Hyperglycemia
Conditions
Brief 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.
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.
Interventions
DEVICEDexcom G6
Continuous Glucose Monitor
Sponsors
Ohio State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
CGM will be used by 100 MICU patients with glycemic control comparison with matched 100 MICU historical controls
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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) * Treated with hydroxyurea * Are pregnant, patients * Using home insulin pump therapy during hospitalization, or * Reside in a corrections institution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time in Target Glycemic Ranges | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Time in Hypoglycemic Ranges | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREILEEN FAULDS, PhD
Ohio State University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 15.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 160 Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 47 Participants |
| Type of Diabetes No history of diabetes | 8 Participants |
| Type of Diabetes Other type of diabetes | 0 Participants |
| Type of Diabetes Type 1 Diabetes | 58 Participants |
| Type of Diabetes Type 2 Diabetes | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 22 / 100 | 23 / 100 |
| other Total, other adverse events | 8 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
None listed