CRO to Incorporate DEXCOM's Continuous Glucose Monitoring "CGM" Technology In the GlucoGuard Multi Patient Study
Del 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.
The 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. During this Study DEXCOM's CGM will be utilized as the monitoring technology to determine Glucose levels.
Glucoguard'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. GlucoGuard'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 Arete Bioscience team. "After extensive research we have devised a plan with a global Contract Research Organization that has the technical know-how and access to patients in order to fulfill the FDA request," commented ADHC. "We expect to begin the Patient Studies in the near term pending normal scheduling issues."
Additionally, This Global CRO will open doors for international expansion of the GlucoGuard technology primarily into China and India.
Global Expansion initiatives have been very well received and the company is seeking to expand via joint venture, licensing for upfront fees and royalites. More Information and details on our global expansion initiative and Human Patient Studies will be forthcoming.
Contact: Phone: 817-525-0057 www.GlucoGuardSleep.com www.UniversalWellnessAI.com John Cacchioli, CEO American Diversified Holdings Corporation Telephone: (212) 537-5900 Email: JC@American-Diversified.com Social Media: Twitter: @ADHCManagement (This Twitter page is the only official Twitter page for ADHC.)
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