Hypoglycemia, HyperglycemiaCGM-ICNCT06645873
Exploration of Continuous Glucose Monitoring on the Intensive Care Unit
A study testing Continuous glucose monitoring (CGM) device in people with Hypoglycemia, Hyperglycemia, run by Kim Kamphorst at 3 sites in Netherlands.
Trial summary
Both hyperglycemia and hypoglycemia in patients at the intensive care unit (ICU) are strongly associated with increased morbidity and mortality. Accurate and timely measurements of glucose levels in this population are therefore crucial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoglycemia, Hyperglycemia
- What is being tested?
- Continuous glucose monitoring (CGM) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesNetherlands
- Study dates
- 17 Dec 2024to 30 Sep 2025
- 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
- Patients admitted to the ICU
- Insulin-dependent as defined in local protocol
- Age: ≥ 18 y
- Expected length of stay in ICU more than 2 days
Who cannot join
- Pregnancy
- No informed consent
- Therapeutic hypothermia (less than 34 degrees celsius)
- Platelet count less than 50,000/μL at time of inclusion
- Use of hydroxyurea
- Use of acetaminophen more than 4 g/day
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Zorggroep Twente Almelo
Almelo, Overijssel, 7609 PP
Deventer Ziekenhuis
Deventer, Overijssel, 7416SE
Medisch Spectrum Twente
Enschede, Overijssel, 7512 KZ
About this study
Official title: Comparison of Continuous Glucose Monitoring and Point-of-Care Measurements on the Intensive Care Unit: An Exploratory Study
Both hyperglycemia and hypoglycemia in patients at the intensive care unit (ICU) are strongly associated with increased morbidity and mortality. Accurate and timely measurements of glucose levels in this population are therefore crucial. Continuous glucose monitoring (CGM) appears promising for this purpose, but it is not yet used in the ICU due to insufficient knowledge about its reliability in critically ill patients. The aim of this study is to investigate the discrepancy between CGM and point-of-care measurements in ICU patients and whether this discrepancy is consistent across all ICU patient groups/characteristics.
This study investigates whether continuous glucose monitoring can be used in the intensive care setting.
Read the detailed description
Hyperglycemia is present in up to 50% of patients admitted to an intensive care unit (ICU) and is strongly associated with elevated morbidity and mortality rates. Therefore, it is important to monitor glucose levels closely. In the ICU, glucose monitoring primarily relies on periodic measurements through point-of-care (POC) meters, which involve invasive blood sampling from venous or arterial lines. To maintain blood glucose concentrations within acceptable ranges, a possible improvement is continuous glucose monitoring (CGM), which is now used to manage glucose levels in diabetic patients in general settings and has shown significant benefits. Studies on the use of CGM in the ICU setting are limited. If CGM reliably measures glucose levels in critically ill patients, it enables earlier intervention and might help to predict hypo- or hyperglycemia based on measurement trends.
Objective: To investigate the discrepancy between CGM and POC measurements in insulin-dependent ICU patients and to study whether these potential discrepancies between CGM and POC vary across patient-related factors, like gender, age, comorbidities, medication use, disease severity scores, treatment in ICU.
Study design: Prospective, multi-centre, single-arm intervention, exploratory study
Intervention: All study participants receive one CGM sensor to monitor glucose levels. A second CGM sensor will only be applied if the first CGM sensor needed to be replaced within 8 days after insertion. The measurements will be blinded to all except the research team.
- Conditions
- Hypoglycemia, Hyperglycemia
- Being tested
- Continuous glucose monitoring (CGM) device
- Keywords
- Intensive care units, insulin, Continuous Glucose Monitoring
- Medical subject headings
- Hypoglycemia, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring (CGM) deviceDevice
All included study participants recieve a CGM sensor (Dexcom G7) to monitor blood glucose. The treatment team is blind for the CGM values; the gold standard for glucose control (POC interval measures) will be followed.
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring | Experimental | Not described Receives: Device: Continuous glucose monitoring (CGM) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrepancy glucose CGM - POC
Discrepancy between glucose levels (in mmol/L) measured with Continuous Glucose Monitoring (measured with the Dexcom G7 sensor) and Point-Of-Care (measured with the Accu-check) measurement in insulin-dependent Intensive Care Unit patients.
The discrepancy is defined as the difference in absolute glucose levels in arterial blood samples.
Measured: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Variation discrepancy across patient-related factors
The variation of the potential difference in glucose levels (in mmol/L) between CGM (measured with the Dexcom G7 sensor) and POC (measured with the Accu-check) will be analyzed among the following patient-related factors:
Age at the time of inclusion (in years). Body Mass Index (BMI) (in kg/m²). Gender (Male/Female).
Comorbidities:
Hypertension (Yes/No). Hypotension (Yes/No). Pre-existing diabetes (Yes/No). Edema (measured as weight gain in kg). Acidosis (pH value, continuous scale).
Medication use:
Corticosteroids (Yes/No). Inotropics (Yes/No and dosage in µg/kg/min). Vasopressors (Yes/No and dosage in µg/kg/min). APACHE II score (Scale). SOFA score (Scale). Reason for ICU admission (Categorical variable, e.g., sepsis, trauma, etc.). Length of ICU stay (in days). Duration of mechanical ventilation (in hours or days). Dialysis (Yes/No).
Measured: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Secondary outcomes (6)
Adverse events
The number of reported adverse events, such as infections, bleeding, and decubitus, linked to the continuous glucose sensor (Dexcom G7)
Measured: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Number of missed hypo- and hypreglycemia episodes
The number and percentage of missed hypoglycemia episodes (defined as a glucose level < 4.0 mmol/L) and hyperglycemia episodes (defined as a glucose level > 10 mmol/L), as indicated by the continuous glucose monitoring (CGM) using the Dexcom G7 sensor, were not detected by point-of-care (POC) interval measurements with the Accu-Chek device.
Measured: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Delay in detection hypo- or hyperglycemia episodes
The time in minutes between the onset of hypoglycemia (defined as a glucose level < 4.0 mmol/L) or hyperglycemia (defined as a glucose level > 10 mmol/L) detected by the continuous glucose monitoring (CGM) using the Dexcom G7 sensor and its subsequent detection via point-of-care (POC) testing with the Accu-Chek device.
Measured: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Insertion CGM: time till reliable data and lasting time
The duration of time, in minutes, it takes for the CGM (Dexcom G7 sensor) to reliably measure the glucose (defined as MARD <14%) after the sensor is inserted. Duration of time, in hours, the CGM reliably measures the glucose (defined as MARD <14%) after the sensor is inserted.
Measured: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Impact radiologic procedure
The difference in discrepancies between glucose levels (in mmol/L) measured by continuous glucose monitoring (CGM) using the Dexcom G7 sensor and point-of-care (POC) testing with the Accu-Chek device following radiologic procedures (e.g., CT scans and X-rays) is evaluated.
Discrepancy is defined as the difference in absolute glucose levels in arterial blood samples measured with the POC compared to the continuous glucose levels measured with the CGM.
Measured: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days, but only if a radiologic procedure is performed
Location GCM sensor
The difference in mean absolute relative difference (MARD) between glucose levels (in mmol/L) measured by continuous glucose monitoring (CGM) using the Dexcom G7 sensor and point-of-care (POC) testing with the Accu-Chek device is assessed when the CGM sensor is placed in the abdomen compared to the upper arm
Measured: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start17 Dec 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoglycemia, HyperglycemiaStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kim Kamphorst
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc., Pioneers in Healthcare
- Responsible party
- Sponsor-investigator, Kim Kamphorst, Deventer Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645873
- Sponsor's protocol ID
- NL87243.100.24
- Acronym
- CGM-IC
- Status last verified
- Feb 2025
- First submitted
- 3 Oct 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We are committed to sharing individual participant data (IPD) in accordance with established data-sharing principles. However, access to our IPD will only be granted upon formal request. Researchers interested in obtaining the data must submit a detailed request to the study\&#39;s designated contact person. This request should include a thorough explanation of the intended use of the data, the research plan, and ethical considerations. Each request will be carefully evaluated based on the proposed study\&#39;s merits and alignment with our data-sharing policies before a decision is made regarding data access.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Glucose Monitoring and Point-of-Care Measurements on the Intensive Care Unit: An Exploratory Study
- ClinicalTrials.gov ID
- NCT06645873
- Acronym / sponsor ID
- CGM-IC / NL87243.100.24
- Conditions
- Hypoglycemia, Hyperglycemia
- Keywords
- Intensive care units, insulin, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kim KamphorstUniversity, hospital or other
- Collaborators
- DexCom, Inc., Pioneers in Healthcare
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 17 Oct 2024 (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.
Both hyperglycemia and hypoglycemia in patients at the intensive care unit (ICU) are strongly associated with increased morbidity and mortality. Accurate and timely measurements of glucose levels in this population are therefore crucial. Continuous glucose monitoring (CGM) appears promising for this purpose, but it is not yet used in the ICU due to insufficient knowledge about its reliability in critically ill patients. The aim of this study is to investigate the discrepancy between CGM and point-of-care measurements in ICU patients and whether this discrepancy is consistent across all ICU patient groups/characteristics.
This study investigates whether continuous glucose monitoring can be used in the intensive care setting.
Detailed description
Hyperglycemia is present in up to 50% of patients admitted to an intensive care unit (ICU) and is strongly associated with elevated morbidity and mortality rates. Therefore, it is important to monitor glucose levels closely. In the ICU, glucose monitoring primarily relies on periodic measurements through point-of-care (POC) meters, which involve invasive blood sampling from venous or arterial lines. To maintain blood glucose concentrations within acceptable ranges, a possible improvement is continuous glucose monitoring (CGM), which is now used to manage glucose levels in diabetic patients in general settings and has shown significant benefits. Studies on the use of CGM in the ICU setting are limited. If CGM reliably measures glucose levels in critically ill patients, it enables earlier intervention and might help to predict hypo- or hyperglycemia based on measurement trends.
Objective: To investigate the discrepancy between CGM and POC measurements in insulin-dependent ICU patients and to study whether these potential discrepancies between CGM and POC vary across patient-related factors, like gender, age, comorbidities, medication use, disease severity scores, treatment in ICU.
Study design: Prospective, multi-centre, single-arm intervention, exploratory study
Intervention: All study participants receive one CGM sensor to monitor glucose levels. A second CGM sensor will only be applied if the first CGM sensor needed to be replaced within 8 days after insertion. The measurements will be blinded to all except the research team.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring | Experimental | Device: Continuous glucose monitoring (CGM) device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted to the ICU
- Insulin-dependent as defined in local protocol
- Age: ≥ 18 y
- Expected length of stay in ICU more than 2 days
Key exclusion criteria (6 listed)
- Pregnancy
- No informed consent
- Therapeutic hypothermia (less than 34 degrees celsius)
- Platelet count less than 50,000/μL at time of inclusion
- Use of hydroxyurea
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 |
|---|---|---|
| Continuous glucose monitoring (CGM) deviceAll included study participants recieve a CGM sensor (Dexcom G7) to monitor blood glucose. The treatment team is blind for the CGM values; the gold standard for glucose control (POC interval measures) will be followed. | Device | Continuous glucose monitoring |
Primary outcome
Discrepancy glucose CGM - POC
Time frame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Discrepancy between glucose levels (in mmol/L) measured with Continuous Glucose Monitoring (measured with the Dexcom G7 sensor) and Point-Of-Care (measured with the Accu-check) measurement in insulin-dependent Intensive Care Unit patients. The discrepancy is defined as the difference in absolute glucose levels in arterial blood samples.
Variation discrepancy across patient-related factors
Time frame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
The variation of the potential difference in glucose levels (in mmol/L) between CGM (measured with the Dexcom G7 sensor) and POC (measured with the Accu-check) will be analyzed among the following patient-related factors: Age at the time of inclusion (in years). Body Mass Index (BMI) (in kg/m²). Gender (Male/Female). Comorbidities: Hypertension (Yes/No). Hypotension (Yes/No). Pre-existing diabetes (Yes/No). Edema (measured as weight gain in kg). Acidosis (pH value, continuous scale). Medication use: Corticosteroids (Yes/No). Inotropics (Yes/No and dosage in µg/kg/min). Vasopressors (Yes/No and dosage in µg/kg/min). APACHE II score (Scale). SOFA score (Scale). Reason for ICU admission (Categorical variable, e.g., sepsis, trauma, etc.). Length of ICU stay (in days). Duration of mechanical ventilation (in hours or days). Dialysis (Yes/No).
6 secondary outcomes
Adverse events
Time frame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Number of missed hypo- and hypreglycemia episodes
Time frame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Delay in detection hypo- or hyperglycemia episodes
Time frame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Insertion CGM: time till reliable data and lasting time
Time frame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Impact radiologic procedure
Time frame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days, but only if a radiologic procedure is performed
Location GCM sensor
Time frame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No. We are committed to sharing individual participant data (IPD) in accordance with established data-sharing principles. However, access to our IPD will only be granted upon formal request. Researchers interested in obtaining the data must submit a detailed request to the study\&#39;s designated contact person. This request should include a thorough explanation of the intended use of the data, the research plan, and ethical considerations. Each request will be carefully evaluated based on the proposed study\&#39;s merits and alignment with our data-sharing policies before a decision is made regarding data access.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring (CGM) device in people with Hypoglycemia, Hyperglycemia, run by Kim Kamphorst at 3 sites in Netherlands.
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 3 Oct 2025. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Discrepancy glucose CGM - POC (time frame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.). The study lists 2 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 3 Oct 2025.