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Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency

NCT05541484 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-02-21

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

SGLT2 inhibitor

See above.

DEVICE

Biosense Breath Ketone Analyzer

The hand-held device tests ketones in exhaled breath

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Janet B McGill, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2023-12-23
Completion
2023-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05541484 on ClinicalTrials.gov