Clinical trial NCT04621656: Sugar Challenge Study
Official title: Sugar Challenge Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Pre-Diabetes
Healthy
Lead sponsor: January, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-09
Enrollment: 1022
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of percent of total time monitored that blood glucose is in range 70-180 mg/dL
timeFrame: 10 Continuous Days
Secondary outcomes:
measure: Assessment of change in the mean daily fasting glucose
timeFrame: 10 days
measure: Assessment of change in the mean daily postprandial glucose levels
timeFrame: 10 days
measure: Assessment of change in the mean daily total caloric intake
timeFrame: 10 days
measure: Assessment of change in the daily number of meals consumed
timeFrame: 10 days
measure: Assessment of micro and macronutrients of meals consumed through manual food logging.
timeFrame: 10 days
measure: Assessment of change in the daily caloric composition of meals consumed through manual food logging.
timeFrame: 10 days
measure: Assessment of change in physical activity as measured by heart rate monitor coupled to participant logs.
timeFrame: 10 days
measure: Assessment of change in sleep quality and pattern as measured by heart rate monitor coupled to participant logs.
timeFrame: 10 days
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: January, Inc.
state: California
Study officials:
References: