Back to resultsEarly Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes
Primary Purpose
Diabetic Ketoacidosis, Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glargine
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Ketoacidosis focused on measuring DKA, type 1 diabetes, children, continuous glucose monitoring
Eligibility Criteria
Inclusion Criteria:
- Age 6-17.9 years at time of enrollment.
- Known history of type 1 diabetes or presumed new-onset type 1 diabetes.
- Diagnosis of DKA (serum glucose or fingerstick glucose concentration ≥ 200 mg/dL.
- Venous pH ≤7.3 and/or serum bicarbonate concentration ≤15 mmol/L.
- Evidence of ketonemia or ketonuria).
Exclusion Criteria:
Participants who present in DKA with conditions that affect neurological function such as:
- suspected alcohol or drug use,
- severe head trauma,
- meningitis, etc., who would not be able to consent/assent for the study.
- Participants who present in DKA who are showing signs of altered mental status at time of enrollment.
Other known complicating illness or poorly-controlled chronic illness that is known to affect blood glucose levels and/or electrolyte balance such as:
- chronic renal disease (requiring hemodialysis),
- chronic liver disease (with evidence of current hepatic dysfunction,
- coagulopathy, and/or chronic hepatitis), or
- severe chronic lung disease (requiring the use of oral steroids).
Use of medications that are known to affect blood glucose levels such as:
- oral glucocorticoids,
- Metformin,
- SGLT2 inhibitors,
- GLP-1 receptor agonists,
- DPP-4 inhibitors,
- thiazolidinediones
- sulfonylureas, and
- vasopressors, etc.
- Participants who have begun DKA treatment prior to being approached for enrollment and have received more than 6 hours of IV insulin therapy.
- Participants who are known to be pregnant.
- Participants who have a known diagnosis of type 2 diabetes.
- Participants for whom the treating physicians feel a specific insulin regimen is necessary such that patient safety or well-being could be compromised by enrollment into the study.
Sites / Locations
- Children's Hospital Colorado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Early glargine (Lantus)
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Rate of Rebound Hyperglycemia
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.
Secondary Outcome Measures
Rate of Recurrent Ketogenesis
Evaluate 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.
Risk of Hypoglycemia Between Those Given Early Administration of Glargine Versus Those Given 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.
Evaluation of CGM and POC Glucose Monitoring During DKA Treatment in Children.
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.
Full Information
NCT ID
NCT03107208
First Posted
March 30, 2017
Last Updated
April 14, 2022
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03107208
Brief Title
Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes
Official Title
Management of Diabetic Ketoacidosis in Children: Does Early Glargine Prevent Rebound Hyperglycemia?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2017 (Actual)
Primary Completion Date
March 13, 2021 (Actual)
Study Completion Date
March 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A frequent complication in the management of diabetic ketoacidosis (DKA) in children with type 1 diabetes is rebound hyperglycemia (blood glucose over 180 mg/dL) which increases the risk of re-developing DKA and can lengthen the hospital stay. The investigators want to study whether giving the long-acting insulin glargine (Lantus®) early in DKA management (versus after complete resolution of the DKA) helps prevent rebound hyperglycemia and makes the transition to insulin injections easier. Participants will also have the option to wear a continuous glucose monitor (CGM) during the study to help us understand blood glucose control during and after DKA.
Detailed Description
Diabetic ketoacidosis (DKA) remains the leading cause of morbidity and mortality in children with type 1 diabetes (T1D) and the incidence of T1D is increasing. A frequent complication in DKA management that is associated with in-hospital mortality and longer hospital stay is hyperglycemia; specifically rebound hyperglycemia (defined as a serum glucose greater than 180 mg/dL) within 12-24 hours after correction of the DKA. Rebound hyperglycemia increases the patient's risk of re-developing DKA. Few adult studies suggest that giving the long-acting insulin analog (glargine or Lantus®) early in the management of DKA (i.e. while still receiving intravenous insulin) can reduce rebound hyperglycemia without an increased risk of hypoglycemia and result in a smoother transition from intravenous insulin to subcutaneous insulin. This has not been well-studied in children to date. In this study the investigators want to determine whether giving glargine early in DKA management in children results in reduced rebound hyperglycemia without an increased risk in hypoglycemia. The investigators will do this by randomizing participants in DKA to either receive glargine early in the management of DKA (study group) or after resolution of DKA (control group); the latter is currently standard-of-care. Additionally, continuous glucose monitoring (CGM) systems have not been studied in a pediatric population with DKA. These devices measure blood sugar levels every 5 minutes and provide a great deal of information about blood sugar control patterns over many days. Not only will the use of CGM in this study provide meaningful information regarding blood sugar patterns during DKA treatment, it will also broaden the investigators knowledge of whether CGM is a feasible and accurate tool to use in this setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ketoacidosis, Type 1 Diabetes Mellitus
Keywords
DKA, type 1 diabetes, children, continuous glucose monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early glargine (Lantus)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glargine
Other Intervention Name(s)
Lantus
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)
Other Intervention Name(s)
CGM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Rebound Hyperglycemia
Description
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.
Time Frame
Within 12 hours after discontinuation of IV insulin
Secondary Outcome Measure Information:
Title
Rate of Recurrent Ketogenesis
Description
Evaluate 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.
Time Frame
Within 12 hours after discontinuation of IV insulin
Title
Risk of Hypoglycemia Between Those Given Early Administration of Glargine Versus Those Given Standard-of-care Management.
Description
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.
Time Frame
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.
Title
Evaluation of CGM and POC Glucose Monitoring During DKA Treatment in Children.
Description
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.
Time Frame
During treatment of DKA and within 12 hours after discontinuation of IV insulin.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 6-17.9 years at time of enrollment.
Known history of type 1 diabetes or presumed new-onset type 1 diabetes.
Diagnosis of DKA (serum glucose or fingerstick glucose concentration ≥ 200 mg/dL.
Venous pH ≤7.3 and/or serum bicarbonate concentration ≤15 mmol/L.
Evidence of ketonemia or ketonuria).
Exclusion Criteria:
Participants who present in DKA with conditions that affect neurological function such as:
suspected alcohol or drug use,
severe head trauma,
meningitis, etc., who would not be able to consent/assent for the study.
Participants who present in DKA who are showing signs of altered mental status at time of enrollment.
Other known complicating illness or poorly-controlled chronic illness that is known to affect blood glucose levels and/or electrolyte balance such as:
chronic renal disease (requiring hemodialysis),
chronic liver disease (with evidence of current hepatic dysfunction,
coagulopathy, and/or chronic hepatitis), or
severe chronic lung disease (requiring the use of oral steroids).
Use of medications that are known to affect blood glucose levels such as:
oral glucocorticoids,
Metformin,
SGLT2 inhibitors,
GLP-1 receptor agonists,
DPP-4 inhibitors,
thiazolidinediones
sulfonylureas, and
vasopressors, etc.
Participants who have begun DKA treatment prior to being approached for enrollment and have received more than 6 hours of IV insulin therapy.
Participants who are known to be pregnant.
Participants who have a known diagnosis of type 2 diabetes.
Participants for whom the treating physicians feel a specific insulin regimen is necessary such that patient safety or well-being could be compromised by enrollment into the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Ohman-Hanson
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes
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