First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 3: Porcine islet product manufacturing and release testing criteria

2016 ◽  
Vol 23 (1) ◽  
pp. 38-45 ◽  
Author(s):  
Gina R. Rayat ◽  
Lawrence S. Gazda ◽  
Wayne J. Hawthorne ◽  
Bernhard J. Hering ◽  
Peter Hosking ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Type 1 Diabetes ◽  
Consensus Statement ◽  
Porcine Islet ◽  
Product Manufacturing ◽  
Release Testing ◽  
Testing Criteria

805-P: Barriers and Facilitators of Participation in Clinical Trials among Youth and Young Adults with Type 1 Diabetes and Their Caregivers

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 805-P
Author(s):  
SARAH C. WESTEN ◽  
LINDSAY M. ANDERSON ◽  
SAMANTHA A. BARRY ◽  
SYDNEY LOOK ◽  
STEFANIA PINTO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Type 1 Diabetes ◽  
Young Adults ◽  
Barriers And Facilitators ◽  
Youth And Young Adults

scholarly journals Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e022353 ◽  
Author(s):  
Catherine Henshall ◽  
Parth Narendran ◽  
Robert C Andrews ◽  
Amanda Daley ◽  
Keith A Stokes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Type 1 Diabetes ◽  
Qualitative Study ◽  
Qualitative Methodology ◽  
Cell Function ◽  
Retention Rates ◽  
Newly Diagnosed ◽  
Advance Study ◽  
New Onset

ObjectivesRegular physical exercise may preserve β cell function in newly diagnosed adults with type 1 diabetes (T1D). However, clinical trials to test this theory require the recruitment and retention of adults with new-onset T1D, which can be challenging. We sought to determine the overall experiences of newly diagnosed adults with T1D in an exercise study, to understand issues that influence the retention of trial participants in such studies.DesignQualitative methodology using individual face-to-face (n=6) and telephone interviews (n=14). Interview transcripts were thematically analysed using the framework method.SettingThe study took place at five participating UK hospitals.ParticipantsTwenty participants, aged 19–55 years, in the Exercise for Type 1 Diabetes study were interviewed to explore their study experiences and identify motivators and deterrents towards the study. Participants in control and intervention arms were interviewed, as were people with T1D who had completed (n=16) and withdrawn (n=4).ResultsParticipants revealed barriers and facilitators to retention; the majority were generalisable to clinical trials of people with newly diagnosed T1D. Coming to terms with a diagnosis of T1D, lack of time, work pressures, level of health professional support, volume, clarity and consistency of information and feedback and a desire for knowledge about their condition were all cited as influencing factors to trial retention.ConclusionsTo our knowledge, this is the first qualitative study to examine the experience of being involved in an exercise trial by people with T1D. Findings suggest appointments could be shorter, available outside of working hours and planned longer in advance; study information should be clear, consistent and in electronic and paper formats; questionnaires need minimising; healthcare support and feedback needs providing regularly; thought is required around how to support non-exercising arm participants. These considerations may improve participant retention rates in new-onset T1D studies.

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