Diabetes MellitusNCT06800365
Assessing Accuracy of the Freestyle Libre Pro Glucose Monitoring in Patients With Diabetes in a Critical Care Setting
A study testing Sensor in people with Diabetes Mellitus and Critical Illness, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
Currently, the standard of care for monitoring sugar levels in patients with diabetes in the intensive care unit is to use finger stick blood sugar monitoring. Finger stick blood sugar monitoring can be uncomfortable and time consuming. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Critical Illness, Continuous Glucose Monitoring
- What is being tested?
- Sensor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2021to 21 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 or females age 18 and older. There is no upper age limit.
- English speakers.
- History of Type 1 or Type 2 diabetes (noted in electronic medical record or confirmed by patient or LAR).
- Admission to the medical intensive care unit with expected stay of at least 48 hours
Who cannot join
- New diagnosis or no known history of type 1 or type 2 diabetes.
- Patients with documentation stating desire not to participate in research.
- Prisoners.
- Documented allergy to adhesives or tape.
Trial locations and contacts
1 site in 1 country.
About this study
Currently, the standard of care for monitoring sugar levels in patients with diabetes in the intensive care unit is to use finger stick blood sugar monitoring. Finger stick blood sugar monitoring can be uncomfortable and time consuming. An alternate way to monitor sugar levels to use a sugar sensor, as part of the Abbott Freestyle Libre Flash glucose monitoring system, which has been approved for use outside of the hospital. The goal of the current research is to see whether using the sugar sensor gives accurate sugar readings in patients that are ill enough to be in the intensive care unit. If research confirms that the sensor is accurate, the investigators could potentially need to do fewer of those uncomfortable and time consuming blood sugar finger sticks.
At this time, the Freestyle Libre Flash Glucose Monitoring system is not available for purchase without a specific prescription for each individual patient and also is not available for purchase for research use from the manufacturer, Abbott Laboratories. However, the Freestyle Libre Pro sensor is available and uses the same measurement technology to measure interstitial glucose as the Libre Flash Glucose Monitoring system sensor (but does not require sensor scanning to retain glucose data). As such, the Libre Pro sensor will be utilized for the current study.
Read more
When a participant is enrolled in this study, they will have a Abbott Freestyle Libre Pro sensor applied to the back of their arm. They will continue to have finger stick glucoses checked as determined by their primary medical ICU team just as if they would if not enrolled in the study.
After the participant leaves the hospital, the data from their finger stick glucoses and from the Libre will be compared by a statistical analysis to see how similar or different the glucose readings from the finger stick glucoses are as compared to the Libre sensor data.
Read the detailed description
This will be a single center, prospective, single arm study including 40 adult patients with Type I or II diabetes, 18 years of age or older, admitted to the Medical Intensive Care Unit (MICU) at the Hennepin County Medical Center during a 4 month time-frame with an expected MICU admission duration of at least 48 hours.
Once patients are deemed eligible based on inclusion and exclusion criteria, patients or their legal authorized representative (LAR) decision makers (if patient is unable to consent) will be approached by the PI or co-investigators. The consent form will be read out loud clearly to the patient or LAR. They will be given an opportunity to read it themselves if they so choose and also ask clarification questions as needed. Patients or LAR will be asked to recall details of the study to confirm understanding and assess capacity to consent. If patient or LAR accepts to be part of the study, the investigators will ask that a consent form be signed. The patient will be provided a copy of the consent and the original copy will be provided to the Health Information Management (HIM) department for secure storage.
Once the consenting process is completed, investigators will place the Libre pro sensor on the back of one of the arms of the patient using the applicator provided with the Libre monitor (see appendix). Investigators will confirm that the device is operational.
The sensor will remain in place for the duration of the patient's hospital stay and be removed prior to discharge. Sensors last a total of 14 days. If a patient remains in the hospital for greater than 14 days, the sensor will be collected on day 14 of hospitalization and will not be replaced with a new sensor. The sensor does need to be removed for CT scans, MRI scans or diathermy. If the sensor is removed for these reasons, a new sensor will be placed after completion of the imaging or procedure. Patients will be followed during their hospitalization in the MICU and after they have been transferred out of the MICU. If a patient discharges during normal business hours of 8AM to 5PM, study investigators will remove and store the monitor and sensor for future data analysis in a locked cabinet. If a patient discharges at any other time (nights and weekends), nurses will remove the sensors. Sensors are easy to remove and nurses will not require special training to remove the sensors. Nurses will store the sensor in a labeled plastic bag and then place the bag in the nursing station medication room. This room requires badge access. The sensor will be picked up by study investigators the following business day.
Nurses or medical assistants will conduct standard of care (SOC) capillary fingerstick glucose monitoring per hospital protocol for patients with diabetes. Nurse decision making will be based on capillary fingerstick glucose monitoring (SOC) alone. FGM glucose level will not be obtained prior to sensor removal. As such, FGM glucose levels will not be available for decision making. Nurses, medical assistants, and clinician researchers will be blinded to glucose data collected via FGM until the study concludes and data analysis begins.
The patient satisfaction and nurse acceptance surveys will be administered on the day of discharge or the day prior to discharge if the patient is expected to be discharged the next morning. If a patient is discharged before completing the survey, investigators may contact the patient by phone to complete the survey. There will otherwise be no follow up after discharge.
- Being tested
- Sensor
- Keywords
- Diabetes Mellitus, Critical Illness, Continuous glucose monitoring, Flash glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SensorDevice
The FreeStyle Libre Pro sensor is a device whereby a sensor is inserted into subcutaneous tissue (upper arm) and measures the interstitial blood glucose which is then available for later download. It comes pre-calibrated meaning that no fingerstick glucose monitoring is required to improve accuracy of the sensor.
| Study group | Role | What they receive |
|---|---|---|
| Sensor arm | Experimental | Sensor arm patients will have a glucose sensor applied to their physical arm. Receives: Device: Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by calculation of the mean absolute relative difference
Numerical accuracy will be defined by the mean absolute relative difference (MARD)
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by use of the Bland-Altman method
Numerical accuracy will be defined by the Bland-Altman method
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by assessing adherence to International Organization for Standardization (ISO) criteria
Numerical accuracy will be informed by whether the International Organization for Standardization (ISO) criteria are met
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by assessing adherence to the Clinical and Laboratory Standards Institute Point of Care Testing (CLSI-POCT) criteria
Numerical accuracy will be informed by whether the Clinical and Laboratory Standards Institute Point of Care Testing (CLSI-POCT) criteria are met
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Determination of clinical accuracy of Freestyle Libre Pro sensor glucose monitoring by Surveillance Error Grid (SEG) analyses
Clinical accuracy will be defined by Surveillance Error Grid (SEG) analyses.
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Determination of clinical accuracy of Freestyle Libre Pro sensor glucose monitoring by Clarke Error Grid (CEG) analyses
Clinical accuracy will be defined by Clarke Error Grid (CEG) analyses.
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Secondary outcomes (5)
Hypoglycemic events
To determine the number of hypoglycemic events (55-70 mg/dl, 40-55 mg/dl, and < 40 mg/dl) detected by sensor and POC testing.
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Time in range
To determine the percentage of BG readings within target BG of 70 and 180 mg/dl per on fingerstick glucose checks and total time in range per glucose sensor.
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Patient satisfaction: survey
Evaluate patient satisfaction with having the sensor in place using a qualitative Patient Satisfaction survey.
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Nursing staff satisfaction and acceptability: survey
Evaluate how nurses predict acceptability and satisfaction of nursing staff use of the Freestyle Libre Flash Glucose monitoring system using a qualitative Nurse Acceptance Survey
Measured: Surveys to be administered to nursing staff at time of sensor removal from participant. Sensor removal takes place at time of patient discharge from hospital or when sensor has been in place for 14 days, whichever time point occurs first.
Adverse event monitoring
Evaluate the tolerability and safety of the FGM in critically ill patients; i.e outline any adverse outcomes from its use.
Measured: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start6 Apr 2021
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Why it stopped: Given the increased strain on nursing staff during the COVID-19 pandemic, Libre sensors were repeatedly being mistakenly removed and discarded by nursing staff prior to data collection.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Model description
- The study will be a single arm, single center, prospective trial. Patients admitted to the medical ICU will be screened for eligibility criteria and enrollment will be offered if criteria are met.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Laura Lafave, Hennepin Healthcare Research Institute
- Investigators
- Laura Lafave, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800365
- Sponsor's protocol ID
- HSR #19-4700
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2020
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Accuracy of the Freestyle Libre Pro Glucose Monitoring in Patients With Diabetes in a Critical Care Setting
- ClinicalTrials.gov ID
- NCT06800365
- Acronym / sponsor ID
- HSR #19-4700
- Keywords
- Diabetes Mellitus, Critical Illness, Continuous glucose monitoring, Flash glucose monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Given the increased strain on nursing staff during the COVID-19 pandemic, Libre sensors were repeatedly being mistakenly removed and discarded by nursing staff prior to data collection.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, the standard of care for monitoring sugar levels in patients with diabetes in the intensive care unit is to use finger stick blood sugar monitoring. Finger stick blood sugar monitoring can be uncomfortable and time consuming. An alternate way to monitor sugar levels to use a sugar sensor, as part of the Abbott Freestyle Libre Flash glucose monitoring system, which has been approved for use outside of the hospital. The goal of the current research is to see whether using the sugar sensor gives accurate sugar readings in patients that are ill enough to be in the intensive care unit. If research confirms that the sensor is accurate, the investigators could potentially need to do fewer of those uncomfortable and time consuming blood sugar finger sticks.
At this time, the Freestyle Libre Flash Glucose Monitoring system is not available for purchase without a specific prescription for each individual patient and also is not available for purchase for research use from the manufacturer, Abbott Laboratories. However, the Freestyle Libre Pro sensor is available and uses the same measurement technology to measure interstitial glucose as the Libre Flash Glucose Monitoring system sensor (but does not require sensor scanning to retain glucose data). As such, the Libre Pro sensor will be utilized for the current study.
When a participant is enrolled in this study, they will have a Abbott Freestyle Libre Pro sensor applied to the back of their arm. They will continue to have finger stick glucoses checked as determined by their primary medical ICU team just as if they would if not enrolled in the study.
After the participant leaves the hospital, the data from their finger stick glucoses and from the Libre will be compared by a statistical analysis to see how similar or different the glucose readings from the finger stick glucoses are as compared to the Libre sensor data.
Detailed description
This will be a single center, prospective, single arm study including 40 adult patients with Type I or II diabetes, 18 years of age or older, admitted to the Medical Intensive Care Unit (MICU) at the Hennepin County Medical Center during a 4 month time-frame with an expected MICU admission duration of at least 48 hours.
Once patients are deemed eligible based on inclusion and exclusion criteria, patients or their legal authorized representative (LAR) decision makers (if patient is unable to consent) will be approached by the PI or co-investigators. The consent form will be read out loud clearly to the patient or LAR. They will be given an opportunity to read it themselves if they so choose and also ask clarification questions as needed. Patients or LAR will be asked to recall details of the study to confirm understanding and assess capacity to consent. If patient or LAR accepts to be part of the study, the investigators will ask that a consent form be signed. The patient will be provided a copy of the consent and the original copy will be provided to the Health Information Management (HIM) department for secure storage.
Once the consenting process is completed, investigators will place the Libre pro sensor on the back of one of the arms of the patient using the applicator provided with the Libre monitor (see appendix). Investigators will confirm that the device is operational.
The sensor will remain in place for the duration of the patient's hospital stay and be removed prior to discharge. Sensors last a total of 14 days. If a patient remains in the hospital for greater than 14 days, the sensor will be collected on day 14 of hospitalization and will not be replaced with a new sensor. The sensor does need to be removed for CT scans, MRI scans or diathermy. If the sensor is removed for these reasons, a new sensor will be placed after completion of the imaging or procedure. Patients will be followed during their hospitalization in the MICU and after they have been transferred out of the MICU. If a patient discharges during normal business hours of 8AM to 5PM, study investigators will remove and store the monitor and sensor for future data analysis in a locked cabinet. If a patient discharges at any other time (nights and weekends), nurses will remove the sensors. Sensors are easy to remove and nurses will not require special training to remove the sensors. Nurses will store the sensor in a labeled plastic bag and then place the bag in the nursing station medication room. This room requires badge access. The sensor will be picked up by study investigators the following business day.
Nurses or medical assistants will conduct standard of care (SOC) capillary fingerstick glucose monitoring per hospital protocol for patients with diabetes. Nurse decision making will be based on capillary fingerstick glucose monitoring (SOC) alone. FGM glucose level will not be obtained prior to sensor removal. As such, FGM glucose levels will not be available for decision making. Nurses, medical assistants, and clinician researchers will be blinded to glucose data collected via FGM until the study concludes and data analysis begins.
The patient satisfaction and nurse acceptance surveys will be administered on the day of discharge or the day prior to discharge if the patient is expected to be discharged the next morning. If a patient is discharged before completing the survey, investigators may contact the patient by phone to complete the survey. There will otherwise be no follow up after discharge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be a single arm, single center, prospective trial. Patients admitted to the medical ICU will be screened for eligibility criteria and enrollment will be offered if criteria are met.
| Arm | Type | Receives |
|---|---|---|
| Sensor arm | Experimental | Device: SensorSensor arm patients will have a glucose sensor applied to their physical arm. |
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 or females age 18 and older. There is no upper age limit.
- English speakers.
- History of Type 1 or Type 2 diabetes (noted in electronic medical record or confirmed by patient or LAR).
- Admission to the medical intensive care unit with expected stay of at least 48 hours
Key exclusion criteria (4 listed)
- New diagnosis or no known history of type 1 or type 2 diabetes.
- Patients with documentation stating desire not to participate in research.
- Prisoners.
- Documented allergy to adhesives or tape.
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 |
|---|---|---|
| SensorThe FreeStyle Libre Pro sensor is a device whereby a sensor is inserted into subcutaneous tissue (upper arm) and measures the interstitial blood glucose which is then available for later download. It comes pre-calibrated meaning that no fingerstick glucose monitoring is required to improve accuracy of the sensor. | Device | Sensor arm |
Primary outcome
Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by calculation of the mean absolute relative difference
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Numerical accuracy will be defined by the mean absolute relative difference (MARD)
Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by use of the Bland-Altman method
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Numerical accuracy will be defined by the Bland-Altman method
Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by assessing adherence to International Organization for Standardization (ISO) criteria
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Numerical accuracy will be informed by whether the International Organization for Standardization (ISO) criteria are met
Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by assessing adherence to the Clinical and Laboratory Standards Institute Point of Care Testing (CLSI-POCT) criteria
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Numerical accuracy will be informed by whether the Clinical and Laboratory Standards Institute Point of Care Testing (CLSI-POCT) criteria are met
Determination of clinical accuracy of Freestyle Libre Pro sensor glucose monitoring by Surveillance Error Grid (SEG) analyses
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Clinical accuracy will be defined by Surveillance Error Grid (SEG) analyses.
Determination of clinical accuracy of Freestyle Libre Pro sensor glucose monitoring by Clarke Error Grid (CEG) analyses
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Clinical accuracy will be defined by Clarke Error Grid (CEG) analyses.
5 secondary outcomes
Hypoglycemic events
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Time in range
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Patient satisfaction: survey
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Nursing staff satisfaction and acceptability: survey
Time frame: Surveys to be administered to nursing staff at time of sensor removal from participant. Sensor removal takes place at time of patient discharge from hospital or when sensor has been in place for 14 days, whichever time point occurs first.
Adverse event monitoring
Time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)
Results and safety
The study was stopped early (reason given: Given the increased strain on nursing staff during the COVID-19 pandemic, Libre sensors were repeatedly being mistakenly removed and discarded by nursing staff prior to data collection.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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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.
Laura Lafave, MD principal investigator
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor in people with Diabetes Mellitus and Critical Illness, run by Hennepin Healthcare Research Institute 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: stopped early, as of the sponsor's last update on 30 Jan 2025. 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?
The study was stopped early (reason given: Given the increased strain on nursing staff during the COVID-19 pandemic, Libre sensors were repeatedly being mistakenly removed and discarded by nursing staff prior to data collection.). Results are not available in the source record.
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?
Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by calculation of the mean absolute relative difference (time frame: From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)). The study lists 6 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 30 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.