At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 21 enrolled
Drug / intervention
SGLT2 inhibitor +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.
Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency
In Brief
A Phase 4 clinical trial evaluating SGLT2 inhibitor and Biosense Breath Ketone Analyzer for Diabetes Mellitus, Type 1. Completed, enrolled 21 participants across 1 site.
Detailed Summary
This proposed study will test whether measurement of breath acetone (BrAce) can be used for the purpose of identifying ketosis (elevated ketones) in persons with type 1 diabetes (T1D). This is important for the potential use of sodium glucose co-transport inhibitors (SGLT2i) in persons with T1D.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation
Timeline
Phase 4CompletedFinished
2023202420252026
First PostedSep 2022
Enrollment StartOct 2022
Primary CompletionDec 2023
TodayJul 2026
First PostedSep 15, 2022
Enrollment StartOct 14, 2022
Primary CompletionDec 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.8 years ago
Interventions
SGLT2 inhibitordrug
See above.
Biosense Breath Ketone Analyzerdevice
The hand-held device tests ketones in exhaled breath