DiabetesNCT03832907
Dexcom G6 Observational Study
A study testing Dexcom G6 CGM - Continues Glucose Monitoring sensor system and POC BG - Point-of-Care Blood Glucose monitoring in people with Diabetes, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Dexcom G6 CGM - Continues Glucose Monitoring sensor system and POC BG - Point-of-Care Blood Glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Dexcom G6 CGM - Continues Glucose Monitoring sensor system, POC BG - Point-of-Care Blood Glucose monitoring
- Keywords
- Glucose monitoring, POC BG, DexcomG6 CGM
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 CGM - Continues Glucose Monitoring sensor systemDevice
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 monitoringDiagnostic test
Also called Standard of Care capillary glucose 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.
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring sensor system | Experimental | 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. Receives: Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system; Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily Blood Glucose by POC Reading сompared to CGM Reading
Mean daily blood glucose will be calculated
Measured: During hospital stay (3 days - up to 30 days)
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
Number of clinical significant hypoglycemia (<54 mg/dl) events will be calculated
Measured: During hospital stay (3 days - up to 30 days)
Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
Number of severe hyperglycemia (>240 mg/dl) events will be recorded
Measured: During hospital stay (3 days - up to 30 days)
Secondary outcomes (47)
Mean Daily Blood Glucose by POC Reading Compared to CGM Reading
Mean daily blood glucose will be calculated
Measured: 10 days post discharge
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
Number of clinical significant hypoglycemia (<54 mg/dl) events will be calculated
Measured: 10 days post discharge
Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
Number of severe hyperglycemia (>240 mg/dl) events will be recorded
Measured: 10 days post discharge
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Number of nocturnal hypoglycemic events < 70 mg/dl (between 22:00 and 06:00) will be recorded
Measured: During hospital stay (3 days - up to 30 days)
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Number of nocturnal hypoglycemic events < 70 mg/dl(between 22:00 and 06:00) will be recorded
Measured: 10 days post discharge
Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading
Number of of hypoglycemic events < 70mg/dl will be recorded
Measured: During hospital stay (3 days - up to 30 days)
Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading
Number of of hypoglycemic events < 70mg/dl will be recorded
Measured: 10 days post discharge
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
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. .
Measured: During hospital stay (3 days - up to 30 days)
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
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. .
Measured: 10 days post discharge
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
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. .
Measured: During hospital stay (3 days - up to 30 days)
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
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.
Measured: 10 days post discharge
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
Number of hyperglycemic events > 240 mg/dl will be recorded
Measured: During hospital stay (3 days - up to 30 days)
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
Number of hyperglycemic events > 240 mg/dl will be recorded
Measured: 10 days post discharge
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated
Measured: During hospital stay (3 days - up to 30 days)
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated
Measured: 10 days post discharge
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading
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.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading
Percentage of patients with greater than 5%-time below glucose target <70 mg/dl will be calculated
Measured: 10 days post discharge
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading
Percentage of patients with greater than 5%-time above glucose target >180 mg/dl will be calculated
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading
Percentage of patients with greater than 5%-time above glucose target >180 will be calculated
Measured: 10 days post discharge
Glycemic Variability Calculated by Standard Deviation by CGM Reading
Glycemic variability will be calculated using Standard Deviation
Measured: During hospital stay (3 days - up to 30 days)
Glycemic Variability Calculated by MAGE by CGM Reading
MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.
Measured: 10 days post discharge
Number of Sensor Removal/Failures/Dislodgments
Number of sensor removal/failures/dislodgments will be recorded
Measured: During hospital stay (3 days - up to 30 days)
Mean Absolute Relative Difference (MARD) of CGM Compared to POC
Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG
Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) meeting %30/30 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen
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.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Values Within Zone A, B, C of the Clarke Error Grid 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.
Measured: During hospital stay (3 days - up to 30 days) measured in arm
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Number of nocturnal hypoglycemic events < 54 mg/dl (between 22:00 and 06:00) will be recorded
Measured: During hospital stay (3 days - up to 30 days)
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Number of nocturnal hypoglycemic events < 54 mg/dl(between 22:00 and 06:00) will be recorded
Measured: 10 days post discharge
Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading
Number of of hypoglycemic events < 54 will be recorded
Measured: During hospital stay (3 days - up to 30 days)
Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading
Number of of hypoglycemic events < 54mg/dl will be recorded
Measured: 10 days post discharge
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading
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.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
Percentage of patients with greater than 5%-time above glucose target >240 will be calculated
Measured: 10 days post discharge
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
Percentage of patients with greater than 5%-time above glucose target >240 mg/dl will be calculated
Measured: During hospital stay (3 days - up to 30 days)
Glycemic Variability Calculated by MAGE by CGM Reading
The average amplitude of glycemic excursions with values exceeding a certain threshold.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading
Percentage of patients with greater than 5%-time below glucose target <54 mg/dl will be calculated
Measured: 10 days post discharge
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
Percentage of CGM glucose values within the 70-140 mg/dl range that meet %30/30 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
Percentage of CGM glucose values within the 140-180 mg/dl range that meet %30/30 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %30/30 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Glycemic Variability Calculated by Standard Deviation by CGM Reading
Glycemic variability will be calculated using Standard Deviation
Measured: 10 days post discharge
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %20/20 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
Percentage of CGM glucose values within the 70-140 mg/dl range that meet %20/20 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %20/20 accuracy criteria..
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
Percentage of CGM glucose values within the 140-180 mg/dl range that meet %20/20 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %15/15 accuracy criteria..
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
Percentage of CGM glucose values within the 70-140 mg/dl range that meet %15/15 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
Percentage of CGM glucose values within the 140-180 mg/dl range that meet %15/15 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %15/15 accuracy criteria.
Measured: During hospital stay (3 days - up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start21 Feb 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, MD, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832907
- Sponsor's protocol ID
- IRB00107627
- Status last verified
- Aug 2021
- First submitted
- 5 Feb 2019
- Last updated
- 5 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03832907
- Acronym / sponsor ID
- IRB00107627
- Conditions
- Diabetes
- Keywords
- Glucose monitoring, POC BG, DexcomG6 CGM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Posted 5 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring sensor system | Experimental | Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system, Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoringThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring sensor systemA 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. | Device | Dexcom G6 CGM - Continues Glucose Monitoring sensor system |
| POC BG - Point-of-Care Blood Glucose monitoringAlso: Standard of Care capillary glucose testStandard 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. | Diagnostic test | Dexcom G6 CGM - Continues Glucose Monitoring sensor system |
Primary outcome
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
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
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
47 secondary outcomes
Mean Daily Blood Glucose by POC Reading Compared to CGM Reading
Time frame: 10 days post discharge
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 Severe Hyperglycemia (>240 mg/dl) Events 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) 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) by POC Reading Compared to CGM Reading
Time frame: 10 days post discharge
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 Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading
Time frame: 10 days post discharge
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 by CGM Reading
Time frame: 10 days post discharge
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 by CGM Reading
Time frame: 10 days post discharge
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 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 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 by POC Reading Compared to CGM Reading
Time frame: 10 days post discharge
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 <70 mg/dl by CGM Reading
Time frame: 10 days post discharge
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 by CGM Reading
Time frame: 10 days post discharge
Glycemic Variability Calculated by Standard Deviation by CGM Reading
Time frame: During hospital stay (3 days - up to 30 days)
Glycemic Variability Calculated by MAGE by CGM Reading
Time frame: 10 days post discharge
Number of Sensor Removal/Failures/Dislodgments
Time frame: During hospital stay (3 days - up to 30 days)
Mean Absolute Relative Difference (MARD) of CGM Compared to POC
Time frame: During hospital stay (3 days - up to 30 days)
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 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 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
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) by POC Reading Compared to CGM Reading
Time frame: 10 days post discharge
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 Hypoglycemic Events < 54mg/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 <54mg/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 by CGM Reading
Time frame: 10 days post discharge
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)
Glycemic Variability Calculated by MAGE 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 <54 mg/dl by CGM Reading
Time frame: 10 days post discharge
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 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 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)
Glycemic Variability Calculated by Standard Deviation by CGM Reading
Time frame: 10 days post discharge
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Umpierrez, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 CGM - Continues Glucose Monitoring sensor system and POC BG - Point-of-Care Blood Glucose monitoring in people with Diabetes, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Daily Blood Glucose by POC Reading сompared to CGM Reading (time frame: During hospital stay (3 days - up to 30 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.