Trial Outcomes & Findings for Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes (NCT NCT03107208)
NCT ID: NCT03107208
Last Updated: 2022-05-10
Results Overview
Evaluate the rate of rebound hyperglycemia with a glucometer, defined as a serum glucose level of greater than 180 mg/dL (\>10 mmol/L) within 12 hours after discontinuation of IV insulin, in children treated for diabetic ketoacidosis (DKA) with early glargine versus standard-of-care management. The number of patients that met this threshold is reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
Within 12 hours after discontinuation of IV insulin
Results posted on
2022-05-10
Participant Flow
4 participants screen failed after consent form was signed.
Participant milestones
| Measure |
Early Glargine (Lantus)
A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
Control Group
A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
|
Overall Study
Received Intervention
|
26
|
24
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Early Glargine (Lantus)
n=30 Participants
A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
Control Group
n=27 Participants
A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.3 years
n=5 Participants
|
12.0 years
n=7 Participants
|
12 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 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=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Diabetic patient status
Newly diagnosed T1D
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Diabetic patient status
Known diagnosis of T1D
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 12 hours after discontinuation of IV insulinEvaluate the rate of rebound hyperglycemia with a glucometer, defined as a serum glucose level of greater than 180 mg/dL (\>10 mmol/L) within 12 hours after discontinuation of IV insulin, in children treated for diabetic ketoacidosis (DKA) with early glargine versus standard-of-care management. The number of patients that met this threshold is reported.
Outcome measures
| Measure |
Early Glargine (Lantus)
n=26 Participants
A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
Control Group
n=24 Participants
A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
|---|---|---|
|
Rate of Rebound Hyperglycemia
|
20 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Within 12 hours after discontinuation of IV insulinEvaluate the rate of recurrent ketogenesis (beta-hydroxybutyrate ≥ 1.5 mmol/L within 12 hours after discontinuation of IV insulin) in children treated for diabetic ketoacidosis (DKA) with early glargine versus standard-of-care management. The number of patients that met this threshold is reported.
Outcome measures
| Measure |
Early Glargine (Lantus)
n=26 Participants
A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
Control Group
n=24 Participants
A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
|---|---|---|
|
Rate of Recurrent Ketogenesis
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During treatment and within 12 hours after d/c IV insulin; while receiving IV insulin in children with DKA given early glargine versus standard-of-care management.Assessment of the frequency of hypoglycemic events during treatment of DKA, and within 12 hours after discontinuation of IV insulin, in children given early glargine versus standard-of-care management vs. the rate of blood glucose decrease while receiving IV insulin in children with DKA given early glargine versus standard-of-care management. The number of participants who experienced hypoglycemia is reported.
Outcome measures
| Measure |
Early Glargine (Lantus)
n=26 Participants
A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
Control Group
n=24 Participants
A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
|---|---|---|
|
Risk of Hypoglycemia Between Those Given Early Administration of Glargine Versus Those Given Standard-of-care Management.
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During treatment of DKA and within 12 hours after discontinuation of IV insulin.Evaluation of the feasibility of CGM as a tool to monitor blood glucose levels during DKA treatment in children. The number of participants who consented to wear and placed the CGM is reported.
Outcome measures
| Measure |
Early Glargine (Lantus)
n=26 Participants
A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
Control Group
n=24 Participants
A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
|---|---|---|
|
Evaluation of CGM and POC Glucose Monitoring During DKA Treatment in Children.
|
4 Participants
|
2 Participants
|
Adverse Events
Early Glargine (Lantus)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Group
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 |
Early Glargine (Lantus)
n=26 participants at risk
A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
Control Group
n=24 participants at risk
A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.
Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
15.4%
4/26 • Number of events 4 • Up to 24 hours
Only participants who received the intervention were monitored for adverse events. Adverse events specific to whether the participant agreed to wear a CGM were not monitored or assessed.
|
8.3%
2/24 • Number of events 2 • Up to 24 hours
Only participants who received the intervention were monitored for adverse events. Adverse events specific to whether the participant agreed to wear a CGM were not monitored or assessed.
|
|
Endocrine disorders
Hypokalemia
|
3.8%
1/26 • Number of events 1 • Up to 24 hours
Only participants who received the intervention were monitored for adverse events. Adverse events specific to whether the participant agreed to wear a CGM were not monitored or assessed.
|
0.00%
0/24 • Up to 24 hours
Only participants who received the intervention were monitored for adverse events. Adverse events specific to whether the participant agreed to wear a CGM were not monitored or assessed.
|
|
Endocrine disorders
Recurrent Ketosis
|
15.4%
4/26 • Number of events 4 • Up to 24 hours
Only participants who received the intervention were monitored for adverse events. Adverse events specific to whether the participant agreed to wear a CGM were not monitored or assessed.
|
4.2%
1/24 • Number of events 1 • Up to 24 hours
Only participants who received the intervention were monitored for adverse events. Adverse events specific to whether the participant agreed to wear a CGM were not monitored or assessed.
|
Additional Information
Rebecca Ohman, MD
University of Colorado Denver | Anschutz
Phone: 303-724-1111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place