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Dexcom G6 Observational Study

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ClinicalTrials.gov Identifier: NCT03832907
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

Brief Summary:
This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2) identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2 diabetes treated with basal bolus insulin regimen.

Condition or disease Intervention/treatment Phase
Diabetes Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring Not Applicable

Detailed Description:

Several studies have shown that the use of a device that can measure blood glucose levels every 5 minutes is more effective in identifying low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia) when compared to regular measurements with fingersticks [point of care (POC)].

This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2) identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2 diabetes treated with basal bolus insulin regimen.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Inpatient and Post-hospital Discharge Assessment of Glycemic Control by Capillary Point-of-care Glucose Testing and by Continuous Glucose Monitoring in Insulin-treated Patients With Type 1 and Type 2 Diabetes: Dexcom G6 Observational Study
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Dexcom G6 CGM - Continues Glucose Monitoring sensor system

The Dexcom G6 CGM is a commercially available factory-calibrated sensor system. The system measures interstitial glucose every 5-15 minutes, providing real-time and more complete glycemic profile during 24-hours compared to standard POC glucose testing, and replaces the need for finger sticking. Potential limitations include the need for removing the sensor before MRI or diathermy treatment, and the potential interference in patients with severe dehydration.

In parallel, same participants will be monitored by the standard of care point-of-care (POC) capillary glucose tests. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital.

Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system
A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.

Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring
Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Other Name: Standard of Care capillary glucose test




Primary Outcome Measures :
  1. Mean daily blood glucose by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Mean daily blood glucose will be calculated

  2. Number of clinical significant hypoglycemia (<54 mg/dl) events by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Number of clinical significant hypoglycemia (<54 mg/dl) events will be recorded

  3. Number of severe hyperglycemia (>240 mg/dl) events by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Number of severe hyperglycemia (>240 mg/dl) events will be recorded


Secondary Outcome Measures :
  1. Mean daily blood glucose by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Mean daily blood glucose will be calculated

  2. Number of clinical significant hypoglycemia (<54 mg/dl) events by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Number of clinical significant hypoglycemia (<54 mg/dl) events will be recorded

  3. Number of clinical significant severe hyperglycemia (>240 mg/dl) events by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Number of severe hyperglycemia (>240 mg/dl) events will be recorded

  4. Number of nocturnal hypoglycemic events < 70 mg/dl and < 54 mg/dl (between 22:00 and 06:00) by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Number of nocturnal hypoglycemic events < 70 mg/dl and < 54 mg/dl (between 22:00 and 06:00) will be recorded

  5. Number of nocturnal hypoglycemic events < 70 mg/dl and < 54 mg/dl (between 22:00 and 06:00) by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Number of nocturnal hypoglycemic events < 70 mg/dl and < 54 mg/dl (between 22:00 and 06:00) will be recorded

  6. Number of of hypoglycemic events (< 70 and 54 mg/dl) in POC group by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Number of of hypoglycemic events (< 70 and 54 mg/dl) will be recorded

  7. Number of hypoglycemic events (< 70 and 54 mg/dl) by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Number of of hypoglycemic events (< 70 and 54 mg/dl) will be recorded

  8. Time in hypoglycemia (minutes) during the day and night by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Time in hypoglycemia (minutes) during the day and night will be recorded

  9. Time in hypoglycemia (minutes) during the day and night by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Time in hypoglycemia (minutes) during the day and night will be recorded

  10. Time in hyperglycemia (minutes) during the day and night> 240 mg/dl by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Time in hyperglycemia (minutes) during the day and night> 240 mg/dl will be recorded

  11. Time in hyperglycemia (minutes) during the day and night> 240 mg/dl by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Time in hyperglycemia (minutes) during the day and night> 240 mg/dl will be recorded

  12. Number of hyperglycemic events > 240 mg/dl by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Number of hyperglycemic events > 240 mg/dl will be recorded

  13. Number of hyperglycemic events > 240 mg/dl by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Number of hyperglycemic events > 240 mg/dl will be recorded

  14. Percentage of BG readings within target BG of 70 and 180 mg/dl by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated

  15. Percentage of BG readings within target BG of 70 and 180 mg/dl by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated

  16. Percentage of patients with greater than 5%-time below glucose target (<70 and 54 mg/dl) by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Percentage of patients with greater than 5%-time below glucose target (<70 and 54 mg/dl) will be calculated

  17. Percentage of patients with greater than 5%-time below glucose target (<70 and 54 mg/dl) by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Percentage of patients with greater than 5%-time below glucose target (<70 and 54 mg/dl) will be calculated

  18. Percentage of patients with greater than 5%-time above glucose target (>180 and 240 mg/dl) by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Percentage of patients with greater than 5%-time above glucose target (>180 and 240 mg/dl) will be calculated

  19. Percentage of patients with greater than 5%-time above glucose target (>180 and 240 mg/dl) by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Percentage of patients with greater than 5%-time above glucose target (>180 and 240 mg/dl) will be calculated

  20. Glycemic variability calculated by Standard Deviation and MAGE by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Glycemic variability will be calculated using Standard Deviation and MAGE

  21. Glycemic variability calculated by Standard Deviation, and MAGE by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Glycemic variability will be calculated using Standard Deviation and MAGE

  22. Number of sensor removal/failures/dislodgments by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Number of sensor removal/failures/dislodgments will be recorded

  23. Number of sensor removal/failures/dislodgments by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Number of sensor removal/failures/dislodgments will be recorded

  24. Mean absolute relative difference (MARD) by POC reading compared to CGM reading [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Accuracy of Dexcom G6 CGM, as defined by overall MARD, as compared to the standard-of-care POC and daily morning laboratory glucose values

  25. Mean absolute relative difference (MARD) by POC reading compared to CGM reading [ Time Frame: 10 days post discharge ]
    Accuracy of Dexcom G6 CGM, as defined by overall MARD, as compared to the standard-of-care POC and daily morning laboratory glucose values

  26. Number of Dexcom G6 CGM sensor values within 30/30%, 20/20%, 15/15% for values < 70 mg/dl, 70-140 mg/dl, >140-180 mg/dl and > 180 mg/dl), compared to the standard-of-care POC BG [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Accuracy of Dexcom G6 CGM, as defined by ISO criteria (sensor values within 30/30%, 20/20%, 15/15% for values < 70 mg/dl, 70-140 mg/dl, >140-180 mg/dl andAccuracy of Dexcom G6 CGM, as defined by ISO criteria (sensor values within 30/30%, 20/20%, 15/15% for values < 70 mg/dl, 70-140 mg/dl, >140-180 mg/dl and > 180 mg/dl), compared to the standard-of-care POC BG > 180 mg/dl), compared to the standard-of-care POC BG

  27. Number of Dexcom G6 CGM sensor values within 30/30%, 20/20%, 15/15% for values < 70 mg/dl, 70-140 mg/dl, >140-180 mg/dl and > 180 mg/dl), compared to the standard-of-care POC BG [ Time Frame: 10 days post discharge ]
    Accuracy of Dexcom G6 CGM, as defined by ISO criteria (sensor values within 30/30%, 20/20%, 15/15% for values < 70 mg/dl, 70-140 mg/dl, >140-180 mg/dl and > 180 mg/dl), compared to the standard-of-care POC BG

  28. Differences in accuracy between G6 CGM in the abdomen and upper arm insertion sites [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Differences in accuracy - defined by overall Mean absolute relative difference (MARD) - between G6 CGM in the abdomen and upper arm insertion sites will be assessed

  29. Percentage of values within Zone A, B, C of the Clarke Error Grid [ Time Frame: During hospital stay (3 days - up to 30 days) ]
    Percentage of values within Zone A, B, C of the Clarke Error Grid

  30. Percentage of values within Zone A, B, C of the Clarke Error Grid [ Time Frame: 10 days post discharge ]
    Percentage of values within Zone A, B, C of the Clarke Error Grid will be calculated



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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:

  1. > 18 years admitted to a general medicine or surgical service.
  2. Known history of T1D or T2D receiving insulin therapy
  3. Subjects must have a randomization BG between 140 mg and 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).
  4. Patients with expected hospital length-of-stay of 3 or more days

Exclusion Criteria:

  1. Patients with acute illness admitted to the ICU or expected to require admission to the ICU.
  2. Patients expected to require MRI procedures during hospitalization.
  3. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  4. Female subjects who are pregnant or breast‑feeding at time of enrollment into the study.

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): NCT03832907


Contacts
Contact: Guillermo Umpierrez, MD 404-778-1665 geumpie@emory.edu
Contact: Georgia Davis, MD georgia.marie.davis@emory.edu

Locations
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Guillermo Umpierrez, MD    404-778-1665    geumpie@emory.edu   
Principal Investigator: Guillermo Umpierrez, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University

Responsible Party: Guillermo Umpierrez, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03832907     History of Changes
Other Study ID Numbers: IRB00107627
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Guillermo Umpierrez, MD, Emory University:
Glucose monitoring
POC BG
DexcomG6 CGM