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American Diversified Holdings Operating Division GlucoGuard Retains Global Contract Research Organization (CRO) to Begin Patient Studies as Required by the FDA
American Diversified Holdings Operating Division GlucoGuard Retains Global Contract Research Organization (CRO) to Begin Patient Studies as Required by the FDA.
About this update from American Diversified Holdings Corp.
[{"type":"text","content":"\r\n\r\n \r\n \r\n American Diversified Holdings Operating Division GlucoGuard Retains Global Contract Research Organization (CRO) to Begin Patient Studies as Required by the FDA\r\n \r\n \r\n\r\n\r\nAmerican Diversified Holdings Operating Division GlucoGuard Retains Global Contract Research Organization (CRO) to Begin Patient Studies as Required by the FDA\r\n\r\n\r\n\r\nNewsfile Corp.\r\n\r\n\r\nNewsfile Corp\r\n\r\n\r\nCRO to Incorporate DEXCOM's Continuous Glucose Monitoring \"CGM\" Technology In the GlucoGuard Multi Patient Study\r\nDel Mar, California--(Newsfile Corp. - April 1, 2026) - American Diversified Holdings Corporation (OTCID: ADHC) announce today that GlucoGuard has retained a internationally recognized Contract Research Organization (CRO) to begin its patient studies to establish safety and efficacy concerns as required by the FDA. The Scope of Work agreement will comply with the FDA's requests to gain approval.\r\nThe FDA had indicated during previous meetings that all criterion were met to approve the BreakThrough Device (BTD) Application. The only remaining concerns were about a sleeping patient potentially aspirating on glucose gel into the buccal cavity. Additionally, the FDA requested a recording of the patient's glucose level before and after the administration of the glucose to determine if the patient would meet end points required, This end point would establish increase the patient's blood glucose from a Hypoglycemic state into the normal range.\r\nDuring this Study DEXCOM's CGM will be utilized as the monitoring technology to determine Glucose levels.\r\nGlucoguard's Medical Advisory Board, led by Dr. Stephen Weber, MD submitted research studies that established positive results on both points in neo-natal patients. Based upon this research coming from highly reputably studies in New Zealand and Ireland the Medical Advisory Board is confident the sleep study will achieve favorable results.\r\nGlucoGuard's previous BTD application included in depth research involving both issues with neo natal patients, adequately establishing both a nominal risk of aspiration and a successful increase in the blood glucose level in newborn babies. Based upon this research it is the opinion of the GlucoGuard team that these two issues can be successfully addressed in the study that will be conducted by Dr. Sur and the ...