Status:
RECRUITING
Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Diabetes Canada
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this 26-week multicenter, randomized, parallel, placebo-controlled trial is to test the effectiveness of empagliflozin use in conjunction with automated insulin delivery (AID) to improve g...
Eligibility Criteria
Inclusion
- Individuals ≥ 18 years of age.
- A clinical diagnosis of type 1 diabetes for at least one year, as per the investigators' clinical judgment (confirmatory C-peptide and antibodies will not be required).
- Minimum 3-month use of a commercial advanced AID system.
- Time in range (3.9 to 10.0 mmol/L) \< 70% on their personal AID system in the 30 days prior to screening (with minimum 70% time spent in closed-loop mode).
- Agreement to use a highly effective method of birth control for individuals of child-bearing age and active avoidance of pregnancy during the trial. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a disclosed medical condition causing sterility (ex: hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.
Exclusion
- Current or ≤ 2 week use of any anti-hyperglycemic agent other than insulin (such as SGTL2i).
- Current or ≤ 1 month use of Glucagon-like Peptide 1 (GLP1)-Receptor Agonists.
- Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.
- Planned or ongoing very low carbohydrate diet (\< 50g/day).
- Glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as per CKD-EPI formula with creatinine levels measured within the last 12 months.
- Use of hydroxyurea.
- Planned or ongoing pregnancy.
- Breastfeeding.
- Ongoing active risk of recurrent genito-urinary infections, as per the clinical judgement of the investigators.
- Severe hypoglycemic episode within 1 month of screening, defined as an event resulting in seizure, loss of consciousness, or need to present to the emergency department.
- Diabetic ketoacidosis within 6 months of screening, defined as an event requiring the need to present to medical attention and administration of intravenous insulin.
- Any serious medical illness likely to interfere with the ability to complete the trial per the judgment of the investigators.
- Clinically significant retinopathy as judged by the investigator.
- Recent (\< 3 months) acute macrovascular event (ex: acute coronary syndrome or cardiac surgery).
- Prior serious reaction to SGLT2i.
- Use of the Medtronic 670G or 770G system in the last 30 days.
- In the opinion of the investigator, inability to observe the contraindications of the study drugs, or failure to comply to the study protocol or research team's recommendations (e.g., changing pump parameters, ketone measurements).
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06021145
Start Date
April 2 2024
End Date
May 1 2025
Last Update
August 9 2024
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1