Trial Outcomes & Findings for Inpatient Diabetes Mellitus (DM) Management With Continuous Glucose Monitoring Devices, a Pilot Study. (NCT NCT02904512)
NCT ID: NCT02904512
Last Updated: 2021-06-22
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Through study completion, during hospital stay, an average of 1 week
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
Continuous Glucose Monitoring and Point of Care Blood Glucose
Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose
Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
|
Point of Care (POC) Blood Glucose
Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only
Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Continuous Glucose Monitoring and Point of Care Blood Glucose
Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose
Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
|
Point of Care (POC) Blood Glucose
Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only
Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Transferred to ICU
|
1
|
0
|
|
Overall Study
Minor Bleeding at site of device insertion
|
1
|
0
|
Baseline Characteristics
Inpatient Diabetes Mellitus (DM) Management With Continuous Glucose Monitoring Devices, a Pilot Study.
Baseline characteristics by cohort
| Measure |
Continuous Glucose Monitoring and Point of Care Blood Glucose
n=6 Participants
Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose
Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
|
Point of Care (POC) Blood Glucose
n=7 Participants
Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only
Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
69.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index
|
33.1 kg/m^2
STANDARD_DEVIATION 9.3 • n=5 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 4.9 • n=7 Participants
|
32.0 kg/m^2
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
A1c, %
|
7.6 % of glycated hemoglobin
STANDARD_DEVIATION 1.3 • n=5 Participants
|
8.4 % of glycated hemoglobin
STANDARD_DEVIATION 2.4 • n=7 Participants
|
8.0 % of glycated hemoglobin
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
DM duration
|
22 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
18.4 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
20.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, during hospital stay, an average of 1 weekOutcome measures
| Measure |
Continuous Glucose Monitoring and Point of Care Blood Glucose
n=6 Participants
Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose
Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
|
Point of Care (POC) Blood Glucose
n=7 Participants
Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only
Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose
|
|---|---|---|
|
Percentage of Time Spent in Hyperglycemia > 180 mg/dL
|
35.47 percentage of time spent > 180mg/dL
Standard Deviation 14.71
|
35.25 percentage of time spent > 180mg/dL
Standard Deviation 29.38
|
PRIMARY outcome
Timeframe: Through study completion, during hospital stay, an average of 1 weekOutcome measures
| Measure |
Continuous Glucose Monitoring and Point of Care Blood Glucose
n=6 Participants
Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose
Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
|
Point of Care (POC) Blood Glucose
n=7 Participants
Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only
Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose
|
|---|---|---|
|
Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL)
|
3.28 percent of time spent > 300mg/dL
Standard Deviation 5.65
|
5.52 percent of time spent > 300mg/dL
Standard Deviation 12.64
|
PRIMARY outcome
Timeframe: Through study completion, during hospital stay, an average of 1 weekOutcome measures
| Measure |
Continuous Glucose Monitoring and Point of Care Blood Glucose
n=6 Participants
Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose
Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
|
Point of Care (POC) Blood Glucose
n=7 Participants
Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only
Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose
|
|---|---|---|
|
Number of Participants With Hypoglycemic Events (< 70mg/dL)
|
2 Participants
|
6 Participants
|
Adverse Events
Continuous Glucose Monitoring and Point of Care Blood Glucose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Point of Care (POC) Blood Glucose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuous Glucose Monitoring and Point of Care Blood Glucose
n=6 participants at risk
Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose
Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
|
Point of Care (POC) Blood Glucose
n=7 participants at risk
Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only
Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose
|
|---|---|---|
|
Infections and infestations
Transferred to ICU (for non study-related reasons)
|
16.7%
1/6 • Number of events 1 • Adverse events collected from the patient enrollment to the end of patient hospitalization, an average of 5 days.
|
0.00%
0/7 • Adverse events collected from the patient enrollment to the end of patient hospitalization, an average of 5 days.
|
|
Blood and lymphatic system disorders
Bleeding at site of the CGM insertion
|
16.7%
1/6 • Number of events 1 • Adverse events collected from the patient enrollment to the end of patient hospitalization, an average of 5 days.
|
0.00%
0/7 • Adverse events collected from the patient enrollment to the end of patient hospitalization, an average of 5 days.
|
Additional Information
Dr. Ilias (Elias) Spanakis
Veterans Affairs Medical Center
Phone: (617) 319-9731
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place