IA Trial Radar | ||
|---|---|---|
L'essai clinique NCT06753994 (EmpaCKM) pour Diabète, Diabète de type 1, T1D est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Université McGillContinuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors (EmpaCKM) Phase I 24 Diététique Exercice Novateur
Continuous Ketone Monitoring in Participants With Type 1 Diabetes (T1D) Using SGLT2 Inhibitors as Adjunctive Therapy
- EmpaCKM
- 2024-0807
Continous Ketone Monitoring
Empagliflozin
SGLT2i
SGLT2 inhibitors
Sodium-glucose cotransporter-2 inhibitors
Low-carb
Exercise
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalSGLT2 inhibitor dose scalation to maximum tolerated dose with Continuous Ketone Monitor This is a single arm study where 24 participants with T1D will use a CKM for a 4-week run-in followed by empagliflozin 2.5 mg for four weeks then empagliflozin 10 mg for nine weeks. Participants will perform an exercise sub-study during the fourth week of the CKM run-in and during the eighth week of empagliflozin 10 mg use. Certain participants will be invited to undergo a low-carb diet during the last week of empagl...Afficher plus | SGLT-2 inhibitor Empagliflozin is an SGLT2i that aids in blood glucose reduction through the urination of excess glucose in the context of hyperglycemia. In this study, participants will start with a dose of 2.5 mg of empagliflozin for four weeks, which will then be increased to 10 mg for the following nine weeks. |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Adults ≥ 18 years old.
A T1D diagnosis for at least one year, as per their treating physician in agreement with the investigator's judgment (confirmatory C-peptide and antibodies will not be required).
HbA1c level of < 11% within the last six months.
Current use of intensive insulin therapy, either multi-daily injection or closed-loop insulin pump therapy, with no plan to change during the study.
Current use of CGM, either real-time or intermittent.
Active avoidance of pregnancy during the trial, which includes effective contraception for any individuals of childbearing potential, who are sexually active.
Ability to consume an average of more than 50 g of carbohydrates per day.
Use of a compatible phone to allow for download of the CKM sensor application.
DKA or severe hypoglycemia within the last six months.
Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).
Current or ≤ one-month use of supraphysiological doses of glucocorticoids.
Body mass index < 20 kg/m2.
Glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as per CKD-EPI formula with creatinine levels measured within the last two months.
Université McGill239 essais cliniques actifs à explorerQuebec