Covid19, Diabetes Mellitus
Conditions
Brief summary
The objective of the study is to improve glycemic control in inpatient/ICU settings using real- time continuous glucose monitors (CGM) data for insulin titration. It may help reduce Coronavirus disease 2019 patient contact with healthcare workers as well.
Detailed description
Due to the increasing need for acute care of COVID-19 patients in ICU settings, the use of continuous glucose monitors (CGM) as a means to reduce patient contact and remotely improve glycemic control for diabetic COVID-19 patients needs to be explored. As demonstrated by recent data published in China, Wuhan province patients with diabetes made up 22.2% of COVID-19 ICU patient populations with a subsequent mortality of 7.3% (3). Not only during COVID-19 pandemic but also previous experiences with SARS and influenza viral respiratory infections demonstrated increased mortality in those patients with hyperglycemia (4). Using CGMs provides timely access to glucose trends, commonly used to determine insulin dosing decisions in outpatient settings (5). Implementing their use for hospitalized patients could be expected to improve healthcare worker insight into glycemic control therapies. Considering the ease of transmission of the SARS-Cov-2 virus, it is important to minimize duration and frequency of patient contact in order to maintain the safety of COVID-19 healthcare workers without compromising on their glycemic control. The WHO recommends that any healthcare provider coming into direct contact with COVID-19 patients should be utilizing appropriate PPE for each encounter. In this time of limited PPE supply (6), remote glucose monitoring can allow for rational use of these limited resources. With appropriate training on CGM data interpretation, nursing and ordering providers could expect to develop and implement more efficient insulin plans, requiring fewer physical contact with COVID-19 positive patients.
Interventions
DEVICEcontinuous glucose monitoring
Use of continuous glucose monitoring in inpatient and ICU settings
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Coronavirus disease 2019 tested positive patient * Age over 18 years * Admitted to Coronavirus disease 2019 specific ICU, with possible transfer to inpatient unit when stable * Patients with known or acquired Type 1 or Type 2 Diabetes requiring insulin therapy during admission
Exclusion criteria
* In state of active diabetic ketoacidosis (DKA) at time of enrollment * Two or more vasopressors in use at time of sensor placement * Unable to use at predetermined sensor site based on assessment of skin health
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | 14 days | Percentage of time spent in target glucose range of 140-180mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days CGM Worn | 14 days | Number of days the CGM was worn |
| Hypoglycemia | 14 days | Average number of hypoglycemia events per participant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CGM Arm continuous glucose meter is placed on the abdomen
continuous glucose monitoring: Use of continuous glucose monitoring in inpatient and ICU settings | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Chart review not completed | 1 |
Baseline characteristics
| Characteristic | CGM Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Time in Range
Percentage of time spent in target glucose range of 140-180mg/dL
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| CGM Arm | Time in Range | 21.6 percentage of time | Standard Deviation 13.47 |
Secondary
Hypoglycemia
Average number of hypoglycemia events per participant
Time frame: 14 days
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| CGM Arm | Hypoglycemia | Low 54-140mg/dl | 13.8 Events | Standard Deviation 10.44 |
| CGM Arm | Hypoglycemia | Very low <54 mg/dl | 0 Events | Standard Deviation 1.07 |
Secondary
Number of Days CGM Worn
Number of days the CGM was worn
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| CGM Arm | Number of Days CGM Worn | 5 days | Standard Deviation 5.39 |