Introduction: Innovations with sensor-augmented pump therapy (SAPT) to reduce hypoglycaemia in patients with type 1 diabetes are an ongoing area of research. The predictive low glucose management (PLGM) system incorporates continuous glucose sensor data into an algorithm and suspends basal insulin before the occurrence of hypoglycaemia. The system was evaluated in in-clinic studies, and has informed the parameters of a larger home trial to study its efficacy and safety in real life.
Methods And Analysis: The aim of this report is to describe the study design and outcome measures for the trial. This is a 6-month, multicentre, randomised controlled home trial to test the PLGM system in children and adolescents with type 1 diabetes. The system is available in the Medtronic MiniMed 640G pump as the 'Suspend before low' feature. Following a run-in period, participants are randomised to either the control arm with SAPT alone or the intervention arm with SAPT and Suspend before low. The primary aim of this study is to evaluate the time spent hypoglycaemic (sensor glucose <3.5 mmol/L) with and without the system. The secondary aims are to determine the number of hypoglycaemic events, the time spent hyperglycaemic, and to evaluate safety with ketosis and changes in glycated haemoglobin. The study also aims to assess the changes in counter-regulatory hormone responses to hypoglycaemia evaluated by a hyperinsulinaemic hypoglycaemic clamp in a subgroup of patients with impaired awareness. Validated questionnaires are used to measure the fear of hypoglycaemia and the impact on the quality of life to assess burden of the disease.
Ethics And Dissemination: Ethics committee permissions were gained from respective Institutional Review boards. The findings of the study will provide high quality evidence of the ability of the system in the prevention of hypoglycaemia in real life.
Trial Registration Number: ACTRN12614000510640, Pre-results.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4838718 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2016-011589 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Assessing early therapeutic drug monitoring of adalimumab as a predictor of treatment efficacy and immunogenicity in rheumatic diseases: "early therapeutic drug monitoring of adalimumab".
Clin Rheumatol
January 2025
Department of Public Health, University of Murcia, Campus de Ciencias de la Salud, Murcia, 30120, Spain.
Introduction: Therapeutic drug monitoring (TDM) in inflammatory rheumatic diseases (RMDs) is gaining interest. However, there are unresolved questions about the best practices for implementing TDM effectively in clinical settings.
Objective: The primary objective of this study was to evaluate whether early TDM of adalimumab predicts drug survival at 52 weeks in patients with RMDs.
Utility of Parent and Teacher Behavior Ratings for Self-Regulatory Outcomes of Preschool Children: A Multi-Study Examination.
Res Child Adolesc Psychopathol
January 2025
Department of Psychology and the Florida Center for Reading Research, Florida State University, Tallahassee, FL, USA.
Despite frequent reliance on teacher and parent ratings of children's behavior for multi-informant assessment, agreement between teachers' and parents' ratings is low. This study examined the predictive utility of teacher and parent ratings for children's self-regulatory outcomes (i.e.
View Article and Find Full Text PDFCombined first-trimester screening for preterm small-for-gestational-age infants: Australian multicenter clinical feasibility study.
Ultrasound Obstet Gynecol
January 2025
Discipline of Obstetrics, Gynaecology and Neonatology, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Objective: To assess the performance of the Fetal Medicine Foundation (FMF) first-trimester competing-risks screening model for small-for-gestational-age (SGA) fetuses requiring delivery at < 37 weeks' gestation, in a large cohort of women receiving maternity care in Australia.
Methods: This was a retrospective analysis of prospectively collected data from a cohort of women attending one of two private multicenter fetal medicine practices for first-trimester screening for preterm pre-eclampsia (PE), defined as PE requiring delivery before 37 weeks' gestation. Risk for preterm SGA, defined as SGA requiring delivery before 37 weeks, was calculated but was not disclosed to the patient or referring physician.
Circulating tumor DNA (ctDNA) levels can help predict outcomes in diffuse large B-cell lymphoma (DLBCL), but its integration with DLBCL molecular clusters remains unexplored. Using the LymphGen tool in 77 DLBCL with both ctDNA and tissue biopsy, a 95.8% concordance rate in molecular cluster assignment was observed, showing the reproducibility of molecular clustering on ctDNA.
View Article and Find Full Text PDFPrediction of pre-eclampsia using maternal hemodynamic parameters at 12 + 0 to 15 + 6 weeks.
Ultrasound Obstet Gynecol
January 2025
Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, SAR, China.
Objectives: To compare the maternal hemodynamic profile at 12 + 0 to 15 + 6 weeks' gestation in women who subsequently developed pre-eclampsia (PE) and those who did not, and to assess the screening performance of maternal hemodynamic parameters for PE in combination with the Fetal Medicine Foundation (FMF) triple test, including maternal factors (MF), mean arterial pressure (MAP), uterine artery pulsatility index and placental growth factor.
Methods: This was a prospective case-control study involving Chinese women with a singleton pregnancy who underwent preterm PE screening at 11 + 0 to 13 + 6 weeks' gestation using the FMF triple test, between February 2020 and February 2023. Women identified as being at high risk (≥ 1:100) for preterm PE by the FMF triple test were matched 1:1 with women identified as low risk (< 1:100) for maternal age ± 3 years, maternal weight ± 5 kg and date of screening ± 14 days.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!