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East Renton Highlands, WA, United States

Jarrahian C.,PATH | Zehrung D.,PATH | Saxon E.,PATH | Griswold E.,PATH | Klaff L.,Rainier Clinical Research Center
Procedia in Vaccinology

Several vaccines, diagnostic tests, and medications are currently delivered intradermally, and it is likely that this route of administration will grow in importance. A phase I clinical study was conducted to evaluate the intradermal (ID) adapter, a prototype intradermal delivery aid, for safety and precision of injection. Healthy adult volunteers received two injections each of 0.1. mL of sterile saline solution in the upper deltoid region of the arm using the ID adapter. Injection performance was determined by the proportion of injections delivered to the dermal layer by measuring wheals and fluid leakage, and through ultrasound imaging. Of the 40 study injections, 100% were determined to be successful intradermal injections. Leakage of liquid at the injection site was negligible. Performance was similar with the bevel orientation both upward and downward. Minor bleeding and skin abrasions were the only reported adverse events. Injections were well tolerated based on self-reporting of pain of injection. Based on these results, the ID adapter appears to be safe and effective as an alternative to the Mantoux method of ID delivery for future use in clinical evaluations of ID delivery of vaccines, skin tests, and other drugs. © 2012. Source

Sussman A.,Rainier Clinical Research Center | Taylor E.J.,MassResearch | Patel M.,Abbott Laboratories | Ward J.,Abbott Laboratories | And 3 more authors.
Journal of Diabetes Science and Technology

Background: Patients consider multiple parameters in adjusting prandial insulin doses for optimal glycemic control. Dificulties in calculations can lead to incorrect doses or induce patients to administer fixed doses, rely on empirical estimates, or skip boluses. Method: A multicenter study was conducted with 205 diabetes subjects who were on multiple daily injections of rapid/short-acting insulin. Using the formula provided, the subjects manually calculated two prandial insulin doses based on one high and one normal glucose test result, respectively. They also determined the two doses using the FreeStyle InsuLinx Blood Glucose Monitoring System, which has a built-in, automated bolus calculator. After dose determinations, the subjects completed opinion surveys. Results: Of the 409 insulin doses manually calculated by the subjects, 256 (63%) were incorrect. Only 23 (6%) of the same 409 dose determinations were incorrect using the meter, and these errors were due to either confirmed or potential deviations from the study instructions by the subjects when determining dose with meter. In the survey, 83% of the subjects expressed more confidence in the meter-calculated doses than the manually calculated doses. Furthermore, 87% of the subjects preferred to use the meter than manual calculation to determine prandial insulin doses. Conclusions: Insulin-using patients made errors in more than half of the manually calculated insulin doses. Use of the automated bolus calculator in the FreeStyle InsuLinx meter minimized errors in dose determination. The patients also expressed confidence and preference for using the meter. This may increase adherence and help optimize the use of mealtime insulin. © Diabetes Technology Society. Source

Garg S.K.,Aurora University | Moser E.G.,Aurora University | Bode B.W.,Atlanta Diabetes Associates | Klaff L.J.,Rainier Clinical Research Center | And 3 more authors.
Endocrine Practice

Objective: Peripheral insulin resistance in type 1 diabetes may be related to a paradoxical postprandial glucagon increase. This study evaluated the effects of sitagliptin (dipeptidyl peptidase-IV [DPP-IV] inhibitor, approved for patients with type 2 diabetes), in adults with type 1 diabetes to improve glycemic control through decreasing postprandial glucagon. Methods: This investigator-initiated, double-blind, randomized-parallel 20-week study enrolled 141 subjects. Subjects received sitagliptin 100 mg/day or placebo for 16 weeks. A subset of 85 patients wore blinded continuous glucose monitors (CGM) for 5 separate 7-day periods. The primary outcome was post-meal (Boost™) reduction in 4-hour glucagon area under the curve (AUC). Secondary endpoints included changes in glycated hemoglobin (A1c), CGM data, insulin dose, glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), and C-peptide levels. Results: There were no differences at screening between groups; however, after a 4-week run-in phase, A1c was significantly lower in the sitagliptin vs. placebo group. Post-meal GLP-1 levels were higher (P<.001) and GIP levels lower (P = .03), with glucagon suppression at 30 minutes (LS means 23.2 ± 1.9 versus 16.0 ± 1.8; P = .006) in the sitagliptin group at 16 weeks. There were no differences between the groups in change in A1c, insulin dose, weight, or C-peptide after 16 weeks of treatment. However, C-peptide positive patients randomized to sitagliplin had a non-significant trend toward decrease in A1c, mean glucose, and time spent in hyperglycemia. Conclusion: Sitagliptin use in type 1 diabetes did not change glucagon AUC, A1c, insulin dose, or weight despite post-meal rise in GLP-1 levels. C-peptide positive subjects treated with sitagliptin had a nonsignificant trend in decreasing hyperglycemia, which needs further evaluation. Copyright © 2013 AACE. Source

Garg S.,University of Colorado at Denver | Brazg R.L.,Rainier Clinical Research Center | Bailey T.S.,AMCR Institute Inc. | Buckingham B.A.,Stanford University | And 5 more authors.
Diabetes Technology and Therapeutics

Background: The efficacy of automatic suspension of insulin delivery in induced hypoglycemia among subjects with type 1 diabetes was evaluated. Subjects and Methods: In this randomized crossover study, subjects used a sensor-augmented insulin pump system with a low glucose suspend (LGS) feature that automatically stops insulin delivery for 2 h following a sensor glucose (SG) value ≤70 mg/dL. Subjects fasted overnight and exercised until their plasma glucose (measured with the YSI 2300 STAT Plus™ glucose and lactate analyzer [YSI Life Sciences, Yellow Springs, OH]) value reached ≤85 mg/dL on different occasions separated by washout periods lasting 3-10 days. Exercise sessions were done with the LGS feature turned on (LGS-On) or with continued insulin delivery regardless of SG value (LGS-Off). The order of LGS-On and LGS-Off sessions was randomly assigned. YSI glucose data were used to compare the duration and severity of hypoglycemia from successful LGS-On and LGS-Off sessions and to estimate the risk of rebound hyperglycemia after pump suspension. Results: Fifty subjects attempted 134 sessions, 98 of which were successful. The mean±SD hypoglycemia duration was less during LGS-On than during LGS-Off sessions (138.5±76.68 vs. 170.7±75.91 min, P=0.006). During LGS-On compared with LGS-Off sessions, mean nadir YSI glucose was higher (59.5±5.72 vs. 57.6±5.69 mg/dL, P=0.015), as was mean end-observation YSI glucose (91.4±41.84 vs. 66.2±13.48 mg/dL, P<0.001). Most (53.2%) end-observation YSI glucose values in LGS-On sessions were in the 70-180 mg/dL range, and none was >250 mg/dL. Conclusions: Automatic suspension of insulin delivery significantly reduced the duration and severity of induced hypoglycemia without causing rebound hyperglycemia. © 2012, Mary Ann Liebert, Inc. Source

Rosenstock J.,Dallas Diabetes and Endocrine Center at Medical City | Klaff L.J.,Rainier Clinical Research Center | Schwartz S.,Diabetes and Glandular Disease Research Associates | Northrup J.,Eli Lilly and Company | And 3 more authors.
Diabetes Care

OBJECTIVE - To assess the effects of exenatide on body weight and glucose tolerance in nondiabetic obese subjects with normal or impaired glucose tolerance (IGT) or impaired fasting glucose (IFG). RESEARCH DESIGNANDMETHODS - Obese subjects (n = 152; age 46 ± 12 years, female 82%, weight 108.6 ± 23.0 kg, BMI 39.6 ± 7.0 kg/m2, IGT or IFG 25%) were randomized to receive exenatide (n = 73) or placebo (n = 79), along with lifestyle intervention, for 24 weeks. RESULTS - Exenatide-treated subjects lost 5.1 ± 0.5 kg from baseline versus 1.6 ± 0.5 kg with placebo (exenatide - placebo, P < 0.001). Placebo-subtracted difference in percent weight reduction was -3.3 ± 0.5% (P < 0.001). Both groups reduced their daily calorie intake (exenatide, -449 cal; placebo, -387 cal). IGT or IFG normalized at end point in 77 and 56% of exenatide and placebo subjects, respectively. CONCLUSIONS - Exenatide plus lifestyle modification decreased caloric intake and resulted in weight loss in nondiabetic obesity with improved glucose tolerance in subjects with IGT and IFG. © 2010 by the American Diabetes Association. Source

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