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Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes Fase 4 61

Afgerond
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De klinische studie NCT03107208 onderzocht behandeling bij Diabetische ketoacidose, Type 1 diabetes mellitus. Deze Fase 4 interventioneel studie is nu afgerond. Er werd gestreefd naar inclusie van 61 deelnemers vanaf 21 juli 2017. De studie werd geleid door University of Colorado, Denver en was gepland te worden voltooid op 13 maart 2021. Laatste update op ClinicalTrials.gov: 10 mei 2022.
Beknopte samenvatting
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 re...Toon meer
Uitgebreide beschrijving
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...Toon meer
Officiële titel

Management of Diabetic Ketoacidosis in Children: Does Early Glargine Prevent Rebound Hyperglycemia?

Aandoeningen
Diabetische ketoacidoseType 1 diabetes mellitus
Andere studie-ID's
  • 16-1965
NCT-ID
NCT03107208
Startdatum (Werkelijk)
2017-07-21
Laatste update geplaatst
2022-05-10
Verwachte einddatum
2021-03-13
Inschrijving (Geschat)
61
Studietype
Interventioneel
FASE
Fase 4
Status
Afgerond
Trefwoorden
DKA
type 1 diabetes
children
continuous glucose monitoring
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelEarly 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.
OverigeControl 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.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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.
Within 12 hours after discontinuation of IV insulin
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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.
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.
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.
During treatment of DKA and within 12 hours after discontinuation of IV insulin.
Geschiktheidscriteria

Leeftijd van deelnemers
Kind, Volwassene
Minimumleeftijd
6 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
  1. Age 6-17.9 years at time of enrollment.
  2. Known history of type 1 diabetes or presumed new-onset type 1 diabetes.
  3. Diagnosis of DKA (serum glucose or fingerstick glucose concentration ≥ 200 mg/dL.
  4. Venous pH ≤7.3 and/or serum bicarbonate concentration ≤15 mmol/L.
  5. Evidence of ketonemia or ketonuria).

  1. Participants who present in DKA with conditions that affect neurological function such as:

    1. suspected alcohol or drug use,
    2. severe head trauma,
    3. meningitis, etc., who would not be able to consent/assent for the study.

  2. Participants who present in DKA who are showing signs of altered mental status at time of enrollment.

  3. Other known complicating illness or poorly-controlled chronic illness that is known to affect blood glucose levels and/or electrolyte balance such as:

    1. chronic renal disease (requiring hemodialysis),
    2. chronic liver disease (with evidence of current hepatic dysfunction,
    3. coagulopathy, and/or chronic hepatitis), or
    4. severe chronic lung disease (requiring the use of oral steroids).

  4. Use of medications that are known to affect blood glucose levels such as:

    1. oral glucocorticoids,
    2. Metformin,
    3. SGLT2 inhibitors,
    4. GLP-1 receptor agonists,
    5. DPP-4 inhibitors,
    6. thiazolidinediones
    7. sulfonylureas, and
    8. vasopressors, etc.

  5. Participants who have begun DKA treatment prior to being approached for enrollment and have received more than 6 hours of IV insulin therapy.

  6. Participants who are known to be pregnant.

  7. Participants who have a known diagnosis of type 2 diabetes.

  8. 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.

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1 Studielocaties in 1 landen

Colorado

Children's Hospital Colorado, Aurora, Colorado, 80045, United States