Sugar Challenge Study

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.

Study Overview

• Status: Unknown
• Conditions: Healthy; Type 2 Diabetes; Pre-Diabetes
• Intervention / Treatment: Combination product: January Mobile Application (Sugar AI)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1022

Contacts and Locations

Study Locations

• United States
  • California
    • Menlo Park, California, United States, 94025
      • January, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals that volunteer for study through web-based advertisement. Includes predefined sub-populations of healthy individuals, pre-diabetes, and Type 2 Diabetes.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type 2 Diabetes; Individuals that have been previously diagnosed with Type 2 Diabetes. Those with Fasting Blood Glucose levels 126 mg/dL in two separate tests and/or HbA1C values greater than 6.5%. Individuals may take Metformin, SGLT2 inhibitors, of GLP-1 therapeutics. Not including those using Insulin therapeutics.	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.
Pre-Diabetes; Individuals that have been previously diagnosed with Pre-Diabetes. This group may include individuals with pre-diabetes that may be unaware of their condition. HbA1C values between 5.7% and 6.4%.	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.
Healthy; Individuals that have not been previously diagnosed with Metabolic Syndromes including Type 2 Diabetes, obesity, or increased levels of blood sugar. HbA1C values below 5.7%.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change in the mean daily fasting glucose		10 days
Assessment of change in the mean daily postprandial glucose levels		10 days
Assessment of change in the mean daily total caloric intake		10 days
Assessment of change in the daily number of meals consumed		10 days
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
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
Assessment of change in physical activity as measured by heart rate monitor coupled to participant logs.		10 days
Assessment of change in sleep quality and pattern as measured by heart rate monitor coupled to participant logs.		10 days

Collaborators and Investigators

• Sponsor: January, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): July 6, 2020
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 1280111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To inform participant and primary care physician of abnormal CGM levels.
• IPD Sharing Time Frame: 30 Days following 10 day participation
• IPD Sharing Access Criteria: Reporting a notification of abnormal CGM data to participant. Primary care physician has access to CGM glucose values on request.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No