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Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

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ClinicalTrials.gov Identifier: NCT03471949
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Other: CGM in a population with normal OGTT Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Profile of Blood Glucose Using Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test
Actual Study Start Date : October 24, 2016
Actual Primary Completion Date : December 11, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: CGM in a population with normal OGTT
A 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.
Other: CGM in a population with normal OGTT
The population with normal OGTT will use CGM and document their values as well as be documenting a capillary blood glucose value




Primary Outcome Measures :
  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 Outcome Measures :
  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.

    2. Do you consider the CGM can be a great educational tool for patients who are at risk for getting diabetes? (yes, no)

    3. Can CGM give you a mindset about diet and lifestyle changes? (yes, no)

    4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Normal oral glucose tolerance test
  2. Normal HbA1c value
  3. Age of 18 years or older

Exclusion Criteria:

  1. Known diabetes
  2. Known prediabetes
  3. Corticosteroid use during the last month
  4. Planned corticosteroid use during the study
  5. Pregnancy or planned pregnancy during the study period
  6. Paracetamol use during the last 2 days
  7. Planned paracetamol use during the study
  8. Allergy to any adhesives used for CGM or clorhexidine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471949


Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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Principal Investigator: Marcus MD Lind, Phd Study Principal Investigator, Nu-Hospital Group, Sweden

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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03471949     History of Changes
Other Study ID Numbers: CGM and healthy population
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No