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KETO-TRACK: Ketone Alert Thresholds for Dapagliflozin in T1D
NCT07225465Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2026
- Primary completion
- Feb 2028
- Countries
- 1
- Sponsor
- St Vincent's Hospital Melbourne
- Modality
- Small Molecules
- Drugs
- dapagliflozin
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 2, randomised, open-label trial of dapagliflozin in type 1 diabetes mellitus (T1D) (2 arms), sponsored by St Vincent's Hospital Melbourne. Primary endpoints: Percent time spent with interstitial ketones ≥3.0mmol/L at 12 weeks and Percent of time spent with interstitial ketones ≥3.0mmol/L during exercise. Planned start Feb 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
DGK threshold 1.0mmol/L
Dapagliflozin 10mg/day + Ketone alerts at 1.0 mmol/L
DGK threshold 1.5mmol/L
Dapagliflozin 10mg/day + Ketone alerts at 1.5 mmol/L
03
Who it enrols
Adults with T1D for >1 year, on insulin (>0.4 U/kg/day), HbA1c <10%, eGFR >=30, consuming >100g carbs/day. Excludes recent DKA, pregnancy, low carb diet, recent SGLT2 use, and certain medications.
04
Endpoints
Primary
Percent time spent with interstitial ketones ≥3.0mmol/L
Percent of time spent with interstitial ketones ≥3.0mmol/L during exercise
Secondary
Percent of time with ketone levels in different ranges
Mean interstitial ketone levels
Incidence of diabetic ketoacidosis (DKA)
Change in HbA1c
CGM metrics
Change in weight
Change in BMI
Change in treatment satisfaction using Diabetes Medication System Rating Questionnaire - Short form
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