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NCT07421518 · ClinicalTrials.gov registry record · Phase 2
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors
A Phase 2 study, sponsored by AdventHealth Translational Research Institute.
- Not yet
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT07421518: Clinical Trial Phase 2 study, sponsored by AdventHealth Translational Research Institute.
NCT07421518 is a Phase 2 study that has not yet begun recruiting, run by AdventHealth Translational Research Institute. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07421518, a Phase 2 study, has not yet begun recruiting, sponsored by AdventHealth Translational Research Institute.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). This special education plan is compared to a general education plan and considers the higher risk of DKA when using medicines like SGLT2 inhibitors.
Primary Outcome
Number of ketone events with BOHB \> 1.5 mmol/L for 15 consecutive minutes, as measured by the DGK. The event will end when BOHB is \< 1.5 for 15 consecutive minutes. These events will be measured during the risk mitigation phase (Period 3 and Period 4) of the study.
Interventions
- DRUG SGLT-2 inhibitor (Sotagliflozin)
- OTHER Insulin withdrawal test (IWT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2026-06 |
| Est. Completion | 2030-04 |
| Phase | Phase 2 |
What is known before NCT07421518 opens enrollment
NCT07421518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which SGLT-2 inhibitor (Sotagliflozin) is the first listed.
NCT07421518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07421518 about?
NCT07421518 is a clinical study titled "Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors". The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2...
What is the current status of trial NCT07421518?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2026-06. Estimated completion is 2030-04.
What interventions are being tested in trial NCT07421518?
The interventions under investigation include: SGLT-2 inhibitor (Sotagliflozin) (DRUG), Insulin withdrawal test (IWT) (OTHER).
Who is sponsoring clinical trial NCT07421518?
This trial is sponsored by AdventHealth Translational Research Institute, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07421518's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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