N/A
Completed N=142
Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus
Source: ClinicalTrials.gov NCT04653454 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD) — 22.6; 14.6; 11.7; 10.4 MARD percentage
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 would prevent episodes of hyperglycemia and hypoglycemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD) |
22.6; 14.6; 11.7; 10.4; 13.7 | — |
| SECONDARY CGM Recorded Hypoglycemia Episodes |
0.47; 1.45 | 0.129 |
| SECONDARY CGM Recorded Duration of Hypoglycemic Episodes |
37.810; 162.81 | 0.203 |
| SECONDARY CGM Recorded Hyperglycemic Episodes |
10.216; 5.935 | — |
| SECONDARY CGM Recorded Duration of Hyperglycemic Episodes |
2419.44; 801.99 | 0.076 |
| SECONDARY Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters |
-0.08; -0.02; 0.024; -0.012; 0.003; 0.034 | <0.0001 sig |
| SECONDARY In Hospital Mortality |
2 | — |
| SECONDARY Hospitalization Length of Stay |
116.5 | — |
| SECONDARY Mortality Rate at 30 Days |
— | — |
| SECONDARY Number of Re-hospitalization Events at the Same Institution Within 30 Days From the Discharge Date of the Preceding Admission. |
60 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04653454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.