Continuous Glucose Monitors Could Modernize Clinical Trials with Remote Data Collection
San Francisco – March 4, 2021 – Diabetes is one of the most prevalent chronic diseases in the world, impacting over 422 million people. In the United States alone, more than 120 million Americans are living with type 2 diabetes (T2D) and prediabetes.
New research published today in JMIR Formative Research shows continuous glucose monitors (CGMs) could modernize T2D clinical trials by using remote data collection. The study – “Medical Food Assessment Using a Smartphone App With Continuous Glucose Monitoring Sensors: Proof-of-Concept Study” – was conducted by scientists at Pendulum Therapeutics.
In the field of T2D research, clinical studies have shown that dietary and behavioral changes can lead to improvements in glucose control. But these studies place a huge burden on participants: they must report to a clinical center – sometimes several times a day – for evaluation and to have their blood drawn. As a result, rigorous trials of dietary interventions are rare which, in turn, limits the body of clinical evidence available to guide T2D treatment. CGMs have been used in clinical studies, but their full potential have not been investigated; for example, they are used only during specific times, such as the beginning and end of the trials.
Within this context, scientists at Pendulum Therapeutics conducted a proof-of-concept trial using CGMs to collect real-world blood glucose data on individuals who consumed a placebo or a product (Pendulum Glucose Control, which is a medical food). In a six week, double-blind, placebo-controlled, 2×2 cross-over pilot study of six individuals, Pendulum scientists also used a custom smartphone app to record food intake, exercise, and alcohol consumption. These data were integrated with CGM data to construct a visual diet log in sync with concurrent glucose levels – all without clinic visits.
With a measurement every 15 minutes for six weeks, study results showed that CGM devices capture a trove of information including unexpected results: in one instance, an unusual spike in blood glucose was detected in a subject who was fasting overnight, a finding that would not have been possible with a finger stick in a clinical setting. Armed with evidence of an overnight spike, researchers could ask the subject if he consumed food later than reported or drank alcohol the night before. By understanding these circumstances and asking the subject to repeat the protocol the following day, researchers could lower variability of the data, resulting in a more precise estimate of the effect of the product or placebo.
In Pendulum’s trial, an average of 3,000 data points per subject were collected across three sensors over 40 days. No adverse events were recorded, and subjects reported general satisfaction with sensor management, the product, and the smartphone app, with an average self-reported satisfaction score of 8.25 out of 10.
In conclusion, the study found CGM devices were well tolerated by the patients; can be used in coordination with other sensors (e.g., smartwatches and mobility data from the smartphone) that could be complementary with little added burden on the patient; can provide high-quality measurements of relevant endpoints; and can enable granular monitoring of subject compliance with low clinical overhead.
About Pendulum Therapeutics
Pendulum Therapeutics believes therapies developed using evidence-based microbiome science and DNA sequencing can help heal the body from within. Armed with 13 patents and 42 pending, the company introduced its flagship product Pendulum Glucose Control, a medical probiotic, in 2020and demonstrated its efficacy in lowering blood sugar spikes and reducing A1C in individuals with T2D taking metformin in a published clinical trial. Founded in 2012 by a diverse team of scientists with deep microbiology, biochemistry, computational, and clinical expertise, Pendulum has raised $57 million to date from Sequoia Capital, True Ventures, Khosla Ventures, AME Cloud Ventures, and Mayo Clinic among others. Pendulum Therapeutics is headquartered in San Francisco.
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