015 – A Phase 1b/2a Study of a Novel Long-Acting Human Growth Hormone (VRS-317) in Children With...
2
management includes repaglinide, an oral blood glucose-lowering drug, and insulin regimens of mixed insulin and basal/bolus insulin via injection or pump. Complex insulin management is needed for patients on tube feedings. With early diagnosis and treatment, advanced practice nurses and nurses educate patients to maintain aggressive blood sugar control, contributing to a longer life expectancy and improved lung function. Because CFRD worsens the prognosis of cystic fibrosis, nurses and advanced practice nurses must provide emotional support to the patient and family. http://dx.doi.org/10.1016/j.pedn.2014.03.015 013 – Weighing in on Health Literacy: Print Education Materials for Teens With Type 2 Diabetes Carol J. Howe PhD, RN, CDE a , Erin Winterhalter MPH, RD, LDN, CDE b , Judy Ayala LCSW, CDE c a University of Texas at Arlington, Arlington, TX, USA b The MacDonald Center for Obesity Prevention and Education, Villanova University, Villanova, PA, USA c The Diabetes Center for Children, The Children's Hospital of Philadelphia, Philadelphia, PA, USA Background: The increasing incidence of type 2 diabetes in adoles- cence is a public health concern. Aggressive self-management of diabetes decreases the risks of chronic health complications and its resultant burden on health care systems. Adolescents are expected to assume some or all of the responsibility for diabetes self-care. In order to do so, they need accessible and age-appropriate infor- mation about the disease, diet, exercise, medications, and com- plication risks. Most printed materials have been written for the adult patient and fail to address the needs of the adolescent. Pediatric materials have not included curriculum content identified in the national standards for diabetes self-management education by the American Diabetes Association. Purpose: The goal of this project was to create engaging, attractive, adolescent-friendly printed patient education materials for adoles- cents with type 2 diabetes. Description of Project: Materials were designed to be develop- mentally and culturally relevant, and to follow a curriculum to meet national standards. With estimates that 46% of adolescents read below grade level, health literacy was a priority during development of materials; plain language, illustrations, photos, and attention to lay out with more readable fonts and white space were incorporated. Materials were kept at a low cost to reproduce. Learner verification was completed with adolescents to review and provide input on content and presentation. Completed pediatric type 2 education materials include a comprehensive package of materials including a full curriculum type 2 book, brochures on mindless eating, eating out, exercise, transitioning to adult care, and depression & coping. “Challenge Cards” were also developed as conversation starters for providers to present a variety of topics that can be used in group or individual diabetes self-management education classes. Clinical Implications: Age-appropriate printed diabetes education materials support and enhance diabetes self-management education for the adolescent with type 2 diabetes. These materials will be available for download on the institution Website to increase the distribution and use of materials. http://dx.doi.org/10.1016/j.pedn.2014.03.016 014 – Strategies for Improving Patient and Family Education in Diabetes Care Rebecca Thompson BSN, RN, CDE Nemours A.I. duPont Hospital for Children, Wilmington, DE, USA Background: Proper storage, preparation, and administration of insulin help to ensure a reliable dose delivery. Insulin can be delivered in multiple available delivery forms: vial and syringe, disposable pen device, reusable pen device with cartridge, or an insulin pump. Challenges in practice include: Manufacturer recom- mendations vary with insulin brand and type of delivery. Lack of knowledge and/or instruction can lead to inaccurate dose delivery. A change in formulary/preferred brand of insulin can cause patient/ caregiver confusion which negatively impacts dose delivery. Observation and discussions with patients and caregivers reveal that current manufacturer guidelines are not consistently followed. Purpose: The purpose of this activity is improvement in practice by enabling the learner to access current recommendations regarding proper storage of insulin and specific use of insulin delivery devices, and thereby provide optimal care for patients on insulin therapy. Description of Topic: After review of up to date manufacturer prescribing and patient information for storage, preparation and administration of commonly prescribed insulin to pediatric patients, manufacturer guidelines were summarized in two patient teaching tools. Friendly patient educational resources were developed: Top 10 List: Ways To Get The Most From Insulin Therapy and a Quick Reference Guide – Insulin Chart. This included manufacturer Website and phone number, available insulin concentration and volume, minimum and maximum pen dose, recommended pen needle brand, current available insulin delivery forms, and insulin pen use and injection technique guidelines. Clinical Implications: This project will provide access to educational resources for staff, patient and family diabetes education related to proper use of different insulin delivery devices. The overall goal is to enhance the current knowledge base and understanding in health care professionals and their patients and caregivers of the required steps to ensure reliable insulin dose delivery. In the future, the effectiveness of the patient teaching tools will be evaluated and additional resources will be developed based on feedback and need. http://dx.doi.org/10.1016/j.pedn.2014.03.017 Product-Based Research 015 – A Phase 1b/2a Study of a Novel Long-Acting Human Growth Hormone (VRS-317) in Children With Growth Hormone Deficiency Terri Luetjen MSN, RN, CPNP, CCRC a , Shaunna Shortes MSN, RN, FNP-C b , Allison Everett MA, BA, CCRC c , Jane Kennedy RN d , George Bright MD e a Children's Mercy Hospital, Kansas City, MO, USA b Sierra Medical Research, Clovis, CA, USA c Swedish Medical Center, Seattle, WA, USA d University of Minnesota, Minneapolis, MN, USA e Versartis, Inc., Redwood City, CA, USA Background: To prevent extreme short stature and its conse- quences, children with growth hormone deficiency (GHD) take several years of recombinant human growth hormone (rhGH) therapy. Daily injection of rhGH is the only approved therapy for 296 Abstracts of the Pediatric Endocrinology Nursing Society Conference 2014
Transcript of 015 – A Phase 1b/2a Study of a Novel Long-Acting Human Growth Hormone (VRS-317) in Children With...
296 Abstracts of the Pediatric Endocrinology Nursing Society Conference 2014
management includes repaglinide, an oral blood glucose-loweringdrug, and insulin regimens of mixed insulin and basal/bolus insulinvia injection or pump. Complex insulin management is needed forpatients on tube feedings. With early diagnosis and treatment,advanced practice nurses and nurses educate patients to maintainaggressive blood sugar control, contributing to a longer lifeexpectancy and improved lung function. Because CFRD worsensthe prognosis of cystic fibrosis, nurses and advanced practice nursesmust provide emotional support to the patient and family.
http://dx.doi.org/10.1016/j.pedn.2014.03.015
013 – Weighing in on Health Literacy: Print Education Materials forTeens With Type 2 DiabetesCarol J. Howe PhD, RN, CDEa, Erin Winterhalter MPH, RD, LDN, CDEb,
Judy Ayala LCSW, CDEc
aUniversity of Texas at Arlington, Arlington, TX, USAbThe MacDonald Center for Obesity Prevention and Education, Villanova
University, Villanova, PA, USAcThe Diabetes Center for Children, The Children's Hospital of Philadelphia,
Philadelphia, PA, USA
Background: The increasing incidence of type 2 diabetes in adoles-cence is a public health concern. Aggressive self-management ofdiabetes decreases the risks of chronic health complications and itsresultant burden on health care systems. Adolescents are expectedto assume some or all of the responsibility for diabetes self-care. Inorder to do so, they need accessible and age-appropriate infor-mation about the disease, diet, exercise, medications, and com-plication risks. Most printed materials have been written for theadult patient and fail to address the needs of the adolescent.Pediatric materials have not included curriculum content identifiedin the national standards for diabetes self-management education bythe American Diabetes Association.Purpose: The goal of this project was to create engaging, attractive,adolescent-friendly printed patient education materials for adoles-cents with type 2 diabetes.Description of Project: Materials were designed to be develop-mentally and culturally relevant, and to follow a curriculum to meetnational standards. With estimates that 46% of adolescents readbelow grade level, health literacy was a priority during developmentof materials; plain language, illustrations, photos, and attention tolay out with more readable fonts and white space were incorporated.Materials were kept at a low cost to reproduce. Learner verificationwas completed with adolescents to review and provide input oncontent and presentation. Completed pediatric type 2 educationmaterials include a comprehensive package of materials including afull curriculum type 2 book, brochures on mindless eating, eatingout, exercise, transitioning to adult care, and depression & coping.“Challenge Cards” were also developed as conversation starters forproviders to present a variety of topics that can be used in group orindividual diabetes self-management education classes.Clinical Implications: Age-appropriate printed diabetes educationmaterials support and enhance diabetes self-management educationfor the adolescent with type 2 diabetes. These materials will beavailable for download on the institution Website to increase thedistribution and use of materials.
http://dx.doi.org/10.1016/j.pedn.2014.03.016
014 – Strategies for Improving Patient and Family Education inDiabetes CareRebecca Thompson BSN, RN, CDE
Nemours A.I. duPont Hospital for Children, Wilmington, DE, USA
Background: Proper storage, preparation, and administration ofinsulin help to ensure a reliable dose delivery. Insulin can bedelivered in multiple available delivery forms: vial and syringe,disposable pen device, reusable pen device with cartridge, or aninsulin pump. Challenges in practice include: Manufacturer recom-mendations vary with insulin brand and type of delivery. Lack ofknowledge and/or instruction can lead to inaccurate dose delivery. Achange in formulary/preferred brand of insulin can cause patient/caregiver confusion which negatively impacts dose delivery.Observation and discussions with patients and caregivers revealthat current manufacturer guidelines are not consistently followed.Purpose: The purpose of this activity is improvement in practice byenabling the learner to access current recommendations regardingproper storage of insulin and specific use of insulin delivery devices,and thereby provide optimal care for patients on insulin therapy.Description of Topic: After review of up to date manufacturerprescribing and patient information for storage, preparation andadministration of commonly prescribed insulin to pediatric patients,manufacturer guidelines were summarized in two patient teachingtools. Friendly patient educational resources were developed: Top10 List: Ways To Get The Most From Insulin Therapy and a QuickReference Guide – Insulin Chart. This included manufacturerWebsite and phone number, available insulin concentration andvolume, minimum and maximum pen dose, recommended penneedle brand, current available insulin delivery forms, and insulinpen use and injection technique guidelines.Clinical Implications: This project will provide access toeducational resources for staff, patient and family diabeteseducation related to proper use of different insulin delivery devices.The overall goal is to enhance the current knowledge base andunderstanding in health care professionals and their patients andcaregivers of the required steps to ensure reliable insulin dosedelivery. In the future, the effectiveness of the patient teaching toolswill be evaluated and additional resources will be developed basedon feedback and need.
http://dx.doi.org/10.1016/j.pedn.2014.03.017
Product-Based Research015 – A Phase 1b/2a Study of a Novel Long-Acting Human GrowthHormone (VRS-317) in Children With Growth Hormone DeficiencyTerri LuetjenMSN,RN,CPNP,CCRCa,Shaunna ShortesMSN,RN,FNP-Cb,
Allison Everett MA, BA, CCRCc, Jane Kennedy RNd,
George Bright MDe
aChildren's Mercy Hospital, Kansas City, MO, USAbSierra Medical Research, Clovis, CA, USAcSwedish Medical Center, Seattle, WA, USAdUniversity of Minnesota, Minneapolis, MN, USAeVersartis, Inc., Redwood City, CA, USA
Background: To prevent extreme short stature and its conse-quences, children with growth hormone deficiency (GHD) takeseveral years of recombinant human growth hormone (rhGH)therapy. Daily injection of rhGH is the only approved therapy for
297Abstracts of the Pediatric Endocrinology Nursing Society Conference 2014
GHD. A significant fraction of patients have compliance issues withdaily rhGH injections and may lose treatment effects when poorlycompliant. A long-acting rhGH may reduce treatment burden,resolve compliance issues, and improve overall treatment effects.VRS-317 is a novel fusion protein of rhGH with amino acidsequences (XTEN) attached to the N- and C-termini. VRS-317exhibits a prolonged period of action in GHD adults.Aims: To study the safety and efficacy of VRS-317 in pre-pubertalGHD children.Methods: Forty-eight naïve to treatment, prepubertal GHD childreneach received a single subcutaneous dose of VRS-317 at 0.8, 1.2,1.8, 2.7, 4.0 or 6.0 mg/kg (8 subjects per dosing arm). VRS-317plasma concentrations and IGF-I responses were measured over 30days and safety monitored for 60 days.Results: Single doses of VRS-317 were safe and well tolerated. Aminority of children reported related adverse events that were mild(CTCAE Grade 1), transient and of the type expected when childrenfirst receive rhGH. No unexpected or serious adverse eventsoccurred. All patients completed the study. Both drug concentra-tions and IGF-I responses increased in proportion to dose. IGF-Iresponses persisted for up to 30 days. No IGF-I standard deviationscore exceeded 3.0.Conclusions: VRS-317 treatment demonstrated drug exposurepatterns and IGF-I responses suitable for up to once a month dosing.Clinical Implications: A subcutaneous, long-acting growthhormone product with dosing up to once a month could lead toincreased satisfaction and better compliance with the treatmentplan. Less frequent dosing could result in fewer disruptions infamily plans and individual activities.
http://dx.doi.org/10.1016/j.pedn.2014.03.018
016 – Earlier Growth Hormone Treatment Initiation in PediatricPatients With Growth Hormone Deficiency Results in Greater HeightGains Per Dose Over 4 Years of TreatmentBradley S. Miller MD, PhDa, Susan R. Rose MDb, Judith L. Ross MDc,
Peter A. Lee MD, PhDd, RicardoMaamari MDe,
Giuseppe Piccoli PhDe, John A. Germak MDe
aAmplatz Children's Hospital, University of Minnesota, Minneapolis,
MN, USAbCincinnati Children's Hospital Medical Center, University of Cincinnati,
Cincinnati, OH, USAcThomas Jefferson University, Philadelphia, PA, USA
dThe Milton S. Hershey Medical Center, Penn State College of Medicine,
Hershey, PA, USAeNovo Nordisk Inc., Princeton, NJ, USA
Background: Recombinant human growth hormone (GH) is used totreat children with growth failure due to growth hormone deficiency(GHD), either isolated (IGHD) or as part of multiple pituitary hormonedeficiency (MPHD). The American Norditropin Studies: Web-EnabledResearch (ANSWER)Program®, aUS-based registry initiated in 2002, isa long-term, observational study designed to assess the clinical outcomesof real-life treatment of pediatric and adult patients with Norditropin®according to standard clinical practice.Aim: To assess the changes in height standard deviation score(DHSDS) per mean GH dose (mcg/kg/day) over 4 years of GHtreatment (GHT) in pediatric patients with GHD relative to genderand age at treatment start.Methods: A cohort of patients with GHD and 4-year longitudinaldata (N = 682) were stratified by gender and age at treatment start(2–5 years, 5–8 years, 8–11 years and N11 years). DHSDS frombaseline to year 4 and DHSDS/mean daily GH dose (mcg/kg) werecompared between each age group and by gender using ANOVAwith Tukey–Kramer adjustment.Results: Mean baseline HSDS and relative daily GH dose werelowest in the youngest boys (−2.78, 42.86 mcg/kg) and girls(−2.76, 40.37 mcg/kg) and increased with age (oldest boys: −2.03,47.25 mcg/kg; oldest girls: −2.41, 45.45 mcg/kg). The youngestgroup achieved the highest mean DHSDS/GH dose ratio after 4 yearsof GHT (boys: 0.060, girls: 0.059); the oldest group had the lowest(boys: 0.027, girls: 0.033), and the 2 middle groups had intermediatemean DHSDS/GH dose ratios. The youngest patients had the highestmean DHSDS/GH dose ratio over all 4 years (p b 0.03) compared tothe older age groups, except girls in year 3when compared to 5–8 years(p = 0.21). Boys and girls achieved similar height gains per mcg/kgof GH within each age group.Conclusion: Male and female children with GHD achieved greaterheight gains per mcg/kg of GH over a 4-year period when treatmentwas initiated between 2–5 years of age than at older ages.Clinical Implications: Earlier referral and GH treatment initiationin children with GHD is associated with greater height gains permean relative daily GH dose. The complete pharmacoeconomicimpact of this observation remains to be investigated.
http://dx.doi.org/10.1016/j.pedn.2014.03.019
