Clinical trial NCT03471949: Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test
Official title: Evaluation of the Profile of Blood Glucose Using Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Eligibility 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

Primary outcomes:
measure: The percentage of time with low CGM values ( blood glucose <4.0 mmol/l)
timeFrame: Day 1-7
Secondary outcomes:
measure: The percentage of time with low CGM values (blood glucose <3.0 mmol/l)
timeFrame: Day 1-7
measure: The difference in mean glucose levels between days 1-7 and day 8-14
timeFrame: Day 1-7 and day 8-14
measure: The percentage of time with glucose levels in euglycaemic range (72-126 mg/dL)
timeFrame: Day 1-14
measure: The percentage of time with glucose levels in euglycaemic range (72-180 mg/dL)
timeFrame: Day 1-14
measure: The percentage of time with glucose levels in hyperglycaemic range (>198 mg/dL)
timeFrame: Day 1-14
measure: The percentage of time with glucose levels in hyperglycaemic range (>252 mg/dL)
timeFrame: Day 1-14
measure: The Standard Deviation (SD)
timeFrame: Day 1-7 and day 8-14
measure: The evaluation of experience of the CGM, glucose monitoring systems.
timeFrame: Week 2, day14
measure: Difference in Mean Amplitude of Glycemic Excursions (MAGE)
timeFrame: Day 1-7, Day 8-14
measure: Mean Absolute Relative Difference (MARD)
timeFrame: Day 1-14
measure: Mean Absolute Difference (MAD)
timeFrame: Day 1-7, Day 8-14
measure: Coefficient of Variation (CV)
timeFrame: Day 1-7, Day 8-14
measure: Pearson correlation coefficient
timeFrame: Day 8-14
Other outcomes:
Locations:
Study officials:
affiliation: Study Principal Investigator, Nu-Hospital Group, Sweden
name: Marcus MD Lind, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.