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

NCT03107208 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16-1965
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Ketoacidosis; Type 1 Diabetes Mellitus

Keywords

DKA; type 1 diabetes; children; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Rate of Recurrent Ketogenesis

  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.

  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.

  During treatment of DKA and within 12 hours after discontinuation of IV insulin.

Study Arms (2)

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.

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.

Drug: Glargine; Device: Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)

Interventions

Glargine DRUG

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).

Also known as: Lantus

Control group; Early glargine (Lantus)

Continuous Glucose Monitor (Abbott FreeStyle Libre Pro) DEVICE

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.

Also known as: CGM

Control group; Early glargine (Lantus)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis; Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Rebecca Ohman, MD
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Rebecca Ohman-Hanson

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: July 21, 2017
• Primary Completion: March 13, 2021
• Study Completion: March 13, 2021
• Last Updated: May 10, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)