, sodium glucose cotransporter-2 inhibitor therapy, and bariatric surgery may be beneficial therapies for glucose control, comorbidity management, and obesity among adults with T1DM. Insulin resistance may be improved among obese individuals with T1DM by biguanides (metformin) and glucagon-like peptide-1 agonists (exenatide). SUMMARY: We review the last 18 months of literature on obesity, insulin resistance, and T1DM to highlight new epidemiologic results and treatments.

GLP-1 receptor agonists: a review of head-to-head clinical studies.

Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are attractive options for the treatment of type 2 diabetes (T2D) because they effectively lower A1C and weight while having a low risk of hypoglycemia. The GLP-1 RA class has grown in the last decade with several agents available for use in the US and Europe and several more in development. Since the efficacy and tolerability, dosing frequency, administration requirements, and cost may vary between agents within the class, each agent may offer unique advantages and disadvantages. Through a review of phase III clinical programs for exenatide twice daily, exenatide once weekly, liraglutide, albiglutide, lixisenatide, and dulaglutide, eight head-to-head trials have evaluated the safety and efficacy of GLP-1 RA active comparators. The purpose of this review is to provide an analysis of these trials. The GLP-1 RA head-to-head clinical studies have demonstrated that all GLP-1 RA agents are effective therapeutic options at reducing A1C. However, differences exist in terms of magnitude of effect on A1C and weight as well as frequency and severity of adverse effects.

Association between glycated hemoglobin and health utility for Type 1 diabetes.

OBJECTIVES: Cost-effectiveness models for diabetes link glycated hemoglobin (HbA1c) to diabetes-related complications. Independent of diabetes-related complications, there is little known on the association between HbA1c and health utility scores. This link can alter the cost effectiveness of interventions designed to improve HbA1c. The cross-sectional relationship between HbA1c and health utility scores in adult type 1 diabetes patients was estimated after adjusting for diabetes-related complications. METHODS: The EuroQoL-5 dimension (EQ-5D) questionnaire and an ad hoc survey requesting demographic information and adherence to glucose monitoring therapies was administered to adult type 1 diabetes patients during a clinic visit and combined with clinical medical record data. Health utility scores were derived using the US time-tradeoff valuation of the EQ-5D. Linear regression was used to estimate the relationship between HbA1c and utility, adjusting for treatments, demographics, and diabetes-related complications. RESULTS: Among 176 patients, mean (standard deviation [SD]) age was 38 (12.2) years, duration of disease was 22 (12.1) years, and number of chronic conditions other than type 1 diabetes was 2.7 (2.0). Unadjusted mean (SD) utility was 0.94 (0.09) for those with HbA1c levels <7 % (n = 54), 0.89 (0.15) for those with HbA1c ≥ 7 % (n = 122), and 0.91 (0.14) for all patients. After adjustment, a 1 % absolute increase in HbA1c was associated with a disutility of -0.03 (95 % confidence interval [CI] -0.049, -0.006). CONCLUSIONS: Findings suggest that, after adjusting for diabetes-related complications, higher HbA1c levels are associated with a significant health disutility. Pending additional data from longitudinal studies, these findings could be used in cost-effectiveness evaluations of type 1 diabetes interventions that impact HbA1c.

Further development of pharmacy student-facilitated diabetes management clinics.

OBJECTIVE: To further develop and evaluate a diabetes disease state management (DSM) program that provided direct patient care responsibilities to advanced pharmacy practice experience (APPE) students as members of healthcare teams. DESIGN: Nine new clinics and 3 established sites that provide self-care management education to patients with diabetes were established and maintained in rural Colorado pharmacies and supported by students in APPE training for 48 weeks per year. EVALUATION: The 12 clinics provided 120 APPE student placements in 2010-2011. Students' perceptions of their experiences were positive. Patients who completed the student-supported diabetes self-management education program had improvements in blood glucose, blood pressure, and lipid values. CONCLUSIONS: Twelve diabetes DSM clinics provided direct patient care opportunities to APPE students working as part of healthcare teams while expanding healthcare resources in underserved communities in Colorado.

Physician acceptance of pharmacotherapy recommendations made by pharmacy students in a rural pharmacy-based diabetes care and education clinic.

OBJECTIVE: To assess outcomes from a rural, community pharmacy-based diabetes care and education program involving collaboration between local pharmacists and physicians, fourth-year pharmacy students, and University of Colorado Denver School of Pharmacy faculty members. DESIGN: Fourth-year pharmacy students provided education and testing (hemoglobin A1c, blood glucose, blood pressure, and lipid profiles) to diabetes patients, once a month for 6 months. Clinical notes with medication recommendations were faxed to each patient's physician following each visit. ASSESSMENT: Twelve pharmacy students made 533 recommendations to 29 physicians for 52 patients over 18 months. Overall, 32% of the recommendations were accepted based on subsequent medication orders and patient reports. Three of the physicians accepted 50%-60% of the recommendations they received while 4 did not accept any recommendations. CONCLUSIONS: Physician acceptance of pharmacy students' medication recommendations for patients attending a rural community pharmacy-based diabetes management clinic varied. Further study is needed to determine the reasons for this.

Use of continuous glucose monitoring in patients with type 1 diabetes.

The prevalence of type 1 diabetes continues to increase worldwide at a rate higher than previously projected, while the number of patients achieving American Diabetes Association (ADA) glycated hemoglobin (A1c) goals remains suboptimal. There are numerous barriers to patients achieving A1c targets including increased frequency of severe hypoglycemia associated with lowering plasma glucose as measured by lower A1c values. Continuous glucose monitoring (CGM) was first approved for retrospective analysis and now has advanced to the next step in diabetes management with the approval of real-time glucose sensing. Real-time CGM, in short term studies, has been shown to decrease A1c values, improve glucose variability (GV), and minimize the time and number of hypoglycemic events in patients with type 1 diabetes. These products are approved for adjunctive use to self-monitoring of blood glucose (SMBG), but future long-term studies are needed to document their safety, efficacy, ability to replace SMBG as a tool of monitoring, and ultimately utility into closed-loop insulin delivery systems. New algorithms will need to be developed that account for rapid changes in the glucose values, so that accuracy of the sensor data can be maintained. In addition, for better clinical care and usage, algorithms also need to be developed for both patients and the providers to guide them for their ongoing diabetes care.