NCT05571397: CGM

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

Completed Phase 1, PHASE2 Results posted Last updated 6 February 2026

What this trial tests

Phase 1, PHASE2 trial testing Dexcom G6 in Hyperglycemia in 201 participants. Completed in 19 September 2024.

Timeline

1 November 2023

Primary endpoint
19 September 2024

19 September 2024

Quick facts

Lead sponsor	Ohio State University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	201
Start date	1 November 2023
Primary completion	19 September 2024
Estimated completion	19 September 2024
Sites	1 location across United States

Drugs / interventions tested

• Dexcom G6

Conditions studied

• Hyperglycemia — all drugs for Hyperglycemia →

Sponsor

Ohio State University

Who can join

18 and older, any sex, with Hyperglycemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Time in Target Glycemic Ranges Primary · 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

70-180mg/dl

Group	Value	95% CI
Dexcom CGM	76	72 – 79
Historical Controls	65	61 – 69

100-180mg/dl

Group	Value	95% CI
Dexcom CGM	69	66 – 73
Historical Controls	61	56 – 64

140-180mg/dl

Group	Value	95% CI
Dexcom CGM	37	34 – 40
Historical Controls	30	27 – 33

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

Percent of time in hypoglycemic ranges \<70mg/dl and \<55mg/dl

<70mg/dl

Group	Value	95% CI
Dexcom CGM	0.41	0.08 – 0.73
Historical Controls	0.19	0.04 – 0.34

<54mg/dl

Group	Value	95% CI
Dexcom CGM	0.06	0 – 0.16
Historical Controls	0.08	0 – 0.17

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dexcom CGM

Serious: 0/100 (0%)

Deaths: 22/100

Historical Controls

Serious: 0/100 (0%)

Deaths: 23/100

Other adverse events (2 terms — click to expand)

Reaction	System	Dexcom CGM	Historical Controls
Failure to Reconsent	Investigations	—	—
Failure to remove CGM when transition to hospice care	Investigations	—	—

Data from ClinicalTrials.gov NCT05571397 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Consensus Statement for Continuous Glucose Monitoring Metrics for Inpatient Clinical Trials.
   Spanakis EK, Cook CB, Kulasa K, Aloi JA, et al · · 2023 · cited 47× · PMID 37592726 · DOI 10.1177/19322968231191104