Trial Outcomes & Findings for Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management (NCT NCT04567225)
NCT ID: NCT04567225
Last Updated: 2022-09-21
Results Overview
Measured in hours from starting insulin infusion till anion gap ≤ 12 milliequivalent/Liter (mEq/L)
TERMINATED
PHASE4
39 participants
Participants monitored from hospital admission to discharge, an average of 5 days
2022-09-21
Participant Flow
The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no analysis was completed. This included no enrollment into the chart review arm.
Participant milestones
| Measure |
Early Glargine
All consecutive adult patients getting admitted to Medical ICU and meet the inclusion criteria and accepted to receive insulin glargine early as per the protocol. They will receive insulin glargine 0.4 unit/kg within 4 hours from initiating the IV Insulin Infusion, as per the Cleveland Clinic DKA protocol.
Glargine: A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion
IV insulin infusion: Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol
IV fluid and electrolytes replacement: The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.
|
Standard Practice (Late Glargine)
Retrospective, prespecified and matched sample of consecutive adults who admitted to the same Medical ICU with a diagnosis of DKA in the period between January 1st 2019 till the Institutional Review Board (IRB) approval date and didn't receive basal insulin before Anion Gap closure.
Glargine: A historical retrospective control group for the adult patients admitted to the same ICU with a diagnosis of DKA and received insulin glargine after anion gap closure.
IV insulin infusion: Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol
IV fluid and electrolytes replacement: The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
Baseline characteristics by cohort
| Measure |
Early Glargine
n=39 Participants
All consecutive adult patients getting admitted to Medical ICU and meet the inclusion criteria and accepted to receive insulin glargine early as per the protocol. They will receive insulin glargine 0.4 unit/kg within 4 hours from initiating the IV Insulin Infusion, as per the Cleveland Clinic DKA protocol.
Glargine: A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion
IV insulin infusion: Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol
IV fluid and electrolytes replacement: The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.
|
Standard Practice (Late Glargine)
Retrospective, prespecified and matched sample of consecutive adults who admitted to the same Medical ICU with a diagnosis of DKA in the period between January 1st 2019 till the Institutional Review Board (IRB) approval date and didn't receive basal insulin before Anion Gap closure.
Glargine: A historical retrospective control group for the adult patients admitted to the same ICU with a diagnosis of DKA and received insulin glargine after anion gap closure.
IV insulin infusion: Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol
IV fluid and electrolytes replacement: The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
—
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
—
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
—
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
—
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants monitored from hospital admission to discharge, an average of 5 daysPopulation: Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis.
Measured in hours from starting insulin infusion till anion gap ≤ 12 milliequivalent/Liter (mEq/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants monitored from hospital admission to discharge, an average of 5 daysPopulation: Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis.
The time, in days, from the patient admission to the hospital till discharge
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants monitored from hospital admission to discharge, an average of 5 daysPopulation: Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis.
The time, in hours, from the patient admission to the ICU till transfer to regular nursing floor
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants monitored from hospital admission to discharge, an average of 5 daysPopulation: Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis.
the total amount of insulin infusion, by International Unit, has been received by the patient during the DKA treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 hours after IVII discontinuationPopulation: Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis.
Defined as the recurrence of DKA (BG ≥ 250 mg/dl, Anion Gap \> 12 milliequivalent/Liter (mEq/L), and positive Ketones in serum or urine) after initial IV insulin infusion (IVII) discontinuation within 24 hours and requiring re-initiating the IVII
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 hours after initial Insulin Glargine dosePopulation: Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis.
Incidence of hyperglycemia (\> 180 mg/dL) after IVII discontinuation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 hours after initial Insulin Glargine dosePopulation: Study withdrawn. The study was closed due to lack of proper resource availability. Since study could not be completed as planned, no data was collected for analysis.
Incidence of hypoglycemia (defined as ≤ 70 mg/dL, \<54 mg/dL, \<40 mg/dl) after IVII discontinuation
Outcome measures
Outcome data not reported
Adverse Events
Early Glargine
Standard Practice (Late Glargine)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mohammed Al-Jaghbeer
The Cleveland Clinic Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place