Diabetic KetoacidosisPhase 4NCT03107208
Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes
A Phase 4 study testing Glargine and Continuous Glucose Monitor (Abbott FreeStyle Libre Pro) in people with Diabetic Ketoacidosis and Type 1 Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Ketoacidosis, Type 1 Diabetes Mellitus
- What is being tested?
- Glargine and Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2017to 13 Mar 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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:
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Management of Diabetic Ketoacidosis in Children: Does Early Glargine Prevent Rebound Hyperglycemia?
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.
Read the 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.
- Conditions
- Diabetic Ketoacidosis, Type 1 Diabetes Mellitus
- Being tested
- Glargine, Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)
- Keywords
- DKA, type 1 diabetes, children, continuous glucose monitoring
- Medical subject headings
- Diabetic Ketoacidosis, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlargineDrug
Also called Lantus
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)Device
Also called CGM
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.
| Study group | Role | What they receive |
|---|---|---|
| Early glargine (Lantus) | Experimental | 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. Receives: Drug: Glargine; Device: Continuous Glucose Monitor (Abbott FreeStyle Libre Pro) |
| Control group | Other | 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. Receives: Drug: Glargine; Device: Continuous Glucose Monitor (Abbott FreeStyle Libre Pro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 hours after discontinuation of IV insulin
Secondary outcomes (3)
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.
Measured: Within 12 hours after discontinuation of IV insulin
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.
Measured: 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.
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.
Measured: During treatment of DKA and within 12 hours after discontinuation of IV insulin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start21 Jul 2017
- Primary completion13 Mar 2021
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Ohman-Hanson, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107208
- Sponsor's protocol ID
- 16-1965
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2017
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Diabetic Ketoacidosis in Children: Does Early Glargine Prevent Rebound Hyperglycemia?
- ClinicalTrials.gov ID
- NCT03107208
- Acronym / sponsor ID
- 16-1965
- Conditions
- Diabetic Ketoacidosis, Type 1 Diabetes Mellitus
- Keywords
- DKA, type 1 diabetes, children, continuous glucose monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 13 Mar 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early glargine (Lantus) | Experimental | Drug: Glargine, Device: Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)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. |
| Control group | Other | Drug: Glargine, Device: Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (23 listed)
- Participants who present in DKA with conditions that affect neurological function such as:
- 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:
- Use of medications that are known to affect blood glucose levels such as:
- Participants who have begun DKA treatment prior to being approached for enrollment and have received more than 6 hours of IV insulin therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlargineAlso: LantusA dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group). | Drug | Control group, Early glargine (Lantus) |
| Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)Also: CGMAll 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. | Device | Control group, Early glargine (Lantus) |
Primary outcome
Rate of Rebound Hyperglycemia
Time frame: Within 12 hours after discontinuation of IV insulin
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.
3 secondary outcomes
Rate of Recurrent Ketogenesis
Time frame: Within 12 hours after discontinuation of IV insulin
Risk of Hypoglycemia Between Those Given Early Administration of Glargine Versus Those Given Standard-of-care Management.
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.
Evaluation of CGM and POC Glucose Monitoring During DKA Treatment in Children.
Time frame: During treatment of DKA and within 12 hours after discontinuation of IV insulin.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Diabetic Ketoacidosis
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
RecruitingObservational study
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
Diabetes Mellitus, Type 1
RecruitingObservational study
Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department
Diabetic Ketoacidosis
Not yet recruitingObservational study
Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis
Diabetic Ketoacidosis, Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Ohman-Hanson principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glargine and Continuous Glucose Monitor (Abbott FreeStyle Libre Pro) in people with Diabetic Ketoacidosis and Type 1 Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Rebound Hyperglycemia (time frame: Within 12 hours after discontinuation of IV insulin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.