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NCT03107208 · ClinicalTrials.gov registry record · Phase 4
Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
NCT03107208: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT03107208 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 61 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03107208, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Glargine
- DEVICE Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2017-07-21 |
| Est. Completion | 2021-03-13 |
| Phase | Phase 4 |
What the finished NCT03107208 record still lists
NCT03107208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Glargine is the first listed.
NCT03107208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03107208 about?
NCT03107208 is a clinical study titled "Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes". 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-...
What is the current status of trial NCT03107208?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2017-07-21. Estimated completion is 2021-03-13.
What interventions are being tested in trial NCT03107208?
The interventions under investigation include: Glargine (DRUG), Continuous Glucose Monitor (Abbott FreeStyle Libre Pro) (DEVICE).
Who is sponsoring clinical trial NCT03107208?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03107208's enrollment target sits among peer trials
61 1119th of 2000 higher than 876 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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