Using empagliflozin with automated insulin delivery for better glucose control in type 1 diabetes
Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes: a Randomized Controlled Parallel Trial
This study is testing if adding empagliflozin to the daily routine of adults with type 1 diabetes using an automated insulin delivery system can help them better control their blood sugar levels.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06021145 on ClinicalTrials.gov |
What this trial studies
This 26-week multicenter, randomized, parallel, placebo-controlled trial aims to evaluate the effectiveness of empagliflozin in improving glucose control for adults with type 1 diabetes who are not achieving optimal glycemic outcomes. Participants will either receive 2.5 mg of empagliflozin or a placebo daily while continuing their current automated insulin delivery (AID) system. The primary focus is to determine if empagliflozin can increase the time spent in the target glucose range of 3.9 to 10.0 mmol/L compared to placebo. The study will involve individuals who have been using an AID system for at least three months and have a history of suboptimal glycemic control.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 1 diabetes who have been using an AID system for at least three months and have not met glycemic targets.
Not a fit: Patients currently using other anti-hyperglycemic agents or those who have not been on an AID system for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glucose control and overall health outcomes for patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where this trial is running
Montreal, Quebec
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Melissa-Rosina Pasqua, MD — Research Institute of the McGill University Health Centre
- Study coordinator: Adelyn Moore
- Email: adelyn.moore@mail.mcgill.ca
- Phone: (438) 866-4807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.