HealthyNCT04529239
Type 2 Diabetes Glucose Biomarker Study With a Continuous Glucose Monitoring System
An observational study of Healthy and Type 2 Diabetes Mellitus, run by Klick Inc. at 1 site in Canada.
Trial summary
Current gold standard methodologies for diagnosing type 2 diabetes (T2D) or prediabetes can be unreliable and inaccurate, and require the need for multiple different tests for comparison. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Healthy, Type 2 Diabetes Mellitus
- What is being tested?
- Abbott Freestyle Libre Pro
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2020to 1 Mar 2022
- 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 60 years
- All sexes
- Adult
Study population: Healthy adults and those at risk of developing prediabetes or type 2 diabetes.
Who may be able to join
- Either male or non-pregnant, non-lactating female aged > 18-60 <years (both inclusive)
- Subjects willing to give written informed consent
- Healthy Volunteers
- Subjects able to comply with the study protocol
- Women of child bearing potential must have a negative urine pregnancy test prior to study entry
- Minimum 4 subjects in each interval of approx 7 years (18-25/26-32/32-38/39-45/46-52/53-59)
- Minimum 40% subjects of one gender to mark relative distribution
Who cannot join
- Any person below the age of 18 years
- Suspected or confirmed pregnancy
- Currently breastfeeding
- Diagnosis of any known chronic or acute medical disease of any kind (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.)
- Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.)
- Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.)
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- Any form of prescription medication
- Use of antibiotics in the three months prior to enrollment
- Any person planning to undergo a Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the duration of the study (as per restrictions of the FreeStyle Libre pro device)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Triple Cohort, Prospective Observational Study to Analyze Type 2 Diabetes Glucose Biomarkers With a Continuous Glucose Monitoring System
Current gold standard methodologies for diagnosing type 2 diabetes (T2D) or prediabetes can be unreliable and inaccurate, and require the need for multiple different tests for comparison. It is possible that a simpler and more refined method of diagnosing T2D or prediabetes involves examining the proportional-integral (PI) control system of the body's glycemic function (i.e., a model of the glucose curve). The purpose of this research is to examine how well a PI model can diagnose nondiabetic, prediabetic, or diabetic patients based on glucose data gathered from a wearable glucose monitoring device.
- Conditions
- Healthy, Type 2 Diabetes Mellitus
- Being tested
- Abbott Freestyle Libre Pro
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott Freestyle Libre ProDevice
Continuous glucose monitoring device to analyze diabetes biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Low to Moderate Risk | The CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk. Receives: Device: Abbott Freestyle Libre Pro | |
| High Risk | The CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk. Receives: Device: Abbott Freestyle Libre Pro | |
| Very High Risk | The CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk. Receives: Device: Abbott Freestyle Libre Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose biomarker data from the continuous glucose monitoring device, which will be analyzed as a function of different homeostasis responses from the 3 different cohorts of individuals (i.e., i) low to moderate risk; ii) high risk, iii) very high risk).
Continuous glucose data from the FreeStyle Libre device will be collected from each individual and analyzed for differences in glucose responses (i.e., "ups" and "downs") across the different study groups.
Measured: The device is worn for 14 days on each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start31 Aug 2020
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klick Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mittal Global Clinical Trial Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529239
- Sponsor's protocol ID
- 036033
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kaufman JM, van Veen L, Fossat Y. Screening for Impaired Glucose Homeostasis: A Novel Metric of Glycemic Control. Mayo Clin Proc Digit Health. 2023 May 24;1(2):189-200. doi: 10.1016/j.mcpdig.2023.02.008. eCollection 2023 Jun.
PubMed 40206722
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple Cohort, Prospective Observational Study to Analyze Type 2 Diabetes Glucose Biomarkers With a Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT04529239
- Acronym / sponsor ID
- 036033
- Conditions
- Healthy, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Klick Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mittal Global Clinical Trial Services
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 27 Aug 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.
Current gold standard methodologies for diagnosing type 2 diabetes (T2D) or prediabetes can be unreliable and inaccurate, and require the need for multiple different tests for comparison. It is possible that a simpler and more refined method of diagnosing T2D or prediabetes involves examining the proportional-integral (PI) control system of the body's glycemic function (i.e., a model of the glucose curve). The purpose of this research is to examine how well a PI model can diagnose nondiabetic, prediabetic, or diabetic patients based on glucose data gathered from a wearable glucose monitoring device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low to Moderate Risk | – | Device: Abbott Freestyle Libre ProThe CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk. |
| High Risk | – | Device: Abbott Freestyle Libre ProThe CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk. |
| Very High Risk | – | Device: Abbott Freestyle Libre ProThe CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy adults and those at risk of developing prediabetes or type 2 diabetes.
Key inclusion criteria (7 listed)
- Either male or non-pregnant, non-lactating female aged > 18-60 <years (both inclusive)
- Subjects willing to give written informed consent
- Healthy Volunteers
- Subjects able to comply with the study protocol
- Women of child bearing potential must have a negative urine pregnancy test prior to study entry
Key exclusion criteria (9 listed)
- Any person below the age of 18 years
- Suspected or confirmed pregnancy
- Currently breastfeeding
- Diagnosis of any known chronic or acute medical disease of any kind (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.)
- Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.)
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 |
|---|---|---|
| Abbott Freestyle Libre ProContinuous glucose monitoring device to analyze diabetes biomarkers. | Device | High Risk, Low to Moderate Risk, Very High Risk |
Primary outcome
Glucose biomarker data from the continuous glucose monitoring device, which will be analyzed as a function of different homeostasis responses from the 3 different cohorts of individuals (i.e., i) low to moderate risk; ii) high risk, iii) very high risk).
Time frame: The device is worn for 14 days on each participant
Continuous glucose data from the FreeStyle Libre device will be collected from each individual and analyzed for differences in glucose responses (i.e., "ups" and "downs") across the different study groups.
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 29 Mar 2022.
- Derived from this study: PubMed 40206722Kaufman JM, van Veen L, Fossat Y. Screening for Impaired Glucose Homeostasis: A Novel Metric of Glycemic Control. Mayo Clin Proc Digit Health. 2023 May 24;1(2):189-200. doi: 10.1016/j.mcpdig.2023.02.008. eCollection 2023 Jun.
- Individual participant dataSharing planned: Undecided
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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 Healthy and Type 2 Diabetes Mellitus, run by Klick Inc. at 1 site in Canada.
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 7 inclusion and 9 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 29 Mar 2022. 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 Canada. 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 biomarker data from the continuous glucose monitoring device, which will be analyzed as a function of different homeostasis responses from the 3 different cohorts of individuals (i.e., i) low to moderate risk; ii) high risk, iii) very high risk). (time frame: The device is worn for 14 days on each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529239, which also lists 1 linked publication.
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 29 Mar 2022.