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| ID | Type | Description | Link |
|---|---|---|---|
| G220050 | Other Identifier | FDA |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexcom CGM | Experimental | Dexcom G6 |
|
| Historical Controls | No Intervention | Matched historical controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 | Device | Continuous Glucose Monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time in Target Glycemic Ranges | Percent of time in target glycemic ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d | For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time in Hypoglycemic Ranges | Percent of time in hypoglycemic ranges <70mg/dl and <55mg/dl | For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| EILEEN FAULDS, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexcom CGM | Dexcom G6 Dexcom G6: Continuous Glucose Monitor |
| FG001 | Historical Controls | Matched historical controls |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexcom CGM | Dexcom G6 Dexcom G6: Continuous Glucose Monitor |
| BG001 | Historical Controls | Matched historical controls |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Time in Target Glycemic Ranges | Percent of time in target glycemic ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d | Posted | Mean | 95% Confidence Interval | percentage of time in target ranges | For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexcom CGM | Dexcom G6 Dexcom G6: Continuous Glucose Monitor | 22 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failure to Reconsent | Investigations | Systematic Assessment | Subjects who were determined to be unable to provide initial consent for study enrollment were enrolled by their legally authorized representative (LAR). Per protocol, subjects are to be reconsented. Study team failed to obtain re-consent. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eileen Faulds | The Ohio State University | 419-989-0730 | faulds.10@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2022 | Oct 4, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2021 | Sep 21, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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CGM will be used by 100 MICU patients with glycemic control comparison with matched 100 MICU historical controls
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type of Diabetes | Count of Participants | Participants |
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| Participants |
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| Secondary | Percent of Time in Hypoglycemic Ranges | Percent of time in hypoglycemic ranges <70mg/dl and <55mg/dl | Posted | Mean | 95% Confidence Interval | Percent of time in hypoglycemic ranges | For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient |
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|
|
| 100 |
| 0 |
| 100 |
| 8 |
| 100 |
| EG001 | Historical Controls | Matched historical controls | 23 | 100 | 0 | 100 | 0 | 100 |
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| Failure to remove CGM when transition to hospice care | Investigations | Systematic Assessment | Participant study participation is to end when transition to comfort care or hospice. Study team failed to remove CGM when transitioned to hospice care |
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