Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

Vastra Gotaland Region

Status: Completed

Conditions: Healthy

Treatments: Other: CGM in a population with normal OGTT

Study type: Interventional

Funder types: Other

Identifiers

NCT03471949

CGM and healthy population

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

CGM in a population with normal OGTT

Experimental group

Description:

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.

Treatment:

Other: CGM in a population with normal OGTT