HyperglycemiaPhase 1/2CGMNCT05571397

Expanding Use of CGM in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes

A Phase 1/2 study testing Dexcom G6 in people with Hyperglycemia, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this implementation study is to assess the feasibility of real time continuous glucose monitoring (CGM) implementation using a CGM plus (+) point-of-care (POC) protocol among patients on IV insulin or those with hyperglycemia (>250mg/dl) in the critical care hospital environments. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperglycemia
What is being tested?: Dexcom G6
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 201 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2023to 19 Sep 2024
Phase: Phase 1/2
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

adults >18 years old,
admitted to Ohio State University Wexner Medical Center MICU and
have hyperglycemia (glucose >250mg/dl) or are currently on IV insulin.

Who cannot join

Current COVID-19 infection,
Refractory shock (Levophed dose >0.5 mcg/kg/min or equivalent)
Actively being treated for diabetic ketoacidosis (DKA)
Actively being treated for hyperosmolar non-ketoacidosis (HONK)
Pitting edema, anasarca, blue or purple discoloration to left upper extremity
Treated with high dose acetaminophen (>1 gram Q6 hours)

Show all 10Show fewer

Treated with hydroxyurea
Are pregnant, patients
Using home insulin pump therapy during hospitalization, or
Reside in a corrections institution.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Expanding Use of Continuous Glucose Monitoring Beyond COVID in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes

Read the detailed description

This study analyzes the feasibility of inpatient real time CGM implementation through the use of a CGM + POC protocol as routine care for glycemic monitoring among patients on IV insulin or those with hyperglycemia (>250mg/dl). The investigators will examine the effects on medical intensive care (MICU) patient's (N=100) glycemic control compared to matched historical control patients (N=100) from the MICU who received fingerstick POC.

Conditions: Hyperglycemia
Being tested: Dexcom G6
Medical subject headings: Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexcom G6Device
Continuous Glucose Monitor

Study groups in NCT05571397
Study group	Role	What they receive
Dexcom CGM	Experimental	Dexcom G6 Receives: Device: Dexcom G6
Historical Controls	No intervention	Matched historical controls

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Time in Target Glycemic Ranges
Percent of time in target glycemic ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d
Measured: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient

Secondary outcomes (1)

Percent of Time in Hypoglycemic Ranges
Percent of time in hypoglycemic ranges <70mg/dl and <55mg/dl
Measured: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202319 Sep 2024

First posted7 Oct 2022
Study start1 Nov 2023
Primary completion19 Sep 2024
Study completion19 Sep 2024

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 HyperglycemiaStudies of the same condition, open and under way.
More trials run by Ohio State 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: CGM will be used by 100 MICU patients with glycemic control comparison with matched 100 MICU historical controls
Masking: None (open label)
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05571397
Sponsor's protocol ID: 2021H0407
Other IDs: G220050
Acronym: CGM
Status last verified: Feb 2026
First submitted: 15 Sep 2022
Last updated: 6 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Faulds ER, Rayan MN, Patterson ES, McNett M, Exline M, Shoben A, Lin CJ, Jones L, Lee B, Rasul A, Mlachak M, Ruvalcaba C, Yin C, Ping Z, Dungan KM. Continuous Glucose Monitoring Hypoglycemia Alarms in Critical Care: Clinical Utility and Workflow Integration. Diabetes Technol Ther. 2026 Sep 16:15209156261487821. doi: 10.1177/15209156261487821. Online ahead of print.
PubMed 42746746

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperglycemia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Expanding Use of Continuous Glucose Monitoring Beyond COVID in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes
ClinicalTrials.gov ID: NCT05571397
Acronym / sponsor ID: CGM / 2021H0407
Conditions: Hyperglycemia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: 1 Nov 2023 (actual)
Primary completion: 19 Sep 2024 (actual)
Study completion: 19 Sep 2024 (actual)
First posted: 7 Oct 2022 (actual)
Results: Posted 6 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: CGM will be used by 100 MICU patients with glycemic control comparison with matched 100 MICU historical controls

Arm	Type	Receives
Dexcom CGM	Experimental	Device: Dexcom G6Dexcom G6
Historical Controls	No intervention	–Matched historical controls

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

adults >18 years old,
admitted to Ohio State University Wexner Medical Center MICU and
have hyperglycemia (glucose >250mg/dl) or are currently on IV insulin.

Key exclusion criteria (10 listed)

Current COVID-19 infection,
Refractory shock (Levophed dose >0.5 mcg/kg/min or equivalent)
Actively being treated for diabetic ketoacidosis (DKA)
Actively being treated for hyperosmolar non-ketoacidosis (HONK)
Pitting edema, anasarca, blue or purple discoloration to left upper extremity

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 G6Continuous Glucose Monitor	Device	Dexcom CGM

Primary outcome

Percentage of Time in Target Glycemic Ranges
Time frame: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient
Percent of time in target glycemic ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d

1 secondary outcome

Percent of Time in Hypoglycemic Ranges
Time frame: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient

Results and safety

Results posted to the registry on 6 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexcom CGM	101	100
Historical Controls	100	100

Primary outcome: Percentage of Time in Target Glycemic Ranges

Time frame: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient. Mean (95% Confidence Interval). Unit: percentage of time in target ranges

Measure	Dexcom CGM n = 100	Historical Controls n = 100
70-180mg/dl	76 (72 to 79)	65 (61 to 69)
100-180mg/dl	69 (66 to 73)	61 (56 to 64)
140-180mg/dl	37 (34 to 40)	30 (27 to 33)

Dexcom CGM vs Historical Controls: p <0.001, Wilcoxon (Mann-Whitney)
Dexcom CGM vs Historical Controls: p = 0.002, Wilcoxon (Mann-Whitney)
Dexcom CGM vs Historical Controls: p = 0.003, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected for each individual while they were enrolled in the study and wearing the continuous glucose monitor. This was an average of 7.6 ± 4.1 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexcom CGM	0 of 100 (0%)	8 of 100 (8%)	22 of 100
Historical Controls	0 of 100 (0%)	0 of 100 (0%)	23 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42746746Faulds ER, Rayan MN, Patterson ES, McNett M, Exline M, Shoben A, Lin CJ, Jones L, Lee B, Rasul A, Mlachak M, Ruvalcaba C, Yin C, Ping Z, Dungan KM. Continuous Glucose Monitoring Hypoglycemia Alarms in Critical Care: Clinical Utility and Workflow Integration. Diabetes Technol Ther. 2026 Sep 16:15209156261487821. doi: 10.1177/15209156261487821. Online ahead of print.
Individual participant dataSharing planned: No

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RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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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.

EILEEN FAULDS, PhD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dexcom G6 in people with Hyperglycemia, run by Ohio State University 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 3 inclusion and 10 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 6 Feb 2026. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2026). 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?

Percentage of Time in Target Glycemic Ranges (time frame: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient). 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 NCT05571397, 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 6 Feb 2026.