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Factors in Accuracy Studies Influencing Measured CGM Performance.

NCT02843503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-01-24

No results posted yet for this study

Summary

Primary objective is to assess the impact of different reference glucose measurement methods on the measured performance of a CGM system, aiming at further standardization for the assessment of CGM systems. Secondary objective is to describe the relationship between glucose concentration of venous, capillary and arterialized-venous measurement samples.

Study design: Open-label trial. Study population: Nineteen patients with type 1 diabetes aged 18 years and older will be included.

Intervention: The study will use the Dexcom G5 Mobile CGM. The participant will visit the clinical research center (CRC) twice during a 6 day period. These visits will have a duration of 8 hours. Blood will be drawn for the determination of glucose concentrations using venous, arterialized-venous and capillary sampling techniques. The patient will receive his usual breakfast and an increased insulin bolus will be administered to correct the breakfast glucose excursion with the aim of inducing a period of minor hypoglycemia. Blood sampling will continue until the end of the admission. The sensor will be worn until the end of the second 8-hour CRC session, which will be planned on day 6 or earlier depending on patient preference. The sensor will be removed and their sensor and blood glucose meter data downloaded from the devices. In the case of sensor failure before the first CRC session, patients will be instructed to insert a new sensor per the manufacturer's instruction and to notify study staff of the event. In case of failure of the sensor after the first CRC session but before the second CRC session, patients will return to the CRC for sensor removal and for data download.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Arterialized-venous reference (YSI)

All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive an iv-catheter to sample venous blood. The samples will be arterialized using a heated-hand-box (arterialized-venous reference (YSI). Blood will be drawn for the determination of glucose concentrations using arterialized-venous sampling techniques per YSI.

DEVICE

Venous reference measurement (YSI)

All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive an iv-catheter to sample venous blood. Blood will be drawn for the determination of glucose concentrations using venous sampling techniques measured per YSI.

DEVICE

Capillary reference (SMBG)

All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive vingerstick measurements to sample capillary blood measured per Self Monitoring of Blood Glucose (SMBG) device.

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02843503 on ClinicalTrials.gov