Trial Outcomes & Findings for Remote Glucose Monitoring System in Hospitalized Patients With Diabetic Ketoacidosis (DKA) (NCT NCT05439928)
NCT ID: NCT05439928
Last Updated: 2025-05-14
Results Overview
Time to resolution of metabolic acidosis measured in hours. Resolution defined as anion gap (AG) \<17 mEq/L and bicarbonate \>19 mEq/L.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
163 participants
Primary outcome timeframe
Up to 10 days
Results posted on
2025-05-14
Participant Flow
Participant milestones
| Measure |
DEXCOM G6 CGM
Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA. This group comprises of both retrospective chart review and prospective patients.
|
Hourly Finger Stick Point of Care (Historical Control)
DKA patients that received hourly glucose monitoring by finger stick while triaged to the ICU.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
119
|
|
Overall Study
COMPLETED
|
44
|
119
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DEXCOM G6 CGM
n=44 Participants
Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA. This group comprises of both retrospective chart review and prospective patients.
|
Hourly Finger Stick Point of Care (Historical Control)
n=119 Participants
DKA patients that received hourly glucose monitoring by finger stick while triaged to the ICU.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=44 Participants
|
47.66 years
n=119 Participants
|
49.26 years
n=163 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=44 Participants
|
56 Participants
n=119 Participants
|
75 Participants
n=163 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=44 Participants
|
63 Participants
n=119 Participants
|
88 Participants
n=163 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
44 participants
n=44 Participants
|
119 participants
n=119 Participants
|
163 participants
n=163 Participants
|
|
Diabetes
Type 1
|
22 Participants
n=44 Participants
|
42 Participants
n=119 Participants
|
64 Participants
n=163 Participants
|
|
Diabetes
Type 2
|
22 Participants
n=44 Participants
|
74 Participants
n=119 Participants
|
96 Participants
n=163 Participants
|
PRIMARY outcome
Timeframe: Up to 10 daysTime to resolution of metabolic acidosis measured in hours. Resolution defined as anion gap (AG) \<17 mEq/L and bicarbonate \>19 mEq/L.
Outcome measures
| Measure |
DEXCOM G6 CGM
n=44 Participants
Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA. This group comprises of both retrospective chart review and prospective patients.
|
Hourly Finger Stick Point of Care (Historical Control)
n=119 Participants
DKA patients that received hourly glucose monitoring by finger stick while triaged to the ICU.
|
|---|---|---|
|
Time to Resolution of Metabolic Acidosis
|
12.84 hours
Interval 10.0 to 21.29
|
12.02 hours
Interval 8.33 to 22.68
|
SECONDARY outcome
Timeframe: Up to 20 daysPopulation: 60 participants in the Control group stayed in the ICU. No participants from the CGM group stayed in the ICU.
Length of ICU stay measured in days
Outcome measures
| Measure |
DEXCOM G6 CGM
Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA. This group comprises of both retrospective chart review and prospective patients.
|
Hourly Finger Stick Point of Care (Historical Control)
n=60 Participants
DKA patients that received hourly glucose monitoring by finger stick while triaged to the ICU.
|
|---|---|---|
|
Length of ICU Stay
|
—
|
28.47 hours
Interval 20.86 to 48.0
|
SECONDARY outcome
Timeframe: Up to 20 daysLength of hospital stay measured in hours
Outcome measures
| Measure |
DEXCOM G6 CGM
n=44 Participants
Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA. This group comprises of both retrospective chart review and prospective patients.
|
Hourly Finger Stick Point of Care (Historical Control)
n=119 Participants
DKA patients that received hourly glucose monitoring by finger stick while triaged to the ICU.
|
|---|---|---|
|
Length of Hospital Stay
|
120 hours
Interval 72.0 to 216.0
|
99.08 hours
Interval 72.73 to 150.73
|
SECONDARY outcome
Timeframe: Up to 20 daysThe number of hypoglycemic events will be recorded. A hypoglycemic event is defined as glucose level \<70 mg/dL.
Outcome measures
| Measure |
DEXCOM G6 CGM
n=44 Participants
Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA. This group comprises of both retrospective chart review and prospective patients.
|
Hourly Finger Stick Point of Care (Historical Control)
n=119 Participants
DKA patients that received hourly glucose monitoring by finger stick while triaged to the ICU.
|
|---|---|---|
|
Number of Hypoglycemic Events
|
0 hypoglycemic events
|
3 hypoglycemic events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 20 daysPopulation: Data was not collected
Cost savings calculated by comparison of cost when non-critically DKA participants have glucose levels monitored via CGM and treated in the stepdown unit compared to participants who have glucose levels monitored via hourly fingersticks and treated in the ICU.
Outcome measures
Outcome data not reported
Adverse Events
DEXCOM G6 CGM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hourly Finger Stick Point of Care (Historical Control)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DEXCOM G6 CGM
n=44 participants at risk
Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA. This group comprises of both retrospective chart review and prospective patients.
|
Hourly Finger Stick Point of Care (Historical Control)
n=119 participants at risk
DKA patients that received hourly glucose monitoring by finger stick while triaged to the ICU.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemic event defined as glucose level <70 mg/dL
|
0.00%
0/44 • Up to 20 days
|
2.5%
3/119 • Up to 20 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place