Diabetes MellitusNCT03877068
Dexcom G6 Intervention 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 Mellitus, run by Emory University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- 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
- 185 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jun 2019to 27 Feb 2021
- 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
- Males and females ≥ 18 years admitted to a general medicine or surgical services.
- History of T1D or T2D receiving insulin therapy during hospital admission.
- Subjects must have a randomization BG <400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalents per litre (mEq/L), potential of hydrogen (pH) < 7.30, or positive serum or urinary ketones).
- Patients with expected hospital length-of-stay of 2 or more day
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.
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
- 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.
- Coronavirus Disease 2019 (COVID-19) infection
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital
Atlanta, Georgia, 30322
Grady Health System
Atlanta, Georgia, 30322
Univeristy of Maryland
Baltimore, Maryland, 21201
About this study
Official title: Management of Inpatient Hyperglycemia by Continuous Glucose Monitoring in Insulin-treated Patients With Diabetes: Dexcom G6 Intervention Study
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 Type 2 Diabetes (T2D) and Type 1 Diabetes (T1D).
Read the detailed description
Diabetes is reported in 20-34% of hospitalized adult patients in general medicine and surgery units and there is a large body of literature showing a strong association between diabetes and increased hospital mortality and morbidity. Clinical guidelines have recommended the use of basal bolus insulin regimens as the preferred management approach of non-intensive care unit (ICU) patients with diabetes, as it has been shown to be effective in improving glycemic control and reducing hospital complications. However, hypoglycemia is a common adverse event of insulin therapy, with incidence rates ranging between 12% and 35% in randomized studies in non-ICU settings. The development of hypoglycemia, like hyperglycemia, has been associated with higher rates of hospital complications, higher health care resource utilization, and hospital mortality.
Bedside point-of-care (POC) capillary glucose monitoring is the standard of care to assess glycemic control in the hospital. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital. In contrast to POC testing, continuous glucose monitoring (CGM) measures interstitial glucose every 5-15 minutes, thus providing a more complete glycemic profile during 24-hours compared to standard POC glucose testing. The study will assess if 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 POC testing, during hospitalization and after hospital discharge in general medicine and surgery patients with T2D and T1D.
Participants will be randomized to have the standard of care POC testing plus wear a sham CGM or to wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days during hospitalization. At the point of hospital discharge, participants with poorly controlled diabetes will be invited to participate in an open label outpatient study where they will wear a Dexcom G6 CGM or sham device for 10 days.
- Conditions
- Diabetes Mellitus
- Being tested
- Dexcom G6 CGM - Continues Glucose Monitoring sensor system, POC BG - Point-of-Care Blood Glucose monitoring
- Keywords
- Glycemic control, Bedside point-of-care capillary glucose monitoring, Dexcom, Continuous glucose monitoring, Hyperglycemia, Inpatient
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
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 up to 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 up to 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring sensor system | Experimental | 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. Receives: Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system; Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring |
| POC BG - Point-of-Care Blood Glucose monitoring | Active comparator | 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 where no results will be visualized by patients, nursing staff, primary care physician (PCP) or research teams. Receives: 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 (BG) Concentration While Hospitalized
A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.
Measured: During hospitalization (up to 10 days)
Percent of Time With BG Between 70-180 mg/dL While Hospitalized
Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL.
Measured: During hospitalization (up to 10 days)
Number of Clinically Significant Hypoglycemia Events While Hospitalized
The mean number of clinically significant hypoglycemia events, defined as BG <54 mg/dl (3.0mmol/L), per participant is presented here.
Measured: During hospitalization (up to 10 days)
Secondary outcomes (14)
Number of Hypoglycemia Events While Hospitalized
The mean number of hypoglycemia events, defined as BG < 70 (<3.9 mmol/L), per participant during hospitalization is presented here.
Measured: During hospitalization (up to 10 days)
Number of Nocturnal Hypoglycemia Events While Hospitalized
The mean number of events of nocturnal hypoglycemia per participant are presented here. Nocturnal hypoglycemia occurs between the hours of 12:00 midnight and 6:00 ante meridiem (AM). Hypoglycemia is defined as BG < 70 mg/dL (<3.9 mmol/L) and severe hypoglycemia is defined as BG < 54 mg/dL (<3.0 mmol/L).
Measured: During hospitalization (up to 10 days)
Percent of Time With Hypoglycemia While Hospitalized
The percentage of time spent with BG below the desired range, during the day and night of hospitalization was assessed. Hypoglycemia is defined as BG < 70 mg/dL (<3.9 mmol/L) and severe hypoglycemia is defined as BG < 54 mg/dL (<3.0 mmol/L).
Measured: During hospitalization (up to 10 days)
Percent of Time With Hyperglycemia While Hospitalized
The percentage of time above the desired BG range, during the day and night while hospitalized was assessed.
Measured: During hospitalization (up to 10 days)
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized
Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, 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 standard deviation of mean glycemia. It is designed to assess major glucose swings and exclude minor ones.
Measured: During hospitalization (up to 10 days)
Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized
The mean absolute relative difference (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.
Measured: During hospitalization (up to 10 days)
Number of Sensor Changes During Hospitalization
Events related to sensor changes (blinded sensor for the POC group or real-time sensor for CGM group), such as removal for procedures or imaging, sensors failures, and sensors dislodgments were recorded.
Measured: During hospitalization (up to 10 days)
Mean Daily BG Concentration After Discharge
A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.
Measured: After hospital discharge (up to 10 days)
Percent of Time With BG Between 70-180 mg/dL After Discharge
Glycemic control after hospital discharge is measured by the percent of time with BG in the range of 70-180 mg/dL.
Measured: After hospital discharge (up to 10 days)
Number of Clinically Significant Hypoglycemia Events After Discharge
The mean number of clinically significant hypoglycemia events, defined as BG <54 mg/dl (3.0mmol/L), during the day and night after hospital discharge, per participant is presented here.
Measured: After hospital discharge (up to 10 days)
Number of Hypoglycemia Events After Discharge
The mean number of hypoglycemia events, defined as BG < 70 (<3.9 mmol/L), per participant after hospital discharge is presented here.
Measured: After hospital discharge (up to 10 days)
Count of Participants With Hypoglycemia After Discharge
Hypoglycemia is defined as BG < 70 mg/dL (<3.9 mmol/L) and severe hypoglycemia is defined as BG < 54 mg/dL (<3.0 mmol/L).
Measured: After hospital discharge (up to 10 days)
Percent of Time With Hyperglycemia After Discharge
The percentage of time above the desired BG range, during the day and night after hospital discharge was assessed.
Measured: After hospital discharge (up to 10 days)
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge
Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, 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 standard of mean glycemia. It is designed to assess major glucose swings and exclude minor ones
Measured: After hospital discharge (up to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start26 Jun 2019
- Primary completion27 Feb 2021
- Study completion27 Feb 2021
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877068
- Sponsor's protocol ID
- IRB00107703
- Status last verified
- Oct 2023
- First submitted
- 14 Mar 2019
- Last updated
- 24 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications for this study (including text, tables, figures, and appendices) will be available for sharing after de-identification.
Publications
Spanakis EK, Urrutia A, Galindo RJ, Vellanki P, Migdal AL, Davis G, Fayfman M, Idrees T, Pasquel FJ, Coronado WZ, Albury B, Moreno E, Singh LG, Marcano I, Lizama S, Gothong C, Munir K, Chesney C, Maguire R, Scott WH, Perez-Guzman MC, Cardona S, Peng L, Umpierrez GE. Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2022 Oct 1;45(10):2369-2375. doi: 10.2337/dc22-0716.
PubMed 35984478Spanakis EK, Singh LG, Siddiqui T, Sorkin JD, Notas G, Magee MF, Fink JC, Zhan M, Umpierrez GE. Association of glucose variability at the last day of hospitalization with 30-day readmission in adults with diabetes. BMJ Open Diabetes Res Care. 2020 May;8(1):e000990. doi: 10.1136/bmjdrc-2019-000990.
PubMed 32398351
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Inpatient Hyperglycemia by Continuous Glucose Monitoring in Insulin-treated Patients With Diabetes: Dexcom G6 Intervention Study
- ClinicalTrials.gov ID
- NCT03877068
- Acronym / sponsor ID
- IRB00107703
- Conditions
- Diabetes Mellitus
- Keywords
- Glycemic control, Bedside point-of-care capillary glucose monitoring, Dexcom, Continuous glucose monitoring, Hyperglycemia, Inpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 27 Feb 2021 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Posted 24 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Type 2 Diabetes (T2D) and Type 1 Diabetes (T1D).
Detailed description
Diabetes is reported in 20-34% of hospitalized adult patients in general medicine and surgery units and there is a large body of literature showing a strong association between diabetes and increased hospital mortality and morbidity. Clinical guidelines have recommended the use of basal bolus insulin regimens as the preferred management approach of non-intensive care unit (ICU) patients with diabetes, as it has been shown to be effective in improving glycemic control and reducing hospital complications. However, hypoglycemia is a common adverse event of insulin therapy, with incidence rates ranging between 12% and 35% in randomized studies in non-ICU settings. The development of hypoglycemia, like hyperglycemia, has been associated with higher rates of hospital complications, higher health care resource utilization, and hospital mortality.
Bedside point-of-care (POC) capillary glucose monitoring is the standard of care to assess glycemic control in the hospital. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital. In contrast to POC testing, continuous glucose monitoring (CGM) measures interstitial glucose every 5-15 minutes, thus providing a more complete glycemic profile during 24-hours compared to standard POC glucose testing. The study will assess if 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 POC testing, during hospitalization and after hospital discharge in general medicine and surgery patients with T2D and T1D.
Participants will be randomized to have the standard of care POC testing plus wear a sham CGM or to wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days during hospitalization. At the point of hospital discharge, participants with poorly controlled diabetes will be invited to participate in an open label outpatient study where they will wear a Dexcom G6 CGM or sham device for 10 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| 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 monitoringPatients 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. |
| POC BG - Point-of-Care Blood Glucose monitoring | Active comparator | Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoringGlucose 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 where no results will be visualized by patients, nursing staff, primary care physician (PCP) or research teams. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ≥ 18 years admitted to a general medicine or surgical services.
- History of T1D or T2D receiving insulin therapy during hospital admission.
- Subjects must have a randomization BG <400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalents per litre (mEq/L), potential of hydrogen (pH) < 7.30, or positive serum or urinary ketones).
- Patients with expected hospital length-of-stay of 2 or more day
Key exclusion criteria (6 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.
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
- 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 up to 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 up to 10 days. | Diagnostic test | Dexcom G6 CGM - Continues Glucose Monitoring sensor system, POC BG - Point-of-Care Blood Glucose monitoring |
Primary outcome
Mean Daily Blood Glucose (BG) Concentration While Hospitalized
Time frame: During hospitalization (up to 10 days)
A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.
Percent of Time With BG Between 70-180 mg/dL While Hospitalized
Time frame: During hospitalization (up to 10 days)
Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL.
Number of Clinically Significant Hypoglycemia Events While Hospitalized
Time frame: During hospitalization (up to 10 days)
The mean number of clinically significant hypoglycemia events, defined as BG <54 mg/dl (3.0mmol/L), per participant is presented here.
14 secondary outcomes
Number of Hypoglycemia Events While Hospitalized
Time frame: During hospitalization (up to 10 days)
Number of Nocturnal Hypoglycemia Events While Hospitalized
Time frame: During hospitalization (up to 10 days)
Percent of Time With Hypoglycemia While Hospitalized
Time frame: During hospitalization (up to 10 days)
Percent of Time With Hyperglycemia While Hospitalized
Time frame: During hospitalization (up to 10 days)
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized
Time frame: During hospitalization (up to 10 days)
Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized
Time frame: During hospitalization (up to 10 days)
Number of Sensor Changes During Hospitalization
Time frame: During hospitalization (up to 10 days)
Mean Daily BG Concentration After Discharge
Time frame: After hospital discharge (up to 10 days)
Percent of Time With BG Between 70-180 mg/dL After Discharge
Time frame: After hospital discharge (up to 10 days)
Number of Clinically Significant Hypoglycemia Events After Discharge
Time frame: After hospital discharge (up to 10 days)
Number of Hypoglycemia Events After Discharge
Time frame: After hospital discharge (up to 10 days)
Count of Participants With Hypoglycemia After Discharge
Time frame: After hospital discharge (up to 10 days)
Percent of Time With Hyperglycemia After Discharge
Time frame: After hospital discharge (up to 10 days)
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge
Time frame: After hospital discharge (up to 10 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35984478Spanakis EK, Urrutia A, Galindo RJ, Vellanki P, Migdal AL, Davis G, Fayfman M, Idrees T, Pasquel FJ, Coronado WZ, Albury B, Moreno E, Singh LG, Marcano I, Lizama S, Gothong C, Munir K, Chesney C, Maguire R, Scott WH, Perez-Guzman MC, Cardona S, Peng L, Umpierrez GE. Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2022 Oct 1;45(10):2369-2375. doi: 10.2337/dc22-0716.
- Derived from this study: PubMed 32398351Spanakis EK, Singh LG, Siddiqui T, Sorkin JD, Notas G, Magee MF, Fink JC, Zhan M, Umpierrez GE. Association of glucose variability at the last day of hospitalization with 30-day readmission in adults with diabetes. BMJ Open Diabetes Res Care. 2020 May;8(1):e000990. doi: 10.1136/bmjdrc-2019-000990.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications for this study (including text, tables, figures, and appendices) will be available for sharing after de-identification.
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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
3 sites 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 Mellitus, run by Emory University at 3 sites 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 6 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 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 24 Oct 2023). 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 (BG) Concentration While Hospitalized (time frame: During hospitalization (up to 10 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?
On the ClinicalTrials.gov record for NCT03877068, which also lists 2 linked publications.
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 24 Oct 2023.