Type 2 DiabetesNCT04621656
Sugar Challenge Study
An observational study of Type 2 Diabetes and Pre-Diabetes, run by January, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Pre-Diabetes, Healthy
- What is being tested?
- January Mobile Application (Sugar AI)
- How many people
- 1,022 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to Oct 2021
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals that volunteer for study through web-based advertisement. Includes predefined sub-populations of healthy individuals, pre-diabetes, and Type 2 Diabetes.
Who may be able to join
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Pre-Diabetes, Healthy
- Being tested
- January Mobile Application (Sugar AI)
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
January Mobile Application (Sugar AI)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: January Mobile Application (Sugar AI) | |
| 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%. Receives: Combination Product: January Mobile Application (Sugar AI) | |
| 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%. Receives: Combination Product: January Mobile Application (Sugar AI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 Continuous Days
Secondary outcomes (8)
Assessment of change in the mean daily fasting glucose
Measured: 10 days
Assessment of change in the mean daily postprandial glucose levels
Measured: 10 days
Assessment of change in the mean daily total caloric intake
Measured: 10 days
Assessment of change in the daily number of meals consumed
Measured: 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
Measured: 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.
Measured: 10 days
Assessment of change in physical activity as measured by heart rate monitor coupled to participant logs.
Measured: 10 days
Assessment of change in sleep quality and pattern as measured by heart rate monitor coupled to participant logs.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Nov 2017
- Primary completion6 Jul 2020
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,022 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- January, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621656
- Sponsor's protocol ID
- 1280111
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To inform participant and primary care physician of abnormal CGM levels.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugar Challenge Study
- ClinicalTrials.gov ID
- NCT04621656
- Acronym / sponsor ID
- 1280111
- Conditions
- Type 2 Diabetes, Pre-Diabetes, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,022 participants (actual)
- Lead sponsor
- January, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- Oct 2021 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | – | Combination Product: January Mobile Application (Sugar AI)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. |
| Pre-Diabetes | – | Combination Product: January Mobile Application (Sugar AI)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%. |
| Healthy | – | Combination Product: January Mobile Application (Sugar AI)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%. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals that volunteer for study through web-based advertisement. Includes predefined sub-populations of healthy individuals, pre-diabetes, and Type 2 Diabetes.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Healthy, Pre-Diabetes, Type 2 Diabetes |
Primary outcome
Assessment of percent of total time monitored that blood glucose is in range 70-180 mg/dL
Time frame: 10 Continuous Days
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.
8 secondary outcomes
Assessment of change in the mean daily fasting glucose
Time frame: 10 days
Assessment of change in the mean daily postprandial glucose levels
Time frame: 10 days
Assessment of change in the mean daily total caloric intake
Time frame: 10 days
Assessment of change in the daily number of meals consumed
Time frame: 10 days
Assessment of micro and macronutrients of meals consumed through manual food logging.
Time frame: 10 days
Assessment of change in the daily caloric composition of meals consumed through manual food logging.
Time frame: 10 days
Assessment of change in physical activity as measured by heart rate monitor coupled to participant logs.
Time frame: 10 days
Assessment of change in sleep quality and pattern as measured by heart rate monitor coupled to participant logs.
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: Yes. To inform participant and primary care physician of abnormal CGM levels.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Pre-Diabetes, run by January, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of percent of total time monitored that blood glucose is in range 70-180 mg/dL (time frame: 10 Continuous Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.