In this trends report, contract research organization Vedic Lifesciences analyzes trends in blood sugar clinical studies.
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Vedic Lifesciences is a contract research organization based in Mumbai, India. We recently analyzed trends in clinical trials on conditions associated with blood sugar. We’re providing this in-depth assessment of 83 studies related to blood sugar, glucose, and diabetes. Our analysis outlines key trends in trial design, including the demographics of study participants, study duration and sample size, and types of tools being used to conduct these studies.
To conduct our analysis, we examined the clinical trials posted over the last six years on clinical trial registry www.clinicaltrials.gov whose outcome measures related to blood sugar. The keywords we searched for were [start ital] diabetes, sugar, and glucose [end ital]. Our decision to analyze a clinical trial registry was made because a clinical trial registry provides more current data, including data on studies that are not yet published but that are in progress.
Our findings should interest a broad range of industry professionals, including: 1) clinical trial managers, chief scientific officers, medical directors, and personnel involved in designing or executing clinical studies; 2) marketing and communications managers who need to identify new studies to support their customer needs; and 3) CEOs, general managers, and senior directors who influence decisions about study design and research budgets.
Here are the filters we used in our analysis:
Our analysis reveals a dynamic landscape of trends within blood sugar–management studies, emphasizing the need for tailored approaches in study design and execution. Researchers should consider the diverse biomarkers available for assessment and align these with specific study objectives to achieve more meaningful trial outcomes.
Figure 1 indicates the status of all of the 83 studies included in our analysis.
Which populations do researchers target while designing blood sugar studies? The gender of volunteers does not appear to play a major role. As shown in Figure 2, most clinical trials for blood sugar–related claims include all genders because study sponsors want to be able to claim efficacy in a generalized population. However, while blood sugar disorders are not vastly different in men and women, certain factors impact women specifically, such as the status of postmenopausal bone health, enhanced recovery after surgery for caesarean section, or neonatal blood glucose status.
These are some of the population types that blood sugar studies address:
Vedic Lifesciences recommends a nuanced approach for supplement studies within the dynamic landscape of blood sugar management research. Specifically, consider directing your focus towards prediabetic or borderline-diabetic individuals to enhance the effect size and relevance of your findings. This strategic adjustment, rather than exclusively targeting completely healthy individuals, can offer a more comprehensive understanding of a supplement’s efficacy and effect size.
Precision Demographic Targeting: Concentrate on individuals at the prediabetic or borderline-diabetic stage who have heightened sensitivity to the intervention, potentially magnifying observed effects.
Confirmation Tests: To validate the prediabetic status of participants, Vedic Lifesciences advises the inclusion of essential diagnostic tests:
Figure 3 illustrates how blood sugar studies differ in terms of duration. Most studies had a duration of 5-12 weeks. The second most common duration was 21-50 weeks. Cumulatively, more than 50% of the total studies had a duration of under 6 months.
Longer treatment durations are ideal in that they often yield more substantial effect sizes; however, the commercial aspirations of brands can impact the decision of how long a study should be. Ideally, a more extended treatment duration allows for a comprehensive evaluation of a product’s impact on blood sugar management. This extended observation period facilitates a thorough understanding of sustained effects and potential long-term benefits. Market dynamics, however, sometimes demand quicker substantiation of health claims. Brands are often inclined to demonstrate efficacy within shorter time frames to align with consumer expectations and to capitalize on immediate market opportunities.
Studies in the 5-12 week range are most common in blood sugar research. This duration, spanning 1.1 to 2.7 months, strikes a balance between the opportunity to acquire meaningful insights and meeting the constraints of commercial timelines.
This delicate balance between scientific rigor and market urgency presents both challenges and opportunities. Researchers must navigate this landscape strategically, ensuring studies align with industry expectations while maintaining scientific integrity.
Brands and researchers must consider the strategic positioning of their studies. Shorter studies serve as initial validations, while longer-term investigations may follow to bolster claims and enhance the product’s market standing.
Note about Figure 3: This figure excludes 22 of the 83 studies. Two studies were terminated and withdrawn. Of the 83 studies, 20 studies were done under 24 hours as area-under-the-curve studies (insulin, glucose, paracetamol, etc.). Hence, Figure 3 reflects data on only the remaining 61 qualified studies.
Figure 4 sheds light on the number of subjects in studies. It reflects 1) the final number of participants who completed those trials (in the case of completed studies), or 2) the target sample size (in the case of not-yet-completed studies).
Let’s take a look at some of the smaller studies (studies with a sample size of less than 50). More than half of blood sugar management studies are done with fewer than 50 participants. Take these two studies, for instance:
Some of the larger studies (with more than 100 subjects) focus on claim areas like area-under-the-blood-glucose-and-insulin curve for type 2 diabetes patients, HbA1c, BMI in people with risk of diabetes, decreased gastrointestinal symptoms, increased time in glucose range, and decreased time in hyperglycemic range in type 2 diabetes and GI-symptomatic patients. Examples of larger studies include:
A noteworthy trend has emerged—an inclination towards smaller sample sizes, meaning predominantly fewer than 50 participants. This approach may stem from logistical ease, cost considerations, or an emphasis on rapid study completion.
While smaller sample sizes may expedite studies, however, they often fall short in providing statistically significant results. This compromises the reliability and generalizability of findings, potentially impacting the credibility of the research.
This raises an imperative consideration: What is the ideal sample size for robust and impactful studies?
A more robust approach is to consider a minimum sample size of at least 100 subjects. This threshold enhances a study’s statistical power, allowing for more reliable detection of meaningful trends and effects.
*Blood glucose level, insulin, HbA1c, HOMA-IR, and serum insulin concentration stand out as crucial biomarkers extensively used in studies.
*Considering the impact of elevated blood sugar levels on overall well-being, it is advisable to carefully select your questionnaire to align with the potential influence on quality of life.
*The current trend involves incorporating continuous glucose monitoring (CGM) devices in research studies for precise data collection when comparing against a placebo.
References
About the Author
Deborah Affonso oversees marketing at Vedic Lifesciences, a contract research organization (CRO) based in Mumbai, India. With a bachelor’s degree in biochemistry and botany, Affonso is entering the field with enthusiasm and a solid academic background. Although new to the industry, she is eager to apply her knowledge and embark on a career in sales and marketing within the nutraceutical and pharmaceutical sector.
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