Safety and monitoring
prediabetes, Digestive, musculoskeletal injuries, Diabetes
DIABETES, ADVERSE EVENTS, EVENT, PREDIABETES, KIDNEY DISEASES, ADVERSE EVENT, LACTIC ACIDOSIS, EVENTS
Potential adverse events include musculoskeletal injuries as a consequence of supervised physical activity, lactic acidosis, and loss of confidentiality of prediabetes diagnosis due to a data breach. Every adverse event will be documented, including events that are reported to the study team and/or research associates through means other than those described above. A report will be generated for each event, including a description of the event, when and how it was reported, as well as any official chart records or documentation to corroborate the event and determine its attribution. Any serious adverse events as described above will be reported within 7 days to the outside Data and Safety Monitoring Plan monitor, and to the UCLA or Intermountain IRB as well as the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) program officer. Additionally, safety reports will be submitted to our Data and Safety Monitor every 6 months throughout the study period. Any action resulting in a temporary or permanent suspension of this study (e.g., IRB actions) will be immediately reported to the appropriate NIDDK program official.Institutional Review Board (IRB) approval has been obtained from the UCLA Office of Human Research Protection Program (approval number 20–001558) and from the Intermountain Healthcare IRB (approval number 1051571). This trial is registered at 