Sugar Challenge Study

Healthy Clinical Trial

Official title:

Sugar Challenge Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04621656
• Other study ID #: 1280111
• Status: Active, not recruiting
• Start date: November 1, 2017
• Est. completion date: October 2021

Study information

• Verified date: November 2020
• Source: January, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a longitudinal study involving use of the January App which collects multiple data streams and employs machine learning techniques to offer personalized lifestyle recommendations and structured food and activity challenges.

Description:

The Sugar Challenge Study is a real-world, longitudinal study aimed at understanding the impact of lifestyle (i.e. food choices, physical activity and sleep patterns), genetics and personalized lifestyle recommendations on blood glucose levels, blood pressure, immune system status, stress hormone levels and microbiome composition. The purpose of this 10-day observational study was to primarily elucidate the impact of food choices, physical activity, and sleep patterns on an individual's blood glucose. In addition, we probed if continuous and personalized feedback to participants would improve glycemic control acutely through better decision making. Multiple investigations may be performed over an indefinite period of time to improve the understanding of these interconnected relationships. For example, we will perform studies to understand an individual's blood glucose response to an oral glucose load or mixed meal. We will also perform studies to determine the phenotype (clinical, metabolic, or immunologic) associated with a particular genotype. The data collected will be analyzed using proprietary machine learning methods.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1022
• Est. completion date: October 2021
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Healthy, have pre-diabetes or metabolic syndrome or type 2 diabetes on metformin or GLP-1 or SGLT-2 therapy

• Have access to smart-phone with NFC reader

• Be willing to wear a continuous glucose monitor (CGM) and a smartwatch 24 hours/day for 10-14 consecutive days at a time

• Be willing to limit swimming to a maximum of 30 minutes per session while wearing CGM

• Available for two in-person or remote study visits (study orientation and close-out)

• Willing to provide weight at baseline and comprehensive logging of their activity, food and water consumption for 10-14 days

• Covered by health insurance plan

• Able and willing to give informed consent for study participation

Exclusion Criteria:

• Use of vitamin C supplements in excess of 200% of the United States Recommended Daily Allowance at least 14 days prior to starting the trial

• Allergy to skin adhesives used in the trial

• Women who are pregnant, lactating, have given birth in the past 6 months, or are planning to get pregnant in the next 6 months

• Individuals deemed unfit for participation by study physician

• Allergy to nuts

• Individuals who are taking any of the following medications:

• Insulin

• Progesterone

• Atypical antipsychotics

• Oral or injectable antidiabetic medications EXCEPT for metformin or Glucagon-like peptide-1 (GLP-1) agonists or Selective sodium-glucose transporter-2 (SGLT-2) inhibitors

• Oral corticosteroid use

• Triphasic oral contraceptives

• Blood thinners

Related Conditions & MeSH terms

• Diabetes Mellitus
• Healthy
• Pre-Diabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Combination Product:
• January Mobile Application (Sugar AI)
Sugar AI is a mobile health and fitness app the allows participants to log and record health-related data through Continuous Glucose Monitors, Heart Rate Monitors, and manual food, water, and activity logging. Using machine learning data science techniques, the Sugar AI App integrates the data collected to personalize lifestyle recommendations and help individuals optimize their health and wellness.

Locations

Country	Name	City	State
United States	January, Inc.	Menlo Park	California

Sponsors (1)

Lead Sponsor	Collaborator
January, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of percent of total time monitored that blood glucose is in range 70-180 mg/dL	The percentage of time an individual remains within a target blood glucose range through the measure of Continuous Glucose Monitor. Ranges defined by the American Diabetes Association (ADA). Current guidelines in range are to 70% of time within 70-180 mg/dL range.	10 Continuous Days
Secondary	Assessment of change in the mean daily fasting glucose		10 days
Secondary	Assessment of change in the mean daily postprandial glucose levels		10 days
Secondary	Assessment of change in the mean daily total caloric intake		10 days
Secondary	Assessment of change in the daily number of meals consumed		10 days
Secondary	Assessment of micro and macronutrients of meals consumed through manual food logging.	Participants will log foods using a proprietary food database consisting of 18M+ items	10 days
Secondary	Assessment of change in the daily caloric composition of meals consumed through manual food logging.	Composition will be calculated based on a cross reference of the logged meal with a proprietary food database to yield caloric contributions of each food item.	10 days
Secondary	Assessment of change in physical activity as measured by heart rate monitor coupled to participant logs.		10 days
Secondary	Assessment of change in sleep quality and pattern as measured by heart rate monitor coupled to participant logs.		10 days