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Clinical Trial Details

Trial ID: L2155
Source ID: NCT06753994
Associated Drug: Sglt-2 Inhibitor
Title: Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors
Acronym: EmpaCKM
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes|Type1diabetes|T1D
Interventions: DRUG: SGLT-2 inhibitor
Outcome Measures: Primary: Number of events ≥ 0.6 mmol/L, ≥ 0.8 mmol/L ≥ 1.5 mmol/L, ≥ 3.0 mmol/L that last for more than one hour, Number of events at each range that last for more than one hour. This will be compared between i) each study period (run-in, 2.5 mg, 10 mg etc) and ii) the first week and the remaining weeks for each study period, 17 weeks | Other: Beta-hydroxybutyrate level (mmol/L), Mean, median, standard deviation and Coefficient of variation (mean/standard deviation): 24-hour, daytime (6h00-24h00), and night-time (24h00-6h00). This will be compared between each study period (run-in, 2.5 mg, 10 mg etc) and ii) the first week and the remaining weeks for each study period, 17 weeks|Time spent above various thresholds of beta-hydroxybutyrate concentrations:, ≥ 0.3 mmol/L, ≥ 0.6 mmol/L, ≥ 0.8 mmol/L ≥ 1.5 mmol/L, ≥ 3.0 mmol/L, 17 weeks
Sponsor/Collaborators: Sponsor: McGill University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-12-05
Completion Date: 2027-01-01
Results First Posted:
Last Update Posted: 2024-12-31
Locations: Hygea Medical Clinic, Montreal, Quebec, H4A 3J1, Canada
URL: https://clinicaltrials.gov/show/NCT06753994