Factors in Accuracy Studies Influencing Measured CGM Performance. (FACT-CGM)

Factors in Accuracy Studies Influencing Measured CGM Performance: a Comparison of Measured Continuous Glucose Monitor Performance Using Venous, Arterialized-venous and Capillary Reference Glucose Samples.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Arterialized-venous reference (YSI); Device: Venous reference measurement (YSI); Device: Capillary reference (SMBG)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Academic Medical Center

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:

• diagnosed with type 1 DM at least 6 months according to the WHO definition
• Body Mass Index (BMI) <35 kg/m²
• willing and able to wear a CGM device for the duration of the study and undergo all study procedures
• HbA1c <10%
• Signed informed consent form prior to study entry

Exclusion Criteria:

• patient is pregnant, or breast feeding during the period of the study.
• patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration.
• patient requires regular use of acetaminophen (paracetamol) while participating in the study due to known negative impact on CGM performance.
• patient is actively enrolled in another clinical trial or took part in a study within 30 days.
• known adrenal gland problem, panhypopitutarism, gastroparesis, migraine, epilepsy or ischemic heart disease or other cardiovascular event in the year previous to study participation .
• inability of the patient to comply with all study procedures.
• inability of the patient to understand the patient information.
• patient donated blood in the last 3 months.
• has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the investigator would compromise the patient's safety or successful participation in the study.
• is assessed by the investigators to have difficult intravenous (IV) access .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arterialized-venous reference YSI; CGM monitoring performance per arterialized venous reference measurement (YSI)	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.
Experimental: Venous reference samples YSI; CGM monitoring performance per venous reference measurement (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Absolute Relative Difference (MARD)	MARD will be assessed per average of the 8 hour arterialization and regular venous study visit.	up to day 6 of use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of sensors (MARD) per hypoglycemic range	Accuracy of the sensor in the hypoglycaemic (defined as a blood glucose value ≤70 mg/dL) area as an average of the first six days of use.	up to day 6 of use
Accuracy (MARD) of sensors per hyperglycemic range	Accuracy of the sensor in the hyperglycaemic (defined as a blood glucose value >180 mg/dL) area as an average of the first six days of use.	up to day 6 of use
Glucose content (mg/dL) of venous reference samples.	Glucose content of venous reference samples will be measured per YSI.	Up day 6 of study during both intervention visits
Glucose content (mg/dL) of venous-arterialized reference samples.	Glucose content of venous-arterialized reference samples will be measured per YSI.	up day 6 of study during both intervention visits
Glucose content (mg/dL) of capillary reference samples.	Glucose content of capillary reference samples will be measured per SMBG.	up day 6 of study during both intervention visits

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: NL57491.018.16

Plan for Individual participant data (IPD)

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