CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Glargine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03107208
NCT03107208Phase 4Completed
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Management of Diabetic Ketoacidosis in Children: Does Early Glargine Prevent Rebound Hyperglycemia?

University of Colorado, Denver·interventional·Posted Apr 11, 2017·Updated May 10, 2022

In Brief

A Phase 4 clinical trial evaluating Glargine and Continuous Glucose Monitor (Abbott FreeStyle Libre Pro) for Diabetic Ketoacidosis and Type 1 Diabetes Mellitus. Completed, enrolled 61 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Ketoacidosis, Type 1 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 11, 2017
Enrollment StartJul 21, 2017
Primary CompletionMar 13, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.2 years ago

Interventions

Glarginedrug

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

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.