Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

N/ACompletedNCT03471949

Vastra Gotaland Region60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Day 1-7

Secondary Outcomes

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

Time frame: Day 1-7

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

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

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

Time frame: Day 1-14

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

Time frame: Day 1-14

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

Time frame: Day 1-14

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

Data from ClinicalTrials.gov

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