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Dexcom G6 Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03877068
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : March 15, 2019
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

Brief Summary:
The study will assess if Continuous Glucose Monitoring (CGM) represents a better tool to guide healthcare providers in adjusting insulin therapy, by providing a more complete 24-hour assessment of glucose values compared to Point of Care (POC) testing, during hospitalization and after hospital discharge in general medicine and surgery patients with T2D and T1D

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

Detailed Description:
The study will assess if Continuous Glucose Monitoring (CGM) represents a better tool to guide healthcare providers in adjusting insulin therapy, by providing a more complete 24-hour assessment of glucose values compared to Point of Care (POC) testing, during hospitalization and after hospital discharge in general medicine and surgery patients with T2D and T1D.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Management of Inpatient Hyperglycemia by Continuous Glucose Monitoring in Insulin-treated Patients With Diabetes: Dexcom G6 Intervention Study
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Dexcom G6 CGM - Continues Glucose Monitoring sensor system
Patients will wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days. In addition, patients will undergo POC testing before meals and bedtime per hospital protocol. Insulin therapy will be titrated based on daily CGM printouts, which will include BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Patients will wear a CGM in the current approved insertion site, the abdomen, and in the upper arm.
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 up to 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 up to 10 days.
Other Name: Standard of Care capillary glucose test

Active Comparator: POC BG - Point-of-Care Blood Glucose monitoring
Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded in the electronic medical record (EMR) system. The research team together with the PCP team will adjust daily insulin orders based on POC readings (standard of care). In addition, patients will wear a 'blinded' CGM (no results will be visualized by patients, nursing staff, PCP or research teams).
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 up to 10 days.
Other Name: Standard of Care capillary glucose test




Primary Outcome Measures :
  1. Time in range blood glucose (BG) between 80-180 mg/dl [ Time Frame: During hospitalization (up to 10 days) ]
    Glycemic control will be measured by time in range BG between 80-180 mg/dl (efficacy outcome)

  2. Number of clinically significant hypoglycemia <54 mg/dl events [ Time Frame: During hospitalization (up to 10 days) ]
    Clinically significant hypoglycemia events <54 mg/dl (safety outcome)


Secondary Outcome Measures :
  1. Number of events of nocturnal hypoglycemia < 70 mg/dl and < 54 mg/dl [ Time Frame: During hospitalization (up to 10 days) ]
    Number of events of nocturnal hypoglycemia < 70 mg/dl and < 54 mg/dl (between 22:00 and 06:00)

  2. Number of events of hypoglycemia (< 70 and 54 mg/dl) [ Time Frame: During hospitalization (up to 10 days) ]
    Number of events of hypoglycemia (< 70 and 54 mg/dl) during the day and night

  3. Number of events of hypoglycemia (< 70 and 54 mg/dl) [ Time Frame: After discharge (up to 10 days) ]
    Number of events of hypoglycemia (< 70 and 54 mg/dl) during the day and night

  4. Number of events of hyperglycemia > 250 mg/dl [ Time Frame: During hospitalization (up to 10 days) ]
    Number of events of hyperglycemia > 250 mg/dlduring the day and night

  5. Number of events of hyperglycemia > 250 mg/dl [ Time Frame: After discharge (up to 10 days) ]
    Number of events of hyperglycemia > 250 mg/dl during the day and night

  6. Time in hypoglycemia (minutes) [ Time Frame: During hospitalization (up to 10 days) ]
    Time in hypoglycemia (minutes) during the day and night

  7. Time in hypoglycemia (minutes) [ Time Frame: After discharge (up to 10 days) ]
    Time in hypoglycemia (minutes) during the day and night

  8. Time in hyperglycemia (minutes) [ Time Frame: During hospitalization (up to 10 days) ]
    Time in hyperglycemia (minutes) during the day and night

  9. Time in hyperglycemia (minutes) [ Time Frame: After discharge (up to 10 days) ]
    Time in hyperglycemia (minutes) during the day and night

  10. Percentage of BG readings within target BG of 80 and 180 mg/dl [ Time Frame: During hospitalization (up to 10 days) ]
    Percentage of BG readings within target BG of 80 and 180 mg/dl of all BG readings

  11. Percentage of BG readings within target BG of 80 and 180 mg/dl [ Time Frame: After discharge (up to 10 days) ]
    Percentage of BG readings within target BG of 80 and 180 mg/dl of all BG readings

  12. Glycemic variability calculated by Mean amplitude of glycemic excursions (MAGE) [ Time Frame: During hospitalization (up to 10 days) ]
    Mean amplitude of glycemic excursions (MAGE), together with mean and SD, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one SD of mean glycemia. It is designed to assess major glucose swings and exclude minor ones

  13. Glycemic variability calculated by Mean amplitude of glycemic excursions (MAGE) [ Time Frame: After discharge (up to 10 days) ]
    Mean amplitude of glycemic excursions (MAGE), together with mean and SD, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one SD of mean glycemia. It is designed to assess major glucose swings and exclude minor ones

  14. Differences in BG by CGM devices placed in the abdomen and upper extremity [ Time Frame: During hospitalization (up to 10 days) ]
    The MARD reflects accuracy of the CGM glucose reading compared to the reference POC reading. This is the current standard for assessing accuracy of glucometer readings. Lower MARD indicates smaller differences between the CGM and meter value; a higher MARD value indicates larger differences. A three way and direct head-to-head comparison of data from the abdomen, upper arm and POC BG will be compared.

  15. Number of sensor malfunctioning/manipulations events [ Time Frame: During hospitalization (up to 10 days) ]
    Events related to sensor malfunctioning/manipulations will be recorded: removal for procedures/imaging, sensors failures, sensors dislodgments

  16. Number of sensor malfunctioning/manipulations events [ Time Frame: After discharge (up to 10 days) ]
    Events related to sensor malfunctioning/manipulations will be recorded: removal for procedures/imaging, sensors failures, sensors dislodgments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Males and females ≥ 18 years admitted to a general medicine or surgical services.
  2. History of T1D or T2D receiving insulin therapy during hospital admission.
  3. Subjects must have a randomization BG <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 day

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. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
  4. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  5. 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): NCT03877068


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Grady Health System
Atlanta, Georgia, United States, 30322
United States, Maryland
Univeristy of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Guillermo Umpierrez, MD Emory University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guillermo Umpierrez, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03877068    
Other Study ID Numbers: IRB00107703
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
Supporting Materials: Study Protocol
Time Frame: Start 6 months after publication End 5 years after publication
Access Criteria: Researchers who provide a methodologically sound proposals should email proposals to geumpie@emory.edu. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Guillermo Umpierrez, MD, Emory University:
Glycemic control
Bedside point-of-care capillary glucose monitoring
POC
Dexcom
Continuous glucose monitoring
Hyperglycemia
Inpatient
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases