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Sugar Challenge Study

NCT ID: NCT04621656

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1022 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Pre-Diabetes Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

January Mobile Application (Sugar AI)

Intervention Type COMBINATION_PRODUCT

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%.

January Mobile Application (Sugar AI)

Intervention Type COMBINATION_PRODUCT

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%.

January Mobile Application (Sugar AI)

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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January, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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January, Inc.

Menlo Park, California, United States

Site Status

Countries

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United States

Other Identifiers

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1280111

Identifier Type: -

Identifier Source: org_study_id