Actively Recruiting
Continuous Ketone Monitoring in Participants With Type 1 Diabetes Using SGLT2 Inhibitors as Adjunctive Therapy
Led by McGill University · Updated on 2024-12-31
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Type 1 diabetes is an autoimmune condition where the body attacks insulin-producing cells, leading to high blood sugar and a lifelong need for insulin therapy. This study focuses on people with type 1 diabetes using empagliflozin, a sodium/glucose cotransporter 2 inhibitor that lowers blood sugar but may raise ketone levels, risking diabetic ketoacidosis. Researchers aim to understand ketone level patterns during various activities and diets while using empagliflozin. Participants will take part in a single-arm study using continuous ketone monitoring for a 4-week run-in period, followed by empagliflozin 2.5 mg daily for four weeks and then 10 mg daily for nine weeks. During the study, participants will engage in an exercise sub-study during the run-in and at the higher dose stage. Some participants will also follow a low-carbohydrate diet near the study's end. Throughout the trial, 24 adults with type 1 diabetes will have their ketone levels continuously monitored, alongside their insulin therapy and glucose control. Researchers will track the frequency and duration of elevated ketone events and observe responses to exercise and diet changes. This study aims to develop new ketone thresholds and provide data to support safe empagliflozin use in type 1 diabetes over time.
CONDITIONS
Brief Title
Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with type 1 diabetes for at least one year as determined by a physician
- HbA1c level less than 11% within the last six months
- Currently using intensive insulin therapy via multiple daily injections or closed-loop insulin pump with no planned changes
- Currently using continuous glucose monitoring (real-time or intermittent)
- Willing to actively avoid pregnancy during the trial with effective contraception if applicable
- Able to consume an average of more than 50 grams of carbohydrates per day
- Have a compatible phone to download the continuous ketone monitoring sensor application
You will not qualify if you...
- Experienced diabetic ketoacidosis or severe hypoglycemia within the last six months
- Current or recent use of any anti-hyperglycemic agents other than insulin (within one month for GLP1-RA, within one week for others)
- Current or recent use (within one month) of high doses of glucocorticoids
- Body mass index less than 20 kg/m2
- Estimated glomerular filtration rate below 30 mL/min/1.73 m2 measured within the last two months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants use a continuous ketone monitor (CKM) for 4 weeks to establish baseline ketone levels.
Duration - 13 weeks
Participants take empagliflozin 2.5 mg daily for 4 weeks, followed by 10 mg daily for 9 weeks while continuing CKM use. Some participants may undergo an exercise sub-study and a low-carb diet during this period.
Trial Site Locations
Total: 1 location
1
Hygea Medical Clinic
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
L
Linden Perz, Bachelor of Medical Sciences
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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