American Diversified Holdings’ GlucoGuard Retains Global CRO for FDA-Required Patient Study

• American Diversified Holdings Corporation announced that its GlucoGuard division has retained a global CRO to begin FDA-required patient studies.

• The multi-patient study will incorporate Dexcom continuous glucose monitoring (CGM) technology to evaluate safety and efficacy endpoints. 

American Diversified Holdings Corporation announced that its GlucoGuard operating division has retained an internationally recognized contract research organization (CRO) to begin patient studies required by the U.S. Food and Drug Administration. The Scope of Work agreement is intended to address remaining FDA requirements and advance the company’s Breakthrough Device pathway. 

According to the announcement, the FDA previously indicated that most criteria for the Breakthrough Device application had been met, with remaining questions focused on potential aspiration risks during sleep and confirmation that glucose delivery could raise patients from hypoglycemic levels to normal ranges. The upcoming multi-patient study will incorporate Dexcom continuous glucose monitoring (CGM) technology to measure glucose levels before and after device use and evaluate study endpoints. 

The company noted that prior research conducted in neonatal patients showed positive outcomes related to both aspiration risk and glucose level improvements. These earlier studies, reviewed by GlucoGuard’s Medical Advisory Board led by Dr. Stephen Weber, MD, are expected to support the design and execution of the upcoming patient trial. The study is expected to be conducted with Dr. Sur and the Arete Bioscience team. 

American Diversified Holdings also indicated that working with a global CRO could support international expansion of the GlucoGuard technology, particularly in markets such as China and India. The company said it is exploring potential joint ventures, licensing arrangements, and commercialization opportunities as clinical development progresses. 

“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. We expect to begin the patient studies in the near term pending normal scheduling issues.” 

ADHC Official Statement