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HealthyNCT03471949

Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

A study testing CGM in a population with normal OGTT in people with Healthy, run by Vastra Gotaland Region.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to obtain reference values of CGM in healthy individuals using the Dexcom G4 sensor and evaluate whether reported low glucose values by the Dexcom G4 sensor are really low when confirmed by capillary testing. 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?
CGM in a population with normal OGTT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
24 Oct 2016to 11 Dec 2018
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

  • Normal oral glucose tolerance test
  • Normal HbA1c value
  • Age of 18 years or older

Who cannot join

  • Known diabetes
  • Known prediabetes
  • Corticosteroid use during the last month
  • Planned corticosteroid use during the study
  • Pregnancy or planned pregnancy during the study period
  • Paracetamol use during the last 2 days
  • Planned paracetamol use during the study
  • Allergy to any adhesives used for CGM or clorhexidine

About this study

Official title: Evaluation of the Profile of Blood Glucose Using Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

The purpose of this study was to obtain reference values of CGM in healthy individuals using the Dexcom G4 sensor and evaluate whether reported low glucose values by the Dexcom G4 sensor are really low when confirmed by capillary testing.

Read the detailed description

Evaluation of the profile of blood glucose using Dexcom G4 in a population with normal oral glucose tolerance test. The investigators have used information from a previous study of 60 participants using Dexcom G4, CGM system. A non-randomized, days 1-7 blinded and days 8-14 non-blinded CGM trial, the study was performed to evaluate the profile of blood glucose using CGM in the population with normal oral glucose tolerance test (OGTT). All enrolled subjects with at least three time-points with evaluable values from CGM system and the reference capillary value obtained from HemoCue during the whole study period were included in the Intent-to-Treat (ITT) population

Conditions
Healthy
Being tested
CGM in a population with normal OGTT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGM in a population with normal OGTTOther

    The population with normal OGTT will use CGM and document their values as well as be documenting a capillary blood glucose value

Study groups in NCT03471949
Study groupRoleWhat they receive
CGM in a population with normal OGTTExperimentalA non-randomized, days 1-7 blinded, and days 8-14 non-blinded Dexcom G4 (CGM) trial. Each subject will sample capillary blood with the HemoCue meter and measure the concentration of glucose, minimum 3 times per day for 14 days.
Receives: Other: CGM in a population with normal OGTT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of time with low CGM values ( blood glucose <4.0 mmol/l)

    Percentage of time with low CGM values, Measured by continuous glucose monitoring (CGM) (<72 mg/dL, <4.0 mmol/L) estimated on days 1-7 when participants used masked CGM.

    Measured: Day 1-7

Secondary outcomes (13)

  1. The percentage of time with low CGM values (blood glucose <3.0 mmol/l)

    Measured by continuous glucose monitoring (CGM) and the percentage of time with low CGM values (<54 mg/dL, <3.0 mmol/L) evaluated on days 1-7

    Measured: Day 1-7

  2. The difference in mean glucose levels between days 1-7 and day 8-14

    Measured by continuous glucose monitoring (CGM) between day 1-7 and 8-14

    Measured: Day 1-7 and day 8-14

  3. The percentage of time with glucose levels in euglycaemic range (72-126 mg/dL)

    Measured by continuous glucose monitoring (CGM) (72-126 mg/dL, 4-7 mmol/L) between day 1-7 and 8-14

    Measured: Day 1-14

  4. The percentage of time with glucose levels in euglycaemic range (72-180 mg/dL)

    Measured by continuous glucose monitoring (CGM) (72-180 mg/dL, 4-10 mmol/L) between day 1-7 and 8-14

    Measured: Day 1-14

  5. The percentage of time with glucose levels in hyperglycaemic range (>198 mg/dL)

    Measured by continuous glucose monitoring (CGM) with high glucose levels (>198 mg/dL, >11 mmol/L) between day 1-7 and 8-14

    Measured: Day 1-14

  6. The percentage of time with glucose levels in hyperglycaemic range (>252 mg/dL)

    Measured by continuous glucose monitoring (CGM) with high glucose (>252 mg/dL, >14 mmol/L) between day 1-7 and 8-14

    Measured: Day 1-14

  7. The Standard Deviation (SD)

    Difference in standard deviation of glucose levels measured by CGM between day 1-7 and day 8-14

    Measured: Day 1-7 and day 8-14

  8. The evaluation of experience of the CGM, glucose monitoring systems.

    Evaluation of the Dexcom G4 system from questionnaire regarding the following questions, 1. The visual analogue scale 1-100 mm. How do you experience the benefits of seeing your daily blood glucose profile with the help of CGM (continuous glucose monitoring)? The evaluation of questions of the Dexcom G4 system were expressed on a 0-100 scale with lowest value (0) equaling to Not rewarding at all and highest value (100) equaling to completely rewarding.

    1. Do you consider the CGM can be a great educational tool for patients who are at risk for getting diabetes? (yes, no)
    2. Can CGM give you a mindset about diet and lifestyle changes? (yes, no)
    3. Can you describe your experiences using CGM?

    Measured: Week 2, day14

  9. Difference in Mean Amplitude of Glycemic Excursions (MAGE)

    Difference in mean amplitude glucose excursion (MAGE) measured by CGM between day 1-7 and 8-14

    Measured: Day 1-7, Day 8-14

  10. Mean Absolute Relative Difference (MARD)

    Mean Absolute Relative Difference (MARD) estimated from HemoCue glucose values and CGM-values from days 1-14.

    Measured: Day 1-14

  11. Mean Absolute Difference (MAD)

    Measured by continuous glucose monitoring (CGM) between day 1-7 and 8-14

    Measured: Day 1-7, Day 8-14

  12. Coefficient of Variation (CV)

    Difference in coefficient of variation measured by continuous glucose monitoring (CGM) between day 1-7 and 8-14

    Measured: Day 1-7, Day 8-14

  13. Pearson correlation coefficient

    Pearson correlation coefficient estimated from HemoCue and CGM glucose values from days 8-14.

    Measured: Day 8-14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2018
  2. Study start24 Oct 2016
  3. Primary completion11 Dec 2018
  4. Study completion11 Dec 2018

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03471949
Sponsor's protocol ID
CGM and healthy population
Status last verified
Apr 2019
First submitted
18 Dec 2017
Last updated
25 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Sofizadeh S, Pehrsson A, Olafsdottir AF, Lind M. Evaluation of Reference Metrics for Continuous Glucose Monitoring in Persons Without Diabetes and Prediabetes. J Diabetes Sci Technol. 2022 Mar;16(2):373-382. doi: 10.1177/1932296820965599. Epub 2020 Oct 26.

    PubMed 33100059

Questions about this trial

What is this clinical trial studying?

A study testing CGM in a population with normal OGTT in people with Healthy, run by Vastra Gotaland Region.

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 8 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 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The percentage of time with low CGM values ( blood glucose <4.0 mmol/l) (time frame: Day 1-7). 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 NCT03471949, 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 25 Apr 2019.

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