HealthySDINCT03612999
Data Acquisition to Model Glycemic Response
A study testing Dexcom continuous glucose monitor, Fitbit activity tracker and Subjects record daily activity in people with Healthy, run by Savvysherpa, Inc. at 1 site in United States.
Trial summary
To learn about individual glycemic response to physiological and psychological conditions across a diverse population, the investigators will collect sensor and lifestyle data directly from participants as they engage in daily activities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dexcom continuous glucose monitor, Fitbit activity tracker and Subjects record daily activity
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2018to 23 Sep 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years old
- Be able to read, speak, and understand English
- Have a primary care provider
Who cannot join
- Not receive or require kidney dialysis
- Not be pregnant
- Not have type 1 diabetes
- Not have type 2 diabetes and be prescribed three or more daily injections of insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Data Acquisition to Model Glycemic Response to Food and Other Events Using Real-Time Continuous Glucose Monitoring (RT-CGM)
To learn about individual glycemic response to physiological and psychological conditions across a diverse population, the investigators will collect sensor and lifestyle data directly from participants as they engage in daily activities. The investigators will collect real-time glucose data from a continuous glucose monitor (CGM) system; accelerometer, aggregated activity, and sleep data from a wrist-worn activity tracker; mood and experiential data; and food information. Non-sensor data will be collected using a paper log, or via a study app when available.
- Conditions
- Healthy
- Being tested
- Dexcom continuous glucose monitor, Fitbit activity tracker, Subjects record daily activity, Subjects record psychological state
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom continuous glucose monitorDevice
Continuous glucose monitors (CGMs) record subjects glucose levels
Fitbit activity trackerDevice
Activity trackers will record subjects' physical activity, heart rate, and sleep.
Subjects record daily activityBehavioural
Subjects will record their daily activities, either on paper or on a secure texting app.
Subjects record psychological stateBehavioural
Subjects will record their psychological state, either on paper or on a secure texting app.
| Study group | Role | What they receive |
|---|---|---|
| CGM and Activity Tracker | Experimental | Subjects receive a continuous glucose monitor (CGM) and activity tracker and are instructed to record daily activities and psychological data. Receives: Device: Dexcom continuous glucose monitor; Device: Fitbit activity tracker; Behavioral: Subjects record daily activity; Behavioral: Subjects record psychological state |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Level (mg./dl.)
Estimated glucose concentration (mg./dl.) sampled every five minutes by a continuous glucose monitor (CGM).
Measured: 20 days per participant
Secondary outcomes (6)
Activity level (steps per hour)
Activity level (steps per hour) as determined from data from wrist-worn accelerometer
Measured: 20 days per participant
Food Consumption (type and quantity)
Food items as described by user in food logs, along with time of consumption.
Measured: 20 days per participant
Activities of daily living (free form)
Participants may log any activity of daily living they choose, including social interactions, house work, and leisure activities. Activities are described by users and logged in interval form with start-time and end-times.
Measured: 20 days per participant
Psychological state (free-form)
Participants may log any psychological information they choose including mood, energy level, or cognitive function. Psychological states are described by users and logged with time or interval in which that psychological state was experienced.
Measured: 20 days per participant
Sensor wear time (wear / no-wear intervals)
Participants will log intervals in which they are and are not wearing the CGM over the course of their participation in the study.
Measured: 20 days per participant
Transmitter life expectancy (number of minutes)
In cases where participants wear sensors until the end of the transmitter's life, the number of minutes transmitter was operational.
Measured: 20 days per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start31 May 2018
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Savvysherpa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612999
- Sponsor's protocol ID
- Pro00022817
- Acronym
- SDI
- Status last verified
- Sep 2020
- First submitted
- 23 Jul 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Acquisition to Model Glycemic Response to Food and Other Events Using Real-Time Continuous Glucose Monitoring (RT-CGM)
- ClinicalTrials.gov ID
- NCT03612999
- Acronym / sponsor ID
- SDI / Pro00022817
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Savvysherpa, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2018 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 2 Aug 2018 (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.
To learn about individual glycemic response to physiological and psychological conditions across a diverse population, the investigators will collect sensor and lifestyle data directly from participants as they engage in daily activities. The investigators will collect real-time glucose data from a continuous glucose monitor (CGM) system; accelerometer, aggregated activity, and sleep data from a wrist-worn activity tracker; mood and experiential data; and food information. Non-sensor data will be collected using a paper log, or via a study app when available.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM and Activity Tracker | Experimental | Device: Dexcom continuous glucose monitor, Device: Fitbit activity tracker, Behavioral: Subjects record daily activity, Behavioral: Subjects record psychological stateSubjects receive a continuous glucose monitor (CGM) and activity tracker and are instructed to record daily activities and psychological data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 18 years old
- Be able to read, speak, and understand English
- Have a primary care provider
Key exclusion criteria (4 listed)
- Not receive or require kidney dialysis
- Not be pregnant
- Not have type 1 diabetes
- Not have type 2 diabetes and be prescribed three or more daily injections of insulin
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 |
|---|---|---|
| Dexcom continuous glucose monitorContinuous glucose monitors (CGMs) record subjects glucose levels | Device | CGM and Activity Tracker |
| Fitbit activity trackerActivity trackers will record subjects' physical activity, heart rate, and sleep. | Device | CGM and Activity Tracker |
| Subjects record daily activitySubjects will record their daily activities, either on paper or on a secure texting app. | Behavioural | CGM and Activity Tracker |
| Subjects record psychological stateSubjects will record their psychological state, either on paper or on a secure texting app. | Behavioural | CGM and Activity Tracker |
Primary outcome
Glucose Level (mg./dl.)
Time frame: 20 days per participant
Estimated glucose concentration (mg./dl.) sampled every five minutes by a continuous glucose monitor (CGM).
6 secondary outcomes
Activity level (steps per hour)
Time frame: 20 days per participant
Food Consumption (type and quantity)
Time frame: 20 days per participant
Activities of daily living (free form)
Time frame: 20 days per participant
Psychological state (free-form)
Time frame: 20 days per participant
Sensor wear time (wear / no-wear intervals)
Time frame: 20 days per participant
Transmitter life expectancy (number of minutes)
Time frame: 20 days per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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?
A study testing Dexcom continuous glucose monitor, Fitbit activity tracker and Subjects record daily activity in people with Healthy, run by Savvysherpa, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 17 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose Level (mg./dl.) (time frame: 20 days per participant). 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 17 Mar 2021.