Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

NCT03471949 | Completed

• 1 other identifier: CGM and healthy population
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• The percentage of time with low CGM values (blood glucose <3.0 mmol/l)

  Day 1-7

• The difference in mean glucose levels between days 1-7 and day 8-14

  Day 1-7 and day 8-14

• The percentage of time with glucose levels in euglycaemic range (72-126 mg/dL)

  Day 1-14

• The percentage of time with glucose levels in euglycaemic range (72-180 mg/dL)

  Day 1-14

• The percentage of time with glucose levels in hyperglycaemic range (>198 mg/dL)

  Day 1-14

Study Arms (1)

CGM in a population with normal OGTT

EXPERIMENTAL

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

Interventions

CGM in a population with normal OGTT OTHER

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

CGM in a population with normal OGTT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal oral glucose tolerance test
• Normal HbA1c value
• Age of 18 years or older

You may not qualify if:

• Known diabetes
• Known prediabetes
• Corticosteroid use during the last month
• Planned corticosteroid use during the study
• Pregnancy or planned pregnancy during the study period
• Paracetamol use during the last 2 days
• Planned paracetamol use during the study
• Allergy to any adhesives used for CGM or clorhexidine

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Related Publications (1)

• 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.

  PMID: 33100059 DERIVED

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Marcus MD Lind, Phd

  Study Principal Investigator, Nu-Hospital Group, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: March 21, 2018
• Study Start: October 24, 2016
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share