Skip to main content
OpenTrials
Completed

NCT Number: NCT03832907

Dexcom G6 Observational Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years admitted to a general medicine or surgical service.
  • Known history of T1D or T2D receiving insulin therapy
  • 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).
  • Patients with expected hospital length-of-stay of 3 or more days

Exclusion criteria

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

Treatment and study plan

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

Device

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.

POC BG - Point-of-Care Blood Glucose monitoring

Diagnostic Test

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 names: Standard of Care capillary glucose test

Primary outcomes

  1. Mean Daily Blood Glucose by POC Reading сompared 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 calculated

  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 outcomes

  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 calculated

  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 (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 (between 22:00 and 06:00) will be recorded

  5. Number of Nocturnal Hypoglycemic Events < 70 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(between 22:00 and 06:00) will be recorded

  6. Number of of Hypoglycemic Events < 70mg/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 < 70mg/dl will be recorded

  7. Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading

    Time frame: 10 days post discharge

    Number of of hypoglycemic events < 70mg/dl will be recorded

  8. Time in Hypoglycemia (Minutes) During the Day and Night by 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. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .

  9. Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading

    Time frame: 10 days post discharge

    Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .

  10. Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by 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. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .

  11. Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading

    Time frame: 10 days post discharge

    Time in hyperglycemia (minutes) during the day and night> 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.

  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 <70mg/dl by CGM Reading

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of patients with greater than 5%-time below glucose target <70mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.

  17. Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading

    Time frame: 10 days post discharge

    Percentage of patients with greater than 5%-time below glucose target <70 mg/dl will be calculated

  18. Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by 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 mg/dl will be calculated

  19. Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading

    Time frame: 10 days post discharge

    Percentage of patients with greater than 5%-time above glucose target >180 will be calculated

  20. Glycemic Variability Calculated by Standard Deviation by CGM Reading

    Time frame: During hospital stay (3 days - up to 30 days)

    Glycemic variability will be calculated using Standard Deviation

  21. Glycemic Variability Calculated by MAGE by CGM Reading

    Time frame: 10 days post discharge

    MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.

  22. Number of Sensor Removal/Failures/Dislodgments

    Time frame: During hospital stay (3 days - up to 30 days)

    Number of sensor removal/failures/dislodgments will be recorded

  23. Mean Absolute Relative Difference (MARD) of CGM Compared to POC

    Time frame: During hospital stay (3 days - up to 30 days)

    Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC

  24. Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) meeting %30/30 accuracy criteria.

  25. Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.

  26. Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm

    Time frame: During hospital stay (3 days - up to 30 days) measured in arm

    Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.

  27. Number of Nocturnal Hypoglycemic Events < 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 < 54 mg/dl (between 22:00 and 06:00) will be recorded

  28. Number of Nocturnal Hypoglycemic Events < 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 < 54 mg/dl(between 22:00 and 06:00) will be recorded

  29. Number of of Hypoglycemic Events < 54 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 < 54 will be recorded

  30. Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading

    Time frame: 10 days post discharge

    Number of of hypoglycemic events < 54mg/dl will be recorded

  31. Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of patients with greater than 5%-time below glucose target <54mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.

  32. Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading

    Time frame: 10 days post discharge

    Percentage of patients with greater than 5%-time above glucose target >240 will be calculated

  33. Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of patients with greater than 5%-time above glucose target >240 mg/dl will be calculated

  34. Glycemic Variability Calculated by MAGE by CGM Reading

    Time frame: During hospital stay (3 days - up to 30 days)

    The average amplitude of glycemic excursions with values exceeding a certain threshold.

  35. Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading

    Time frame: 10 days post discharge

    Percentage of patients with greater than 5%-time below glucose target <54 mg/dl will be calculated

  36. Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values within the 70-140 mg/dl range that meet %30/30 accuracy criteria.

  37. Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values within the 140-180 mg/dl range that meet %30/30 accuracy criteria.

  38. Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %30/30 accuracy criteria.

  39. Glycemic Variability Calculated by Standard Deviation by CGM Reading

    Time frame: 10 days post discharge

    Glycemic variability will be calculated using Standard Deviation

  40. Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %20/20 accuracy criteria.

  41. Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values within the 70-140 mg/dl range that meet %20/20 accuracy criteria.

  42. Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %20/20 accuracy criteria..

  43. Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values within the 140-180 mg/dl range that meet %20/20 accuracy criteria.

  44. Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %15/15 accuracy criteria..

  45. Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values within the 70-140 mg/dl range that meet %15/15 accuracy criteria.

  46. Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values within the 140-180 mg/dl range that meet %15/15 accuracy criteria.

  47. Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG

    Time frame: During hospital stay (3 days - up to 30 days)

    Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %15/15 accuracy criteria.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2019
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.