Endocrine Research Solutions (United States)

IntroductionThis study evaluated 6-month effectiveness and safety of automated insulin delivery (AID) in comparison with multiple daily injections (MDI) in pediatric and adult type 1 diabetes (T1D).Materials and methodsIndividuals with T1D, aged 2–80 years, were enrolled across 32 international centers (in the United States, Europe, Canada, and New Zealand) and randomized 1:1 to AID intervention (MiniMed™ 670G or 770G system) or MDI with or without continuous glucose monitoring. Primary endpoints were change in mean HbA1c for participants with a baseline HbA1c >8.0% (Group 1) and percentage of time spent below 70 mg/dL (%TBR <70 mg/dL [<3.9 mmol/L]) for participants with baseline HbA1c ≤8.0% (Group 2), to show superiority of AID intervention versus MDI. Safety endpoints including rates of severe hypoglycemia and diabetic ketoacidosis (DKA), and difference in diabetes treatment satisfaction score were assessed.ResultsFor Group 1, N = 56 participants (aged 29.4 ± 17.0 years) were randomized to AID intervention and N = 54 participants (aged 36.8 ± 19.6 years) were randomized to MDI. For Group 2, N = 73 (aged 37.4 ± 21.0 years) and N = 69 (aged 39.2 ± 19.3 years), respectively, were randomized to AID and MDI. Change in HbA1c (mean [95% CI] difference of −0.7% [−1.1, −0.3], P = 0.0002) and difference in %TBR <70 mg/dL (4.8% [−6.4, −3.1], P<0.001) favored AID intervention versus MDI. Rates of severe hypoglycemia (AID: 1.82/100 patient-years) and DKA (MDI: 3.52/100 patient-years) were low and met preestablished success criteria for safety.DiscussionThis large, international, multicenter randomized controlled trial demonstrates safety of the MiniMed™ 670G/770G systems. AID significantly improved HbA1c and time spent in hypoglycemia when compared with MDI, in both youth and adults living with T1D.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT02748018.

To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus. This was a phase 3, multicenter, open-label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks. The primary endpoint was the proportion of participants in each treatment arm who manifested treatment-induced anti-insulin antibodies (AIA). Secondary endpoints included efficacy and safety metrics, changes in glycated haemoglobin levels, and a comparative assessment of adverse events. Results were analysed using an equivalence test comparing the limits of the 90% confidence interval (CI) for treatment-induced AIA development to the prespecified margins. The percentages of participants positive for treatment-induced glycated haemoglobin by week 26 were similar between the GL Glargine (19.2%) and Lantus® (21.3%) treatment groups, with a treatment difference of -2.1 percentage points and a 90% CI (-7.6%, 3.5%) (predefined similarity margins: -10.7%, 10.7%). The difference in glycated haemoglobin was -0.08% (90% CI, -0.23, 0.06). The overall percentage of participants with any treatment-emergent adverse events was similar between the GL Glargine (80.1%) and Lantus® (81.6%) treatment groups. GL Glargine was similar to Lantus® in terms of immunogenicity, efficacy,and safety, based on the current study.

When a database is first created, for a given amount of time, the tables in the database will remain small. Depending on the nature of the data stored in the table or the amount of time that has passed, you may find yourself in a situation where one or more of your tables have experienced a significant amount of growth since the table was first created. There can be many motivations for managing the relative age of the data stored in a table or how data is stored overall. This chapter will focus on organizing your data in a way that can be managed long term. While many companies also have the goal of improving performance when it comes to managing data, that will not be the focus of this chapter.

In the previous chapter, I introduced the concepts of partitioned tables and partitioned views. This chapter continues the discussion on partitions by discussing how to use partition switching. The first section introduces the concept of partition switching. The second section guides you to use all the information you have learned about partition switching to manage data retention and archival.

Various complications of hyperemesis gravidarum and pneumomediastinum have been documented in the literature. Commonly, these cases resolve spontaneously or with the use of antiemetics and supportive care. In rare instances, these symptoms persist into the second trimester and are associated with an increased risk of complications. Herein, we present a case of a healthy 20-year-old female with a history of marijuana use who presented with intractable nausea and vomiting and was found to have multiple rare complications of spontaneous pneumomediastinum.

Periodontal regeneration of lost tissue, including periodontal ligament (PDL), cementum, and bone, has evolved with regard to surgical techniques, biomaterials, and growth factors. Simultaneous orthodontic therapy and periodontal surgical treatment has been documented previously and shown to enhance the regenerative outcome due to stimulation of the PDL by tooth movement. This combined strategy is becoming increasingly common as clinicians explore the capabilities of a collaborative approach. This article presents a case series that documents three cases in which combined orthodontic and surgical procedures were used to enhance the regenerative outcome in challenging clinical scenarios. The article includes a review of the literature and discusses clinical factors related to increasing predictability in such cases.

Free, prior informed consent is a universally acknowledged ethical requirement for research with human participants. In social sciences, informed consent guidelines are mostly critiqued for its inherent universalism and support of the individualised principlist notion of autonomy. Therefore, social science researchers working with rural communities in Africa cannot ignore the values, concepts and theories relevant to collective autonomy. This chapter advocates for an integrated informed consent approach founded on Afro-communitarianism. We argue that the process of obtaining free, prior informed consent is deeply entrenched in cultural values. A one-size-fits-all approach to informed consent is in itself a form of disrespect for those concerned. The significant contribution of the chapter is a comparative analysis of individual and collective autonomy as it pertains to informed consent from two theoretical perspectives, namely principlism and Afro-communitarianism. We hope to encourage social researchers working in these settings to consider an African perspective on how to preserve participant autonomy.