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Trial record 43 of 80731 for:    measured

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

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ClinicalTrials.gov Identifier: NCT02843503
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
J.H. DeVries, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Arterialized-venous reference (YSI) Device: Venous reference measurement (YSI) Device: Capillary reference (SMBG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : July 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




Primary Outcome Measures :
  1. Mean Absolute Relative Difference (MARD) [ Time Frame: up to day 6 of use ]
    MARD will be assessed per average of the 8 hour arterialization and regular venous study visit.


Secondary Outcome Measures :
  1. Accuracy of sensors (MARD) per hypoglycemic range [ Time Frame: up to day 6 of use ]
    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.

  2. Accuracy (MARD) of sensors per hyperglycemic range [ Time Frame: up to day 6 of use ]
    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.

  3. Glucose content (mg/dL) of venous reference samples. [ Time Frame: Up day 6 of study during both intervention visits ]
    Glucose content of venous reference samples will be measured per YSI.

  4. Glucose content (mg/dL) of venous-arterialized reference samples. [ Time Frame: up day 6 of study during both intervention visits ]
    Glucose content of venous-arterialized reference samples will be measured per YSI.

  5. Glucose content (mg/dL) of capillary reference samples. [ Time Frame: up day 6 of study during both intervention visits ]
    Glucose content of capillary reference samples will be measured per SMBG.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843503


Locations
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Netherlands
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
DexCom, Inc.

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Responsible Party: J.H. DeVries, professor of diabetes medicine, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02843503     History of Changes
Other Study ID Numbers: NL57491.018.16
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases