Sugar Challenge Study

January, Inc.

Status: Unknown

Conditions: Healthy; Type 2 Diabetes; Pre-Diabetes

Treatments: Combination Product: January Mobile Application (Sugar AI)

Study type: Observational

Funder types: Industry

Identifiers

NCT04621656

1280111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,022 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,022 participants in 3 patient groups

Type 2 Diabetes

Description:

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.

Treatment:

Combination Product: January Mobile Application (Sugar AI)

Pre-Diabetes

Description:

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%.

Treatment:

Combination Product: January Mobile Application (Sugar AI)

Healthy

Description:

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%.

Treatment:

Combination Product: January Mobile Application (Sugar AI)