Can continuous glucose monitors safely tighten hospital blood sugar control?
NCT ID NCT05135676
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers test whether continuous glucose monitors (CGM) can help hospitalized adults with type 2 diabetes reach a tighter average blood sugar target of 90 to 130 mg/dL without causing dangerous low blood sugar. Participants are randomly assigned to standard care (target 140 to 180 mg/dL) or intensive care (target 90 to 130 mg/dL with real-time CGM). The trial measures average glucose and time spent below 54 mg/dL over up to 10 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- continuous glucose monitoring (CGM) devices
- What this could lead to
- If tight glucose control with CGM proves safe, it could lead to a larger trial testing whether it reduces complications and deaths in hospitalized patients with diabetes.
- What could go wrong
- This is an early-phase study with 166 participants. Tight glucose control has caused dangerous low blood sugar in past hospital trials, and CGM accuracy in sick patients may vary.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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166 people
The number who actually took part.
- Started
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May 2022
- Finished
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Mar 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age \>= 18 years old 2. Type 2 diabetes (per investigator assessment); or if not previously diagnosed as having diabetes, HbA1c\>=7.0% (laboratory-measured at or since hospital admission or within prior 3-months). • Type 1 diabetes, atypical forms of diabetes (including pancreatectomy and pancreatitis) and stress hyperglycemia alone are not eligible. 3. At least 1 blood glucose measurement \>180 mg/dL since admission 4. Insulin already initiated since admission or planned to be initiated 5. Non-critical hospitalization with expected length of stay on non-ICU floor \>3 days at time of randomization Exclusion Criteria: 1. Inability to provide written consent 2. Admission to ICU • Patients transferred from ICU with an expected length of stay \>3 days on a non-ICU floor are eligible 3. Treatment with systemic immunosuppressive agents such as high dose (\>7.5 mg/day Prednisone equivalent) steroids or biologics that are not regimented and have been started within the last 3 months at time of enrollment or planned treatment prior to randomization. 4. Suspected or confirmed acute myocardial infarction or stroke as reason for hospital admission or since admission 5. Considered unlikely to survive hospitalization per investigator's judgment 6. Diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the 6 months prior to hospital admission, at hospital admission or prior to randomization during the current hospital admission 7. One or more severe hypoglycemic events within the 6 months prior to hospital admission or prior to randomization during the current admission 8. For females, pregnant or breastfeeding • A negative serum or urine pregnancy test will be required for all females of child-bearing potential. 9. CGM other than study CGM being used during hospitalization or planned to be used 10. Blood glucose \>400 mg/dL at time of potential enrollment (most recent blood glucose measurement in hospital) 11. Insulin pump being used to deliver insulin during hospitalization or planned to be used 12. Use of IV insulin at time of potential enrollment 13. Hypoxia (O2 saturation \<90) present at time of potential enrollment 14. Anasarca present at time of potential enrollment 15. Use of hydroxyurea or high dose acetaminophen use of \>4g daily 16. eGFR \<20 mL/min or dialysis being received or planned 17. ALT \>3X normal or current diagnosis of cirrhosis 18. Cystic fibrosis 19. Expected need for surgery requiring general anesthesia during hospitalization • Post-surgical enrollment is permitted 20. Known allergy to medical grade adhesives or a skin condition that may impact CGM performance per investigator discretion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baltimore Research and Education Foundation
Baltimore, Maryland, 21201, United States
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Emory University
Atlanta, Georgia, 30303, United States
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University of Colorado, Anschutz Inpatient Pavilion 1 and 2
Aurora, Colorado, 80045, United States
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University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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University of Washington Medical Center
Seattle, Washington, 98195, United States
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