| Trial ID: | L5190 |
| Source ID: | NCT05541484
|
| Associated Drug: |
Sglt2 Inhibitor
|
| Title: |
Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT05541484/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: SGLT2 inhibitor|DEVICE: Biosense Breath Ketone Analyzer
|
| Outcome Measures: |
Primary: Capillary Blood Beta-hydroxybutyrate (BOHB) During Outpatient Care, Differences between usual care v dapagliflozin of capillary beta hydroxybutyrate (BOHB) measurements during outpatient care., Measurements were taken 2-3 times daily for 2 weeks|Breath Acetone (BrACE) During Outpatient Care, Differences of breath acetone (BrACE) measurements between usual care v dapagliflozin during outpatient care., Measurements were taken 2-3 times daily for 2 weeks | Other: Ketone Levels in Persons With T1D Undergoing Insulin Withdrawal, Comparison of ketone levels (BOHB and BrAce) during insulin withdrawal after usual care and during insulin withdrawal after usual care plus treatment with an SGLT2i., 2 days
|
| Sponsor/Collaborators: |
Sponsor: Washington University School of Medicine | Collaborators: Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2022-10-14
|
| Completion Date: |
2023-12-23
|
| Results First Posted: |
2025-02-21
|
| Last Update Posted: |
2025-02-21
|
| Locations: |
Washington University, Saint Louis, Missouri, 63110, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05541484
|
