Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-24

Study Completion Date

2018-12-11

Brief Summary

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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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Detailed Description

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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

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CGM in a population with normal OGTT

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes