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Completed

NCT Number: NCT03471949

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

CGM in a population with normal OGTT

Other

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

Primary outcomes

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

    Time frame: Day 1-7

    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.

Secondary outcomes

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

    Time frame: Day 1-7

    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

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

    Time frame: Day 1-7 and day 8-14

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

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

    Time frame: Day 1-14

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

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

    Time frame: Day 1-14

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

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

    Time frame: Day 1-14

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

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

    Time frame: Day 1-14

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

  7. The Standard Deviation (SD)

    Time frame: Day 1-7 and day 8-14

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

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

    Time frame: Week 2, day14

    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.

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

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

    Time frame: Day 1-7, Day 8-14

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

  10. Mean Absolute Relative Difference (MARD)

    Time frame: Day 1-14

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

  11. Mean Absolute Difference (MAD)

    Time frame: Day 1-7, Day 8-14

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

  12. Coefficient of Variation (CV)

    Time frame: Day 1-7, Day 8-14

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

  13. Pearson correlation coefficient

    Time frame: Day 8-14

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

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2018
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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