Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

Evaluation of the Profile of Blood Glucose Using Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: CGM in a population with normal OGTT

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1-7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	Day 1-14
The percentage of time with glucose levels in hyperglycaemic range (>252 mg/dL)	Measured by continuous glucose monitoring (CGM) with high glucose (>252 mg/dL, >14 mmol/L) between day 1-7 and 8-14	Day 1-14
The Standard Deviation (SD)	Difference in standard deviation of glucose levels measured by CGM between day 1-7 and day 8-14	Day 1-7 and day 8-14
The evaluation of experience of the CGM, glucose monitoring systems.	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?	Week 2, day14
Difference in Mean Amplitude of Glycemic Excursions (MAGE)	Difference in mean amplitude glucose excursion (MAGE) measured by CGM between day 1-7 and 8-14	Day 1-7, Day 8-14
Mean Absolute Relative Difference (MARD)	Mean Absolute Relative Difference (MARD) estimated from HemoCue glucose values and CGM-values from days 1-14.	Day 1-14
Mean Absolute Difference (MAD)	Measured by continuous glucose monitoring (CGM) between day 1-7 and 8-14	Day 1-7, Day 8-14
Coefficient of Variation (CV)	Difference in coefficient of variation measured by continuous glucose monitoring (CGM) between day 1-7 and 8-14	Day 1-7, Day 8-14
Pearson correlation coefficient	Pearson correlation coefficient estimated from HemoCue and CGM glucose values from days 8-14.	Day 8-14

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Marcus MD Lind, Phd, Study Principal Investigator, Nu-Hospital Group, Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2016
• Primary Completion (Actual): December 11, 2018
• Study Completion (Actual): December 11, 2018

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CGM and healthy population

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No