Factors in Accuracy Studies Influencing Measured CGM Performance.

NCT02843503 | Completed

• 1 other identifier: NL57491.018.16
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Accuracy of sensors (MARD) per hypoglycemic range

  up to day 6 of use

• Accuracy (MARD) of sensors per hyperglycemic range

  up to day 6 of use

• Glucose content (mg/dL) of venous reference samples.

  Up day 6 of study during both intervention visits

• Glucose content (mg/dL) of venous-arterialized reference samples.

  up day 6 of study during both intervention visits

• Glucose content (mg/dL) of capillary reference samples.

  up day 6 of study during both intervention visits

Study Arms (2)

Arterialized-venous reference YSI

EXPERIMENTAL

CGM monitoring performance per arterialized venous reference measurement (YSI)

Device: Arterialized-venous reference (YSI)

Venous reference samples YSI

EXPERIMENTAL

CGM monitoring performance per venous reference measurement (YSI)

Device: Venous reference measurement (YSI); Device: Capillary reference (SMBG)

Interventions

Arterialized-venous reference (YSI) DEVICE

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.

Arterialized-venous reference YSI

Venous reference measurement (YSI) DEVICE

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.

Venous reference samples YSI

Capillary reference (SMBG) DEVICE

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.

Venous reference samples YSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

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

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of diabetes medicine

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 26, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)