Diabetes MellitusNCT04653454
Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus
A study testing Continuous Glucose Monitor (CGM) in people with Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if patient's own Continuous Glucose Monitor (CGMs) worn in the non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucose measurement, and to determine if alerts given by CGMs worn in the non-ICU hospital… 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?
- Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 10 Nov 2023
- 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
- Patients with Type 1 or 2 Diabetes Mellitus,
- Patients 18 years of age or older,
- Patients admitted under medical or surgical services.
- Patients treated with diet alone, insulin (SQ, insulin pump) or oral hypoglycemic medications.
- Have their own Continuous Glucose Monitoring (CGM) monitor present on admission or able to be placed after admission.
Who cannot join
- Individuals under 18 years of age.
- COVID-19 infection.
- Infection of the skin at the CGM site requiring removal of the sensor.
- Patients with altered Mental Status.
- Patients unable to scan their flash CGMs at least every 8 hours.
- Inability to provide written consent.
- Hospitalized for less than 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CGM Use in Hospitalized Patients With Diabetes Mellitus
The purpose of this study is to determine if patient's own Continuous Glucose Monitor (CGMs) worn in the non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucose measurement, and to determine if alerts given by CGMs worn in the non-ICU hospital would prevent episodes of hyperglycemia and hypoglycemia.
Read the detailed description
All patients admitted to the hospital in inpatient or observation status and having a Continuous Glucose Monitor (CGMs) attached will be screened and identified by providers and nurses. An order will be placed by providers to continue patient's home CGM use in the hospital. "CGM patient agreement" describing the hospital policy for use of CGMs will be provided to the patient for signature. Patients will be encouraged to continue to wear their CGMs in the hospital unless their presence interferes with patients' medical care. CGM presence will be recorded by nursing in patient chart under LDA (lines, drains, airway) section. Patients will be approached by the research staff and will be offered enrollment in the study. A research consent will be reviewed with patients and will be provided for signature. Patients will be asked to continue to use their home CGMs in the hospital. If CGM sensor will reach the end of life, patients have the option to place a new sensor and to follow manufacturer recommendations for calibration and setting. Patients are responsible to provide their own sensors, transmitters and readers during the hospitalization period. If it is determined that the current sensor will interfere with hospital medical and surgical care (MRI testing, procedure at the site), patients will be asked to remove the CGM sensor and transmitter. Patients will have the option to replace the sensor after the procedure if they so desire.
Patients will continue to monitor their glucose level via CGM. For flash sensors, patients will be asked to scan their sensor at least every 8 and as needed. CGMs that require calibration will be calibrated by the patients using hospital glucometer readings. .
Patients alerted by their CGM about low glucose levels or fast downward or upward trending will have to notify their nursing staff. A POC blood glucose check will be done by nursing staff to confirm the alert or the trend. Treatment decisions will be made based on POC readings.
During hospitalization patients will continue to have their blood glucose checked with POC glucometers per hospital policy.
Treatment of diabetes and the associated complications, dosing of insulin, change from PO to insulin treatment and back to PO medications during hospitalization or at discharge will be done by the admitting team with help from the inpatient Endocrinology Consultation Service.
Decisions about insulin dosing or other diabetes treatments will be made based on hospital glucometer readings, and not based on CGM readings alone.
Patients will be asked to give the research team "provider access" to their cloud CGM software, or to allow the team to download their CGM data prior to discharge if their reading devices do not automatically synchronize with the cloud software.
CGM data will be compared with POC glucometer readings obtained in the hospital at approximately the same time. Different patient variables (demographics, comorbidities, labs and vitals, administered medications) will be collected from electronic health record and will be evaluated to determine if they interfere with CGM readings. The accuracy of CGM for glucose measurement in the hospital will be calculated.
- Conditions
- Diabetes Mellitus
- Being tested
- Continuous Glucose Monitor (CGM)
- Keywords
- CGM, Continuous Glucose Monitor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitor (CGM)Device
CGM data will be downloaded prior to discharge and it will be compared with hospital glucometer readings taken at the same time.
| Study group | Role | What they receive |
|---|---|---|
| CGM Patients | Experimental | Patients with diabetes mellitus admitted to the hospital and using a CGM will be encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels will be communicated to the nursing staff. Receives: Device: Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings <70 mg/dl, 70-180 mg/dL, >180 mg/dl, 181-250mg/dl, >250 mg/dl respectively.
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
Secondary outcomes (9)
CGM Recorded Hypoglycemia Episodes
The incidence of hypoglycemic episodes
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Duration of Hypoglycemic Episodes
CGM recorded duration of hypoglycemic episodes
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Hyperglycemic Episodes
The incidence of hyperglycemic episodes
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Duration of Hyperglycemic Episodes
The duration of hyperglycemic episodes
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters
The correlation between MARD point of care (POC) and Creatinine, Glomerular Filtration Rate (GFR), Bicarbonate, Hemoglobin (Hb), Mean Arterial Pressure (MAP), and Peripheral Oxygen Saturation (SpO2). The Spearman's rank correlation method was used to calculate the correlation coefficient.
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
In Hospital Mortality
Mortality during index hospitalization
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
Hospitalization Length of Stay
Duration of hospital stay in hours
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
Mortality Rate at 30 Days
Mortality rate at 30 days post discharge from the hospital
Measured: From date of enrollment up to 60 days.
Number of Re-hospitalization Events at the Same Institution Within 30 Days From the Discharge Date of the Preceding Admission.
Number of re-hospitalization events that occurred at the same institution within 30 days from the discharge date of the preceding admission.
Measured: From date of enrollment up to 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jan 2021
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
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 (1)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 Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian G. Dumitrascu, Mayo Clinic
- Investigators
- Adrian Dumitrascu, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653454
- Sponsor's protocol ID
- 20-008826
- Status last verified
- Jul 2025
- First submitted
- 6 Nov 2020
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dumitrascu AG, Perry M, Chindris AM, Chirila RM, Boone RJ, Blumenfeld SG, Hodge DO, White LJ, Gnanapandithan K, De La Cruz DA, Pagan RJ, Smerina M, Gavrancic T, Cortes MP, Murawska Baptista A, Wilson JR. Real-World Performance of Personal Continuous Glucose Monitors During Hospitalization. Diabetes Technol Ther. 2025 Aug;27(8):613-622. doi: 10.1089/dia.2024.0639. Epub 2025 Apr 14.
PubMed 40229126
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CGM Use in Hospitalized Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04653454
- Acronym / sponsor ID
- 20-008826
- Conditions
- Diabetes Mellitus
- Keywords
- CGM, Continuous Glucose Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Posted 31 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if patient's own Continuous Glucose Monitor (CGMs) worn in the non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucose measurement, and to determine if alerts given by CGMs worn in the non-ICU hospital would prevent episodes of hyperglycemia and hypoglycemia.
Detailed description
All patients admitted to the hospital in inpatient or observation status and having a Continuous Glucose Monitor (CGMs) attached will be screened and identified by providers and nurses. An order will be placed by providers to continue patient's home CGM use in the hospital. "CGM patient agreement" describing the hospital policy for use of CGMs will be provided to the patient for signature. Patients will be encouraged to continue to wear their CGMs in the hospital unless their presence interferes with patients' medical care. CGM presence will be recorded by nursing in patient chart under LDA (lines, drains, airway) section. Patients will be approached by the research staff and will be offered enrollment in the study. A research consent will be reviewed with patients and will be provided for signature. Patients will be asked to continue to use their home CGMs in the hospital. If CGM sensor will reach the end of life, patients have the option to place a new sensor and to follow manufacturer recommendations for calibration and setting. Patients are responsible to provide their own sensors, transmitters and readers during the hospitalization period. If it is determined that the current sensor will interfere with hospital medical and surgical care (MRI testing, procedure at the site), patients will be asked to remove the CGM sensor and transmitter. Patients will have the option to replace the sensor after the procedure if they so desire.
Patients will continue to monitor their glucose level via CGM. For flash sensors, patients will be asked to scan their sensor at least every 8 and as needed. CGMs that require calibration will be calibrated by the patients using hospital glucometer readings. .
Patients alerted by their CGM about low glucose levels or fast downward or upward trending will have to notify their nursing staff. A POC blood glucose check will be done by nursing staff to confirm the alert or the trend. Treatment decisions will be made based on POC readings.
During hospitalization patients will continue to have their blood glucose checked with POC glucometers per hospital policy.
Treatment of diabetes and the associated complications, dosing of insulin, change from PO to insulin treatment and back to PO medications during hospitalization or at discharge will be done by the admitting team with help from the inpatient Endocrinology Consultation Service.
Decisions about insulin dosing or other diabetes treatments will be made based on hospital glucometer readings, and not based on CGM readings alone.
Patients will be asked to give the research team "provider access" to their cloud CGM software, or to allow the team to download their CGM data prior to discharge if their reading devices do not automatically synchronize with the cloud software.
CGM data will be compared with POC glucometer readings obtained in the hospital at approximately the same time. Different patient variables (demographics, comorbidities, labs and vitals, administered medications) will be collected from electronic health record and will be evaluated to determine if they interfere with CGM readings. The accuracy of CGM for glucose measurement in the hospital will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM Patients | Experimental | Device: Continuous Glucose Monitor (CGM)Patients with diabetes mellitus admitted to the hospital and using a CGM will be encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels will be communicated to the nursing staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Type 1 or 2 Diabetes Mellitus,
- Patients 18 years of age or older,
- Patients admitted under medical or surgical services.
- Patients treated with diet alone, insulin (SQ, insulin pump) or oral hypoglycemic medications.
- Have their own Continuous Glucose Monitoring (CGM) monitor present on admission or able to be placed after admission.
Key exclusion criteria (7 listed)
- Individuals under 18 years of age.
- COVID-19 infection.
- Infection of the skin at the CGM site requiring removal of the sensor.
- Patients with altered Mental Status.
- Patients unable to scan their flash CGMs at least every 8 hours.
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 Monitor (CGM)CGM data will be downloaded prior to discharge and it will be compared with hospital glucometer readings taken at the same time. | Device | CGM Patients |
Primary outcome
Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings <70 mg/dl, 70-180 mg/dL, >180 mg/dl, 181-250mg/dl, >250 mg/dl respectively.
9 secondary outcomes
CGM Recorded Hypoglycemia Episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Duration of Hypoglycemic Episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Hyperglycemic Episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Duration of Hyperglycemic Episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
In Hospital Mortality
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Hospitalization Length of Stay
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Mortality Rate at 30 Days
Time frame: From date of enrollment up to 60 days.
Number of Re-hospitalization Events at the Same Institution Within 30 Days From the Discharge Date of the Preceding Admission.
Time frame: From date of enrollment up to 60 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40229126Dumitrascu AG, Perry M, Chindris AM, Chirila RM, Boone RJ, Blumenfeld SG, Hodge DO, White LJ, Gnanapandithan K, De La Cruz DA, Pagan RJ, Smerina M, Gavrancic T, Cortes MP, Murawska Baptista A, Wilson JR. Real-World Performance of Personal Continuous Glucose Monitors During Hospitalization. Diabetes Technol Ther. 2025 Aug;27(8):613-622. doi: 10.1089/dia.2024.0639. Epub 2025 Apr 14.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Adrian Dumitrascu, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor (CGM) in people with Diabetes Mellitus, run by Mayo Clinic 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 5 inclusion and 7 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 31 Jul 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?
Yes. Results are posted in the registry (first posted 31 Jul 2025). 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?
Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD) (time frame: From date of enrollment and until discharge from the hospital up to 30 days.). 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 NCT04653454, which also lists 1 linked publication.
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 31 Jul 2025.